choledocholithiasis
Conditions
Interventions
A prospective randomized controlled clinical trial compared three management options for the patients with choledocholithiasis. In summary, the intake was restricted to fit patients (ASA I and II) in
Sphincterotomy, Endoscopic
Cholecystectomy, Laparoscopic
Cholangiopancreatography, Endoscopic Retrograde
Sponsors
National Center for Minimal Access Surgery
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "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
| Measure | Time frame |
|---|---|
| "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. | — |
Countries
Cuba
Contacts
Public ContactJavier Barreras González
National Center for Minimal Access Surgery
Outcome results
None listed