UnknownNot Applicable

Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent

South Korea256 participantsStarted 2017-07-12

Plain-language summary

The aim of this animal study is determining the technical feasibility of the novel flower-type covered self-expandable metal stent (F-CSEMS) and investigating whether the novel flower-type covered self-expandable metal stent (F-CSEMS) could prevent cholecystitis and pancreatitis, comparing with conventional covered self-expandable metal stent (C-CSEMS).

Who can participate

Age range

19 Years – 85 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: * Adults from 19 to 85 years of age who have voluntarily agreed to the clinical trial and signed a written agreement * Patients with malignant extrahepatic bile duct obstruction without surgery Exclusion Criteria: * Patients who had already undergone surgical biliary drainage * Patients who previously underwent percutaneous spinal cholecystectomy (PTGBD) * Patients who underwent conventional metal-on-metal self-expandable metal stents (C-CSEMS) * Patients who underwent biliary plastic stent implantation for more than 15 days * Patients with malignant stricture of the intrahepatic bile duct and patients with stenosis within 2 cm of the liver * Patients whose expected life expectancy is less than 3 months * Pregnant patient * Patients who can not undergo endoscopic procedures based on the judgment of the researcher

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

Pancreatitis, Cholecystitis - Occurrence rate : %

Timeframe: 3 months after procedure

Pancreatitis, Cholecystitis - Severity

Timeframe: 3 months after procedure

Trial details

NCT IDNCT03215108

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-01

Contact for this trial

Jong Kyun Lee, MD PhD

+82-2-3410-3409 jongk.lee@samsung.com

View on ClinicalTrials.gov More Malignant Biliary Obstruction trials