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To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.
Cholecystectomy was recommended for patients with stones in their bile ducts and gallbladders in European and American countries after clearance of bile duct stones with ERCP, which reduced the incidence of biliary events. However, some researches showed that the incidence of biliary events was not reduced but increased.The purpose of this study is to discuss the necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gallbladder preserved | Placebo Comparator | Patients with stones in their bile ducts and gallbladders will keep gallbladders in stay after clearance of bile duct stones with ERCP. |
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| cholecystectomy | Experimental | Patients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gallbladder preserved | Other | Gallbladders will be remained after clearance of bile duct stones with ERCP and conventional therapy, such as fluid replacement and prophylactic anti infection, will be accepted. |
| Measure | Description | Time Frame |
|---|---|---|
| biliary events | The incidence of biliary events will be compared in the two groups. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Number of participants with adverse events: type, frequency and intensity of adverse events. | 12 months |
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Inclusion Criteria:
Obtention of a written informed consent; Clinical diagnosis of gallbladder stones and common bile duct stones; No absolute operation indications of cholecystectomy
Exclusion Criteria:
Intrahepatic stones; Malignant tumor disease ;
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| Name | Affiliation | Role |
|---|---|---|
| Xiangfeng Zhang, M.S | First People's Hospital of Hangzhou | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | 31006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25294531 | Background | Heo J, Jung MK, Cho CM. Should prophylactic cholecystectomy be performed in patients with concomitant gallstones after endoscopic sphincterotomy for bile duct stones? Surg Endosc. 2015 Jun;29(6):1574-9. doi: 10.1007/s00464-014-3844-8. Epub 2014 Oct 8. |
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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 |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| cholecystectomy | Procedure | Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted. |
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