Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

Patients will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

Single needle

Patients will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

Multiple needle

Irving Waxman, MD

The aim of this study is to evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer allows an earlier preliminary cytological diagnosis of neoplasia.

This is a prospective randomized controlled trial which will recruit patients referred for suspicion of pancreatic mass and indication of EUS-FNA as part of standard of care in the Interventional Endoscopy Unit at the University Of Chicago Medical Center. Basic demographic data will be recorded for each patient. If a pancreatic mass is confirmed in EUS evaluation the patient will be randomized in a 1:1 ratio to either Control group (Single needle) or Investigational group (Multiple Needle). There will be an expert cytopathologist in the exploration room (blinded to the group assignment). Samples obtained through FNA will be prepared onsite either for cytological evaluation by the cytopathologist: each fine needle sample will be expressed by using a 10mL air-filled syringe onto a separate glass slide, and a direct smear will be made by an on-site cytopathologist. Each slide will be air-dried and/or alcohol fixed (95% ethanol), and direct smears will be prepared for immediate interpretation by staining with Diff-quick staining system.

Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

A cytopathologist (#1) will be present during each EUS-FNA procedure to prepare the slides and determine whether each specimen was adequately cellular. After the procedure, all the cytological samples will be sent to the Pathology department in order to complete the study. A cytopathologist (#2) not present during the procedure will study all the sampling specimens obtained during the EUS-FNA procedure and produce the final and definitive cytopathological diagnosis.

Criteria for pancreatic cancer and benign pancreatic lesions will be defined. Follow-up of all patients to assess early and late complications will be carried out for 30 days after the procedure.

Endpoints:

1. Primary endpoint: Evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer can reduce the number of passes needed to obtain a preliminary cytological diagnosis of neoplasia. We hypothesized that the number of passes needed using the multiple needles will be significantly less than that using the single needle.
2. Secondary endpoints:

   * Rate of complications related with EUS-FNA
   * Influence of different factors in obtaining a positive cytological result (histological differentiation)

Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer

EMUNE-07 Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer

Cook Group Incorporated

University of Chicago

Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization

Fine needle aspiration

Rapid on-site evaluation

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.

Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.

Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

Cases with a sample suitable for a definitive diagnosis over the total number of cases

Total number of adverse events of all procedures

Cases in which a final diagnostic could be established over the total number of cases

Universidade Federal do Rio de Janeiro

Associate Professor, Internal Medicine

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

collection of cervical cells using spatula

Cervical smear test

Holly I Clarke, MBBS

Pierre Vassilakos

The investigators will collect PAP-test samples from women undergoing colposcopy. Laboratory providers will prepare the samples with a liquid-based cytology method. The providers will then digitalise the slides using a digital scanner. The slides will be sent to cytopathologists who will assess the quality of the slides.

The study will take place over four months. The consultation where the clinician undertakes the colposcopy and takes the additional cytological sample will be the only visit necessary for the patient in relation to the study.

The investigators will require thirty usable cervical samples from the colposcopy clinic of the Maternity of Geneva. The spatula used to take the smear should be immediately transferred to a 10ml sample pot and the head of the spatula should be snapped off and left inside. The investigators will only accept samples that have followed the aformentioned conditions, and it is expected to recruit more than the 30 participants needed if sampling is insufficient. The samples will be prepared by one of 3 laboratory technicians at the same hospital using the manual Surepath® liquid-based preparation method. This includes cell randomization, pipetting and enrichment of diagnostic cervical cells through centrifugation using a settling chamber to create a cellular slide preparation in a circle of 13 mm diameter. The Pap staining procedure is then applied within the chamber.

All thirty glass slides will be scanned and digitalized with a compact portable scanner (Ocus, ®40 by Grundium, Finland). The same laboratory technician who prepared the cervical sample will scan the slide. Ocus ®40 has a 1-slide capacity and permits the acquisition of a whole-slide image as well as robotic microscopy. The scanner features a 12-megapixel image sensor with a 40x objective (numerical aperture: 0.75) and can be connected to a laptop computer over a Wireless Local Area Network (WLAN) connection. To avoid areas being out of focus, the Z-stack modality of acquisition will be used at three focal plane levels with a 1 µ interval. In Europe, Ocus®40 is IVDR certified for diagnostic use.

The ease of the manual preparation method and scanning of slides will be assessed by asking the laboratory technician to rate the difficulty from very easy to very difficult on a 5-point rating scale (score 1= very difficult, 5=very easy) for each preparation step. The time taken for the manual preparation and scanning of glass slides will also be measured with a stopwatch and recorded by the technician.

Quality characteristics of the thirty digitalized slides will be scored as excellent, good, fair, or poor (based on sharpness and visualization through thick cell clusters) by two cytopathologists reading the slides. The time taken to screen digitized slides will be calculated.

