Two-in-one Covered and Uncovered Metal Stent

July 20, 2021 updated by: Jin Hong Kim, Ajou University School of Medicine

Feasibility and Safety of a Newly Developed Two-in-one Covered and Uncovered Metal Stent for Inoperable Malignant Distal Biliary Obstruction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeong Gi Do
      • Suwon, Gyeong Gi Do, Korea, Republic of, 443-721
        • Recruiting
        • Ajou University Hospital
        • Contact:
        • Sub-Investigator:
          • Min Jae Yang, MD
    • Gyeonggido
      • Suwon, Gyeonggido, Korea, Republic of, 443-380
        • Recruiting
        • Ajou University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Two-in-one stent
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
Device: Two-in-one stent
Endoscopic placement of a Two-in-one metal stent into extrahepatic bile duct

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From the date of stent insertion until the date of first documented stent dysfunction, assessed upto 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall patient survival
Time Frame: From the date of stent insertion until the date of death from any cause, assessed upto 12 months
From the date of stent insertion until the date of death from any cause, assessed upto 12 months
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Study Director: Jin Hong Kim, MD, PhD, Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-DEV-INT-20-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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