Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000013
• Date of registration: 14/11/2008
• Primary sponsor: National Center for Minimal Access Surgery
• Public title: Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis
• Scientific title: Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis
• Date of first enrolment: 06/11/2007
• Target sample size: 450 patients (150 patients per group)
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000013-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Single Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Javier, MD Barreras González
• Affiliation: National Center for Minimal Access Surgery

• Name: Javier, MD Barreras González
• Affiliation: National Center for Minimal Access Surgery

Key inclusion & exclusion 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: - 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

Age minimum: 15 years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

choledocholithiasis

Intervention(s)

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 whom choledocholithiasis were proven or suspected on the basis of the clinical features, liver function tests and external ultrasound findings. Essential investigations included full liver function tests and external ultrasound examination of the gallbladder and bile ducts and if not any exclusion criterion was present, the patients were randomized in three groups (I-experimental, II-control, III-control) by the sealed-envelope method based on a computer-generated list. The experimental group (I) received intraoperative cholangiography (IOC) to confirm the choledocholithiasis followed by laparoscopic cholecystectomy (LC) associated with intraoperative endoscopic retrograde cholangiography (ERC) and endoscopic stone extraction (ESE). The control group (II) received preoperative ERC with ESE followed by LC during the same hospital admission (24-48 hours after). The control group (III) received IOC to confirm the choledocholithiasis followed by LC associated with laparoscopic common bile duct exploration (LCBDE) with laparoscopic stone extraction.

Primary Outcome(s)

"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(s)

"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.

Secondary ID(s)

cncma002

Source(s) of Monetary Support

MINSAP