Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

Yiqi Du

Status: Unknown

Conditions: Pancreatic Pseudocyst

Treatments: Device: Lumen-apposing metal stent (LAMS); Device: Double pigtail plastic stent (DPPS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03027895

2017010302

Details and patient eligibility

About

The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.

Full description

Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.

Enrollment: 256 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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256 participants in 2 patient groups

Lumen-apposing metal stent(LAMS)

Experimental group

Description:

Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS

Treatment:

Device: Lumen-apposing metal stent (LAMS)

Double pigtail plastic stent(DPPS)

Active Comparator group

Description:

Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS

Treatment:

Device: Double pigtail plastic stent (DPPS)