Back to resultsEndoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts
Primary Purpose
Pancreatic Pseudocyst
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic Ultrasound-guided Drainage
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
Active Comparator
Experimental
Arm Label
plastic stent
lumen-apposing metal stent (LAMS)
Arm Description
Endoscopic Ultrasound-guided Drainage with plastic stent
Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent
Outcomes
Primary Outcome Measures
Cyst recurrence rate
Secondary Outcome Measures
Technical success rate
Clinical success rate
Complication rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03022110
Brief Title
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts
Official Title
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yiqi Du
4. Oversight
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 traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.
Detailed Description
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
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
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
plastic stent
Arm Type
Active Comparator
Arm Description
Endoscopic Ultrasound-guided Drainage with plastic stent
Arm Title
lumen-apposing metal stent (LAMS)
Arm Type
Experimental
Arm Description
Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent
Intervention Type
Device
Intervention Name(s)
Endoscopic Ultrasound-guided Drainage
Intervention Description
Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound
Primary Outcome Measure Information:
Title
Cyst recurrence rate
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Technical success rate
Time Frame
up to 48 hours
Title
Clinical success rate
Time Frame
up to 12 months
Title
Complication rate
Time Frame
up to 12 months
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
Learn more about this trial
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts
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