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Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis (EEPAB2)

This study has been terminated.
(Insufficient number of participants)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00987428
First received: September 29, 2009
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention
Pancreatitis Acute Biliary
 Procedure: ultrasonography with or not sphincterotomy
Procedure: Usual procedure

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The difference between the SOFA score measured at entry in the study (day 0) and at day 8 [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in SOFA score as measured at entry in the study and at day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Procedure-related morbidity [ Time Frame: at Day 15 to 3 months ] [ Designated as safety issue: Yes ]
  • Overall morbidity [ Time Frame: at day 15 ] [ Designated as safety issue: Yes ]
  • Overall mortality [ Time Frame: at day 15 ] [ Designated as safety issue: Yes ]
  • Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15 [ Time Frame: at day 8 and day 15 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: August 2009
Estimated Study Completion Date: March 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: groupe 1
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
 Procedure: ultrasonography with or not sphincterotomy
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Other Name: ultrasonography with or not sphincterotomy
Active Comparator: Groupe 2
usual procedure
 Procedure: 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.
Other Name: Usual procedure

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987428

Locations
France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frederic Prat, MD, PhD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00987428     History of Changes
Other Study ID Numbers: P080903
Study First Received: September 29, 2009
Last Updated: January 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ERCP
EUS
Pancreatitis biliary
 Severe
Interventional endoscopy
Choledocolithiasis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013