Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Colitis

Colitis, Ulcerative

Ulcer

Cholangitis

Cholangitis, Sclerosing

Gastroenteritis

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Bile Duct Diseases

Biliary Tract Diseases

Primary Sclerosing Cholangitis

Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.

Patients with chronic ulcerative colitis and known dysplasia or cancer.

Christopher J Gostout, MD

This study is being done to:

To attempt to increase the detection of precancerous colon tissue in patients with chronic ulcerative colitis and primary sclerosing cholangitis;

To determine if an investigational scope that can look at the lining of the colon in different ways will help the doctor identify abnormal tissue in patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis; and

To determine if this investigational scope can accurately detect precancerous or cancerous tissue in patients with chronic ulcerative colitis that are known to have had cancerous or precancerous tissue in the past.

Patients with concurrent chronic ulcerative colitis and primary sclerosing cholangitis or patients with chronic ulcerative colitis and known colorectal dysplasia or cancer, presenting for surveillance colonoscopy will be recruited. After giving informed consent patients will then undergo colonoscopy in a segmental fashion. Colonoscopy with white light will be performed to the cecum and examination will be performed on withdrawal. First conventional white light will be used to examine the cecum and ascending colon and random biopsies will be obtained. All endoscopically apparent lesions will be biopsied separately. Immediately following will be examination of that segment of cecum and ascending colon under AFI first, then NBI with targeted biopsies of suspicious areas being taken. The AFI and NBI modality will be achieved by simply flipping a switch.. If necessary, washing of oozing blood from random biopsy sites will be performed., The remainder of the colon will be assessed in like fashion: transverse, descending and rectosigmoid. Because high definition endoscopy is the default modality, this will be in use throughout the procedure.

All lesions detected will be documented and biopsied for a maximum of four biopsies per suspicious lesion. Note will be taken of which modality resulted in visualization of the lesion. Data on the factors under study will be collected: i) disease type (CUC + PSC or CUC with known dysplasia), ii) Age, iii) Sex, iv) length of time with disease, v) extent of disease, vi) the interaction between iv and v will be collected. In addition, dysplasia yes/no will be established after biopsy histology is established and the modality under which abnormalities were observed will also be recorded.

Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis

A Blinded Comparison of Conventional Colonoscopy to Endoscopic AFI and NBI for Dysplasia Detection in Patients With Ulcerative Colitis and Sclerosing Cholangitis or Known Colorectal Dysplasia or Cancer- A Pilot Clinical Study

Mayo Clinic

Neoplasms

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Keratosis, Actinic

Keratosis

Lichen Planus, Oral

Lichen Planus

Mouth Neoplasms

Mouth Diseases

Leukoplakia

Leukoplakia, Oral

Skin Diseases

Precancerous Conditions

Lichenoid Eruptions

Exanthema

Skin Diseases, Papulosquamous

Head and Neck Neoplasms

Stomatognathic Diseases

Pathological Conditions, Anatomical

Oral Cancer

Lip and Oral Cavity Cancer

Oral Leukoplakia

All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.

After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".

Screening examination

Luca Ramaglia

The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.

Tissue autofluorescence analysis will be performed using GOOCLES® glasses, a device capable of detecting variations in fluorescence when the examined area is illuminated with a common photopolymerising lamp. Three clinical professionals will be identified:

* Dental hygienist (1);
* General dentist (2);
* Dentist expert in Medicine and Oral Pathology (3).

All patients will be included in the study after receiving an initial dental visit, in order to rule out patients with noticeable oral lesions.

Dental hygienist (1) will collect the patient's data by filling the "anamnestic record". Furthermore, (1) will perform the first clinical examination (with and without GOOCLES®), reporting his observations on his own "operator module".

The same screening (with and without GOOCLES®) will be conducted blindly by the general dentist (2) who, if he deems it necessary, will refer the patient to the oral pathologist (3), who will confirm or not (with and without GOOCLES®) the presence of an oral region such as to be further investigated (follow up or biopsy) and will report the observations on its own "operator module".

Inter-operator and intra-operator comparisons will be performed and the data thus obtained will be processed for statistical processing.

The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.

