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Endoscopic papillary gradual balloon dilation versus endoscopic sphincterotomy with balloon dilatation on postoperative complications of common bile duct stones =1cm: a randomized, controlled, prospective, multi-center clinical study

Endoscopic papillary gradual balloon dilation versus endoscopic sphincterotomy with balloon dilatation on postoperative complications of common bile duct stones =1cm: a randomized, controlled, prospective, multi-center clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099872
Enrollment
Unknown
Registered
2025-03-31
Start date
2024-06-25
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Common bile duct stones

Interventions

Group A:Slow balloon dilation + ENBD
Group B:Duodenal papillotomy balloon dilation ENBD

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Imaging examination showed that the maximum diameter was less than 1.0cm, and the diameter of the common bile duct was =100×10^9/L Serum creatinine < = 1.5 × ULN INR < 1.5, or prothrombin time < ULN 4 seconds; 6. The patient has good compliance, can cooperate with the trial observation, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Acute obstructive purulent cholangitis; 2. Preoperative complication with acute pancreatitis; 3. Malignant tumors of the bile ducts; 4. After gastrectomy; 5. Previous ERCP; 6. Imaging showed intrahepatic bile duct stones; 7. Patients with obvious stenosis of intrahepatic and extrahepatic bile ducts, or combined with immune or sclerosing cholangitis; 8. HCG-positive females of childbearing potential or lactating females; 9. Poor general condition or cachexia; 10. Any of the following conditions within the 12 months prior to the start of the study: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; Occurring: Arrhythmias according to NCI-CTCAE criteria >=grade 2 with QTc interval prolongation (>450 msec for males and 470 msec > females); 11. History of malignancy within 5 years; 12. Renal insufficiency, requiring peritoneal dialysis or hemodialysis; 13. Severe dysfunction of other important organs; 14. Hemophilia or bleeding tendency, taking therapeutic amounts of coumarin derivatives and other anticoagulant therapy; 15. History of previous organ transplantation; 16. Known HIV infection; 17. Have a mental illness; 18. Refuse to participate; 19. Patients with other serious acute or chronic physical or psychiatric diseases or abnormal laboratory tests that may increase the risk associated with participating in study treatment, or that may interfere with the interpretation of study results or that the investigator considers unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Post-ERCP pancreatitis;

Secondary

MeasureTime frame
Success rate of stone removal;Short-term complications;Long-term complications;

Countries

China

Contacts

Public ContactYunpeng Hua

The First Affiliated Hospital,Sun Yat-sen University

hyp0427@163.com+86 13318835569

Outcome results

None listed

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