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

Not Applicable

• Conditions: Pancreatic Pseudocyst
• Interventions: Device: Double pigtail plastic stent (DPPS); Device: Lumen-apposing metal stent (LAMS)

• Registration Number: NCT03027895
• Lead Sponsor: Yiqi Du

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-14
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-23
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30
• Study Start: 2018-09
• Primary Completion: 2019-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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

Primary Outcome Measures

Name	Time	Method
clinical success	uo to 1 months	The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased

Secondary Outcome Measures

Name	Time	Method
adverse event	up to 2months/ stent remove	any adverse event occured after stent inserted
recurrence rate	up to 12 months	After the clinical success, imaging examination show cyst again and accompanied by symptoms
technical success	up to 48 hours	Stent placed through the wall bracket and pancreatic pseudocyst successfully