Early Precut in Difficult Biliary Cannulation

Common Bile Duct Diseases Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02596646
• Other study ID #: PRECUT PRECOCE/01
• Status: Terminated
• Phase: N/A
• First received: September 7, 2015
• Last updated: November 5, 2015
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2015
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 375
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Diseases
• Common Bile Duct Diseases

Intervention

Procedure:
• Early Precut
Early precut was performed during ERCP with difficult biliary cannulation
• Prolonged cannulation attempts
Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (8)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele	Azienda Ospedaliera Universitaria Senese, Cardarelli Hospital, Istituti Ospitalieri di Cremona, Maresca Hospital, Papa Giovanni XXIII Hospital, San Giuseppe Moscati Hospital, Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PEP		24 hours	Yes
Secondary	Incidence of overall complications	The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.	24 hours	Yes