CompletedNot Applicable

A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis

China50 participantsStarted 2021-05-01

Plain-language summary

Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Obtention of a written informed consent * According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON * The diameter of WON ≥6cm * Patient capable of fill in the quality of life questionnaire * The distance between the EUS-probe and WON was \< 1 cm. Exclusion Criteria: * No written informed consent * pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors * pancreatic pseudocyst * WON too far from the stomach and duodenum to perform endoscopic drainage * Serious abnormalities in liver and kidney function and coagulation function * Pregnant, parturient or breastfeeding women

What they're measuring

clinical success (clinical improvement and resolution of WON)

Timeframe: two months

Trial details

NCT IDNCT04876235

SponsorFirst People's Hospital of Hangzhou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Walled-off Necrosis trials