Neoplasms

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Adenoma

Thyroid Neoplasms

Thyroid Diseases

Pain

Thyroid Nodule

Hyperplasia

Behavior, Addictive

Goiter

Parathyroid Diseases

Parathyroid Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antipyretics

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Antitussive Agents

Respiratory System Agents

Anti-Obesity Agents

Vasoconstrictor Agents

Acetaminophen

Analgesics, Opioid

Tramadol

Narcotics

Parathyroid Hormone

Codeine

Analgesics, Non-Narcotic

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Tylenol (also known as acetaminophen) 1000mg every 6 hours for 3 days and tramadol 50 mg every 6 hours as needed for moderate to severe pain

Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain

non-narcotic medication first with narcotic as second choice

Acetaminophen 500Mg Cap

Tylenol #3 Oral Tablet

Minerva A Romero Arenas, MD, MPH

Samuel K Snyder, MD

Henry A Reinhart, MD

This research is being done to better understand and test if the investigators can minimize narcotic medication for controlling pain after thyroid or parathyroid surgery. This research will be performed at Doctors Hospital At Renaissance in the investigators clinic and the perioperative area.

Participants will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients after surgery. One option includes a narcotic medication and one option includes a non-narcotic and a narcotic as needed.

Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery.

A study team member will give the participant a copy of the informed consent form to read. Participants will have a chance to ask questions about the study before agreeing to participate. If participants agree, they will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients (option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed) after surgery.

Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will come to the GME General Surgery Center approximately one week after surgery for a post-operative visit so that the investigators can see how much pain medication was used and how much pain the participant had in the first few days after surgery.

Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery. It should take approximately 2 minutes each day to complete.

option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed

Minimizing Narcotic Analgesics After Endocrine Surgery

Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery

De-identified information only will be made available to interested researchers.

Patient pain scores will be logged using Wong-Baker FACES pain rating scale (range 0-10) and scores will be assessed for differences between the study arms

The number of days after surgery that participants required pain medications will be counted and assessed for difference between the study arms

The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms

The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed

Minerva A Romero Arenas

Principal Investigator

Nutritional and Metabolic Diseases

Rare Diseases

Hyperparathyroidism

Hyperparathyroidism, Primary

Hypercalcemia

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Primary Hyperparathyroidism

Parathyroid Carcinoma

Dermatologic Agents

Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).

Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).

Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).

After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.

NIRAF Detection Technology

Carmen C Solorzano, MD, FACS

This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Inability of the surgeon to identify or localize the diseased PG can occur in 5 - 10% of cases resulting in failed parathyroidectomies (PTx). As a result, persistent hyperparathyroidism can occur in these patients resulting in unnecessary repeat surgeries that may be associated with increased morbidity and costs. Ultrasound imaging, 99mTechnetium-sestamibi scintigraphy, and computed tomography (CT) have so far demonstrated variable efficacy in preoperative localization of diseased PGs and may not always correlate well with the surgical field of view as observed intraoperatively. Consequently, most surgeons rely on visual identification of PGs during surgery, whereby the accuracy of PG identification is eventually determined by her/his surgical skill and experience. When in doubt, a surgeon routinely confirms the identity of PG tissue intraoperatively by sending the specimen for frozen section analysis that typically requires a wait time of 20-30 minutes per sample and has additional costs.

By easily being able to distinguish parathyroid from other tissues intraoperatively, postsurgical complications and associated costs may be reduced. The unique discovery of near infrared autofluorescence (NIRAF) in parathyroid tissues demonstrated that optical modalities that detect NIRAF can be utilized for non-invasive and label-free identification of parathyroid tissues with an accuracy as high as 97%. Since then, several research groups have explored the feasibility of localizing parathyroid glands using NIRAF detection with reasonable success, resulting in FDA clearance for marketing this optical technique. In this study, we plan to evaluate whether an FDA-cleared device called 'PTeye' (AiBiomed, Santa Barbara, CA) is beneficial or not, for the surgeon and patient during PTx operations. The results of such a study will help us to understand and assess the true impact of optical modalities such as PTeye on (i) improving the quality and efficiency of PTx surgeries and (ii) minimizing risk of postsurgical complications and related expenses.

The aim of this prospective single blinded randomized study is to compare 2 groups of patients: PTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during PTx procedures with regard to PG identification, duration of surgery, number of frozen section analysis performed, number of intraoperative PTH assays sent and incidence of postsurgical complications, if any and history of ER visits or hospitalization or repeat surgeries due to persistent high blood calcium after PTx procedure, compared to standard of care.

NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo parathyroidectomy (PTx) in the interventional group.

Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology).

The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a near infrared (NIR) 785 nanometer (nm) laser source, and also transmits the resulting tissue NIRAF to a photo-detector. The 785 nm laser source emits a maximum power of 20 milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).

Only participants will be masked to the intervention.

Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy

Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Informed Consent Form and Clinical Study Report will be made available to other researchers as per the specified time-frame

Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient

If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month.

Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue

Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient

Number of nights spent for postoperative recovery in the hospital after the surgical procedure.

Number of tissues that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology

Number of patients with repeat PTx procedure performed after the current procedure.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Professor of Surgery Chair, Department of Surgery Director, Vanderbilt Endocrine Surgery

Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).

NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).

After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.

NIRAF Detection Technology +

NIRAF Detection Technology -

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian

Other

Race/Ethnicity, Customized

Non-Hispanic

Hispanic

United States

Region of Enrollment

Body Mass Index (BMI)

Diagnosis

Preoperative calcium (pg/dL)

Preoperative PTH (pg/mL)

Preoperative vitamin D

Procedure by intention

Only 63% of the cohort had follow-up for 6-months or longer, which may underestimate the rate of failure. The relatively small sample size may miss rare events such as operative failure. Additionally, inter-variability amongst the two surgeons and their surgical approaches adds more complexity. Lastly, these findings may only be generalizable to higher volume centers with more experienced surgeons.

Dr. Carmen C Solorzano

Average Number of Parathyroid Glands Identified With High Confidence Per Patient

Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).

Number of Frozen Sections Sent for Analysis

Duration of Parathyroidectomy (PTx) Procedure

Number of Participants Stratified by Duration of Hospital Stay

Only the NIRAF Detection Technology + arm was included in the analysis to calculate the rate of false positives by the device. Since the NIRAF Detection Technology - did not use the device that arm was not included.

Number of 'False Positive' Tissues Excised by Surgeon

Nearly all patients attended their first follow-up appointment (5-14 days post-operation), however about 30 patients were lost for long-term follow-up.

Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure

Overall Study

Occasionally tumors of the parathyroid gland cannot be detected by standard x-ray diagnostic procedures (CT scans, MRIs, and ultrasounds). In order for the tumor to be removed surgically it must first be localized. To do this often requires a procedure known as parathyroid arteriography and parathyroid venous sampling.

This procedure begins by placing a catheter through a blood vessel in the groin. The catheter is then guided through blood vessels to reach the area of the neck. The blood vessels in this region flow in and out of the thyroid and parathyroid. An X-ray dye is then injected through the catheter into the arteries of the thyroid/parathyroid (parathyroid arteriography). The alternative is taking a small sample of the veins found in this same region (parathyroid venous sampling).

Researchers prefer parathyroid arteriography because it causes less discomfort to the patient and requires less experience to do the procedure. However, parathyroid arteriography provides positive results in only 50% of patients undergoing the procedure. Parathyroid venous sampling provides greater amounts of positive results but the readings are often imprecise. Parathyroid tissue secretes a hormone known as PTH (parathyroid hormone). The release of PTH is stimulated by low levels of calcium in the blood.

The idea behind the study is to inject a dye into the area of the parathyroid that will cause a release of PTH. Several parathyroid venous samplings will be taken following the abrupt elevation of PTH. This will provide information on the effectiveness of an intraarterial hypocalcemic stimulus (injection of dye into the arteries of the parathyroid when calcium blood levels are low) and venous sampling as techniques to improve localizing parathyroid tumors.

Although noninvasive diagnostic studies \[ultrasound (US), computed tomography (CT), sestamibi scanning, magnetic resonance imaging (MRI)\] detect parathyroid pathology in one-half the patients referred to NIH with recurrent or persistent hyperparathyroidism (1), the invasive studies (direct aspiration for PTH, arteriography, venous sampling) must be performed in the remaining patients to provide definitive preoperative localization (2). Arteriography is positive in less than half the patients who must then proceed to parathyroid venous sampling, a technique requiring broad experience and yielding positive, but imprecise results as regards localization. The abrupt lowering of calcium in blood perfusing a parathyroid adenoma should stimulate the release of PTH which could be detected by simultaneous venous sampling. This principle, the intraarterial injection of a secretagogue with subsequent sampling for released hormone, has been applied successfully in the localization of insulinomas (3) and gastrinomas (4). In fact, portal venous sampling is no longer performed in this group of patients, having been completely replaced by the intraarterial injection of secretin or calcium as appropriate secretagogues for gastrin and insulin.

