DIGEST I Drug Coated Balloon for Biliary Stricture

Not Applicable

Active, not recruiting

• Conditions: Biliary Disease; Biliary Anastomotic Stenosis; Biliary Stricture; Biliary Obstruction
• Interventions: Device: GIE Drug Coated Balloon

• Registration Number: NCT03997994
• Lead Sponsor: GIE Medical

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.

Study Timeline

• Study Start: 2019-05-12
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-17
• Primary Completion: 2024-03-21
• Study Completion: 2025-03-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: DCB Treatment	GIE Drug Coated Balloon	Stricture patients treated by DCB

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Adventista Hospital; 🇵🇾 Asunción, Paraguay