Clinical trial NCT06130163: Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis
Official title: Benefits and Advantages of Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis in a High Expertise Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholelithiasis, Common Bile Duct
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgery and ERCP in context to cholecysto-, choledocholithiasis in out hospital

Brief summary: At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) are performed in cases of simultaneous cholecysto- and choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. A standardized procedure with implemented logistics has been established. This study compares intraoperative and postoperative ERCP.

Detailed description: At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) in cases of simultaneous cholecysto- and choledocholithiasis are performed. Usually an intraoperative ERCP followed by a preoperative ERCP is preferred. At the Kepler University hospital 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. A standardized procedure with implemented logistics has been established.

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 clinics.

Eligibility criteria: Inclusion Criteria:

* simultaneous cholecysto-, choledocholithiasis
* emergency or elective
* confirmed choledocholithiasis
* intraoperative ERCP
* preoperative ERCP followed by cholecystectomy
* postoperative ERCP

Exclusion Criteria:

- \< 18 years

Primary outcomes:
measure: Post-ERCP Pancreatitis
timeFrame: 48 hours after intervention
Secondary outcomes:
measure: LOS
timeFrame: 9 months after first admission
measure: Surgical method
timeFrame: at surgery
measure: Re-choledocholithiasis
timeFrame: up to one year after first admission
measure: Re-Intervenition
timeFrame: 30 days after surgery and/or ERCP
measure: Successful ERCP
timeFrame: at ERCP
measure: Costs
timeFrame: until 30 days after second surgery and/or ERCP
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hosital Linz
Study officials:
affiliation: Kepler University Hospital Linz
name: Andreas Shamiyeh, Dr.
role: STUDY_CHAIR
affiliation: Kepler University Hospital Linz
name: Sandra Raab, Dr.
role: PRINCIPAL_INVESTIGATOR
References: