Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis

Biliary Pancreatitis Clinical Trial

— EEPAB  

Official title:

Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505128
• Other study ID #: P051054
• Status: Completed
• Phase: N/A
• First received: July 20, 2007
• Last updated: May 6, 2011
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: May 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Description:

Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.

Prospective multicenter randomized controlled study with direct patient benefit

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous medical examination

• Age over 18

• Acute biliary pancreatitis

• Timespan between onset of symptoms and randomization <72h

• No involvement in another clinical study

• Informed consent obtained

Exclusion Criteria:

• Non biliary pancreatitis

• Age < 18

• Timespan between onset of symptoms and randomization >72h

• No follow-up possible beyond 3 months after inclusion

• Ongoing pregnancy

• No informed consent

• No health insurance affiliation

• Involvement in another clinical study

• Incapacity to understand subject information

• Counter indication of MRI examination if echo-endoscopy is not available

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Endoscopic sphincterotomy
procedure

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients cured or consolidated as a function of time		during 12 months	Yes
Secondary	overall morbidity		during the 36 months	Yes
Secondary	overall mortality		during the 36 months	Yes
Secondary	endoscopic procedure-related morbidity and mortality		during the 12months	Yes
Secondary	LOS		during the 12 months	Yes
Secondary	morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)		during the 12 months	Yes
Secondary	economic data		during the 36 months	Yes