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

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ClinicalTrials.gov Identifier: NCT00987428
Recruitment Status : Terminated (Insufficient number of participants)
First Posted : October 1, 2009
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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).

Condition or disease Intervention/treatment Phase
Pancreatitis Acute Biliary Procedure: ultrasonography with or not sphincterotomy Procedure: Usual procedure Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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.



Primary Outcome Measures :
  1. The difference between the SOFA score measured at entry in the study (day 0) and at day 8 [ Time Frame: Day 8 ]

Secondary Outcome Measures :
  1. Differences in SOFA score as measured at entry in the study and at day 15 [ Time Frame: Day 15 ]
  2. Procedure-related morbidity [ Time Frame: at Day 15 to 3 months ]
  3. Overall morbidity [ Time Frame: at day 15 ]
  4. Overall mortality [ Time Frame: at day 15 ]
  5. Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15 [ Time Frame: at day 8 and day 15 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987428


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00987428     History of Changes
Other Study ID Numbers: P080903
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

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