Identification of Oral Lesions Through an Autofluorescence System

Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions

Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance

Presence of a mucosal area with reduced or increased fluorescence

Federico II University

Clinical Professor

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Coagulants

Fibrinolytic Agents

Anticoagulants

Vitamins

Anesthetics

Acetic Acid

Retinol acetate

Tolonium Chloride

Hemostatics

Heparin

Calcium heparin

73 patients are to be recruited from the ones that go to the oral medicine service at the university clinic of Rey Juan Carlos in Madrid that present a compatible clinic diagnostic compatible with oral potentially malignant disorders. Each patient will receive first an intraoral exploration, taking note of location and size of the injury. After that, an exploration with the GOCCLES® device will be made, also taking note of the location and size data. Thereafter, the blue toluidine stain will be used, taking note of the size and location of the marked areas. Pictures will be taken through all the steps. Finally, a biopsy will be made of the area or areas the clinic considers and/or marked by the device or the toluidine blue.

Inspection using GOCCLES®. An UV light source will be administered, with polymerization lamp sdi radii xpert, with a potency of 1500 mW/cm2 and a wavelength of 440-480nm, applied at 20cm of the injury.

Notes will be taken on the location and size of the injury observed with the device.

Image register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.

GOCCLES

To value the toluidine blue diagnosis capacity, the sequence described by Mashberg will be followed: The patient will realize a mouthwash with acetic acid at 1% for 20 seconds. Two using water for 20 seconds. Toluidine blue at 1% will be applied for 20 seconds. New mouthwash with acetic acid for 60 seconds and a final mouthwash with water.

Notes on the and pictures will be taken on the location and size of the injury.

Toluidine blue stain

The area to biopsy will be chosen, and, using local anaesthesia, it will be resected. The specimens will be sent to the oral and maxillofacial pathology diagnostic service of the University of Basque Country for anatomopathological study

Biopsy

Rocío Teresa Martín Muñoz

María Victoria Fuentes Fuentes

Antonio Francisco López Sánchez

Blanca del Carmen Migueláñez Medrán

Jesús Rodríguez Molinero

Oral potentially malignant disorders (OPMDs) are chronic pathologies which can suffer dysplastic alterations and evolve into oral cancer.

The diagnosis of those pathologies is commonly done by visual inspection, which is not capable of determining the presence or not of dysplasia. Furthermore, this type of diagnosis depends greatly on the expertise and training of the professional.

In recent years, new methods that can help early oral cancer diagnosis have been developed. A new device has been commercialized, named GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), based on the autofluorescence principle.

The hypothesis of this study is that GOCCLES® device could be an effective tool to help in early detection of oral cancer.

The main objective of this study is to establish GOCCLES® autofluorescence method predictive value in early diagnostic of malignant oral disorders and/or potentially malignant oral cavities.

The secondary objectives are comparing the match in zone detection between this method and blue toluidine staining, and valuing if blue toluidine staining brings additional information to the dysplastic injuries diagnoses when combined to the GOCCLES® device.

This study will follow the STARD (Standards for Reporting of Diagnostic Accuracy Studies) guideline.

It is intended to recruit 73 patients from the oral medicine service at the university clinic of Rey Juan Carlos University in Madrid, that present a compatible clinic diagnostic with oral potentially malignant disorders. Each patient will receive first an intraoral exploration, taking note of location and size of the injury. After that, an exploration with the GOCCLES® device will be made, also taking note of the location and size data. Thereafter, the blue toluidine stain will be used, taking note of the size and location of the marked areas. Pictures will be taken through all the steps. Finally, a biopsy will be made of the area or areas the clinic considers and/or marked by the device or the toluidine blue.

