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| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
| Linyi People's Hospital | OTHER |
| Rizhao People's Hospital | OTHER |
| Taian City Central Hospital |
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In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. The study aims to analyze the impact of pancreatic duct stent implantation on the incidence of post-ERCP pancreatitis in gallstone patients treated with ERCP-GPC by comparing the efficacy differences between the experimental and control groups. Additionally, the study investigate the effects of pancreatic duct stent placement post-ERCP on other postoperative complications, conduct a comparative analysis of the economic benefits of placing versus not placing pancreatic duct stents after ERCP, and develop effective clinical strategies for preventing pancreatitis after gallbladder-preserving stone extraction in gallstone patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive rectal indomethacin alone | Other |
| |
| Combination of indomethacin plus a prophylactic pancreatic stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic pancreatic stent | Device | All procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although the technical approach, including the amount of time and effort expended for this purpose, was not standardized.All patients received 100mg indomethacin suppositories. |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients with Post-ERCP Pancreatitis | If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis. | 24 hours to 72 hours after ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis | The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of > 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| OTHER |
| Shandong Province Third hospital | OTHER |
| Binzhou Medical University | OTHER |
| Liaocheng People's Hospital | OTHER |
| Weifang People's Hospital | OTHER |
| Central Hospital of Zibo | OTHER |
| Qianfoshan Hospital | OTHER |
| Qilu Hospital of Shandong University (Qingdao) | OTHER |
| Qingdao Municipal Hospital | OTHER |
| Shengli Oilfield Hospital | OTHER |
| The Second Hospital of Shandong University | OTHER |
| Dezhou Hospital Qilu Hospital of Shandong University | OTHER |
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|
| rectal indomethacin alone | Drug | rectal indomethacin was used alone in the control group |
|
| Within 1 months after ERCP |
| Clinical Success Rate | Complete removal of gallbladder stones. | Within 1 months after ERCP |
| The Proportion of Patients with Other Complications | Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc. | Within 6 months after ERCP |