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Study of Forceps Cannulation During ERCP

NCT05336630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-10-30

Study results available
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Summary

A difficult cannulation has been identified as one of the high risk factors for developing post-ERCP pancreatitis (PEP). The accessibility and morphology of the papilla influence the level of cannulation difficulty. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access. Thus, the objective of our study is to determine whether a forceps assisted cannulation leads to less difficult cannulation during ERCP. Because difficult cannulation is associated with increased risk of PEP, our study investigates whether the forceps assisted cannulation also reduces the incidence of PEP as a secondary outcome. Eligible patients who have consented will either be randomized to cannulation with forceps or cannulation with no forceps.

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

DEVICE

Forceps

The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the ampullary position to permit an easier cannulation. The forceps is an FDA approved instrument and does not put the patient at any higher risk for any adverse event. Please note that for the explicit purpose of the study the forceps will be used to grab tissue and not take biopsies. The forceps may still be used to take biopsies if the physician believes it is indicated.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Timothy B Gardner, MD MS · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2024-10-15
Completion
2024-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05336630 on ClinicalTrials.gov