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Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.
Prospective multicenter randomized controlled study with direct patient benefit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sphincterotomy | Procedure | procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients cured or consolidated as a function of time | during 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall morbidity | during the 36 months | |
| overall mortality | during the 36 months | |
| endoscopic procedure-related morbidity and mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic PRAT, MD, | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cochin | Paris | 75679 | France |
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| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D016717 | Sphincterotomy, Endoscopic |
| D008722 | Methods |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016099 | Endoscopy, Gastrointestinal |
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| during the 12months |
| LOS | during the 12 months |
| morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies) | during the 12 months |
| economic data | during the 36 months |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
| D008919 | Investigative Techniques |