Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct

This study is currently recruiting participants.

Verified January 2013 by Hospital San Paolo

Sponsor:

Information provided by (Responsible Party):

Benedetto Mangiavillano, Hospital San Paolo

ClinicalTrials.gov Identifier:

NCT01771419

First received: January 15, 2013

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Post-ERCP Pancreatitis	Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD Device: Cannulotome CT-25mm Cook Medical

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

U.S. FDA Resources

Further study details as provided by Hospital San Paolo:

Primary Outcome Measures:

post ERCP pancreatitis rate [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Estimated Enrollment:	320
Study Start Date:	October 2010
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: loop-tip arm The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)	Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD
Active Comparator: Control arm The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)	Device: Cannulotome CT-25mm Cook Medical

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771419

Locations

Italy
San Paolo Hospital	Recruiting
Milan, Italy, 20142
Contact: Benedetto Mangiavillano, MD 0039 02 8184 ext 4273 b_mangiavillano@hotmail.com

Sponsors and Collaborators

Hospital San Paolo

More Information

No publications provided

Responsible Party:	Benedetto Mangiavillano, MD, Hospital San Paolo
ClinicalTrials.gov Identifier:	NCT01771419 History of Changes
Other Study ID Numbers:	H San Paolo
Study First Received:	January 15, 2013
Last Updated:	January 16, 2013
Health Authority:	Italy: Ethics Committee

Keywords provided by Hospital San Paolo:

loop-tip
ERCP
cannulation of CBD

Additional relevant MeSH terms:

Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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