DIGEST I Drug Coated Balloon for Biliary Stricture (DIGEST)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Biliary Disease; Biliary Stricture; Biliary Obstruction; Biliary Anastomotic Stenosis
• Intervention / Treatment: Device: GIE Drug Coated Balloon

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Adventista Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. Benign biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
3. 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).
4. Greater than 40% stenosis of the biliary tract via ERCP.
5. 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.
6. Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
7. Stricture length <4 cm.
8. Not currently listed for liver transplantation.
9. Voluntary participation and provided written informed consent.

Exclusion Criteria:

1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
2. Benign biliary strictures caused by pancreatic pseudocyst compression.
3. Malignant biliary obstruction.
4. Biliary obstruction associated with an attack of acute pancreatitis.
5. Inability to pass guidewire across stricture.
6. Subjects with cholangitis or bile leak or duct fistula.
7. Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
8. Subject with an internal/external biliary drainage catheter.
9. Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
10. Subject with symptomatic duodenal stenosis (with gastric stasis)
11. Active systemic infection.
12. Allergy to paclitaxel or any components of the delivery system.
13. Currently undergoing required thoracic or abdominal cavity radiation therapy.
14. Has life expectancy <12 months.
15. Unwilling or unable to comply with the follow-up study requirements.
16. Lacking capacity to provide informed consent.
17. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
18. Currently participation in another pre-market drug or medical device clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GIE Medical
• Investigators: Principal Investigator: Bret T Petersen, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2019
• Primary Completion (ANTICIPATED): March 21, 2024
• Study Completion (ANTICIPATED): March 21, 2025

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (ACTUAL): June 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis; Gallbladder Diseases
• Other Study ID Numbers: PR 2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes