Clinical trial NCT04559867: Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial
Official title: Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Biliary Tract Diseases
Keywords: Needle Knife Fistulotomy
Sphincterotomy
Post-ERCP pancreatitis
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During the procedure, the study doctor will evaluate the participant's anatomy to determine if both approaches are possible to safely perform. If both approaches are assessed as safe to perform, then the participant will be randomly assigned (like the toss of a coin) to one approach. If the study doctor is unable to gain access using the approach the patient is initially assigned to, then they will switch approaches and use the other approach.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-ERCP pancreatitis
timeFrame: Up to 7 days
Secondary outcomes:
measure: Cannulation Success Rate
timeFrame: Day 0
measure: Inspection Time
timeFrame: Day 0
measure: Time to successful cannulation
timeFrame: Day 0
measure: Total procedure time
timeFrame: Day 0
measure: Ampullary morphology
timeFrame: Day 0
measure: Difficulty of cannulation
timeFrame: Day 0
measure: Incidence of complications
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert Bechara, MD
role: PRINCIPAL_INVESTIGATOR
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