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

Primary Purpose

Cholangiopancreatography, Endoscopic Retrograde, Biliary Tract Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Needle knife fistulotomy

Sphincterotomy

About this trial

This is an interventional other trial for Cholangiopancreatography, Endoscopic Retrograde focused on measuring Needle Knife Fistulotomy, Sphincterotomy, Post-ERCP pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kingston Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Needle Knife Fistulotomy

Sphincterotomy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Post-ERCP pancreatitis

The primary objective to be examined is the incidence of post-ERCP pancreatitis.

Secondary Outcome Measures

Cannulation Success Rate

Rate of successful cannulation of the common bile duct, with technical success determined by a cholangiogram.

Inspection Time

Inspection time of the ampulla, defined as the visualization of the ampulla to the appearance of the needle knife or sphinctertome.

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.

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.

Ampullary morphology

The type of ampulla, as determined by the study doctor.

Difficulty of cannulation

Difficulty of cannulation, as graded on a 3-point scale, based on the study doctor's subjective opinion.

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.

Full Information

NCT ID

NCT04559867

First Posted

September 10, 2020

Last Updated

April 29, 2023

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT04559867

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 10, 2020 (Actual)

Primary Completion Date

September 10, 2025 (Anticipated)

Study Completion Date

December 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiopancreatography, Endoscopic Retrograde, Biliary Tract Diseases

Keywords

Needle Knife Fistulotomy, Sphincterotomy, Post-ERCP pancreatitis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

538 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Needle Knife Fistulotomy

Arm Type

Active Comparator

Arm 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.

Arm Title

Sphincterotomy

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Needle knife fistulotomy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sphincterotomy

Intervention Description

A sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it.

Primary Outcome Measure Information:

Title

Post-ERCP pancreatitis

Description

The primary objective to be examined is the incidence of post-ERCP pancreatitis.

Time Frame

Up to 7 days

Secondary Outcome Measure Information:

Title

Cannulation Success Rate

Description

Rate of successful cannulation of the common bile duct, with technical success determined by a cholangiogram.

Time Frame

Day 0

Title

Inspection Time

Description

Inspection time of the ampulla, defined as the visualization of the ampulla to the appearance of the needle knife or sphinctertome.

Time Frame

Day 0

Title

Time to successful cannulation

Description

Time Frame

Day 0

Title

Total procedure time

Description

Total procedure time is measured for completed procedures from the time of esophageal intubation to the time of scope withdrawal from the patient mouth.

Time Frame

Day 0

Title

Ampullary morphology

Description

The type of ampulla, as determined by the study doctor.

Time Frame

Day 0

Title

Difficulty of cannulation

Description

Difficulty of cannulation, as graded on a 3-point scale, based on the study doctor's subjective opinion.

Time Frame

Day 0

Title

Incidence of complications

Description

Incidence of complications, notably intraprocedural bleeding that required intervention, delayed or sustained bleeding requiring transfusion or repeat endoscopy, and immediate or delayed perforation.

Time Frame

Up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Bechara, MD

Phone

613-544-3400

Ext

3369

robert.bechara@kingstonhsc.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Melinda Allen

Phone

613-544-3400

Ext

3385

melinda.allen@kingstonhsc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Bechara, MD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kingston Health Sciences Centre

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5G2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jackie McKay

Phone

613-544-3400

jackie.mckay@kingstonhsc.ca

12. IPD Sharing Statement

Plan to Share IPD

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

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