UnknownNot Applicable

DIGEST I Drug Coated Balloon for Biliary Stricture

Paraguay8 participantsStarted 2019-05-12

Plain-language summary

DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

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

. Age ≥ 18 and ≤ 80 years.
. Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
. Restenosis after plain balloon dilation with at least 2 previous balloon dilation sessions and recurrence of biliary obstructive symptoms/signs or being managed with implantable prosthetics (e.g. plastic stents).
. Greater than 40% stenosis of the biliary tract via ERCP.
. Total serum bilirubin \>2 mg/dL. Alkaline phosphatase level \>3 times higher than normal level. \*Note: This IC is waved if the patient is being managed with implantable prosthetics.
. Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
. Stricture length \<4 cm.
. Not currently listed for liver transplantation.

Exclusion criteria

. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
. Benign biliary strictures caused by pancreatic pseudocyst compression.

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

Incident of serious balloon dilation-related complications

Timeframe: 30 days

Freedom from Biliary Stricture Re-intervention

Timeframe: 12 months

Trial details

NCT IDNCT03997994

SponsorGIE Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-21

View on ClinicalTrials.gov More Biliary Stricture trials