NCT02596646

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

September 7, 2015

Last Update Submit

November 5, 2015

Conditions

Common Bile Duct Diseases

Outcome Measures

Primary Outcomes (1)

  • Incidence of PEP

    24 hours

Secondary Outcomes (1)

  • Incidence of overall complications

    24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Early Precut

Procedure: Early Precut

Group B

ACTIVE COMPARATOR

Prolonged cannulation attempts

Procedure: Prolonged cannulation attempts

Interventions

Early PrecutPROCEDURE

Early precut was performed during ERCP with difficult biliary cannulation

Group A
Prolonged cannulation attemptsPROCEDURE

Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Group B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Common Bile Duct Diseases

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Pier Alberto Testoni, Professor

    San Raffaele Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2015

First Posted

November 4, 2015

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

IT(1)