Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire

Not Applicable

Suspended

• Conditions: Pancreatitis
• Interventions: Device: Long guide wire; Device: Short guide wire rapid exchange

• Registration Number: NCT02290769
• Lead Sponsor: Niguarda Hospital

Brief Summary

The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.

Detailed Description

In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.

Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients

Study Timeline

• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-14
• Study Start: 2018-01-28
• Primary Completion: 2018-01-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Study Completion: 2025-12-14

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• indication to primary ERCP
• ASA (American Society of Anesthesiologists) 1, 2, 3

Exclusion Criteria

• pancreas neoplasia
• pancreatitis
• ampulloma
• duodenum stenosis
• under mucous membrane haematoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long guide wire	Long guide wire	Use of long wire to guide the cannulation during primary ERCP
Short guide wire rapid exchange	Short guide wire rapid exchange	Use of short guide wire rapid exchange to guide the cannulation during primary ERCP

Primary Outcome Measures

Name	Time	Method
Time of cannulation	8 hours from intervention	Time (in seconds) required to perform a complete and successful deep cannulation of the "biliary papilla" and the biliary tree assessed by timing it and reporting it in the prefashioned database

Secondary Outcome Measures

Name	Time	Method
Incidence of post ERCP pancreatitis	8 hours post ERCP	Incidence of post ERCP pancreatitis

Trial Locations

Locations (1)

Niguarda Hospital; 🇮🇹 Milano, Italy