Biodegradable Airway Stent Post Lung Transplant

NCT ID: NCT05334199

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2022-03-31

Brief Summary

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.

Detailed Description

• 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

Conditions

Airway Complications Post Lung Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biodegradable stent treatment group

Biodegradable stent treatment group

Group Type: EXPERIMENTAL

Biodegradable stent

Intervention Type: DEVICE

Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant

Interventions

Biodegradable stent

Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who underwent a lung transplantation and developed airway stenosis or malacia with airway stent requirement

Exclusion Criteria

• No

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AIDS Malignancy Consortium

NETWORK

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Dirk-Jan Slebos

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk-Jan Slebos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

AMC

Amsterdam, , Netherlands

UMCG

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

20220075

Identifier Type: -

Identifier Source: org_study_id