Back to resultsEarly Precut in Difficult Biliary Cannulation
Primary Purpose
Common Bile Duct Diseases
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Early Precut
Prolonged cannulation attempts
Sponsored by
About this trial
This is an interventional treatment trial for Common Bile Duct Diseases
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.
Sites / Locations
- San Raffaele Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Early Precut
Prolonged cannulation attempts
Outcomes
Primary Outcome Measures
Incidence of PEP
Secondary Outcome Measures
Incidence of overall complications
The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.
Full Information
NCT ID
NCT02596646
First Posted
September 7, 2015
Last Updated
November 5, 2015
Sponsor
Università Vita-Salute San Raffaele
Collaborators
San Giuseppe Moscati Hospital, Istituti Ospitalieri di Cremona, Valduce Hospital, Papa Giovanni XXIII Hospital, Cardarelli Hospital, Azienda Ospedaliera Universitaria Senese, Maresca Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02596646
Brief Title
Early Precut in Difficult Biliary Cannulation
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis recommended terminating the study
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele
Collaborators
San Giuseppe Moscati Hospital, Istituti Ospitalieri di Cremona, Valduce Hospital, Papa Giovanni XXIII Hospital, Cardarelli Hospital, Azienda Ospedaliera Universitaria Senese, Maresca Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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").
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Early Precut
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Prolonged cannulation attempts
Intervention Type
Procedure
Intervention Name(s)
Early Precut
Intervention Description
Early precut was performed during ERCP with difficult biliary cannulation
Intervention Type
Procedure
Intervention Name(s)
Prolonged cannulation attempts
Intervention Description
Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation
Primary Outcome Measure Information:
Title
Incidence of PEP
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Incidence of overall complications
Description
The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.
Time Frame
24 hours
10. Eligibility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pier Alberto Testoni, Professor
Organizational Affiliation
San Raffaele Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Hospital
City
Milan
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Early Precut in Difficult Biliary Cannulation
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