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.

Study Overview

• Status: Completed
• Conditions: Airway Complications Post Lung Transplant
• Intervention / Treatment: Device: Biodegradable stent

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • AMC
  • Groningen, Netherlands
    • UMCG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biodegradable stent treatment group	Device: Biodegradable stent; Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events associated with airway stents	4 months after placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1	Change in FEV1 measured by spirometry pre and post stent placement	1 week post placement
Change in FVC	Change in FVC measured by spirometry pre and post stent placement	1 week post placement
Time to need for new stent placement	Endurance and life span of biodegradable stent measured by time to need for new stent placement	6 months after placement

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: AIDS Malignancy Consortium
• Investigators: Principal Investigator: Dirk-Jan Slebos, MD, PhD, UMCG

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20220075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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