MedTrace Logo

Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

NCT02916199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2019-01-30

No results posted yet for this study

Summary

The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods.

Conditions

  • Common Bile Duct Stone
  • Malignant Hepatobiliary Neoplasm
  • Biliary Stricture
  • Pancreatic Diseases
  • Sphincter of Oddi Dysfunction

Interventions

DEVICE

cannulation of ampulla of Vater

Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2017-11-28
Completion
2017-11-28

Countries

  • South Korea

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 NCT02916199 on ClinicalTrials.gov