Brief Title
Efficacy of Fistulotomy for Biliary Cannulation
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
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).
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 Type
Interventional
Primary Outcome
Cannulation success rate within 5 minutes
Secondary Outcome
Adverse event rate
Condition
Cholangiocarcinoma
Intervention
Fistulotomy - High experienced.
Study Arms / Comparison Groups
Fistulotomy - High experienced
Description: Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
320
Start Date
July 3, 2019
Completion Date
December 3, 2022
Primary Completion Date
October 1, 2022
Eligibility Criteria
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.
Elimination Criteria:
- Incomplete procedure due to anesthesia adverse events.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Oscar V Hernandez Mondragon, MD, +525556276900, [email protected]
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT04037007
Organization ID
R-2019-3601-147
Responsible Party
Sponsor
Study Sponsor
Coordinación de Investigación en Salud, Mexico
Study Sponsor
Oscar V Hernandez Mondragon, MD, Principal Investigator, Instituto Mexicano del Seguro Social
Verification Date
July 2022