Back to resultsDIGEST I Drug Coated Balloon for Biliary Stricture (DIGEST)
Primary Purpose
Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction
Status
Active
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
GIE Drug Coated Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Stricture
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)
- 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.
Sites / Locations
- Adventista Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: DCB Treatment
Arm Description
Stricture patients treated by DCB
Outcomes
Primary Outcome Measures
Incident of serious balloon dilation-related complications
No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.
Freedom from Biliary Stricture Re-intervention
Biliary stricture re-intervention rate
Secondary Outcome Measures
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)
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
Biliary Stricture Diameter
Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)
Time to the First Re-intervention
The mean time to the first re-intervention (scheduled and unscheduled) will be assessed
Sustained Clinical Success (SCS)
SCS defined as a period of at least 6 months with no need for further endoscopic intervention
Long Term Clinical Success (LTCS)
LTCS, defined as no need for further endoscopic intervention for at least 24 months
Mean number of dilations
Mean number of dilations required to achieve SCS and LTCS
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03997994
Brief Title
DIGEST I Drug Coated Balloon for Biliary Stricture
Acronym
DIGEST
Official Title
Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2019 (Actual)
Primary Completion Date
March 21, 2024 (Anticipated)
Study Completion Date
March 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GIE Medical
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction, Biliary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: DCB Treatment
Arm Type
Experimental
Arm Description
Stricture patients treated by DCB
Intervention Type
Device
Intervention Name(s)
GIE Drug Coated Balloon
Intervention Description
The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.
Primary Outcome Measure Information:
Title
Incident of serious balloon dilation-related complications
Description
No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.
Time Frame
30 days
Title
Freedom from Biliary Stricture Re-intervention
Description
Biliary stricture re-intervention rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Liver Function
Description
. Liver function tests include total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)
Time Frame
Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months
Title
Change in Existing Biliary Obstructive Symptoms
Description
The common biliary obstructive symptoms are right upper quadrant pain (survey), fever/chills (cholangitis), jaundice, itching, dark urine, pale stools, nausea/vomiting, weight loss
Time Frame
Baseline, 30 days, 3 months, 6 months, 12 months and 24 months
Title
Biliary Stricture Diameter
Description
Stricture diameter will be assessed via endoscopic retrograde cholangiopancreatography (ERCP)
Time Frame
Baseline, 6 months
Title
Time to the First Re-intervention
Description
The mean time to the first re-intervention (scheduled and unscheduled) will be assessed
Time Frame
12 months and 24 months
Title
Sustained Clinical Success (SCS)
Description
SCS defined as a period of at least 6 months with no need for further endoscopic intervention
Time Frame
12 months and 24 months
Title
Long Term Clinical Success (LTCS)
Description
LTCS, defined as no need for further endoscopic intervention for at least 24 months
Time Frame
12 months and 24 months
Title
Mean number of dilations
Description
Mean number of dilations required to achieve SCS and LTCS
Time Frame
12 months and 24 months
Title
Technical Success
Description
Technical success is defined as successful insertion, dilatation of the target biliary stricture, and finally withdrawal of the device with no device malfunctions.
Time Frame
0 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret T Petersen, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adventista Hospital
City
Asunción
Country
Paraguay
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
DIGEST I Drug Coated Balloon for Biliary Stricture
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