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

NCT ID: NCT03439020

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2019-10-31

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.

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.

Conditions

Malignant Biliary Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Plastic stent anchoring

Intervention Type: PROCEDURE

Insert an additional plastic stent to anchor the fully covered self expandable metal stent.

FCSEMS

Intervention Type: PROCEDURE

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

FCSEMS

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

Group Type: ACTIVE_COMPARATOR

FCSEMS

Intervention Type: PROCEDURE

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

Interventions

Plastic stent anchoring

Insert an additional plastic stent to anchor the fully covered self expandable metal stent.

Intervention Type: PROCEDURE

FCSEMS

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Hyub Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Hyub Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

Paik WH, Woo SM, Chun JW, Song BJ, Lee WJ, Ahn DW, Lee YS, Choi YH, Ryu JK, Kim YT, Lee SH. Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled study. Endoscopy. 2021 Jun;53(6):578-585. doi: 10.1055/a-1256-0571. Epub 2020 Oct 8.

Reference Type: DERIVED

PMID: 32886935 (View on PubMed)

Other Identifiers

1709-081-886

Identifier Type: -

Identifier Source: org_study_id