Malignant Biliary StrictureNCT03439020
The Efficacy of Plastic Stent Anchoring to Reduce Migration of Metal Stent
A study testing Plastic stent anchoring and FCSEMS in people with Malignant Biliary Stricture, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Biliary Stricture
- What is being tested?
- Plastic stent anchoring and FCSEMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant biliary stricture requiring biliary drainage through endoscopic procedure
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Plastic stent anchoring, FCSEMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastic stent anchoringProcedure or surgery
Insert an additional plastic stent to anchor the fully covered self expandable metal stent.
FCSEMSProcedure or surgery
Insert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture
| Study group | Role | What they receive |
|---|---|---|
| FCSEMS + Plastic | Experimental | 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) Receives: Procedure: Plastic stent anchoring; Procedure: FCSEMS |
| FCSEMS | Active comparator | Insert only a fully covered self expandable metal stent (FCSEMS) without a plastic stent for malignant biliary stricture. Receives: Procedure: FCSEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after randomization
Secondary outcomes (3)
Stent-related adverse events
According to lexicon for endoscopic adverse events
Measured: 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
Measured: 6 months after randomization
Overall survival
Period from stenting to death
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start26 Feb 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
- Investigators
- Sang Hyub Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439020
- Sponsor's protocol ID
- 1709-081-886
- Status last verified
- Nov 2019
- First submitted
- 1 Feb 2018
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32886935
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03439020
- Acronym / sponsor ID
- 1709-081-886
- Conditions
- Malignant Biliary Stricture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCSEMS + Plastic | Experimental | Procedure: Plastic stent anchoring, Procedure: FCSEMSInsert 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) |
| FCSEMS | Active comparator | Procedure: FCSEMSInsert only a fully covered self expandable metal stent (FCSEMS) without a plastic stent for malignant biliary stricture. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Malignant biliary stricture requiring biliary drainage through endoscopic procedure
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plastic stent anchoringInsert an additional plastic stent to anchor the fully covered self expandable metal stent. | Procedure or surgery | FCSEMS + Plastic |
| FCSEMSInsert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture | Procedure or surgery | FCSEMS, FCSEMS + Plastic |
Primary outcome
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
3 secondary outcomes
Stent-related adverse events
Time frame: 6 months after randomization
Duration of stent patency
Time frame: 6 months after randomization
Overall survival
Time frame: 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Derived from this study: PubMed 32886935Paik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Hyub Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plastic stent anchoring and FCSEMS in people with Malignant Biliary Stricture, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent migration rate (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.