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Terminated early due to slow recruitment
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The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy | Procedure | Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bile duct clearance | Peri-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and mortality | 30 day or directly relating to intervention | |
| Post-operative stay | Post-operative stay | |
| Procedures per patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Thompson, MD, FRCS | North Bristol NHS Trust | Study Director |
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| Laparoscopic bile duct exploration during cholecystectomy | Procedure | Laparoscopic bile duct exploration during cholecystectomy |
|
| Interventions required to acheive duct clearance |
| Conversion to open surgery | Peri-operative |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016717 | Sphincterotomy, Endoscopic |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
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