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Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation

NCT05068739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-10-12

No results posted yet for this study

Summary

The aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult biliary cannulation and to assess the incidence rate of complications between these cannulation methods.

Conditions

  • Biliary Disease
  • Common Bile Duct Calculi
  • Biliary Stricture
  • Malignant Hepatobiliary Neoplasm
  • Pancreatic Disease

Interventions

PROCEDURE

PA-EMR

Standard oval-shaped, braided wire polypectomy snare with 10 mm or 20 mm loop diameter will be used. With the duodenoscope in a semi-long position, the tip of the snare will be anchored just below the transverse fold of the ampulla and opened above-downwards fashion until the orifice will be seen. The orifice will be strictly preserved to avoid the risk of PEP and approximately the upper two-thirds of the ampullary mound will be grabbed by the snare. The direction and the depth will be controlled by combined movements of the elevator and wheels of the duodenoscope. After removal of the mucosa, the wall of choledochus will be seen clearly and standard wire-guided cannulation (WGC) will be performed. If cannulation can not be achieved with WGC, an additional incision will be performed to the wall of the choledochus with a needle knife.

PROCEDURE

NKF

The needle knife will be placed at the junction of the upper one-third and lower two-thirds of the papillary roof (bulging portion). Minimal, superficial incisions will be made in the 11-12 o'clock direction. The length of the fistulotomy will be at the endoscopist's discretion, depending on the shape of the papilla. The cut will be extended until bile juice, the pinkish bile duct mucosa, and/or the bulging of the white sphincter of the Oddi's muscle is visible.

Sponsors & Collaborators

  • Cukurova University

    collaborator OTHER

  • Duzce University

    lead OTHER

Principal Investigators

  • Salih Tokmak, Assist. prof · Duzce University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-06-21
Completion
2022-10-11

Countries

  • Turkey (Türkiye)

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 NCT05068739 on ClinicalTrials.gov