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

Yiqi Du256 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

256

Conditions

Pancreatic Pseudocyst

Interventions

Lumen-apposing metal stent (LAMS)DEVICE

Endoscopic Ultrasound-guided Drainage of WON with LAMS

Double pigtail plastic stent (DPPS)DEVICE

Endoscopic Ultrasound-guided Drainage of WON with DPPS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

clinical success

The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased

Time frame: uo to 1 months

Secondary Outcomes

adverse event

any adverse event occured after stent inserted

Time frame: up to 2months/ stent remove

recurrence rate

After the clinical success, imaging examination show cyst again and accompanied by symptoms

Time frame: up to 12 months

technical success

Stent placed through the wall bracket and pancreatic pseudocyst successfully

Time frame: up to 48 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.