Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
| Shandong Province Third hospital | OTHER |
| Qingdao Municipal Hospital | OTHER |
| Shengli Oilfield Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy | The patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy |
| |
| ERCP plus Laparoscopic Cholecystectomy | The patients intend to receive ERCP plus laparoscopic cholecystectomy |
| |
| Conservative Treatment | After removal of common bile duct stone via ERCP,neither ERCP nor laparoscopic cholecystectomy will be carried out to treat cholecystolithiasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic transpapillary gallbladder-preserving | Procedure | Based on the patient's preference, they will receive the following treatment:endoscopic transpapillary gallbladder-preserving |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications. | Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc. | From enrollment to 3 years after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis. | Compare the gallbladder stone clearance rate and bile duct stone clearance rate among the three groups; meanwhile, record the rates of successful gallbladder access establishment via FCMS and successful guidewire cannulation into the gallbladder in the gallbladder-preserving cholecystolithotomy group, so as to clarify the clinical success rate and technical success rate of this technique. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
patients with cholelithiasis with concomitant choledocholithiasis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Li, MD | Contact | 18560086106 | qilulizhen@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tao Yu, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250063 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Liaocheng People's Hospital | OTHER |
| Binzhou Medical University | OTHER |
| Weifang People's Hospital | OTHER |
| Taian City Central Hospital | OTHER |
| Qianfoshan Hospital | OTHER |
| Linyi People's Hospital | OTHER |
| Qilu Hospital of Shandong University (Qingdao) | OTHER |
| Central Hospital of Zibo | OTHER |
| The Second Hospital of Shandong University | OTHER |
| Dezhou Hospital Qilu Hospital of Shandong University | OTHER |
| Rizhao People's Hospital | OTHER |
Not provided
Not provided
Not provided
| ERCP plus Laparoscopic Cholecystectomy | Procedure | Based on the patient's preference, they will receive the following treatment:ERCP plus Laparoscopic Cholecystectomy |
|
| Conservative treatment | Drug | Based on the patient's preference, they will receive the following treatment:ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care. |
|
|
| From enrollment to 3 years after the end of treatment |
| Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment. | Record duration of Hospitalization and total Medical Expenses of the three groups then calculate them as total medical expenses / duration of hospitalization (Unit: [e.g., CNY/USD] per day).It can reflect the average daily inpatient economic cost for each treatment, enabling integrated comparison of economic efficiency across the three groups. | From enrollment to 3 years after the end of treatment |
| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D017081 | Cholecystectomy, Laparoscopic |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D010535 | Laparoscopy |
| D013812 | Therapeutics |
Not provided
Not provided