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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| groupe 1 | Experimental | Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone |
|
| Groupe 2 | Active Comparator | usual procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasonography with or not sphincterotomy | Procedure | Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference between the SOFA score measured at entry in the study (day 0) and at day 8 | Day 8 |
| Measure | Description | 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 |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Frederic Prat, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cochin | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Usual procedure | 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. |
|
| 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 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D055585 |
| Physical Phenomena |