In addition, cellularity will be assessed in the preparation area of the glass slide. Under a 40× objective and an eyepiece with a field number of 20, the total number of cells will be computed using the following formula: N=n(acd/amf), where N=total cell count, n=mean cell count of 10 adjacent fields of view along the horizontal diameter in the center of the circle, acd=area of cell deposit and amf=area of microscopic field.

The following data will be recorded and stored for each patient

* the number between 1-30 that has been given to the patient plus previous cytological diagnosis
* the easiness rating for each step of the manual preparation of the slide (lab technician)
* The easiness rating for the scanning/digitalization of the slides (lab technician)
* the quality rating based on sharpness and visualization through thick cell clusters for each slide (cytopathologists)
* the cellularity of each slide (cytopathologists)
* the time taken to prepare (lab technician), digitalize (lab technician) and read (cytopathologists) the slides

There will be a separate form for the laboratory providers and the cytopathologists. The data from the lab technician and the cytopathologists will be subsequently unified.

Telecytology as a Triage Tool in LMICs

Pilot Study Evaluating the Feasibility of Digitalised Cytolological Slides for Telecytology, Before Implementation in Cameroon

Quality of the prepared and digitalised slide as measured by a score allocated by cytopathologists pertaining to sharpness and visualisation through thick cell clusters (scored as excellent (maximal value), good, fair or poor (minimum value)) as well as the cellularity of the slide.

- Easiness score allocated by the laboratory providers after the preparation and digitalisation of each slide (1=very difficult; 5=very easy)

Ecole Polytechnique Fédérale de Lausanne

University Hospital, Geneva

Professor Patrick Petignat

Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of FNA passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis.

After EUS-FNA is performed all slides will be sent to the pathology department. The slides will be sent for review regardless of which arm the patient is randomized into, and they will be reviewed by experienced cytopathologists for the purpose of determining the final diagnoses.

In the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist).

After EUS-FNA is performed all slides will be sent to the pathology department. The slides will be sent for review regardless of which arm the patient is randomized into, and they will be reviewed by experienced cytopathologists for the purpose of determining the final diagnoses.

Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of FNA passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis.

EUS-guided FNA performed with on-site Cytopathologist

In the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist).

EUS-guided FNA performed without on-site Cytopathologist

Sachin Wani, M.D.

This study is a multicenter prospective randomized controlled trial. Potential participants in this study include patients referred for Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If the patient meets inclusion criteria and signs the informed consent, they will be randomized into one of the two study arms in a 1:1 ratio. Patients will either undergo EUS-FNA with or without an on-site cytopathologist present during EUS-FNA. Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of fine needle aspiration (FNA) passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis. In the other arm, in the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist). The technique of performing EUS-FNA (needle type, use of stylet, suction) will be standardized among all endosonographers in order to rule out confounding factors. After EUS-FNA is performed all slides will be sent to the pathology department. The slides will be sent for review regardless of which arm the patient is randomized into, and they will be reviewed by experienced cytopathologists for the purpose of determining the final diagnoses.

Future clinical intervention will be monitored for the purpose of reporting the impact EUS-FNA has on the patient's clinical course and determining diagnostic accuracy. Patients will be followed prospectively for at least one year, and the gold-standard for final diagnosis of pancreatic malignancy will be defined by the presence of malignant cytology or histologic evidence (if the patient undergoes surgery) or with clinical and/or imaging follow-up consistent with pancreatic cancer (death or clinical progression). A detailed account of medical equipment used during each procedure, procedure time, clinic visits/hospitalizations due to procedure related complications, and number of repeat procedures will be recorded systematically.

The investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic masses improves diagnostic yield, accuracy, and lowers the duration, complications and the need for repeat procedures.

Endoscopic Ultrasound (EUS) plays an integral role in the diagnosis of suspected pancreatic cancer, and the EUS findings are crucial for determining the course of future management and potential treatment options for these patients. EUS is the most sensitive imaging modality for the detection of pancreatic masses, and has a sensitivity of greater than or equal to 90%. Furthermore, EUS-guided fine needle aspiration (EUS-FNA) plays an important role in accurate staging of pancreatic cancer with a sensitivity of 85% and specificity close to 100%. EUS-FNA is considered to be cost-effective by virtue of its impact on therapeutic management. In particular, real-time tissue sampling by EUS-FNA is possible when a cytopathologist (pathologist skilled in evaluating fine needle aspiration specimens) is able to be present at the time of FNA in order to review the biopsy slides and make a preliminary diagnosis. The availability of an on-site cytopathologist has the potential to provide quick diagnostic and predictive information to confirm the presence and staging of suspected malignancy. The rationale for an on-site cytopathologist includes increasing the adequacy and yield of biopsy tissue/aspirate which can decrease the need for additional passes to obtain a diagnostic yield of tissue. This hypothesis, however, has not been formally examined.

