Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

Yiqi Du

Status: Unknown

Conditions: Pancreatic Pseudocyst

Treatments: Device: Endoscopic Ultrasound-guided Drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT03022110

2017010301

Details and patient eligibility

About

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.

Full 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

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

plastic stent

Active Comparator group

Description:

Endoscopic Ultrasound-guided Drainage with plastic stent

Treatment:

Device: Endoscopic Ultrasound-guided Drainage

lumen-apposing metal stent (LAMS)

Experimental group

Description:

Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent

Treatment:

Device: Endoscopic Ultrasound-guided Drainage