Choledocholithiasis
Conditions
Keywords
Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Complication, Safety, Choledocholithiasis
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.
Interventions
PROCEDUREEPLBD
Endoscopic papillary large balloon dilation for Choledocholithiasis
PROCEDUREELPBD+ESD
Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis
Sponsors
First Affiliated Hospital of Zhejiang University
Second Affiliated Hospital of Wenzhou Medical University
The Second Affiliated Hospital of Jiaxing University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Shanghai Fourth People's Hospital Tongji University
Jianfeng Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of complications | within 1 months after the procedure | The incidence of complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The success rate of 1st session treatment | within 1 months after the procedure | The success rate of 1st session treatment |
| The rate of mechanical lithotripsy | within 1 months after the procedure | The rate of mechanical lithotripsy |
| Total ercp times | within 1 months after the procedure | Total ercp numbers |
| Overall successful stone removal rate | within 1 months after the procedure | Overall successful stone removal rate |
Countries
China
Contacts
Primary ContactJianfeng Yang, Doctor
Backup ContactLei Lu
Outcome results
None listed