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Completed

NCT Number: NCT07490730

Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones

Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Estonia Medical Centre

Tallinn, Harju, 13419, Estonia

About this study

Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Radiographically confirmed (ultrasonography, computed tomography, magnetic resonance cholangiopancreatography) stones in the common bile duct
  • Eligible for laparoscopic cholecystectomy
  • Understood and signed written consent form

Exclusion criteria

  • Severe cholangitis (according to TOKYO2018 guidelines)
  • Severe pancreatitis (BISAP score of 3 or more)
  • Septic shock
  • Common bile duct stones larger than 15 mm

Treatment and study plan

Primary outcomes

  1. Common bile duct clearance

    Time frame: 30 days

    The clearance rate of common bile duct from stones confirmed by post-procedural Magnetic Resonance Cholangiopancreatography (MRCP)

Secondary outcomes

  1. Operative time, 30-day post-operative complications, hospital length of stay

    Time frame: 30 days

    The duration of the operation in minutes from incision to skin closure; post-operative complications that were registered within 30 days after the operation, patients' hospital length of stay in days

Sponsors and collaborators

Lead sponsor

North Estonia Medical Centre

Other

Registry information

Official study title

Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones: A Prospective Validation Study With Postoperative MRCP Confirmation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

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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