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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Biliary Stricture
• Intervention / Treatment: Procedure: Plastic stent anchoring; Procedure: FCSEMS

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent migration rate	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	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent-related adverse events	According to lexicon for endoscopic adverse events	6 months after randomization
Duration of stent patency	The period from the insertion of the stent to the point at which stent revision is required	6 months after randomization
Overall survival	Period from stenting to death	6 months after randomization

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Daewoong Pharmaceutical Co. LTD.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 18, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 1709-081-886

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No