Cholelithiasis
Conditions
Interventions
A: Traditional two-steps group:ERCP for removing calculus + ENBD + LC
B: One-step group:LC + LCBDE + choledochoscope + one stage suture after CBD incision
C: New two-steps group:ERCP for examination + 6-8mm balloon dilatation +ENBD+LC+LCBDE+choledochoscope+one stage suture after CBD incision
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
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 0.6-1.0cm, diameter of CBD is <2.5cm; 3. General condition is fine without other organ diseases; 4. The ERCP or surgical indications are clear without contraindications (selective operation: cholelithiasis has been controlled over a month; emergency operation: cholangitis attack is in 72 hours); 5. No other treatments for biliary calculus before this study, such as ERCP or operations; 6. Aged 18 to 80 years; 7. Baseline laboratory examination: PLT=100×10^9/L, ALT or AST = 3 ×ULN; TBIL=85µmol/L; creatinine= 1.5 × ULN; INR < 1.5 or PT< 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 suffered from malignancy tumor in 5 years; 12. Renal insufficiency, which is treated with 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. HIV infection; 17. Nervous system disease; 18. 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
| Measure | Time frame |
|---|---|
| Operative successful rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early postoperative complications and death;Late postoperative complications;Total operation time;Opration time for ERCP;Time of laparoscope operation;Length of stay;Total cost;Postoperative pain score;Patients' satisfaction;Symptom of digestive tract;Function of Oddi's sphincter; | — |
Countries
China
Contacts
Public ContactHua Yunpeng
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed