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Two-in-one Covered and Uncovered Metal Stent

Primary Purpose

Extrahepatic Bile Duct Cancer, Pancreatic Cancer, Lymph Node Metastases

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Two-in-one stent
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ㆍMalignant biliary obstruction, 2 cm distal to the hilum ㆍNot eligible for curative surgical resection owing to metastasis, locally advanced stage, or high operation risk ㆍEastern Cooperative Oncology Group Performance status 0-3

Exclusion Criteria:

ㆍBeing evaluated for potential benign biliary stricture or possible operation ㆍHistory of biliary surgery except cholecystectomy ㆍCoagulopathy (International normalized ratio >1.5, platelet count <50,000) ㆍCoexist other organ dysfunction (American Society of Anesthesiologist physical status grade III or IV) ㆍInability to obtain informed consent

Sites / Locations

  • Ajou University HospitalRecruiting
  • Ajou University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Two-in-one stent

Arm Description

Endoscopic placement of a Two-in-one stent into the extrahepatic bile duct, considering the longitudinal location of the stricture segment and predicted safety margin

Outcomes

Primary Outcome Measures

Cumulative patency of inner covered stent and Two-in-one stent

Secondary Outcome Measures

Overall patient survival
Stent dysfunction-free patient survival

Full Information

First Posted
March 31, 2020
Last Updated
July 20, 2021
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04337333
Brief Title
Two-in-one Covered and Uncovered Metal Stent
Official Title
Feasibility and Safety of a Newly Developed Two-in-one Covered and Uncovered Metal Stent for Inoperable Malignant Distal Biliary Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. However, none of bare, covered, and anti-reflux metal stent alone constantly demonstrated superiority over the others in the stent patency. To compensate for the limitations of each stent, a double stent system in which both covered and bare SEMSs are integrated into one stent system was introduced. In the current study, the investigators aimed to evaluate the efficacy and safety of this stent in patients with inoperable malignant distal biliary obstruction.
Detailed Description
Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. As the survival time for those patients has improved due mainly in part to development of chemotherapeutic intervention, it is becoming important to prevent recurrent cholangitis and liver failure by prolonging the SEMS patency, leading to continuation of chemotherapy and better prognosis. Therefore, one-time stent insertion before disease-progression-related death is an ultimate goal of developing an ideal biliary stent. SEMSs have been found to be superior to plastic stents in terms of the stent patency, because it prevent accumulation of biliary sludge owing to larger diameter. The ideal designs of biliary SEMSs for prolongation of the stent patency include 1) bare metal mesh for tissue embedding to prevent stent migration, 2) covering material to counteract neoplastic tumor ingrowth, and 3) anti-reflux structure to reduce enteric biliary reflux. However, none of bare, covered, and anti-reflux metal stent alone constantly demonstrated superiority over the others in the stent patency. To compensate for the limitations of each stent, a double stent system in which both covered and bare SEMSs are integrated into one stent system was introduced in the field of the interventional radiology, but further data accumulation is needed to assess the comparability with various conventional SEMS types in terms of stent patency, reintervention efficacy, and clinical outcomes following reintervention, because in this system two metal stents are implanted at once exclusively via percutaneous route and clogged inner covered stent cannot be removed at the time of the reintervention. Recently a new covered and uncovered SEMS in which the clogged inner stent can be endoscopically removed leaving the outer stent in place, was introduced. In the current study, we aimed to evaluate the efficacy and safety of this stent in patients with inoperable malignant distal biliary obstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Pancreatic Cancer, Lymph Node Metastases, Gallbladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two-in-one stent
Arm Type
Other
Arm Description
Endoscopic placement of a Two-in-one stent into the extrahepatic bile duct, considering the longitudinal location of the stricture segment and predicted safety margin
Intervention Type
Device
Intervention Name(s)
Two-in-one stent
Intervention Description
Endoscopic placement of a Two-in-one metal stent into extrahepatic bile duct
Primary Outcome Measure Information:
Title
Cumulative patency of inner covered stent and Two-in-one stent
Time Frame
From the date of stent insertion until the date of first documented stent dysfunction, assessed upto 12 months
Secondary Outcome Measure Information:
Title
Overall patient survival
Time Frame
From the date of stent insertion until the date of death from any cause, assessed upto 12 months
Title
Stent dysfunction-free patient survival
Time Frame
From the date of stent insertion until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ㆍMalignant biliary obstruction, 2 cm distal to the hilum ㆍNot eligible for curative surgical resection owing to metastasis, locally advanced stage, or high operation risk ㆍEastern Cooperative Oncology Group Performance status 0-3 Exclusion Criteria: ㆍBeing evaluated for potential benign biliary stricture or possible operation ㆍHistory of biliary surgery except cholecystectomy ㆍCoagulopathy (International normalized ratio >1.5, platelet count <50,000) ㆍCoexist other organ dysfunction (American Society of Anesthesiologist physical status grade III or IV) ㆍInability to obtain informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Jae Yang, MD, PhD
Phone
82-31-219-7821
Email
creator1999@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Hong Kim, MD, PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeong Gi Do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Hong Kim, MD, PhD
Phone
82-31-219-6939
Email
jinhkim@ajou.ac.kr
First Name & Middle Initial & Last Name & Degree
Min Jae Yang, MD
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
443-380
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Jae Yang, MD
Phone
82-31-219-6939
Ext
6939
Email
creator1999@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Two-in-one Covered and Uncovered Metal Stent

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