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

Post-ERCP Pancreatitis Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01771419
• Other study ID #: H San Paolo
• Status: Unknown status
• Phase: N/A
• First received: January 15, 2013
• Last updated: January 16, 2013
• Start date: October 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2013
• Source: Hospital San Paolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 320
• Est. completion date: January 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Pancreatitis

Intervention

Device:
• Loop-tip wire (Cook Medical) for the cannulation of the CBD

• Cannulotome CT-25mm Cook Medical

Locations

Country	Name	City	State
Italy	San Paolo Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Paolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	up to 4 weeks