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Endoscopic sphincterotomy combined with restricted balloon dilation versus endoscopic sphincterotomy combined with full balloon dilation in the treatment of difficult choledocholithiasis <=15mm in diameter: a single-center, open-label, randomized controlled trial

Endoscopic sphincterotomy combined with restricted balloon dilation versus endoscopic sphincterotomy combined with full balloon dilation in the treatment of difficult choledocholithiasis <=15mm in diameter: a single-center, open-label, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102473
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-03-27
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Choledocholithiasis

Interventions

Experimental group (restricted balloon dilation group):The balloon is not fully dilated, retaining the lumbar line
Control group(Full balloon dilation group):The balloon is fully expanded without retaining the waistline

Sponsors

Xiangyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old with clinically diagnosed choledocholithiasis and planned to undergo surgery; 2. The distal diameter of the common bile duct is greater than or equal to 10mm; 3. Diameter of choledocholithiasis 10-15mm; 4. With the approval of the medical Ethics Committee, the patient and his family members will voluntarily sign the informed consent; 5. No serious systemic diseases. 6. Complete clinical data.

Exclusion criteria

Exclusion criteria: 1. Patients with coagulation dysfunction (international normalized ratio >1.3) and thrombocytopenia (platelet count <50×10? cells per liter) who have taken anticoagulant or antiplatelet drugs in the last 3 days; 2. Previous history of gastrointestinal reconstructive surgery, such as Bi II gastrectomy, gastrointestinal Roux-en-Y anastomosis, pancreaticoduodenectomy; 3. History of EST or EPBD before the surgery; 4. And pre-existing conditions, such as acute pancreatitis, gastrointestinal bleeding, severe liver disease, primary sclerosing cholangitis, cholangitis with septic shock; 5. Known Mirizzi syndrome or intrahepatic bile duct calculus or cholestroduodenal fistula; 6. Pregnant women and lactation period; 7. Common bile duct intubation failed.

Design outcomes

Primary

MeasureTime frame
Incidence of Oddi sphincter dysfunction (cholangitis, choledocholithiasis recurrence);

Secondary

MeasureTime frame
Success rate of stone removal during ERCP surgery;Incidence of postoperative gastrointestinal bleeding, duodenal perforation, and acute pancreatitis;operative time;

Countries

China

Contacts

Public ContactSun Huapeng

Xiangyang Central Hospital

sunhuapeng1@163.com+86 15971087436

Outcome results

None listed

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