An interventional study of Fistulotomy - High experienced. and Fistulotomy - Low experienced. in Cholangiocarcinoma, Choledocholithiasis; Cholangitis and Pancreatic Cancer, sponsored by Coordinación de Investigación en Salud, Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Coordinación de Investigación en Salud, Mexico · Not applicable, Interventional, and Treatment
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).
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.
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Exclusion Criteria:
Elimination Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.
Procedure: Fistulotomy - High 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.
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
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 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.
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.
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.
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.
Cannulation success rate within 5 minutes
Successful access to the main biliary duct and subsequently to the biliary tree
Time frame: 8 months
Adverse event rate
Post-ERCP pancreatitis, perforation and bleeding rates
Time frame: 8 months
Technical success
Therapeutic success according to the patient indication
Time frame: 8 months
Plan to share: No
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Coordinación de Investigación en Salud, Mexico