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 range

18 Years – 80 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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