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
  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:


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 April 17, 2014