Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs?

April 2, 2024 updated by: Lawrence Charles Hookey

Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts.

Patients will consent to allow the study physician to access these areas of the digestive system by making a cut using a technique called a needle-knife fistulotomy. If the physician is unable to gain access through this method, they will make the cut using a technique called a sphincterotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ERCP procedure enables doctors to examine the regions of the digestive system called the pancreas and bile ducts. After sedating a patient, a bendable tube with a light (called an endoscope), is inserted through the mouth and into the digestive system. Within the digestive system, the doctor is able to identify the opening to where the gallbladder drains into the small bowel called the ampulla. Using the endoscope, a small plastic tube is then placed in the opening and dye (also called contrast material) is injected bile duct (where bile leaves the liver from). X-ray pictures can then be taken to provide further information to the doctor.

Sometimes it is necessary to make a cut to enlarge the opening to allow easier removal of stones from the bile duct or to place plastic tubes (stents) in the bile duct. To make this cut, there are two different approaches that the doctor can take:

  1. The standard way of making the cut is referred to as a "sphincterotomy". Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it.
  2. The second way of making the cut is referred to as a "pre-cut". There are various types of "pre-cut" techniques; the technique being evaluated in this study is called the "needle knife fistulotomy". When using this technique, the doctor makes a cut directly into the bile duct using a tiny knife called a "needle knife".

Currently, there is not a standard that tells doctors what cutting technique to use. The decision is entirely up to the individual doctor.

Patients that participate in this study give their permission to allow the study doctor to use the "needle knife fistulotomy" cutting technique first to gain access to the bile ducts. If the study doctor is unable to gain access through this method, then they will use the standard sphincterotomy technique.

The purpose of this study, called a feasibility study, is to determine if the needle-knife fistulotomy is at least as safe and effective as the standard access technique, if not safer.

If it can be shown that the needle-knife fistulotomy is safer and/or more effective, then it could change the way that doctors conduct this procedure in Canada and the rest of the world.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Kingston Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients, ages > 18, with an intact sphincter undergoing ERCP by at Kingston Health Sciences Center for therapeutic purposes who can provide informed consent. This includes patients who have confirmed choledocholithiasis on imaging and those who have a high suspicion of it based on imaging and lab values. Patients with and without a high suspicion for cholangitis will be eligible for the study. Other indications include: type 1 sphincter of Oddi dysfunction, gallstone pancreatitis or other benign pancreaticobiliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome. Furthermore, patients with suspected diagnosis of biliary leak following cholecystectomy will also be considered for enrollment in this study.
  2. Ability to read and understand the English language

Exclusion criteria:

  1. Bleeding disorder (Von Willebrand disorder, platelet count <100 000, or INR >1.5)
  2. Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC)
  3. Prior biliary sphincterotomy
  4. Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy)
  5. Evidence of Malignant infiltration of the ampulla or peri-ampullary area.
  6. Inability to identify intra-duodenal portion of the bile duct, including deep peri-ampullary diverticulum.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All Enrolled Patients
Receive needle knife fistulotomy as a starting technique to gain access to the biliary system
Procedure: Needle knife fistulotomy
A needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ERCP pancreatitis
Time Frame: Up to 7 days post-procedure
The primary objective to be examined is the incidence of post-ERCP pancreatitis
Up to 7 days post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Day of procedure
Determined by successful cannulation of the CBD as evidenced on cholangiogram
Day of procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total procedure time
Time Frame: Day of procedure
Measured for completed procedures from the time of esophageal intubation to the time of scope withdrawal from the patient mouth
Day of procedure
Time to successful cannulation
Time Frame: Day of procedure
Measured from the time of identification of the papilla to successful CBD cannulation as evident by the cholangiogram
Day of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawrence Charles Hookey

Investigators

  • Principal Investigator: Lawrence C Hookey, MD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2018

Primary Completion (Actual)

January 29, 2020

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMED-2175-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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