Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

Study Overview
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Brief Summary
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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
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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

Official Title
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Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial

Conditions
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Pancreatic Pseudocyst

Intervention / Treatment
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* Device: Endoscopic Ultrasound-guided Drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: plastic stent<br>Endoscopic Ultrasound-guided Drainage with plastic stent | Device: Endoscopic Ultrasound-guided Drainage<br>* Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound<br>|
| Experimental: lumen-apposing metal stent (LAMS)<br>Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent | Device: Endoscopic Ultrasound-guided Drainage<br>* Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cyst recurrence rate |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate |  | up to 48 hours | 
| Clinical success rate |  | up to 12 months | 
| Complication rate |  | up to 12 months |