EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02116322
• Other study ID #: NA_00090101
• Status: Terminated
• Phase: N/A
• First received: April 14, 2014
• Last updated: April 25, 2017
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: April 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• EUS-FNA with Corkscrew technique

Device:
• Expect 19 G Flex needle

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety		30 days
Secondary	Diagnostic yield of the FNA using corkscrew technique	Diagnostic yield; as measured by the adequacy of the sample per on-site cytopathologist	30 days