MedTrace Logo

Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone

NCT04492137 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2021-08-16

No results posted yet for this study

Summary

Compare the ultra early fistulotomy strategy with standard cannulation methods for accessing the bile duct during endoscopic retrograde cholangiopancreatography (ERCP)

Conditions

Interventions

PROCEDURE

Cannulation technique

Participants in the ultra early NKF group will be submitted to 2 standard cannulation attempts (2 contacts with the papilla) before starting NKF. If any of these 2 attemps is successful, NKF won't take place. If NKF is indeed performed and cannulation is not achieved within 8 minutes, the endoscopist is free to perform techniques other than NKF. On the other hand, participants in the standard cannulation group in which cannulation is not achieved within 8 minutes can cross-over to other advanced cannulation techniques (e.g. NKF). For ethical reasons we choose to exclude flat and intradiverticular/diverticular border papillas. During ERCP all participants will be submitted to PEP prophylaxis with rectal indomethacin. A pancreatic stent will be placed whenever there is cannulation or opacification of the Wirsung duct. For the purposes of the study, a dedicated form (attached) will be created with the various variables to be analyzed

Sponsors & Collaborators

  • Unidade Local de Saúde do Alto Minho

    collaborator OTHER

  • University of Minho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

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 NCT04492137 on ClinicalTrials.gov