Early Precut in Difficult Biliary Cannulation

Sponsor

Università Vita-Salute San Raffaele (Other)

Overall Status

Terminated

CT.gov ID

NCT02596646

Collaborator

San Giuseppe Moscati Hospital (Other), Istituti Ospitalieri di Cremona (Other), Valduce Hospital (Other), Papa Giovanni XXIII Hospital (Other), Cardarelli Hospital (Other), Azienda Ospedaliera Universitaria Senese (Other), Maresca Hospital (Other)

375

Enrollment

Location

Arms

Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Diseases	Procedure: Early Precut Procedure: Prolonged cannulation attempts	N/A

Detailed Description

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").

Study Design

Study Type:

Interventional

Actual Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Early Precut	Procedure: Early Precut Early precut was performed during ERCP with difficult biliary cannulation
Active Comparator: Group B Prolonged cannulation attempts	Procedure: Prolonged cannulation attempts Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Arm

Intervention/Treatment

Active Comparator: Group A

Early Precut

Procedure: Early Precut

Early precut was performed during ERCP with difficult biliary cannulation

Active Comparator: Group B

Prolonged cannulation attempts

Procedure: Prolonged cannulation attempts

Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Outcome Measures

Primary Outcome Measures

Incidence of PEP [24 hours]

Secondary Outcome Measures

Incidence of overall complications [24 hours]
The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Raffaele Hospital	Milan		Italy	20132

Investigators

Principal Investigator: Pier Alberto Testoni, Professor, San Raffaele Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Testoni Pier Alberto, Professor, Università Vita-Salute San Raffaele

ClinicalTrials.gov Identifier:

NCT02596646

Other Study ID Numbers:

PRECUT PRECOCE/01

First Posted:

Nov 4, 2015

Last Update Posted:

Nov 6, 2015

Last Verified:

Nov 1, 2015

Additional relevant MeSH terms:

Bile Duct Diseases

Common Bile Duct Diseases

Study Results

No Results Posted as of Nov 6, 2015