Efficacy of Fistulotomy for Biliary Cannulation

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT04037007

Collaborator

(none)

320

Enrollment

Location

Arms

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Access to the main bile duct is the first step in order to perform a therapeutic maneuver for biliary diseases. Early precut has been shown to ameliorate cannulation success rate, specially in difficult cannulation cases, when compared to guidewire cannulation (which is considered, for most, the standard technique). We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (> 200 ERCPs[Endoscopic Retrograde cholangiopancreatography]) and low experienced endoscopists (< 200 ERCPs).

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma Choledocholithiasis; Cholangitis Pancreatic Cancer Pancreatitis	Procedure: Fistulotomy - High experienced. Procedure: Fistulotomy - Low experienced. Procedure: Conventional (guidewire) cannulation- High experienced Procedure: Conventional (guidewire) cannulation - Low experienced	N/A

Detailed Description

Endoscopic Retrograde Pancreatography Cholangiography (ERCP) is the standard procedure for the treatment of pathologies that affect the bile duct. Approaching to the ampulla followed by deep selective biliary cannulation is the first step in order to apply any therapeutic method for bile duct pathologies. In patients with a normal anatomy it is estimated that about 11% of therapeutic ERCPs will be considered difficult biliary cannulation (duration of cannulation> 5 minutes, more than 5 attempts, > 1 cannulation of the main pancreatic duct). When early conventional precut has been compared to guidewire cannulation, cannulation success is in favor of precut with 86.7% compared to 66.7%; with a lower post-ERCP acute pancreatitis event rate: 6.1% vs 9.1%.

Objective: To determine the rate of biliary cannulation by comparing two techniques (fistulotomy versus standard biliary cannulation technique with guidewire) according to the endoscopist experience in ERCP.

Material and methods: A randomized prospective clinical trial will be conducted in the gastrointestinal endoscopy department of the CMN SXXI specialties hospital between the period of August 2019 and March 2020. 2 groups will be assigned as following: in group A the primary approach to access the bile duct will be conventional cannulation (CC) with guidewire, and group B for fistulotomy (F). On the other hand, there will be 2 groups of endoscopists (high experience> 200 ERCP) [HE] and low experience (<200 ERCP) [LE]. In total 4 groups: CCHE, CCLE, FHE, FLE. All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign stenosis of the bile duct, men and women between 18 and 90 years will be included. Exclusion criteria: patients with previous ERCP, gastro-duodenal anatomy altered by previous surgery, suspicion or diagnosis of ampullary neoplasm, duodenal cancer, periampullar diverticula types 1 and 2, pregnant women, coagulopathy with INR greater than 1.5. Elimination criteria: patients with incomplete ERCP due to adverse anesthesia events. The reason and indication of the ERCP study will be determined, a data collection sheet will be used compiling: clinical data such as age, sex, concomitant diseases, symptoms, biochemical data, imaging studies (abdominal ultrasound, abdominal CT and MRCP), findings on ERCP (characteristics of the papilla, presence of periampullar diverticula); details of the cannulation technique such as the number of attempts, time to access the bile duct. A comparison will be made between both techniques and both groups HE and LE. The success rate of biliary cannulation and complication for both groups of doctors and maneuvers used will be documented.

Statistical analysis: Continuous variables will be described with mean, median or standard deviation according to their distribution; and categorical variables will be described as percentages. Categorical variables will be compared using Chi-square or Fisher's exact test, while quantitative variables will be compared using T-Student or Mann Whitney U test. A P less than 0.05 will be considered statistically significant (for T-Student and Mann-Whitney U will be 2-tailed). A sample size of 80 patients for each group was calculated.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (> 200 ERCPs) and low experienced endoscopists (< 200 ERCPs).We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (> 200 ERCPs) and low experienced endoscopists (< 200 ERCPs).

Masking:

Single (Participant)

Masking Description:

The participant will be allocated to one group of the intervention conventional guidewire biliary cannulation or fistulotomy based on program software

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Precut Fistulotomy vs Conventional Cannulation Technique as a Primary Approach to Biliary Access According to the Endoscopist Experience Degree in ERCP

Actual Study Start Date :

Jul 3, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fistulotomy - High experienced Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.	Procedure: Fistulotomy - High experienced. We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.
Active Comparator: Fistulotomy - Low experienced Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in low experienced endoscopists.	Procedure: Fistulotomy - Low experienced. We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.
Active Comparator: Conventional (guidewire) cannulation- High experience Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in high experienced endoscopists.	Procedure: Conventional (guidewire) cannulation- High experienced We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.
Active Comparator: Conventional (guidewire) cannulation - Low experienced. Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in low experienced endoscopists.	Procedure: Conventional (guidewire) cannulation - Low experienced We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.

Outcome Measures

Primary Outcome Measures

Cannulation success rate within 5 minutes [8 months]
Successful access to the main biliary duct and subsequently to the biliary tree

Secondary Outcome Measures

Adverse event rate [8 months]
Post-ERCP pancreatitis, perforation and bleeding rates
Technical success [8 months]
Therapeutic success according to the patient indication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.

Exclusion Criteria:

patients with previous ERCP, altered gastro-duodenal anatomy by previous surgery, suspicion or diagnosis of ampullary neoplasm, duodenal cancer, periampullary diverticula types 1 and 2, pregnant women, coagulopathy with INR greater than 1.5.