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The Efficacy of Plastic Stent Anchoring to Reduce Migration of 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439020
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital

Brief Summary:
The aim of this study is to demonstrate that the group with an additional plastic stent to anchor the fully covered self expandable metal stent (FCSEMS) in patients with malignant biliary stricture has less stent migration than the group with FCSEMS only. The primary outcome is stent migration for 6 months. The secondary outcomes are stent related adverse events, stent patency, and overall survival.

Condition or disease Intervention/treatment Phase
Malignant Biliary Stricture Procedure: Plastic stent anchoring Procedure: FCSEMS Not Applicable

Detailed Description:
Endoscopic retrograde biliary drainage using a plastic stent for the treatment of malignant biliary stricture has advantages in that it is easy to perform and low cost, but it has a short period of patency. To overcome this drawback, self-expandable metal stents (SEMS) have been developed and are now widely used. But, over time, the SEMS also develop restenosis, due to tumor ingrowth and the tissue hyperplasia caused by the stimulation of the surrounding tissues by the metal thin wire. To overcome these disadvantages, a fully covered self-expandable metal stents (FCSEMS) covered with a polymer coating have been developed and used. However, the FCSEMS showed more stent migration than the uncovered SEMS, which was not superior to the uncovered SEMS in terms of loss of stent function. In order to overcome the limitations of the FCSEMS, small-scale studies have shown that stent migration can be reduced by anchoring the FCSEMS using a plastic stent. To date, there has been no randomized controlled study to determine whether the FCSEMS can be anchored with a plastic stent in patients with malignant biliary stricture to reduce the stent migration. Therefore, the purpose of this study is to evaluate the efficacy of plastic stent anchoring to reduce migration of FCSEMS.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of a Fully Covered Self-expandable Metal Stent Anchored by a Plastic Stent for Anti-migration in the Management of Malignant Biliary Strictures: a Prospective Randomized Controlled Study
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: FCSEMS + Plastic

Insert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture and insert an additional plastic stent to anchor the metal stent.

(Plastic stent anchoring)

Procedure: Plastic stent anchoring
Insert an additional plastic stent to anchor the fully covered self expandable metal stent.

Procedure: FCSEMS
Insert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture

Active Comparator: FCSEMS
Insert only a fully covered self expandable metal stent (FCSEMS) without a plastic stent for malignant biliary stricture.
Procedure: FCSEMS
Insert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture




Primary Outcome Measures :
  1. Stent migration rate [ Time Frame: 6 months after randomization ]

    Stent migration is classified as proximal or distal migration. Proximal stent migration is defined as any migration of the FCSEMS(Fully covered self expandable metal stent) into the bile duct, preventing its easy removal.

    Distal stent migration is defined in three ways. The first is when the stent is completely distally migrated without being lodged into the duodenum.

    The second is when the stent is lodged in the distal bile duct below the stricture.

    The third case is when the stent is migrated to the distal portion of the stricture and is lodged in the duodenum opposite the papilla



Secondary Outcome Measures :
  1. Stent-related adverse events [ Time Frame: 6 months after randomization ]
    According to lexicon for endoscopic adverse events

  2. Duration of stent patency [ Time Frame: 6 months after randomization ]
    The period from the insertion of the stent to the point at which stent revision is required

  3. Overall survival [ Time Frame: 6 months after randomization ]
    Period from stenting to death



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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:

  • Malignant biliary stricture requiring biliary drainage through endoscopic procedure

Exclusion Criteria:

  • Previous history of metal stent placement for malignant biliary stricture
  • Hilar cholangiocarcinoma
  • Malignant biliary stricture of intrahepatic duct
  • A recurrence after surgery due to malignant biliary stricture
  • Life expectancy less than 3 months
  • Pregnancy
  • If endoscopy is not possible based on the judgement of the researcher

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): NCT03439020


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Daewoong Pharmaceutical Co. LTD.
Investigators
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Principal Investigator: Sang Hyub Lee, MD, PhD Seoul National University Hospital
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Responsible Party: Sang Hyub Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03439020    
Other Study ID Numbers: 1709-081-886
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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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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Constriction, Pathologic
Pathological Conditions, Anatomical