DETAILED PROCEDURE:

1. Specific location of the injury or injuries will be taken.
2. Its maximum size will be measured.
3. Photographic record with Canon EFS 60mm camera and Canon Macro Ring Lite MR-14EX ring flash.
4. Inspection using GOCCLES®. An UV light source will be administered, with Sdi Radii Xpert polymerization lamp with a potency of 1500mW/cm2 and a wavelength of 440-480nm, applied at 20cm of the injury.
5. Notes will be taken on the location and size of the injury observed with the device.
6. Image register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.
7. To value the toluidine blue diagnosis capacity, the sequence described by Mashberg will be followed: The patient will realize a mouthwash with acetic acid at 1% for 20 seconds. Two using water for 20 seconds. Toluidine blue at 1% will be applied for 20 seconds. New mouthwash with acetic acid for 60 seconds and a final mouthwash with water.
8. Notes on the and pictures will be taken on the location and size of the injury.
9. The area to biopsy will be chosen, and, using local anaesthesia, it will be resected.
10. The sample or samples will be sent to the Oral and Maxillofacial Pathology Diagnostic Service of the University of the Basque Country, properly preserved in formalin and with the corresponding report.
11. In addition, the following data of each patient will be registred: age, sex, harmful habits, medical history of interest, type of injury, location of the injury, size of the injury and presumptive diagnosis.

If the area chosen by the investigator as the most adequate one matches the one referred by the GOCCLES® glasses and the toluidine blue, only one biopsy will be made. Otherwise, two or three samples will be taken. The patient will be called after 7-15 days, to receive the results and the retiring of the suture if required, and to start treatment in cases which it is needed.

A lesion will be considered positive if, when using GOCCLES® device, a loss of fluorescence is observed in an area or areas of the lesion, that is, when a brownish, brown or dark brown area or areas are observed.

A lesion will be considered to be positive for toluidine blue staining when, after carrying out the sequence described by Mashberg, an intense blue staining is produced in an area or areas of the lesion

A positive result will be considered after performing biopsy in those cases in which the anatomopathological analysis indicates the presence of dysplasia, whatever its grade, or the presence of malignant transformation.

Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders

Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders

Intraoral examination of the injury with white light. Information about location will be recorded in a data collection document, individual for each patient.

Intraoral examination of the injury with white light. The size of the injury will be measured with an acetate rule. This information will be recorded in a data collection document, individual for each patient.

Photographs of the lesion will be recorded with a Canon EFS 60 mm camera and Canon Macro Ring Lite MR-14EX ring flash

An UV light source will be administered, with polymerization lamp sdi radii xpert, with a potency of 1500 mW/cm2 and a wavelength of 440-480nm, applied at 20cm of the injury. Notes will be taken on the location and size of the injury observed with the device.

Image register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.

For this procedure, Mashberg technique will be realised. The patient will realize a mouthwash with acetic acid at 1% for 20 seconds. Two using water for 20 seconds. Toluidine blue at 1% will be applied for 20 seconds. New mouthwash with acetic acid for 60 seconds and a final mouthwash with water. Information about location and size of the stained area will be recorded in the data collection document. Photographs will be taken with the Canon EFS 60mm camera and Canon Macro Ring Lite MR-14EX ring flash.

The area to biopsy will be chosen, and, using local anaesthesia, it will be resected. If the area chosen by the investigator as the most adequate one matches the one referred by the GOCCLES® glasses and the toluidine blue, only one biopsy will be made. Otherwise, two or three samples will be taken.

Universidad Rey Juan Carlos

Bachelor of Dentistry and Specialist in Oral Medicine

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Hypoparathyroidism

Endocrine System Diseases

Endocrine Gland Neoplasms

Parathyroid Diseases

Parathyroid Hormone

Patients randomized to the experimental group will have surgery performed in the exact same manner as in the control group.

In the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize PGs during surgery. The surgeon will use AF at minimum two timepoints on each side of the neck: First, when the thyroid lobe is exposed and mobilized, and secondly after removal of the thyroid lobe. This is repeated in the contralateral side of the neck in case of TT. If a central neck dissection is performed, the specimen is also examined with AF following removal. Autotransplantation of inadvertently removed PGs may be performed after frozen section histology.

In the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize parathyroid glands during surgery.

Surgery with autofluorescence

Jacob Kinggaard Lilja-Fischer, MD

Lars Rolighed, MD, PhD

The study aims to test if use of autofluorescence imaging (AF) reduces the risk of developing hypoparathyroidism (hypoPT) following surgery for thyroid cancer, either total thyroidectomy (TT) or completion hemithyroidectomy (cHT).

Purpose The study aims to test if use of autofluorescence imaging (AF) reduces the risk of developing hypoparathyroidism (hypoPT) following surgery for thyroid cancer, either total thyroidectomy (TT) or completion hemithyroidectomy (cHT).

Background The mainstay of treatment of thyroid cancer is surgery. Many patients will need only surgery with removal of one half of their thyroid gland, a hemithyroidectomy (HT), while others will need to have all of the thyroid gland removed.1 This may be done in one procedure, a total thyroidectomy (TT), or in two procedures with a completion hemithyroidectomy (cHT) after an initial HT. The indication for complete removal of the thyroid gland, may be to remove all cancer tissue, to facilitate adjuvant treatment with radioactive iodine, or both.

Following adequate treatment, overall prognosis is very favorable, with a 3-year overall survival of 98% for all Danish patients diagnosed in 2018.2 Thus, a major point of attention is to minimize treatment-related morbidity, and enable cancer survivorship with as few late-effects as possible.

Surgery for thyroid cancer comes with general surgical risks of bleeding and infection, and specific for thyroid surgery is the risk of injury to nerves to the larynx, which is relatively rare, below 5%. Hypothyroidism is obligatory after TT/cHT, and is seen in 10-15% after HT.

Specific to patients after TT/cHT is damage to the parathyroid glands (PGs), which leads to hypoparathyroidism (hypoPT).

HypoPT is generally thought to be an avoidable surgical complication, but nonetheless it is relatively frequent after surgery for thyroid cancer, depending on the definition applied.3-5 Only patients who have a TT or cHT are at risk of developing hypoPT, since the two contralateral PGs will not have been disturbed and HT is generally not associated with hypoPT.

HypoPT may be transient, but is often permanent. Chronic hypoPT leads to lifelong need for medical surveillance and treatment, and is often difficult to treat. It comes with a risk of health complications (renal and neuropsychiatric), is frequently symptomatic (often cognitive and neuromuscular), and leads to decreased quality of life.6 Thus, there is a need to decrease the risk of hypoPT after surgery for thyroid cancer. Further, due to the favorable prognosis and relatively young age of patients, any improvement will lead to a substantial gain in years lived without complications for each patient, and decreased medical spending for society as a whole. Recently, the national guidelines have been revised to reduce the number of patients who will need TT/cHT and thus be at risk of hypoPT, but still there is a substantial burden of morbidity that needs to be reduced.

Avoidance of hypoPT mainly lies with the surgeon's experience and skills, since identification and preservation of PGs may be very difficult, due to their small size and delicate structure. Identification of PGs is visual, and depends on the surgeon's knowledge of their usual position in relation to the thyroid gland. In the setting of advanced thyroid cancer, preservation of PGs may be extremely difficult, since removal of the primary tumor and metastases adjacent to the PGs is the overwhelming priority.

Recently, it has been discovered that PGs possess unique autofluorescent properties, in that the tissue will return light in a specific wavelength after illumination with infrared light of a specific wavelength. This autofluorescence (AF) may be observed with a hand-held camera system during surgery, allowing the surgeon to more easily visualize and identify PGs.7 This could potentially lead to improved preservation of PGs, and thus decreased risk of hypoPT.

Study design The planned trial is a randomized, controlled superiority trial with two parallel arms. The investigators seek to include patients undergoing surgery for thyroid cancer, who are at risk of developing hypoPT as a complication to surgery. Patients will be randomized 1:1 to surgery with or without the added use of AF during surgery.

Study setting and practical conduct The trial is to be conducted at Aarhus University Hospital, in a collaboration between Department of Otorhinolaryngology - Head \& Neck Surgery and Department of Endocrinology. Here, approximately 100 patients undergo surgery for thyroid cancer annually. A further 4-500 patients have thyroid surgery for benign disease, and another approximately 300 patients have surgery for parathyroid disease. Thus, there is a steady high flow of eligible patients, and the hospital as well as the treating surgeons are highly qualified to undertake this study. Autofluorescence imaging with the EleVision IR system is available, and is used ad hoc for thyroid and parathyroid surgery.

