Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

Study Overview
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Brief Summary
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At our hospital (Kepler University Hospital Linz) we perform all variants of ERCP (preoperative, intraoperative, postoperative ERCP). In cases of simultaneous cholecysto- and choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. We have established a standardized procedure with implemented logistics. We want to compare intraoperative and postoperative ERCP.

Detailed Description
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At our hospital (Kepler University Hospital Linz) we perform all variants of ERCP (preoperative, intraoperative, postoperative ERCP). In cases of simultaneous cholecysto- and choledocholithiasis, we prefer an intraoperative ERCP followed by a preoperative ERCP. We have a high level of expertise in endoscopy and an interdisciplinary endoscopy team (surgical and internal medicine department) makes this high level of effort possible. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. We have established a standardized procedure with implemented logistics. The aim of this study is to demonstrate and compare the advantages of both procedures at KUK from 1.1.2020 to 30.6.2023 (intraoperative and postoperative ERCP) in terms of morbidity, endoscopic success and the better way for patients and surgeons in our clinic.

Official Title
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Benefits and Advantages of Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis in a High Expertise Center

Conditions
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Cholelithiasis, Common Bile Duct

Intervention / Treatment
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* Procedure: endoscopic retrograde cholangiopancreatography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: simultaneous cholecysto-, choledocholithiasis emergency or elective confirmed choledocholithiasis intraoperative ERCP preoperative ERCP followed by cholecystectomy postoperative ERCP Exclusion Criteria: - < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraoperative ERCP<br>Patients with cholecystocholedocholithiasis getting intraoperative ERCP | Procedure: endoscopic retrograde cholangiopancreatography<br>* endoscopical clearance of the common bile duct<br>* Other names: ERCP;|
| Splitting<br>Patients with cholecystocholedocholithiasis getting therapeutic splitting | Procedure: endoscopic retrograde cholangiopancreatography<br>* endoscopical clearance of the common bile duct<br>* Other names: ERCP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP Pancreatitis | radiological/blood sample/pain | 48 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOS | length of stay | 9 months after first admission | 
| Surgical method | LSK, robotic, open | at surgery | 
| Re-choledocholithiasis | choledocholithiasis after ERCP | up to one year after first admission | 
| Re-Intervenition | any endoscopic/surgical/radiological intervention after surgery or ERCP | 30 days after surgery and/or ERCP | 
| Successful ERCP | yes or no | at ERCP | 
| Costs | costs for one patient | until 30 days after second surgery and/or ERCP |