Clinical trial NCT05056506: EPLBD With Limited EST vs. EPLBD for Choledocholithiasis
Official title: A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Choledocholithiasis
Keywords: Endoscopic sphincterotomy
Endoscopic papillary balloon dilation
Complication
Safety
Choledocholithiasis
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Second Affiliated Hospital of Wenzhou Medical University
name: The Second Affiliated Hospital of Jiaxing University
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Shanghai Fourth People's Hospital Tongji University
First posted: 2021-09-24
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of complications
timeFrame: within 1 months after the procedure
Secondary outcomes:
measure: The success rate of 1st session treatment
timeFrame: within 1 months after the procedure
measure: The rate of mechanical lithotripsy
timeFrame: within 1 months after the procedure
measure: Total ercp times
timeFrame: within 1 months after the procedure
measure: Overall successful stone removal rate
timeFrame: within 1 months after the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Xiaofeng Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.