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Two-in-one Covered and Uncovered Metal Stent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337333
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Jin Hong Kim, Ajou University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Pancreatic Cancer Lymph Node Metastases Gallbladder Cancer Device: Two-in-one stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Safety of a Newly Developed Two-in-one Covered and Uncovered Metal Stent for Inoperable Malignant Distal Biliary Obstruction
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Measures :
  1. Overall patient survival [ Time Frame: From the date of stent insertion until the date of death from any cause, assessed upto 12 months ]
  2. 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337333


Contacts
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Contact: Min Jae Yang, MD, PhD 82-31-219-7821 creator1999@hanmail.net

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Gyeong Gi Do, Korea, Republic of, 443-721
Contact: Jin Hong Kim, MD, PhD    82-31-219-6939    jinhkim@ajou.ac.kr   
Sub-Investigator: Min Jae Yang, MD         
Ajou University Hospital Recruiting
Suwon, Gyeonggido, Korea, Republic of, 443-380
Contact: Min Jae Yang, MD    82-31-219-6939 ext 6939    creator1999@hanmail.net   
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Study Director: Jin Hong Kim, MD, PhD Ajou University School of Medicine
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Responsible Party: Jin Hong Kim, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT04337333    
Other Study ID Numbers: AJIRB-DEV-INT-20-035
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Neoplasms
Bile Duct Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Adenocarcinoma
Carcinoma