Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
Primary Purpose
Pancreatic Pseudocyst
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumen-apposing metal stent (LAMS)
Double pigtail plastic stent (DPPS)
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Pseudocyst
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lumen-apposing metal stent(LAMS)
Double pigtail plastic stent(DPPS)
Arm Description
Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
Outcomes
Primary Outcome Measures
clinical success
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
Secondary Outcome Measures
adverse event
any adverse event occured after stent inserted
recurrence rate
After the clinical success, imaging examination show cyst again and accompanied by symptoms
technical success
Stent placed through the wall bracket and pancreatic pseudocyst successfully
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03027895
Brief Title
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
Official Title
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yiqi Du
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Pseudocyst
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lumen-apposing metal stent(LAMS)
Arm Type
Experimental
Arm Description
Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
Arm Title
Double pigtail plastic stent(DPPS)
Arm Type
Active Comparator
Arm Description
Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
Intervention Type
Device
Intervention Name(s)
Lumen-apposing metal stent (LAMS)
Intervention Description
Endoscopic Ultrasound-guided Drainage of WON with LAMS
Intervention Type
Device
Intervention Name(s)
Double pigtail plastic stent (DPPS)
Intervention Description
Endoscopic Ultrasound-guided Drainage of WON with DPPS
Primary Outcome Measure Information:
Title
clinical success
Description
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
Time Frame
uo to 1 months
Secondary Outcome Measure Information:
Title
adverse event
Description
any adverse event occured after stent inserted
Time Frame
up to 2months/ stent remove
Title
recurrence rate
Description
After the clinical success, imaging examination show cyst again and accompanied by symptoms
Time Frame
up to 12 months
Title
technical success
Description
Stent placed through the wall bracket and pancreatic pseudocyst successfully
Time Frame
up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30305160
Citation
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.
Results Reference
derived
Learn more about this trial
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
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