Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial

Lawrence Charles Hookey

Status: Suspended

Conditions: Cholangiopancreatography, Endoscopic Retrograde; Biliary Tract Diseases

Treatments: Procedure: Needle knife fistulotomy; Procedure: Sphincterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04559867

6029074

Details and patient eligibility

About

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 either making a cut called a needle-knife fistulotomy or a sphincterotomy.

Full description

The ERCP procedure enables the study doctor to examine regions of the digestive system called the pancreas and bile ducts. After a patient is sedated, 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 into the bile duct (area where bile leaves the liver). X-ray pictures can then be taken to provide further information to the doctor.

During the procedure, 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, the doctor determines which cutting technique to use. The decision is entirely up to the individual doctor.

The purpose of this study, called a randomized, controlled trial, is to compare the safety and effectiveness of the two different approaches to the ERCP.

This type of study involves a large number of participants and the results may answer the question as to which approach should be used for patients having the ERCP procedure. The results may change the standard way that doctors conduct this procedure.

Enrollment: 538 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients, greater than, or equal to 18 years of age, 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: other benign biliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome requiring biliary decompression. 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,
3. Ability to follow-up in a reliable manner.

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. P2Y12 inhibitors not held for 5 days prior to the procedure,
4. Prior biliary sphincterotomy,
5. Concurrent pancreatitis (with inability to tolerate oral intake and requiring pain management),
6. Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy),
7. Inability to achieve adequate sedation,
8. Evidence of malignant infiltration of the ampulla or peri-ampullary area,
9. Pregnancy,
10. Operator inability to access and identify intra-duodenal portion of the bile duct,
11. Presumptive diagnosis of sphincter of Oddi dysfunction,
12. Inability to access intraduodenal segment due to altered anatomy (eg. ampulla within deep diverticulum),
13. Requirement for pancreatogram or pancreatic intervention,
14. Inability to provide informed consent.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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538 participants in 2 patient groups

Needle Knife Fistulotomy

Active Comparator group

Description:

The study doctor will gain access to the bile ducts using the cutting technique called a needle knife fistulotomy. When using this technique, the study doctor makes a cut directly into the bile duct.

Treatment:

Procedure: Needle knife fistulotomy

Sphincterotomy

Active Comparator group

Description:

The study doctor will gain access to the bile ducts using the cutting technique called a sphincterotomy. Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it.

Treatment:

Procedure: Sphincterotomy