Efficacy of Fistulotomy for Biliary Cannulation

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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

July 3, 2020

Primary Completion Date

March 3, 2020

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 2019