Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 15, 2013
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJanuary 18, 2013
January 1, 2013
2.3 years
January 15, 2013
January 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post ERCP pancreatitis rate
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
up to 4 weeks
Secondary Outcomes (1)
Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability
up to 4 weeks
Study Arms (2)
loop-tip arm
EXPERIMENTALThe cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)
Control arm
ACTIVE COMPARATORThe cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)
Interventions
Eligibility Criteria
You may qualify if:
- high-risk patients for post-ERCP pancreatitis
You may not qualify if:
- age \< 18 years
- allargy to the contrast medium
- previous biliary or gastric surgery
- neoplastic patients
- previous biliary or pancreatic sphincterotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Paolo Hospital
Milan, Italy, 20142, Italy
Related Publications (1)
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.
PMID: 26528503DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 15, 2013
First Posted
January 18, 2013
Study Start
October 1, 2010
Primary Completion
February 1, 2013
Study Completion
January 1, 2014
Last Updated
January 18, 2013
Record last verified: 2013-01