Endoscopic papillary large balloon dilation with or without small endoscopic sphincterotomy do not preserve sphincter of Oddi function after large bile duct stones management: a prospective randomized study
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000877
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
One week after EPLBD alone and EST with EPLBD, the basal pressure of SO dropped from 30.4 (8.2) to 6.4 (8.4) (p < .001) and 29.5 (18.9) to 2.9 (3.6) mmHg (p < .001), respectively. SO function was not recovered at 1 year, as the manometric measures were similar to those taken at the 1-week time point in both groups. Similar outcomes were obtained in patients with EPLBD alone compared with those with EST and EPLBD, including initial stone clearance rate (95.2% vs. 97.7%, p = .612), frequency of mechanical lithotripsy (21.4% vs. 13.6%), and overall complications (11.9% vs. 13.6%, p = 1.0) including post-procedure pancreatitis rate (7.1% vs. 11.4%, p = .714). During an overall median follow-up of 17.8 months, the bile duct stone recurrence rate was 16.7% in EPLBD alone patients and 15.9% in EST with EPLBD patients (p = .924).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Patients who have large bile duct stones (stone diameter > 12mm) and do not perfom a previous ednoscopic sphincterotomy
1. coagulopathy (> 1.5 INR)
2. pregnant
3. Previous EST
4. Anticoagulants or antiplateate agents user
5. Stone diameter more than 50mm
6. Failure a selective bile duct cannulation
9. less than 18 years or more than 90 years
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of sphincter of Oddi funtion after two procedures;Success rate of common bile duct stones
- Secondary Outcome Measures
Name Time Method Complications rate related with procedures;Mechanical lithotripsy use