Choledocholithiasis Clinical Trial
Official title:
A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis
Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ML). The present study aims to compare the efficacy and safety of limited EST plus endoscopic papillary balloon dilation (EST-EPBD) with endoscopic papillary large balloon dilation for large choledocholithiasis.
Status | Recruiting |
Enrollment | 168 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - large bile duct stones (=10 mm) Exclusion Criteria: - pregnancy - refusal of written informed consent - Patients with benign or malignant biliary stricture - Contraindications to ERCP exist - Complicated with acute pancreatitis or acute cholangitis - Coagulation dysfunction,thrombocytopenia - prior EST or EPBD - Patients after gastrointestinal reconstruction |
Country | Name | City | State |
---|---|---|---|
China | Hangzhou First People's Hospital | Hangzhou | Zhejiang |
China | Shanghai Fourth People's Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jianfeng Yang | First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Wenzhou Medical University, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University |
China,
Hwang JC, Kim JH, Lim SG, Kim SS, Shin SJ, Lee KM, Yoo BM. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol. 2013 Jan 17;13:15. doi: 10.1186/1471-230X-13-15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of complications | The incidence of complications | within 1 months after the procedure | |
Secondary | The success rate of 1st session treatment | The success rate of 1st session treatment | within 1 months after the procedure | |
Secondary | The rate of mechanical lithotripsy | The rate of mechanical lithotripsy | within 1 months after the procedure | |
Secondary | Total ercp times | Total ercp numbers | within 1 months after the procedure | |
Secondary | Overall successful stone removal rate | Overall successful stone removal rate | within 1 months after the procedure |
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