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Trial record 11 of 42 for:    "Klatskin tumor"

Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction

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ClinicalTrials.gov Identifier: NCT02166970
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Tae Hoon Lee, Soon Chun Hyang University

Brief Summary:
In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

Condition or disease Intervention/treatment Phase
Klatskin Tumor Device: Metallic stent deployment in hilar obstruction Not Applicable

Detailed Description:

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.

However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.

The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

First as an unilateral or bilateral stent will be deployed according to criteria.

In bilateral group, stent-in-stent or side-by-side deployment will be included.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : February 28, 2016
Actual Study Completion Date : October 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single stent deployment
Metallic stent deployment in hilar obstruction. Insertion of metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).
Device: Metallic stent deployment in hilar obstruction
Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment
Other Names:
  • Single stent insertion
  • Multiple stent insertion using stent-in-stent method
  • Multiple stent insertion using side-by-side method

Active Comparator: Multiple stent deployment
Metallic stent deployment in hilar obstruction. Insertion of multiple metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).
Device: Metallic stent deployment in hilar obstruction
Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment
Other Names:
  • Single stent insertion
  • Multiple stent insertion using stent-in-stent method
  • Multiple stent insertion using side-by-side method




Primary Outcome Measures :
  1. Reintervention rate when stents occluded [ Time Frame: 2 years ]
    When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.


Secondary Outcome Measures :
  1. Technical success of single or multiple stents [ Time Frame: 1 month ]
    When the bilirubin level decrease more than 50% within one week or 75% within one month.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • inoperable hilar malignancy

Exclusion Criteria:

  • age under 18 years
  • uncontrolled coagulopathy
  • inability to provide 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): NCT02166970


Locations
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Korea, Republic of
Tae Hoon Lee
Cheonan, Korea, Republic of, 330721
Sponsors and Collaborators
Soon Chun Hyang University
Investigators
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Principal Investigator: Tae Hoon Lee, MD, PhD SoonChunHyang University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tae Hoon Lee, Professor, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT02166970     History of Changes
Other Study ID Numbers: Hilar stenting
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tae Hoon Lee, Soon Chun Hyang University:
Hilar tumor
Metal stent
Single
Multiple
Additional relevant MeSH terms:
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Klatskin Tumor
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms