Early Precut in Difficult Biliary Cannulation | NCT02596646

Studies
Early Precut in Difficult Biliary Cannulation

NCT02596646

Sponsor

Università Vita-Salute San Raffaele

Status

Terminated

Last Update Posted

Nov 6, 2015Estimated

Enrollment

375Actual

Phase

Not Applicable

Conditions

Common Bile Duct Diseases

Interventions

Early Precut
Prolonged cannulation attempts

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis recommended terminating the study

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Sep 7, 2015

First Submission Date that Met QC Criteria

Nov 3, 2015

First Posted Date

Nov 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2015

Last Update Posted Date

Nov 6, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Testoni Pier Alberto, Professor, Università Vita-Salute San RaffaelePrincipal Investigator

Lead Sponsor

Università Vita-Salute San RaffaeleOTHER

Collaborators

Name	Class
San Giuseppe Moscati Hospital	OTHER
Istituti Ospitalieri di Cremona	OTHER
Valduce Hospital	OTHER
Papa Giovanni XXIII Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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").

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

375Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Early Precut	Procedure: Early Precut
Group B	Active Comparator	Prolonged cannulation attempts	Procedure: Prolonged cannulation attempts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early Precut	Procedure	Early precut was performed during ERCP with difficult biliary cannulation	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of PEP		24 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pier Alberto Testoni, Professor	San Raffaele Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Raffaele Hospital		Milan		20132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003137	Common Bile Duct Diseases

Ancestor Terms

ID	Term
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

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