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A Prospective, Randomized Controlled Trial of Laparoscopic Transcystic Common Bile Duct Exploration plus Laparoscopic Cholecystectomy versus Endoscopic Retrograde Cholangiopancreatography plus Laparoscopic Cholecystectomy for Choledocholithiasis

A Prospective, Randomized Controlled Trial of Laparoscopic Transcystic Common Bile Duct Exploration plus Laparoscopic Cholecystectomy versus Endoscopic Retrograde Cholangiopancreatography plus Laparoscopic Cholecystectomy for Choledocholithiasis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051547
Enrollment
Unknown
Registered
2021-09-26
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis

Interventions

Study Group:Laparoscopic common bile duct exploration through the cystic duct + laparoscopic cholecystectomy
Control Group:Endoscopic retrograde cholangiopancreatography combined with laparoscopic cholecystectomy

Sponsors

The First Affiliated Hospital of Chengdu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the clinical diagnosis of secondary choledocholithiasis, and imaging evidence proves choledocholithiasis combined with gallbladder stones; 2. Age 18-65 years old, no gender restrictions, normal spirit and full capacity for civil conduct; 3. Agree and sign the informed consent form for the study in writing, the consent form for related treatment, anesthesia and surgery, and accept the treatment plan formulated according to the random grouping; 4. Baseline laboratory tests meet the following criteria: serum ALT, AST =100x10^9/L; 5. Preoperative imaging measurements: the diameter of the confluence of the cystic duct is >5mm (can pass through the choledochoscope), and the minimum diameter of the largest stone in the common bile duct is <5mm (can be taken out through the cystic duct); 6. The indications for laparoscopic and ERCP surgery are clear, and there are no surgical contraindications (ASA score <= 3).

Exclusion criteria

Exclusion criteria: 1. Any preoperative imaging examination showing intrahepatic gallbladder, liver cirrhosis, liver mass or abscess; 2. Any preoperative imaging examination evidence of suppurative or necrotizing cholecystitis, gallbladder empyema or perforation; 3. History of previous upper abdominal surgery, previous history of ERCP and EST operations; 4. Patients who are converted to laparotomy for any reason; 5. Morbid obesity (BMI> 40.0); 6. Female patients who are pregnant, within 28 days of postpartum or breastfeeding; 7. Requires continuous immunosuppressive therapy or systemic corticosteroids; 8. Severe interstitial pneumonia, pulmonary fibrosis or severe emphysema; 9. Uncontrolled diabetes; 10. Severe systemic organ dysfunction (chronic liver, kidney, heart disease); 11. HIV positive; 12. Patients who only underwent ERCP without LC.

Design outcomes

Primary

MeasureTime frame
Stone Clearance;

Secondary

MeasureTime frame
Postoperative pancreatitis incidence;Postoperative biliary fistula incidence;Ovarall postoperative complication rate;

Countries

China

Contacts

Public ContactHao Jingcheng

The First Affiliated Hospital of Chengdu Medical College

jingcheng.hao@cmc.edu.cn+86 18908011416

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026