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

Pancreatitis Clinical Trial

— RELG  

Official title:

Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02290769
• Other study ID #: 382 - 072014
• Status: Suspended
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: December 14, 2025

Study information

• Verified date: March 2023
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 292
• Est. completion date: December 14, 2025
• Est. primary completion date: January 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Device:
• Short guide wire rapid exchange
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
• Long guide wire
Use of long wire to guide the cannulation during primary ERCP

Locations

Country	Name	City	State
Italy	Niguarda Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of cannulation	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	8 hours from intervention
Secondary	Incidence of post ERCP pancreatitis	Incidence of post ERCP pancreatitis	8 hours post ERCP