Kryo-LUTPL: Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients

Sponsor
University of Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT05006742
Collaborator
(none)
75
1
2
19.8
3.8

Study Details

Study Description

Brief Summary

CLAD is defined as loss of lung function after other factors, particularly infections have been excluded. Readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. Serial lung function tests, laboratory testing and pulmonary imaging are only clinical indicators of chronic allograft dysfunction in lung transplant recipients. Since forceps biopsy to detect acute cellular rejection in lung transplant recipients has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryoprobe.

Condition or Disease Intervention/Treatment Phase
  • Procedure: CB study arm
  • Procedure: FB-CB study arm
N/A

Detailed Description

Eventually, histopathological confirmation is indispensable to establish the diagnosis of acute cellular rejection. The current gold standard for diagnosis and grading of acute cellular rejection in order to initialize the optimal treatment, with particular regard to adjusting immunosuppression, is forceps biopsy to obtain ≥ five samples. Forceps biopsy has a reasonable risk profile in experienced centers and is performed 2, 4, 6 and 12 months posttransplant and when indicated. Given these concerns about diagnostic yield in forceps biopsy and unjustifiable risks after surgical lung biopsy, cryobiopsy has arisen as promising alternative diagnostic procedure. The value of cryobiopsy to obtain a conclusive diagnosis of ACR is discussed controversially due the lack of safety and efficacy data in lung transplant recipients

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different transbronchial biopsy techniques. Included patients are 1:1 randomized to receive either cryobiopsy (CB study arm) or forceps biopsy and cryobiopsy within the same session (FB-CB study arm). Both, forceps biopsy and cryobiopsy are performed according to official recommendations. The biopsies will be scored for ACR according to the ISHLT criteria (A0 - A4) by 3 pathologists. A subgroup analysis in the FB-CB study arm will compare FB and CB of the same patient in order to prevent second bronchoscopy due to inconclusive histological result of FB and lung function decline being suspicious for ACR.This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different transbronchial biopsy techniques. Included patients are 1:1 randomized to receive either cryobiopsy (CB study arm) or forceps biopsy and cryobiopsy within the same session (FB-CB study arm). Both, forceps biopsy and cryobiopsy are performed according to official recommendations. The biopsies will be scored for ACR according to the ISHLT criteria (A0 - A4) by 3 pathologists. A subgroup analysis in the FB-CB study arm will compare FB and CB of the same patient in order to prevent second bronchoscopy due to inconclusive histological result of FB and lung function decline being suspicious for ACR.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients: A Prospective Analysis for Acute Cellular Rejection
Actual Study Start Date :
May 7, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CB study arm

Included patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm

Procedure: CB study arm
Included patients are randomized to receive cryobiopsy

Active Comparator: FB-CB study arm

Included patients are 1:1 randomized to receive either CB (CB study arm) or FB and CB within the same session (FB-CB study arm

Procedure: FB-CB study arm
Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session

Outcome Measures

Primary Outcome Measures

  1. diagnostic yield [up to 1 month]

    To investigate the diagnostic yield of two different transbronchial lung biopsy techniques (forceps and cryobiopsy) for diagnosis of acute cellular rejection in lung transplant recipients.

Secondary Outcome Measures

  1. % of patients with treatment alteration due to the biopsy result [up to 1 month]

    Impact on treatment decisions depending of the pathology results

  2. Incidence of treatment-emergent adverse events as assessed by pneumothorax rate [up to 1 week]

    data on safety

  3. Incidence of treatment-emergent adverse events as assessed by bleeding events [up to 1 week]

    data on safety

  4. interobserver agreement between 3 pathologists [up to 3 months]

    The biopsies are assessed for acute cellular rejection by three pathologists.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • routinely performed surveillance bronchoscopy and when indicated including serial FB and CB in the same session in patients wo had undergone lung transplant

  • male or female subject of at least 18 years of age

  • written informed consent after participant's information signed by patient

Exclusion Criteria:
  • age < 18 years

  • Lacking ability to form an informed consent (including impaired judgement, communication barriers)

  • Contraindication against bronchoscopy (e.g. co-morbidities)

  • INR > 2 or Thrombocytes < 50000

  • Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy

  • Anticoagulation with NOAK within 48 hours before biopsy

  • Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University hospital Zurich Zurich Switzerland 8091

Sponsors and Collaborators

  • University of Zurich

Investigators

  • Principal Investigator: Carolin Steinack, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carolin Steinack, principal investigator, University of Zurich
ClinicalTrials.gov Identifier:
NCT05006742
Other Study ID Numbers:
  • ID 2021-00466
First Posted:
Aug 16, 2021
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carolin Steinack, principal investigator, University of Zurich

Study Results

No Results Posted as of Aug 16, 2021