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

NCT ID: NCT02290769

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-28
• Study Completion Date: 2025-12-14

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

Conditions

Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short guide wire rapid exchange

Use of short guide wire rapid exchange to guide the cannulation during primary ERCP

Group Type: EXPERIMENTAL

Short guide wire rapid exchange

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

Long guide wire

Intervention Type: DEVICE

Use of long wire to guide the cannulation during primary ERCP

Interventions

Short guide wire rapid exchange

Use of short guide wire rapid exchange to guide the cannulation during primary ERCP

Intervention Type: DEVICE

Long guide wire

Use of long wire to guide the cannulation during primary ERCP

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Niguarda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Pugliese, MD

Role: STUDY_CHAIR

Niguarda Ca' Granda Hospital

Edoardo Forti, MD

Role: STUDY_CHAIR

Niguarda Ca' Granda Hospital

Raffaele Manta, MD

Role: STUDY_CHAIR

Niguarda Ca' Granda Hospital

Locations

Niguarda Hospital

Milan, , Italy

Countries

Italy

Other Identifiers

382 - 072014

Identifier Type: -

Identifier Source: org_study_id