DIGEST I Drug Coated Balloon for Biliary Stricture

Biliary Stricture Clinical Trial

— DIGEST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03997994
• Other study ID #: PR 2002
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2019
• Est. completion date: March 21, 2025

Study information

• Verified date: August 2022
• Source: GIE Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: March 21, 2025
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Anastomotic Stenosis
• Biliary Disease
• Biliary Obstruction
• Biliary Stricture
• Cholestasis
• Constriction, Pathologic
• Gallbladder Diseases

Intervention

Device:
• GIE Drug Coated Balloon
The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.

Locations

Country	Name	City	State
Paraguay	Adventista Hospital	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
GIE Medical

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from Biliary Stricture Re-intervention	Biliary stricture re-intervention rate	12 months
Secondary	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
Secondary	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
Secondary	Biliary Stricture Diameter	Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)	Baseline, 6 months
Secondary	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
Secondary	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
Secondary	Long Term Clinical Success (LTCS)	LTCS, defined as no need for further endoscopic intervention for at least 24 months	12 months and 24 months
Secondary	Mean number of dilations	Mean number of dilations required to achieve SCS and LTCS	12 months and 24 months
Secondary	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