In this proposed randomized controlled multicenter trial, the investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic masses improves diagnostic yield, accuracy, and lowers the duration, complications and the need for repeat procedures. This hypothesis will be explored in the context of the following specific aims.

Specific aim #1: To compare the diagnostic yield of malignancy and proportion of inadequate specimens between the two groups.

Specific aim #2: To compare the sensitivity, specificity and accuracy of EUS-FNA between the two groups using histologic diagnosis or cytologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard.

Specific aim #3: To compare the duration, rate of complications and repeat procedures between the two groups.

On-site Cytopathology EUS-FNA

The Clinical Impact of Immediate On-site Cytopathology Evaluation During Endoscopic Ultrasound-Guided Fine Needle Aspiration of Pancreatic Mass: A Multicenter, Prospective Randomized Controlled Trial

The Investigators would like to look at each of the two groups to assess whether or not having an onsite cytopathologist during EUS-FNA increases the diagnostic accuracy of pancreatic malignancies. To do this, the Investigators will compare the percent of patients in each group who were accurately diagnosed with a malignancy during EUS-FNA to see if the on-site cytopathologist group yields a higher percent of positively diagnosed malignancies.

Final slides will be reviewed by three experienced cytopathologists blinded to the patient's randomization group. The slides for each pass will be assessed for: cellularity, adequacy of specimen, contamination, amount of blood, and diagnosis. Using the cytopathologists' assessment of the FNA specimens, the Investigators will compare the percent of patients with inadequate samples in each group to see if the absence of an on-site cytopathologist corresponds with a higher percent of inadequate FNA samples.

Sensitivity, specificity and accuracy of EUS-FNA will be evaluated using histologic diagnosis or cytologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard.

Once all patients have been enrolled and have undergone EUS-FNA with or without an on-site cytopathologist, the Investigators will be able to compare the mean number of fine needle aspiration passes taken during EUS for patients in each group.

The complication rates from the two groups of subjects will be evaluated when all subjects have been enrolled.

The EUS procedure duration from the two groups of subjects will be evaluated when all subjects have been enrolled.

The investigators will follow patients for one year after enrollment to see if they have had any repeat procedures for the purpose of diagnosing their pancreatic mass.

Kansas City Veteran Affairs Medical Center

University of Colorado, Denver

Jaihwan Kim, M.D.

The purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.

1. background

   1. Pancreatic cancer is the challenging malignancy in diagnosis and treatment.
   2. Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.
   3. Samples from EUS-FNA are sent to following three types of preparations.

      * cytologic smear (by pull apart method)
      * cell block
      * histologic biopsy
   4. In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy.
   5. Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist.
2. Method

   1. We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test.
   2. One identical and skilled endoscopist performs EUS-FNA with multiple punctures.
   3. We get total 8 pairs of slides (= 8 covers + 8 bases).
   4. All the cover slides are collected to the bottle-A, all the base slide to the bottle-B.
   5. One identical and skilled pathologist inspects these slide in blind method. (She cannot show the label of bottle so that she does not know what bottle is A or B.)
   6. She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.)
   7. In these manner, we collect the all subjects' cytopathologic results as a pair of outcome. All the possible combinations are following four examples:

      * (cover/base) = (positive/positive) = (+/+)
      * (cover/base) = (positive/negative) = (+/-)
      * (cover/base) = (negative/positive) = (-/+)
      * (cover/base) = (negative/negative) = (-/-)
   8. Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.

One identical and skilled endoscopist's EUS-FNA sampling with multiple punctures

Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer

Comparison of the Diagnostic Accuracy Between Base and Cover Slide Smear After Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer

comparison between diagnostic accuracy between cover slide sets and base slide sets

comparison of three types of test in rate of positive malignancy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer	NCT00548626	Pancreatic Canc...	Single needle Multiple needle	18 Years -	University of Chicago
Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?	NCT04002778	Pancreatic Neop...	Fine needle asp... Rapid on-site e...	18 Years -	Universidade Federal do Rio de Janeiro
Telecytology as a Triage Tool in LMICs	NCT05474404	Cervical Cancer	Cervical smear ...	18 Years -	University Hospital, Geneva
Telecytology as a Triage Tool in LMICs	NCT05474404	Cervical Cancer	Cervical smear ...	18 Years -	University Hospital, Geneva
Telecytology as a Triage Tool in LMICs	NCT05474404	Cervical Cancer	Cervical smear ...	18 Years -	University Hospital, Geneva
Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer	NCT00548626	Pancreatic Canc...	Single needle Multiple needle	18 Years -	University of Chicago
On-site Cytopathology EUS-FNA	NCT01386931	Pancreatic Neop... Pancreatic Canc...	EUS-guided FNA ... EUS-guided FNA ...	18 Years -	University of Colorado, Denver
Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer	NCT02190071	Pancreatic Canc...		-	Seoul National University Hospital

Spots Global Cancer Trial Database for cytopathology