Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture

GIE Medical1 site in 1 country8 target enrollmentMay 12, 2019

ConditionsBiliary Stricture Biliary Anastomotic Stenosis Biliary Obstruction Biliary Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Biliary Stricture
Sponsor: GIE Medical
Enrollment: 8
Locations: 1
Primary Endpoint: Freedom from Biliary Stricture Re-intervention
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on biliary tract stricture. Up to 15 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Registry

clinicaltrials.gov

Start Date

May 12, 2019

End Date

March 21, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GIE Medical

Responsible Party

Sponsor

Eligibility Criteria

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.
•Voluntary participation and provided written informed consent.

Exclusion Criteria

•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.
•Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
•Subject with symptomatic duodenal stenosis (with gastric stasis)

Outcomes

Primary Outcomes

Freedom from Biliary Stricture Re-intervention

Time Frame: 12 months

Biliary stricture re-intervention rate

Incident of serious balloon dilation-related complications

Time Frame: 30 days

No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.

Secondary Outcomes

Change in Liver Function(Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months)
Time to the First Re-intervention(12 months and 24 months)
Technical Success(0 months)
Biliary Stricture Diameter(Baseline, 6 months)
Long Term Clinical Success (LTCS)(12 months and 24 months)
Mean number of dilations(12 months and 24 months)
Change in Existing Biliary Obstructive Symptoms(Baseline, 30 days, 3 months, 6 months, 12 months and 24 months)
Sustained Clinical Success (SCS)(12 months and 24 months)