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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014