Clinical Trial: Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial
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 Summary:
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
Sponsor: Yiqi Du
Current Primary Outcome: Cyst recurrence rate [ Time Frame: up to 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Technical success rate [ Time Frame: up to 48 hours ]
- Clinical success rate [ Time Frame: up to 12 months ]
- Complication rate [ Time Frame: up to 12 months ]
Original Secondary Outcome: Same as current
Information By: Changhai Hospital
Dates:
Date Received: January 11, 2017
Date Started: February 2017
Date Completion: December 2017
Last Updated: January 12, 2017
Last Verified: January 2017
