Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 256
- Primary Endpoint
- clinical success
Study Overview
Brief Summary
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.
Detailed Description
Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject with ages from 18-80 years old
- •Subject with pancreatic pseudocysts confirmed by CT
- •Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
- •The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
- •Subject has the symptoms related with the pseudocyst
- •The consent form has been signed
Exclusion Criteria
- •Subject is younger than 18 years or older than 80 years
- •Pancreatic pseudocyst communicate with the main pancreatic duct
- •Subject can't accept the endoscopic procedure
- •Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
- •The distance between gastric and the wall of the pseudocyst is more than 1 cm
- •Subject with 2 or more than 2 cysts
- •Subject has blood coagulation dysfunction
- •Pregnant or subject has mental disorders
Arms & Interventions
Lumen-apposing metal stent(LAMS)
Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
Intervention: Lumen-apposing metal stent (LAMS) (Device)
Double pigtail plastic stent(DPPS)
Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
Intervention: Double pigtail plastic stent (DPPS) (Device)
Outcomes
Primary Outcomes
clinical success
Time Frame: uo to 1 months
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
Secondary Outcomes
- adverse event(up to 2months/ stent remove)
- recurrence rate(up to 12 months)
- technical success(up to 48 hours)
Investigators
Yiqi Du
Professor
Changhai Hospital