Cholelithiasis Clinical Trial
— CREST CholesOfficial title:
Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
Verified date | November 2018 |
Source | Beijing Friendship Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 2700 |
Est. completion date | December 30, 2018 |
Est. primary completion date | December 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with age between 18 - 80 years. - Patients diagnosed with gallstones. - Patients diagnosed with common bile duct stone by one of the three exam (MRI?MRCP and CT). - Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration. - Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE). Exclusion Criteria: - Combined with Mirizzi syndrome and intrahepatic bile duct stones - Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD) - History of upper abdominal surgery. - Serious heart,brain,lung, metabolic diseases history. - Pregnant women - Unwillingness or inability to consent for the study. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Friendship Hospital | Beijing Tongren Hospital, China-Japan Friendship Hospital, LanZhou University, Luhe Hospital, Capital Medical University, Peking Union Medical College Hospital, Peking University, Peking University First Hospital, Peking University Third Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Dalian Medical University, Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Adverse outcomes | The patients with complication / the total patients | 3 years | |
Secondary | Incremental cost-effectiveness ratio | the average incremental cost associated with 1 additional unit of the measure of effect | 3 years | |
Secondary | Hospital stay | The total days in hospital | 3 years | |
Secondary | Acute cholangitis rate | The patients with acute cholangitis / the total patients | 30 days | |
Secondary | Bile leakage rate | The patients with bile juice found in the abdominal cavity after procedures / the total patients | 30 days | |
Secondary | Stricture of the bile duct rate rate | The patients with any stricture appeared after the procedures / the total patients | 3 years | |
Secondary | Mortality | Number of death connected with the procedures and complications / total patients | 3 years | |
Secondary | Perforation Rate | The patients with perforation after the procedures / the total patients | 30 days | |
Secondary | Hemorrhage Rate | The patients with hemorrhage after the procedures / the total patients | 3 years | |
Secondary | Operation time | The total time of all the procedures (min) | 3 years | |
Secondary | Acute pancreatitis Rate | The patients with acute pancreatitis after the procedures / the total patients | 30 days |
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