The Efficacy of Plastic Stent Anchoring to Reduce Migration of Metal Stent

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Seoul National University

Status

Completed

Conditions

Malignant Biliary Stricture

Treatments

Procedure: FCSEMS
Procedure: Plastic stent anchoring

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03439020
1709-081-886

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

FCSEMS + Plastic
Experimental group
Description:
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)
Treatment:
Procedure: Plastic stent anchoring
Procedure: FCSEMS
FCSEMS
Active Comparator group
Description:
Insert only a fully covered self expandable metal stent (FCSEMS) without a plastic stent for malignant biliary stricture.
Treatment:
Procedure: FCSEMS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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