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

Study Overview
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Brief Summary
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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
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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: 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. 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.

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

Conditions
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Cholangiopancreatography, Endoscopic Retrograde, Biliary Tract Diseases

Intervention / Treatment
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* Procedure: Needle knife fistulotomy
* Procedure: Sphincterotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Ability to read and understand the English language, Ability to follow-up in a reliable manner. Exclusion Criteria: Bleeding disorder (Von Willebrand disorder, platelet count <100 000, or INR >1.5), Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC), P2Y12 inhibitors not held for 5 days prior to the procedure, Prior biliary sphincterotomy, Concurrent pancreatitis (with inability to tolerate oral intake and requiring pain management), Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy), Inability to achieve adequate sedation, Evidence of malignant infiltration of the ampulla or peri-ampullary area, Pregnancy, Operator inability to access and identify intra-duodenal portion of the bile duct, Presumptive diagnosis of sphincter of Oddi dysfunction, Inability to access intraduodenal segment due to altered anatomy (eg. ampulla within deep diverticulum), Requirement for pancreatogram or pancreatic intervention, Inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Needle Knife Fistulotomy<br>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. | Procedure: Needle knife fistulotomy<br>* 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.<br>|
| Active Comparator: Sphincterotomy<br>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. | Procedure: Sphincterotomy<br>* A sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation Success Rate | Rate of successful cannulation of the common bile duct, with technical success determined by a cholangiogram. | Day 0 | 
| Inspection Time | Inspection time of the ampulla, defined as the visualization of the ampulla to the appearance of the needle knife or sphinctertome. | Day 0 | 
| Time to successful cannulation | For the sphincterotomy group, time to successful cannulation is defined as time of endoscopic visualization of the sphinctertome on the screen to contact with the papilla orifice. For the NKF group, this is defined as the time of endoscopic visualization of the metal point of the needle knife on the screen to successful cannulation of the common bile duct as evident by the cholangiogram or wire advancement into the common bile duct. | Day 0 | 
| Total procedure time | Total procedure time is measured for completed procedures from the time of esophageal intubation to the time of scope withdrawal from the patient mouth. | Day 0 | 
| Ampullary morphology | The type of ampulla, as determined by the study doctor. | Day 0 | 
| Difficulty of cannulation | Difficulty of cannulation, as graded on a 3-point scale, based on the study doctor's subjective opinion. | Day 0 | 
| Incidence of complications | Incidence of complications, notably intraprocedural bleeding that required intervention, delayed or sustained bleeding requiring transfusion or repeat endoscopy, and immediate or delayed perforation. | Up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Needle Knife Fistulotomy, Sphincterotomy, Post-ERCP pancreatitis