Patient flow Patients referred on suspicion of thyroid cancer to the Head and Neck Surgery Clinic at Aarhus University Hospital will be considered for inclusion in the trial. Approximately half of patients with thyroid cancer will need TT or cHT, and will thus be eligible for the trial. The investigators aim to include 110 patients, which should be achievable in approximately two years.

Randomization Following patient consent, an electronic case file will be created in the REDCap electronic data capture tool. Randomization is performed electronically in the dedicated REDCap randomization module.

Randomization will be stratified by TT or cHT.

Intervention Patients randomized to the experimental group will have surgery performed in the exact same manner as in the control group.

In the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize PGs during surgery. The surgeon will use AF at minimum two timepoints on each side of the neck: First, when the thyroid lobe is exposed and mobilized, and secondly after removal of the thyroid lobe. This is repeated in the contralateral side of the neck in case of TT. If a central neck dissection is performed, the specimen is also examined with AF following removal. Autotransplantation of inadvertently removed PGs may be performed after frozen section histology.

Endpoints HypoPT following surgery is defined as hypocalcemia (ionized plasma calcium levels below lower limit of reference, 1,18 mmol/l), with inappropriately low plasma levels of PTH (assessed by 2 separate measurements) necessitating treatment with active vitamin D, as determined by the treating physician.

Deviation from standard treatment All patients, whether randomized to standard or experimental treatment arm, will receive treatment according to national clinical guidelines published by the Danish Thyroid Cancer Group (DATHYRCA).1 The extent of surgery will be exactly the same in either group, and will not deviate from standard treatment.

Sample size The investigators estimate that the rate of hypoPT requiring medical treatment in the control group will be approximately 30%. A reduction to 10% will be clinically significant, and statistically significant at α=0.05 with a power of β=0.8 with inclusion of 98 patients. To allow for dropouts, the investigators aim to include 110 patients, which should be achievable in approximately two years.

Interim analysis The investigators plan to perform an interim analysis after inclusion of 50 patients with available data on the primary endpoint. The trial may be terminated if the investigators are able to show that it would be highly unlikely to reach the primary endpoint. This may be due to no effect of the intervention, or a lower than expected risk of hypoPT in the control group. Both scenarios would make it highly unlikely to reach the primary endpoint of the study.

Statistical analysis plan For the primary endpoint, relative risk for hypoPT will be calculated along with its associated 95% confidence interval, and a p-value will be calculated from a chi2-test. The investigators will provide a crude estimate, as well as adjusted for operating surgeon, or suspicion of lymph node metastases on imaging and/or planned neck dissection.

For secondary endpoints, a similar analysis will be performed for categorical data (Permanent hypoPT; extent of surgery; complications). Continuous data (ioPTH reduction, time to resolution of hypoPT, number of days hospitalized) will be described and analysed using a t-test, or ranksum test in case of non-normal data. Survival endpoints will be described by a hazard ratio with 95% confidence interval.

Patient characteristics, including demographics, disease status and treatment will be characterized using descriptive statistics only.

Risk, side effects and disadvantages Use of AF during surgery involves nothing but 2 to 5 minutes of illumination of the surgical field with infrared light through a hand-held camera, which displays an image on a monitor in which the infrared wavelengths are converted to wavelengths visual to the human eye. The potential effect of use of AF in thyroid cancer surgery is to make the surgeon more aware of the PGs, and thus incite the surgeon to change his/her strategy in a more patient-safe direction.

Illumination of the surgical field with infrared light has no biological effect, cannot be felt, and poses no danger to the patient. Thus, the intervention should not lead to discomfort or pain, has no known side effects and would not pose a risk to the patient.

Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism

Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism - a Randomized, Controlled Trial

Pseudonymized IPD may be shared for meta-analysis, if IRB approval is granted.

Number of parathyroid glands (PGs) and lymph node metastases identified.

Central neck dissection, lateral neck dissection, autotransplantation of PGs.

Bleeding, infection, recurrent nerve palsy, serious adverse events.

Description of AF pattern of tissue during central neck dissection / exploration, specifically with regards to lymph nodes, lymph node metastases and PGs.

Surgeons assessment of identified parathyroid glands with or without autofluorescence.

