Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
1 other identifier
interventional
256
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 30, 2018
March 1, 2018
1 year
January 14, 2017
March 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
clinical success
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
uo to 1 months
Secondary Outcomes (3)
adverse event
up to 2months/ stent remove
recurrence rate
up to 12 months
technical success
up to 48 hours
Study Arms (2)
Lumen-apposing metal stent(LAMS)
EXPERIMENTALLumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
Double pigtail plastic stent(DPPS)
ACTIVE COMPARATORDouble pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
Interventions
Endoscopic Ultrasound-guided Drainage of WON with LAMS
Endoscopic Ultrasound-guided Drainage of WON with DPPS
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yiqi Dulead
Related Publications (1)
Zhu HY, Xie P, Song YX, Li ZS, Jin ZD, Du YQ. Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial. Trials. 2018 Oct 11;19(1):549. doi: 10.1186/s13063-018-2901-3.
PMID: 30305160DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 14, 2017
First Posted
January 23, 2017
Study Start
September 1, 2018
Primary Completion
September 1, 2019
Study Completion
September 1, 2020
Last Updated
March 30, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share