Prevalence and Predictive Factors of Difficult Biliary Cannulation

NCT06591364 | Not Yet Recruiting

• 1 other identifier: PRECABIDO
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well as the predictive factors for this event in a prospective, multicenter study. Consecutive patients undergoing ERCP will be included in the study We will also assess: Evaluate the failure of biliary cannulation in our setting. Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria. Design an "a priori" predictive model for difficult cannulation and cannulation failure. Cost study: record of materials used.

Conditions

Difficult Biliary Cannulation

Keywords

ERCP; Endoscopic retrograde cholangiopancreatography; Difficult biliary cannulation

Outcome Measures

Primary Outcomes (1)

• Difficult biliary cannulation

  (\> 5 minutes duration until cannulation, \> 5 cannulation attempts, \> 1 passage of the guidewire into the main pancreatic duct

  1 year

Secondary Outcomes (4)

• Failure of biliary cannulation

  1 year

• Predictive factors for difficult cannulation and cannulation failure

  1 year

• Designing an "a priori" predictive model for difficult cannulation and cannulation failure

  1 year

• To carry out a cost study

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the consecutive patients with an indication of a endoscopic retrograde cholangiopancreatography meeting inclusion and exclusion criteria will be included

You may qualify if:

• Age \>18 years
• Signed informed consent
• Patients indicated for ERCP

You may not qualify if:

• INR \> 1.5
• Platelets \< 50,000/mm³
• Patients with a prior endoscopic sphincterotomy
• Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
• Known pancreas divisum
• Indication due to pancreatic duct pathology

Sponsors & Collaborators

• University of La Laguna: lead

Related Publications (4)

• Baron TH, Petersen BT, Mergener K, Chak A, Cohen J, Deal SE, Hoffinan B, Jacobson BC, Petrini JL, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for endoscopic retrograde cholangiopancreatography. Am J Gastroenterol. 2006 Apr;101(4):892-7. doi: 10.1111/j.1572-0241.2006.00675.x. No abstract available.

  PMID: 16635233 BACKGROUND

• Caceres-Escobar D, Munoz-Velandia OM, Vargas-Rubio R. FACTORS ASSOCIATED WITH DIFFICULT BILIARY CANNULATION IN A TRAINING CENTER FOR ENDOSCOPIC INTERVENTION OF THE BILIARY TRACT. Arq Gastroenterol. 2022 Jan-Mar;59(1):29-34. doi: 10.1590/S0004-2803.202200001-06.

  PMID: 35442332 BACKGROUND

• Dalal A, Gandhi C, Patil G, Kamat N, Vora S, Maydeo A. Safety and efficacy of different techniques in difficult biliary cannulation at endoscopic retrograde cholangiopancreatography. Hosp Pract (1995). 2022 Feb;50(1):61-67. doi: 10.1080/21548331.2022.2029451. Epub 2022 Jan 20.

  PMID: 35025705 BACKGROUND

• Saito H, Kadono Y, Shono T, Kamikawa K, Urata A, Nasu J, Imamura H, Matsushita I, Kakuma T, Tada S. Factors Predicting Difficult Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography for Common Bile Duct Stones. Clin Endosc. 2022 Mar;55(2):263-269. doi: 10.5946/ce.2021.153. Epub 2021 Nov 12.

  PMID: 34763384 BACKGROUND

Study Officials

• Antonio Z Gimeno García, MD, PhD

  University Hospital of the Canary Islands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Z Gimeno García, MD, PhD

CONTACT

34922678554; agimenog@ull.edu.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share