EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056506
• Other study ID #: 2021-02-01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Choledocholithiasis

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