Since release of PTH from parathyroid adenomas is stimulated by hypocalcemic perfusions, we propose to perform serial venous sampling from a catheter positioned in the SVC to detect abrupt elevations of PTH following the injection of contrast agent into each of the vessels selectively catheterized at the time of parathyroid arteriography (superior thyroid arteries, thyrocervical trunks, internal mammary arteries). Samples from the SVC catheter will be obtained at 20 second intervals up to one minute and in some patients simultaneous peripheral samples. An elevation of parathyroid hormone 1.5 times above the baseline will be considered diagnostic. This technique will be applied routinely at each injection of standard parathyroid arteriography even in the absence of an angiographically-visualized adenoma: an elevation of PTH will provide localizing information comparable to venous sampling. In addition, when any of the imaging studies suggest that a particular anatomic site is the likely location of the patient's adenoma, sodium citrate, a calcium chelating agent, will be injected into the artery supplying this region. Blood samples will be obtained in similar fashion to those samples taken with contrast injections to measure PTH release following sodium citrate injection and determine whether this is a more effective hypocalcemic stimulant.

Using X-Ray Dye to Locate Hidden Parathyroid Tumors

Use of Hypocalcemic Intraarterial Infusion Into the Thyroid/Parathyroid Bed to Localize Occult Parathyroid Adenomas

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Kidney Diseases

Kidney Failure, Chronic

Neoplasm Metastasis

Hyperparathyroidism, Secondary

Renal Insufficiency

Neoplastic Processes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

High Intensity Focused Ultrasound treatment

Ultrasonic ablation device

Angel Luis Martin DE FRANCISCO, Pr

Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term haemodialysis treatment. sHPT is characterized by persistently elevated levels of parathyroid hormone (PTH) and major disturbances in phosphorus and calcium metabolism. When glomerular filtration rate (GFR) falls, the phosphorus clearance decreases significantly, leading to phosphorus retention. The resulting hyperphosphatemia is thought to be one of the principal causes of secondary hyperparathyroidism which is a very early complication of patients with CKD. Its diagnosis and treatment is crucial in the management of such patients.The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of phosphate binders, correction of hypocalcaemia, the use of vitamin D and its derivatives. The calcimimetic agent cinacalcet hydrochloride may be also used in combination with vitamin D. While the majority of patients can be controlled in this way, medical therapy is not always successful in achieving adequate control of secondary hyperparathyroidism. Oral medications (calcimimetics, recently developed phosphate binders, and active vitamin D derivatives amount to very high monthly costs, and have efficacy limitations as well as side-effects.

HIFU may become a valuable alternative treatment that help control secondary hyperparathyroidism in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.

The aim of this study is to evaluate the efficacy and safety of HIFU treatment in chronic haemodialysis patients with secondary hyperparathyroidism presenting with enlarged parathyroid gland(s) which are visible at ultrasonography and for whom medical therapy has been unsuccessful.

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Uncontrolled Secondary Hyperparathyroidism in Chronic Haemodialysis Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimizing Narcotic Analgesics After Endocrine Surgery	NCT03469310	Thyroid Cancer Thyroid Nodule Thyroid Neoplas... Thyroid Goitre Thyroid Disease... Parathyroid Dis... Parathyroid Ade... Parathyroid Hyp...	Acetaminophen 5... Tylenol #3 Oral... Tramadol	18 Years -	DHR Health Institute for Research and Development
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT04299425	Parathyroid Ade... Parathyroid Neo... Parathyroid Hyp... Parathyroid Can... Hypercalcemia Primary Hyperpa...	NIRAF Detection...	18 Years - 99 Years	Vanderbilt-Ingram Cancer Center
Using X-Ray Dye to Locate Hidden Parathyroid Tumors	NCT00001394	Parathyroid Neo...		-	National Institutes of Health Clinical Center (CC)
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT04299425	Parathyroid Ade... Parathyroid Neo... Parathyroid Hyp... Parathyroid Can... Hypercalcemia Primary Hyperpa...	NIRAF Detection...	18 Years - 99 Years	Vanderbilt-Ingram Cancer Center
Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism	NCT01421407	Secondary Hyper... End Stage Renal... Parathyroid Hyp...	Ultrasonic abla...	18 Years -	Theraclion

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