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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987428

Acronym

EEPAB2

Enrollment

Registered

2009-10-01

Start date

2009-08-31

Completion date

2012-03-31

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis Acute Biliary

Keywords

ERCP, EUS, Pancreatitis biliary, Severe, Interventional endoscopy, Choledocolithiasis

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).

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.

Interventions

PROCEDUREultrasonography with or not sphincterotomy

Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone

PROCEDUREUsual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The difference between the SOFA score measured at entry in the study (day 0) and at day 8	Day 8

Secondary

Measure	Time frame
Differences in SOFA score as measured at entry in the study and at day 15	Day 15
Procedure-related morbidity	at Day 15 to 3 months
Overall morbidity	at day 15
Overall mortality	at day 15
Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15	at day 8 and day 15

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026