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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Capital Medical University | OTHER |
| Peking University Third Hospital |
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Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EST+LC group | Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy. |
| |
| LCBDE+LC group | Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy. |
| |
| LTCBDE+LC group | Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic sphincterotomy | Procedure | Sphincterotomy (EST) is performed to remove the common bile duct stone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse outcomes | The patients with complication / the total patients | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost-effectiveness ratio | the average incremental cost associated with 1 additional unit of the measure of effect | 3 years |
| Hospital stay | The total days in hospital |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are diagnosed with gallstones and common bile duct stones.
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| Name | Affiliation | Role |
|---|---|---|
| Zhongtao Zhang, Doctor | Beijing Friendship Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31767583 | Derived | Zhu JG, Wu S, Feng Q, Li F, Han W, Xiu D, Tan H, Fu J, Li X, Shang D, Liu H, Li B, Yang L, Kong Y, Zhan S, Guo W, Zhang ZT. Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study. BMJ Open. 2019 Nov 24;9(11):e030293. doi: 10.1136/bmjopen-2019-030293. |
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| OTHER |
| China-Japan Friendship Hospital | OTHER |
| Beijing Tongren Hospital | OTHER |
| LanZhou University | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Peking University | OTHER |
| Peking Union Medical College Hospital | OTHER |
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| laparoscopic common bile duct exploration | Procedure | Transductal exploration was carried out to remove the common bile duct stone. Primary closure or a T tube drainage was performed according to the results of transductal surgery. |
|
| laparoscopic transcystic common bile duct exploration | Procedure | A wide local dissection of Calot's triangle is performed and a 2.8mm, 3-mm or 5-mm flexible choledochoscope according to the diameter of the cystic duct is inserted through the cystic duct into the common bile duct. After the common bile duct stone is removed, the cystic duct was ligated with Hem-o-lok. |
|
| laparoscopic cholecystectomy | Procedure | Laparoscopic cholecystectomy is performed to remove the gallbladder. |
|
| 3 years |
| Acute cholangitis rate | The patients with acute cholangitis / the total patients | 30 days |
| Bile leakage rate | The patients with bile juice found in the abdominal cavity after procedures / the total patients | 30 days |
| Stricture of the bile duct rate rate | The patients with any stricture appeared after the procedures / the total patients | 3 years |
| Mortality | Number of death connected with the procedures and complications / total patients | 3 years |
| Perforation Rate | The patients with perforation after the procedures / the total patients | 30 days |
| Hemorrhage Rate | The patients with hemorrhage after the procedures / the total patients | 3 years |
| Operation time | The total time of all the procedures (min) | 3 years |
| Acute pancreatitis Rate | The patients with acute pancreatitis after the procedures / the total patients | 30 days |
| ID | Term |
|---|---|
| D042882 | Gallstones |
| D002769 | Cholelithiasis |
| D041761 | Cholecystolithiasis |
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
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| ID | Term |
|---|---|
| D016717 | Sphincterotomy, Endoscopic |
| D017081 | Cholecystectomy, Laparoscopic |
| 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 |
| D002763 | Cholecystectomy |
| D010535 | Laparoscopy |
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