Back to resultsComparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct
Primary Purpose
Post-ERCP Pancreatitis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Loop-tip wire (Cook Medical) for the cannulation of the CBD
Cannulotome CT-25mm Cook Medical
Sponsored by
About this trial
This is an interventional prevention trial for Post-ERCP Pancreatitis focused on measuring loop-tip, ERCP, cannulation of CBD
Eligibility Criteria
Inclusion Criteria:
- high-risk patients for post-ERCP pancreatitis
Exclusion Criteria:
- age < 18 years
- allargy to the contrast medium
- previous biliary or gastric surgery
- neoplastic patients
- previous biliary or pancreatic sphincterotomy
Sites / Locations
- San Paolo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
loop-tip arm
Control arm
Arm Description
The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)
The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)
Outcomes
Primary Outcome Measures
post ERCP pancreatitis rate
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary Outcome Measures
Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01771419
Brief Title
Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Paolo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Pancreatitis
Keywords
loop-tip, ERCP, cannulation of CBD
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
loop-tip arm
Arm Type
Experimental
Arm Description
The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)
Intervention Type
Device
Intervention Name(s)
Loop-tip wire (Cook Medical) for the cannulation of the CBD
Intervention Type
Device
Intervention Name(s)
Cannulotome CT-25mm Cook Medical
Primary Outcome Measure Information:
Title
post ERCP pancreatitis rate
Description
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability
Description
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high-risk patients for post-ERCP pancreatitis
Exclusion Criteria:
age < 18 years
allargy to the contrast medium
previous biliary or gastric surgery
neoplastic patients
previous biliary or pancreatic sphincterotomy
Facility Information:
Facility Name
San Paolo Hospital
City
Milan
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedetto Mangiavillano, MD
Phone
0039 02 8184
Ext
4273
Email
b_mangiavillano@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26528503
Citation
Masci E, Mangiavillano B, Luigiano C, Bizzotto A, Limido E, Cantu P, Manes G, Viaggi P, Spinzi G, Radaelli F, Mariani A, Virgilio C, Alibrandi A, Testoni PA. Comparison between loop-tip guidewire-assisted and conventional endoscopic cannulation in high risk patients. Endosc Int Open. 2015 Oct;3(5):E464-70. doi: 10.1055/s-0034-1392879. Epub 2015 Sep 15.
Results Reference
derived
Learn more about this trial
Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct
We'll reach out to this number within 24 hrs