Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

Not Applicable

• Conditions: Pancreatic Pseudocyst
• Interventions: Device: Endoscopic Ultrasound-guided Drainage

• Registration Number: NCT03022110
• Lead Sponsor: Yiqi Du

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

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Last Update Submitted: 2017-01-12
• Study First Posted: 2017-01-16
• Last Update Posted: 2017-01-16
• Study Start: 2017-02
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plastic stent	Endoscopic Ultrasound-guided Drainage	Endoscopic Ultrasound-guided Drainage with plastic stent
lumen-apposing metal stent (LAMS)	Endoscopic Ultrasound-guided Drainage	Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent

Primary Outcome Measures

Name	Time	Method
Cyst recurrence rate	up to 12 months

Secondary Outcome Measures

Name	Time	Method
Complication rate	up to 12 months
Technical success rate	up to 48 hours
Clinical success rate	up to 12 months