Biodegradable Airway Stent Post Lung Transplant
Evaluation of Treatment With Biodegradable Airway Stent for Post Lung Transplant Airway Complication
Introduction and rationale
Benign airway stenosis or malacia is a frequent complication of lung transplantation occurring in 4-24% of patients, most often occurring two to nine months post-transplant. Initial therapeutic approach consists of conservative endobronchial treatment with recurrent balloon dilatation, radial incision, and electro cautery. For severe case of recurrent stenosis or malacia, airway stent placement can be considered. Different types of airway stent exist, for instance self-extendable metallic stent (SEMS), silicone stent and biodegradable airway stent. Conventional airway stents (SEMS, silicone) are associated with complications as granulation tissue and recurrent infections and can be difficult to remove. Newly developed biodegrabale stents are made of polydioxanone and disintegrate after a period of time are thought to have less side effects, and has been standard of care for the last few years. A sub selection of patients have been treated with conventional stent before treated with biodegradable stent.
Research question
- To assess the efficacy and efficiency of biodegradable airway stent.
- Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
- Asses if biodegradable stent lead to improvement of lung function.
- Assessment of the life span of biodegradable stents.
연구 개요
상세 설명
- Background Recurrent airway stenosis or malacia can be treated with airway stents. Conventional airway stents, for instance self-extendable metallic stent (SEMS) and silicone stent are associated with adverse events as recurrent infection or granulation tissue and can be difficult to remove because of in stent-granulation. Therefore they are used with restraint for benign airway problems. Biodegradable stents are made of polydioxanone and disintegrate after a period of time. They are thought to be well tolerated and associated with less adverse events compared to traditional airway stent and have been used as standard care for multiple years.
Main research question
- To assess the efficacy and efficiency of biodegradable airway stent
- Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
- Asses if biodegradable stent lead to improvement of lung function.
- Assessment of the life span of biodegradable stents.
- Design (including population, confounders/outcomes) Retrospective cohort study of patients with airway stenosis or malacia treated with biodegradable airway stent from 2019 in the UMCG and Amsterdam UMC.
Expected results
- Less adverse events, hospital admittance and need for bronchoscopic interventions compared to patients treated with conventional stents. No complications associated with removal of stents.
- Life span around 4 months
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Amsterdam, 네덜란드
- AMC
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Groningen, 네덜란드
- UMCG
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients who underwent a lung transplantation and developed airway stenosis or malacia with airway stent requirement
Exclusion Criteria:
- No
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Biodegradable stent treatment group
|
Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adverse events
기간: 4 months after placement
|
Adverse events associated with airway stents
|
4 months after placement
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in FEV1
기간: 1 week post placement
|
Change in FEV1 measured by spirometry pre and post stent placement
|
1 week post placement
|
|
Change in FVC
기간: 1 week post placement
|
Change in FVC measured by spirometry pre and post stent placement
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1 week post placement
|
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Time to need for new stent placement
기간: 6 months after placement
|
Endurance and life span of biodegradable stent measured by time to need for new stent placement
|
6 months after placement
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dirk-Jan Slebos, MD, PhD, UMCG
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20220075
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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