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Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with concomitant gallbladder stones and common bile duct stones: a randomized controlled trial

Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with concomitant gallbladder stones and common bile duct stones: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036651
Enrollment
Unknown
Registered
2020-08-24
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Concomitant gallbladder stones and common bile duct stones

Interventions

Group 1:LCBDE plus LC
Group 2:ERCP plus LC

Sponsors

Shanghai Tenth Peoples' Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Gallstones and CBD stones are indicated by image examinations; 2. CT or MRCP shows that the biggest CBD stone is between 1.0-2.5cm, diameter of CBD is = 100 x 10^9/L, ALT or AST <= 3 x ULN; TBIL <= 85µmol/L; creatinine <= 1.5 x ULN; INR < 1.5PT < ULN+4s; 8. Patients with good compliance can follow the protocol of the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute obstructive pyogenic cholangitis; 2. Combining with acute pancreatitis before operation; 3. Malignancy tumor of bile duct; 4. After subtotal gastrectomy; 5. After cholecystectomy; 6. Combining with intrahepatic duct stones indicated by imaging examinations; 7. Obvious stenosis of bile duct, immunity or sclerosing cholangitis; 8. HCG positive female or lactating female; 9. Cachexy or poor general conditions; 10. Have any conditions described below 12 months before study: myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting, CHF, stroke (including transient ischemic cerebrovascular disease), pulmonary embolism, in progress: arrhythmia over stage 2 in NCI-CTCAE, QT interval prolongation (male > 450ms, female > 470ms); 11. Have had malignancy tumor in 5 years; 12. Renal insufficiency which needs hemodialysis or peritoneal dialysis; 13. Other severe dysfunction of other organ; 14. Haemophilia or bleeding tendency with anticoagulant therapy; 15. Have had organ grafting; 16. Have other physiologically or nervous system diseases and abnormal condition of laboratory examination which can increase risks related to the study or disturb discussion of the study results.

Design outcomes

Primary

MeasureTime frame
Operative successful rate;early postoperative complications and death;late postoperative complications;—

Secondary

MeasureTime frame
Operative time of "one step";Operative time of ERCP;length of stay;patients' satisfaction;diastase & lipase;—

Countries

China

Contacts

Public ContactZhenshun, Song

Shanghai Tenth Peoples' Hospital

zhenshunsong@aliyun.com+86 021-66307365

Outcome results

None listed

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