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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05056506
Other study ID # 2021-02-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date October 30, 2023

Study information

Verified date August 2023
Source First People's Hospital of Hangzhou
Contact Jianfeng Yang, Doctor
Phone 086-13454132186
Email yjf-1976@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

ERCP is the best option to remove bile duct stones. It can be done by either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. Some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (EPLBD) alone or combined with limited EST, establishing it as a safe treatment for the removal of large bile duct stones. The investigators conducted the present study to compare the therapeutic outcome and complications between EPLBD alone and limited EST plus EPLBD for the treatment of large bile duct stones.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
EPLBD
Endoscopic papillary large balloon dilation for Choledocholithiasis
ELPBD+ESD
Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis

Locations

Country Name City State
China Hangzhou First People's Hospital Hangzhou Zhejiang
China Shanghai Fourth People's Hospital Shanghai Shanghai

Sponsors (6)

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

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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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