Proportion of patients who develop transient or permanent hypoPT requiring medical treatment with active vitamin D. HypoPT is diagnosed and treated according to protocol.

Proportion of patients who develop permanent hypoPT.

PTH is measured before start and immediately after surgery.

Number of days hospitalized during first 30 days after surgery.

Overall survival. Disease-free survival. Disease- and hypoPT-free survival.

Aarhus University Hospital

Bone Density Conservation Agents

Hormones

Calcium

Calcium, Dietary

Patients that participate in this study will always receive standard care. For the purpose of this study, the camera settings (i.e. camera distance to the operating field, switching of OR-lights, and angle of the camera on the operating field) and ICG-protocol (i.e. dose, injection speed) will be standardized among the participating centers in order to generate an homogeneous data set for quantification of the fluorescence signal intensity.

Fluorescence imaging of the parathyroid glands of children

Daniël van de Berg, MD

Joep Derikx, MD, PhD

The aim of this study is to develop a standardized and user-independent imaging workflow model for autofluorescence and quantified fluorescence angiography with Indocyanine Green (ICG) of the parathyroid glands of children. For this purpose, all pediatric patients will undergo thyroid surgery with the use of autofluorescence and quantified ICG-fluorescence.

This study could be the first step in reducing the rate of postoperative hypocalcemia in children, by using fluorescence angiography during pediatric thyroid surgery.

Background:

Children with thyroid cancer have excellent survival rates. However, postoperative hypocalcemia, due to inadvertent excision of the parathyroid glands or damage to their vasculature during thyroid surgery, is a severe complication which occurs in 24% - 67% of the children with thyroid cancer and causes lifelong reduced quality of life and increased morbidity rates. In adults, intraoperative identification of the parathyroid glands with autofluorescence and assessment of their perfusion using quantified ICG-fluorescence angiography has shown to reduce postoperative hypocalcemia. However, in children no studies regarding quantified fluorescence of the parathyroid glands have been conducted. There is a clear need for surgical techniques to identify and preserve the parathyroid glands during thyroid surgery in children.

Therefore, the aim of this study is to develop a standardized imaging workflow model for autofluorescence and quantified ICG-angiography of the parathyroid glands in children. This workflow model can be the first step in reducing the rate of postoperative hypocalcemia in children.

Study design:

This will be a prospective, observational, multicenter, feasibility study. The aim is to generate the patterns of intraoperative autofluorescence and quantified ICG-fluorescence angiography of the parathyroid glands in children, resulting in a user-independent, standardized imaging workflow model for autofluorescence and quantified ICG-angiography of the parathyroid glands of children.

Fluorescence Imaging of the Parathyroid Glands of Children

Fluorescence Imaging for the Detection and Perfusion of the Parathyroid Glands of Children

Request for data sharing will be considered by the project leaders upon written request. Deidentified participant data will be made available after receipt of a written proposal and a signed data sharing agreement. Furthermore, an amendment will be handed in to the MEC for ethical approval before starting this additional research.

Need for (extra) postoperative calcium supplementation

Total duration of the operation in minutes

Any (postoperative) complications, following the Clavien-Dindo classification

Need for autotransplantation of the parathyroid glands by visual assessment (non-fluorescence) of the surgeon

Number and location of autofluorescent parathyroid glands

Quantification of the fluorescent signal of ICG

Stichting Kinderen Kankervrij (KiKa)

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with white light bronchoscopy

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with autofluorescence bronchoscopy

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with narrow band imaged bronchoscopy

The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope and the flexible white light video-bronchoscope. Biopsies are taken of a normal region and all abnormal regions.

Bronchoscopy

Joseph LoCicero, MD

The purpose of the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. The ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique separately and for their combination.

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will be invited to participate in the study. All patients must be over 18 years old and must sign informed consent. The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope (11004BI; Karl Storz; Culver City, CA) and the flexible white light video-bronchoscope (BF-T180; Olympus; Center Valley, PA).

Images obtained will be photographed using both video recordings and parallel images of white light and imaged bronchoscopy. These digital images will be electronically stored and evaluated at a later time. Biopsies will be obtained of all suspected abnormalities. These will be correlated with the images.

