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Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

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Johns Hopkins University

Status

Terminated

Conditions

Pancreatic Cancer

Treatments

Procedure: EUS-FNA with Corkscrew technique
Device: Expect 19 G Flex needle

Study type

Interventional

Funder types

Other

Identifiers

NCT02116322
NA_00090101

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

Pancreatic mass
Experimental group
Description:
Patients with pancreatic mass presenting for EUS-FNA
Treatment:
Device: Expect 19 G Flex needle
Procedure: EUS-FNA with Corkscrew technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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