Early Precut in Difficult Biliary Cannulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.

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Detailed Description

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In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").

Conditions

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Common Bile Duct Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Early Precut

Group Type ACTIVE_COMPARATOR

Early Precut

Intervention Type PROCEDURE

Early precut was performed during ERCP with difficult biliary cannulation

Group B

Prolonged cannulation attempts

Group Type ACTIVE_COMPARATOR

Prolonged cannulation attempts

Intervention Type PROCEDURE

Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Interventions

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Early Precut

Early precut was performed during ERCP with difficult biliary cannulation

Intervention Type PROCEDURE

Prolonged cannulation attempts

Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.

Exclusion Criteria

* active cholangitis or pancreatitis
* chronic pancreatitis,
* previous sphincterotomy,
* prior gastric surgery,
* coagulopathy,
* severe comorbidity (need for tracheal intubation)
* patients who refused or were unable to give informed consent.
* patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"),
* detection of ampulloma or peri-papillary diverticula during ERCP.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

Accepts Healthy Volunteers

No