Skip to main content
Clinical Trials/NCT02116322
NCT02116322
Terminated
Not Applicable

EUS-guided Fine Needle Tissue Acquisition of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

Johns Hopkins University1 site in 1 country4 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Johns Hopkins University
Enrollment
4
Locations
1
Primary Endpoint
Number of Participants With Adverse Events as a Measure of Safety
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
May 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)

Exclusion Criteria

  • Uncorrectable coagulopathy (INR \> 1.5)
  • Uncorrectable thrombocytopenia (platelet \< 50,000)
  • Uncooperative patients
  • Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
  • Refusal to consent form
  • Prior negative FNTA
  • In situ metallic biliary stents
  • Predominantly cystic lesions
  • Inaccessible lesions to EUS

Outcomes

Primary Outcomes

Number of Participants With Adverse Events as a Measure of Safety

Time Frame: 30 days

Secondary Outcomes

  • Diagnostic Yield of the FNA Using Corkscrew Technique(30 days)

Study Sites (1)

Loading locations...

Similar Trials