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.

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.

✓. 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.

✕. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
✕. Benign biliary strictures caused by pancreatic pseudocyst compression.
✕. Malignant biliary obstruction.
✕. Biliary obstruction associated with an attack of acute pancreatitis.
✕. Inability to pass guidewire across stricture.
✕. Subjects with cholangitis or bile leak or duct fistula.
✕. Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
✕. Subject with an internal/external biliary drainage catheter.

Incident of serious balloon dilation-related complications

Timeframe: 30 days

Freedom from Biliary Stricture Re-intervention

Timeframe: 12 months

NCT IDNCT03997994

SponsorGIE Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-21

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.

✓. 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.

✕. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
✕. Benign biliary strictures caused by pancreatic pseudocyst compression.
✕. Malignant biliary obstruction.
✕. Biliary obstruction associated with an attack of acute pancreatitis.
✕. Inability to pass guidewire across stricture.
✕. Subjects with cholangitis or bile leak or duct fistula.
✕. Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
✕. Subject with an internal/external biliary drainage catheter.