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Completed

NCT Number: NCT06130163

Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

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.

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Key information

Conditions

Cholelithiasis, Common Bile Duct Bile Duct Diseases Biliary Tract Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler University Hosital Linz

Linz, Austria, 4020

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • < 18 years

Treatment and study plan

Endoscopic retrograde cholangiopancreatography

Procedure

endoscopical clearance of the common bile duct

Other names: ERCP

Primary outcomes

  1. Post-ERCP Pancreatitis

    Time frame: 48 hours after intervention

    radiological/blood sample/pain

Secondary outcomes

  1. LOS

    Time frame: 9 months after first admission

    length of stay

  2. Surgical method

    Time frame: at surgery

    LSK, robotic, open

  3. Re-choledocholithiasis

    Time frame: up to one year after first admission

    choledocholithiasis after ERCP

  4. Re-Intervenition

    Time frame: 30 days after surgery and/or ERCP

    any endoscopic/surgical/radiological intervention after surgery or ERCP

  5. Successful ERCP

    Time frame: at ERCP

    yes or no

  6. Costs

    Time frame: until 30 days after second surgery and/or ERCP

    costs for one patient

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2023
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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