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Efficacy of Fistulotomy for Biliary Cannulation

Primary Purpose

Cholangiocarcinoma, Choledocholithiasis; Cholangitis, Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Fistulotomy - High experienced.
Fistulotomy - Low experienced.
Conventional (guidewire) cannulation- High experienced
Conventional (guidewire) cannulation - Low experienced
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Precut sphincterotomy, Fistulotomy, Biliary cannulation, Efficacy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Elimination Criteria:

- Incomplete procedure due to anesthesia adverse events.

Sites / Locations

  • Centro Medico Nacional Siglo XXI Hospital de EspecialidadesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Fistulotomy - High experienced

Fistulotomy - Low experienced

Conventional (guidewire) cannulation- High experience

Conventional (guidewire) cannulation - Low experienced.

Arm Description

Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.

Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in low experienced endoscopists.

Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in high experienced endoscopists.

Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in low experienced endoscopists.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2019
Last Updated
July 21, 2022
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04037007
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Choledocholithiasis; Cholangitis, Pancreatic Cancer, Pancreatitis
Keywords
Precut sphincterotomy, Fistulotomy, Biliary cannulation, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Participant
Masking Description
The participant will be allocated to one group of the intervention conventional guidewire biliary cannulation or fistulotomy based on program software
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fistulotomy - High experienced
Arm Type
Active Comparator
Arm Description
Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.
Arm Title
Fistulotomy - Low experienced
Arm Type
Active Comparator
Arm Description
Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in low experienced endoscopists.
Arm Title
Conventional (guidewire) cannulation- High experience
Arm Type
Active Comparator
Arm Description
Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in high experienced endoscopists.
Arm Title
Conventional (guidewire) cannulation - Low experienced.
Arm Type
Active Comparator
Arm Description
Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in low experienced endoscopists.
Intervention Type
Procedure
Intervention Name(s)
Fistulotomy - High experienced.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fistulotomy - Low experienced.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional (guidewire) cannulation- High experienced
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional (guidewire) cannulation - Low experienced
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cannulation success rate within 5 minutes
Description
Successful access to the main biliary duct and subsequently to the biliary tree
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Adverse event rate
Description
Post-ERCP pancreatitis, perforation and bleeding rates
Time Frame
8 months
Title
Technical success
Description
Therapeutic success according to the patient indication
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar V Hernández Mondragón, MD
Phone
+525556276900
Ext
21317-8
Email
mondragonmd@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Mendoza Segura, Fellow
Phone
+525556276900
Ext
21317-8
Email
carlosms.gastro@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar V Hernandez Mondragon, MD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Nacional Siglo XXI Hospital de Especialidades
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar V Hernández Mondragón, MD
Phone
+525556276900
Ext
21317-8
Email
mondragonmd@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Carlos Mendoza Segura, Fellow
Phone
+525556276900
Ext
21317-8
Email
carlosms.gastro@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24814775
Citation
Lopes L, Dinis-Ribeiro M, Rolanda C. Early precut fistulotomy for biliary access: time to change the paradigm of "the later, the better"? Gastrointest Endosc. 2014 Oct;80(4):634-641. doi: 10.1016/j.gie.2014.03.014. Epub 2014 May 6.
Results Reference
background
PubMed Identifier
27102829
Citation
Jin YJ, Jeong S, Lee DH. Utility of needle-knife fistulotomy as an initial method of biliary cannulation to prevent post-ERCP pancreatitis in a highly selected at-risk group: a single-arm prospective feasibility study. Gastrointest Endosc. 2016 Nov;84(5):808-813. doi: 10.1016/j.gie.2016.04.011. Epub 2016 Apr 19.
Results Reference
background
PubMed Identifier
29713133
Citation
Furuya CK, Sakai P, Marinho FRT, Otoch JP, Cheng S, Prudencio LL, de Moura EGH, Artifon ELA. Papillary fistulotomy vs conventional cannulation for endoscopic biliary access: A prospective randomized trial. World J Gastroenterol. 2018 Apr 28;24(16):1803-1811. doi: 10.3748/wjg.v24.i16.1803.
Results Reference
background
PubMed Identifier
16082283
Citation
Abu-Hamda EM, Baron TH, Simmons DT, Petersen BT. A retrospective comparison of outcomes using three different precut needle knife techniques for biliary cannulation. J Clin Gastroenterol. 2005 Sep;39(8):717-21. doi: 10.1097/01.mcg.0000173928.82986.56.
Results Reference
background
PubMed Identifier
10462652
Citation
Mavrogiannis C, Liatsos C, Romanos A, Petoumenos C, Nakos A, Karvountzis G. Needle-knife fistulotomy versus needle-knife precut papillotomy for the treatment of common bile duct stones. Gastrointest Endosc. 1999 Sep;50(3):334-9. doi: 10.1053/ge.1999.v50.98593.
Results Reference
background

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Efficacy of Fistulotomy for Biliary Cannulation

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