EVALUATION OF FINE NEEDLE BIOPSY (FNB) FOR EUS GUIDED TISSUE ACQUISITION OF PANCREATIC MASSES TO NEGATE THE NEED FOR RAPID ON-SITE EVALUATION: A RANDOMIZED CONTROL TRIAL

PHRR220714-004875

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Unspecified

EVALUATION OF FINE NEEDLE BIOPSY (FNB) FOR EUS GUIDED TISSUE ACQUISITION OF PANCREATIC MASSES TO NEGATE THE NEED FOR RAPID ON-SITE EVALUATION: A RANDOMIZED CONTROL TRIAL

Endoscopic ultrasound guided fine needle aspiration (EUS FNA) is a key component for the investigation and diagnosis of solid pancreatic masses.  It has a proven track record for being safe with complications and tumour seeding being a rare occurrence.  The sensitivity, specificity and diagnostic accuracy for pancreatic lesions in many studies is high and exceeds 85%, specifically if paired with rapid on site evaluation (ROSE) of the samples read on slides by a pathologist . The fine needle biopsy (FNB) needle was introduced to further improve upon EUS guided tissue sampling.  It is designed to collect a larger amount of core sample tissue by having better needle tip configurations.  Several studies favor the EUS FNB needle over the classic FNA needle for obtaining more adequate histological specimens with a high diagnostic yield.  Also the FNB needle has been shown to obtain samples with higher cellularity compared to the standard FNA needles.  Data comparing the performance of EUS FNB without ROSE versus EUS FNA with ROSE is currently lacking.  With this in mind, needles that provide histological specimens with an excellent (>95%) diagnostic yield (thus negating the need for ROSE) are the ideal devices for obtaining EUS guided diagnostic tissue.   We therefore aim to compare the diagnostic yield of solid pancreatic masses using EUS FNA with ROSE versus EUS FNB without ROSE.

Start Date Duration in Months Target Completion Date Actual Completion Date
2022-08-01 3 2022-11-01 2022-11-01

Ongoing

Institution Classification Region LTO #
University of the Philippines - Philippine General Hospital, Department of Medicine Government NCR
Institution Classification Region LTO #
None None None
Institution Region
Self-funded None
Name E-Mail Institution and Institution Address
Mark Anthony De Lusong madelusong@up.edu.ph UP College of Medicine, Manila, Philippines
Name E-Mail Institution and Institution Address
Mark Anthony De Lusong madelusong@up.edu.ph UP College of Medicine, Manila, Philippines
Name Expertise Affiliation
Mark Anthony Ayuyao De Lusong Gastroenterology and Endoscopy University of the Philippines - Manila, College of Medicine
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
University of the Philippines - Manila, College of Medicine UP College of Medicine, Manila, Philippines University of the Philippines Manila - Research Ethics Board Mark Anthony Ayuyao De Lusong Gastroenterology and Endoscopy
Project Location Institutional Ethics Review Board
University of the Philippines - Manila, College of Medicine University of the Philippines Manila - Research Ethics Board

Clinical Trial

Unspecified

Pancreatic tumors

Pancreatic cancer

Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) or biopsy  (FNB) of pancreatic tumors.

Rapid onsite evaluation (ROSE) of biopsy/aspiration samples

 

Diagnostic yield of EUS FNA with ROSE versus EUS FNB without ROSE for solid pancreatic masses.

1. Lengths of procedure time between the two groups
2. Acquired tissue characteristics between the two groups
3. Complication rates and need for a repeat procedure

Pending

  • Philippines

Unspecified

Unspecified

0000-00-00

0000-00-00

No result found.

100

100

Unspecified

Unspecified

2018-08-01

Inclusion Criteria
• Age more than 18 years old
• Patients requiring endoscopic ultrasound and tissue sampling of solid lesions greater than 1cm diameter in the pancreas that are visualized and within the reach of EUS FNA

Interventional

Endoscopic Ultrasound with Fine Needle Aspiration or Biopsy

Videoendoscope is inserted into the mouth, passing through the esophagus into the stomach and duodenum. The scope has a built in ultrasound probe at the tip permitting visualization of organs and structures beyond the gastrointestinal lumen allowing safe access for needle aspiration or biopsy of pancreatic tumors. Procedure is done under anesthesia and lasts 30-45 mins.

None

Method of Allocation

Randomized

Masking or Blinding

Open Label

Masking Details

Randomization for allocation to groups will be done via computer generated random numbers.

Control

Unspecified

Assignment

Parallel

Phase

Not Applicable

Purpose of the Study

To compare the groups head to head with all parameters equal save for the Fine Needle used.

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
Publication

All analysis of acquired data will be made into a manuscript for the purposes of publication.

Oral Presentation

Analyzed data may be presented in conferences for sharing with equal interest groups.

Drug Literature
Posters

Final manuscript canbe submitted as a poster in international or national conferences.

Others
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