Clinical trial NCT03439020: The Efficacy of Plastic Stent Anchoring to Reduce Migration of Metal Stent
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Biliary Stricture
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2018-02-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stent migration rate
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Stent-related adverse events
timeFrame: 6 months after randomization
measure: Duration of stent patency
timeFrame: 6 months after randomization
measure: Overall survival
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Hyub Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.