Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis

Phase 3

Recruiting

• Conditions: choledocholithiasis; Choledocholithiasis; Cholelithiasis; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

• Registration Number: RPCEC00000013
• Lead Sponsor: ational Center for Minimal Access Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients older than 15 years-old, both gender, with gallbladder in situ and preoperative suspect of choledocholithiasis CLINICAL FEATURES: Jaundice – Recent acute pancreatitis or cholangitis – Colic pain with jaundice and pyrexia LIVER FUNCTION TESTS: Elevated bilirubin, alkaline phosphatase and GGT EXTERNAL ULTRASOUND FINDINGS Common bile duct > 8 mm- Common bile duct Stone

Exclusion Criteria

- Acute cholecystitis – Acute cholangitis – Acute pancreatitis - Contraindication for laparoscopic surgery and/or ERCP – Anesthetic contraindication ( ASA IV y V)- Pregnant woman- ERCP previous- Extensive adhesions in abdominal right quadrant- Patients that refuse the treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success on the procedures of stone extraction, timepoint: at the end of surgical procedure. Morbidity and mortality, timepoint: at the follow-up, on 30 days after procedure.

Secondary Outcome Measures

Name	Time	Method
Operative time”, timepoint: at the end of surgical procedure. Hospital stay, timepoint: at the follow-up, on 1-7 days after procedure. Diagnosis of residual choledocholithiasis, timepoint: at the follow-up, on 2 years after procedure. Cost of surgical procedure”, timepoint: at the end of hospital stay.