Images will be identified as normal, suspect or abnormal based upon each modality independently, paired with the spectral image and all three combined. The control will be an area considered normal by all modes of bronchoscopy. Images will be graded at the time of bronchoscopy. Later, all images will be graded in a blind fashion by two independent bronchoscopists. Standard statistical analysis using paired Student's t test will be applied. We anticipate that the combination of one or more imaged bronchoscopy techniques will increase accuracy by 25%. Power calculation to detect such a difference will require 140 abnormal specimens. If 50% of patients examined have an abnormality, the study population will need to be around 300 patients.

Histopathology reports will be obtained on all specimens. Abnormal results will be discussed with the individual patient and appropriate procedures will be performed based upon best medical practices. These procedures and patient follow-up are beyond the scope of the study.

Endobronchial biopsies of normal and abnormal mucosa for histopathology

Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy

A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy

Antonios Likourezos

Research Administration Director

The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients:

Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland

The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection without autofluorescence device. The following intraoperative variables will be recorded for all patients:

Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands

Theodossis Papavramidis, MD, PhD

Theodosios Papavramidis, Ass.Prof.

Theodosios S Papavramidis, PhD

Ioannis Pliakos, Acad. Fellow

Antonios Michalopoulos, Professor

Angeliki Chorti, Resident

Stavros Panidis, Acad. Fellow

Georgios Kotsovolis, Anesthesiologist

George Tzikos, Resident

Sohail Bakkar, PhD

Ethem Unal, PhD

Sema Yuksekdag, MD

Kadir Yildirak, MD

Kirkan Furkan, MD

The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy with central lymph node compartment dissection.

Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing \[1\]. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons \[1-3\]. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue \[2\].

Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies.

Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal.

The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy with central lymph node compartment dissection. Moreover, we are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.

Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy With Central Lymph Node Compartment Dissection

The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy with central lymph node dissection (TTCC). We will measure the number of parathyroids accidentally excised during TTCC with and without autofluorescence.

If autofluorescence is proved to be a useful tool in endocrine surgeons hands, the preservation of parathyroid glands during thyroidectomy with central lymph node dissection would be easier.

To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with PTH.

To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with Ca.

This study will sign out the disadvantages of FLUOBEAM XS or cases that its use should be avoided.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis	NCT00587236	Colitis, Ulcera... Cholangitis, Sc...		18 Years - 75 Years	Mayo Clinic
Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis	NCT00587236	Colitis, Ulcera... Cholangitis, Sc...		18 Years - 75 Years	Mayo Clinic
Identification of Oral Lesions Through an Autofluorescence System	NCT05942794	Oral Leukoplaki... Autofluorescenc... Secondary Preve... Keratosis Oral Lichen Pla... Oral Cancer Oral Disease	Screening exami...	18 Years - 70 Years	Federico II University
Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders	NCT05562375	Oral Potentiall... Oral Cancer	GOCCLES Toluidine blue ... Biopsy	18 Years -	Universidad Rey Juan Carlos
Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism	NCT06222606	Thyroid Cancer	Surgery with au...	18 Years -	Aarhus University Hospital
Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism	NCT06222606	Thyroid Cancer	Surgery with au...	18 Years -	Aarhus University Hospital
Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders	NCT05562375	Oral Potentiall... Oral Cancer	GOCCLES Toluidine blue ... Biopsy	18 Years -	Universidad Rey Juan Carlos
Fluorescence Imaging of the Parathyroid Glands of Children	NCT05917067	Childhood Thyro... Thyroid Disease...	Fluorescence im...	- 18 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy	NCT00548730	Lung Cancer	Bronchoscopy	18 Years -	Maimonides Medical Center
Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy With Central Lymph Node Compartment Dissection	NCT04339478	Thyroid Cancer Thyroidectomy W...		18 Years -	Aristotle University Of Thessaloniki
Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders	NCT05562375	Oral Potentiall... Oral Cancer	GOCCLES Toluidine blue ... Biopsy	18 Years -	Universidad Rey Juan Carlos
Fluorescence Imaging of the Parathyroid Glands of Children	NCT05917067	Childhood Thyro... Thyroid Disease...	Fluorescence im...	- 18 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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