Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Pseudocyst
- Sponsor
- Yiqi Du
- Enrollment
- 106
- Primary Endpoint
- Cyst recurrence rate
- Last Updated
- 9 years ago
Overview
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 1. Subject with ages from 18-80 years old 2. Subject with pancreatic pseudocysts confirmed by CT 3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months 4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall 5. Subject has the symptoms related with the pseudocyst 6. The consent form has been signed Exclusion criteria 1. Subject is younger than 18 years or older than 80 years 2. Pancreatic pseudocyst communicate with the main pancreatic duct 3. Subject can't accept the endoscopic procedure 4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess 5. The distance between gastric and the wall of the pseudocyst is more than 1 cm 6. Subject with 2 or more than 2 cysts 7. Subject has blood coagulation dysfunction 8. Pregnant or subject has mental disorders
Investigators
Yiqi Du
Professor
Changhai Hospital
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
Outcomes
Primary Outcomes
Cyst recurrence rate
Time Frame: up to 12 months
Secondary Outcomes
- Complication rate(up to 12 months)
- Technical success rate(up to 48 hours)
- Clinical success rate(up to 12 months)