Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis

Pancreatitis Acute Biliary Clinical Trial

— EEPAB2  

Official title:

Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00987428
• Other study ID #: P080903
• Status: Terminated
• Phase: N/A
• First received: September 29, 2009
• Last updated: April 29, 2015
• Start date: August 2009
• Est. completion date: March 2012

Study information

• Verified date: April 2015
• 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

The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).

Description:

The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS.

Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: March 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• age > 18

• predicted severe acute biliary pancreatitis (including age > 80, BMI >30, pre-existing organ failure, Modified Glasgow score > 3)

• timespan between onset and randomization < 48 hrs

• informed consent signed by patient or liable person in case of emergency

Exclusion criteria :

• non biliary pancreatitis

• non severe pancreatitis

• age < 18

• timespan between onset and randomization > 48 hrs

• absence of consent

• ongoing pregnancy

• no social security insurance

Study Design

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis Acute Biliary

Intervention

Procedure:
• ultrasonography with or not sphincterotomy
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
• Usual procedure
The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

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	The difference between the SOFA score measured at entry in the study (day 0) and at day 8		Day 8	No
Secondary	Differences in SOFA score as measured at entry in the study and at day 15		Day 15	No
Secondary	Procedure-related morbidity		at Day 15 to 3 months	Yes
Secondary	Overall morbidity		at day 15	Yes
Secondary	Overall mortality		at day 15	Yes
Secondary	Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15		at day 8 and day 15	No