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

Niguarda Hospital

Status: Suspended

Conditions: Pancreatitis

Treatments: Device: Short guide wire rapid exchange; Device: Long guide wire

Study type: Interventional

Funder types: Other

Identifiers

NCT02290769

382 - 072014

Details and patient eligibility

About

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.

Full 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

Enrollment: 292 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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292 participants in 2 patient groups

Short guide wire rapid exchange

Experimental group

Description:

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

Treatment:

Device: Short guide wire rapid exchange

Long guide wire

Active Comparator group

Description:

Use of long wire to guide the cannulation during primary ERCP

Treatment:

Device: Long guide wire