DIGEST I Drug Coated Balloon for Biliary Stricture

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

Detailed Description
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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.

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

Conditions
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Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction, Biliary Disease

Intervention / Treatment
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* Device: GIE Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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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) Active systemic infection. Allergy to paclitaxel or any components of the delivery system. Currently undergoing required thoracic or abdominal cavity radiation therapy. Has life expectancy <12 months. Unwilling or unable to comply with the follow-up study requirements. Lacking capacity to provide informed consent. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. Currently participation in another pre-market drug or medical device clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: DCB Treatment<br>Stricture patients treated by DCB | Device: GIE Drug Coated Balloon<br>* The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident of serious balloon dilation-related complications | No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc. | 30 days | 
| Freedom from Biliary Stricture Re-intervention | Biliary stricture re-intervention rate | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Function | . Liver function tests include total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) | Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months | 
| Change in Existing Biliary Obstructive Symptoms | The common biliary obstructive symptoms are right upper quadrant pain (survey), fever/chills (cholangitis), jaundice, itching, dark urine, pale stools, nausea/vomiting, weight loss | Baseline, 30 days, 3 months, 6 months, 12 months and 24 months | 
| Biliary Stricture Diameter | Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP) | Baseline, 6 months | 
| Time to the First Re-intervention | The mean time to the first re-intervention (scheduled and unscheduled) will be assessed | 12 months and 24 months | 
| Sustained Clinical Success (SCS) | SCS defined as a period of at least 6 months with no need for further endoscopic intervention | 12 months and 24 months | 
| Long Term Clinical Success (LTCS) | LTCS, defined as no need for further endoscopic intervention for at least 24 months | 12 months and 24 months | 
| Mean number of dilations | Mean number of dilations required to achieve SCS and LTCS | 12 months and 24 months | 
| Technical Success | Technical success is defined as successful insertion, dilatation of the target biliary stricture, and finally withdrawal of the device with no device malfunctions. | 0 months |