Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients

NCT05006742 | Completed DMC

• 1 other identifier: ID 2021-00466
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Rejection; Lung Transplant Failure and Rejection

Keywords

Cryobiopsy; Transbronchial Biopsy

Outcome Measures

Primary Outcomes (1)

• diagnostic yield

  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.

  up to 1 month

Secondary Outcomes (4)

• % of patients with treatment alteration due to the biopsy result

  up to 1 month

• Incidence of treatment-emergent adverse events as assessed by pneumothorax rate

  up to 1 week

• Incidence of treatment-emergent adverse events as assessed by bleeding events

  up to 1 week

• interobserver agreement between 3 pathologists

  up to 3 months

Study Arms (2)

CB study arm

ACTIVE COMPARATOR

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

FB-CB study arm

ACTIVE COMPARATOR

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

Interventions

CB study arm PROCEDURE

Included patients are randomized to receive cryobiopsy

CB study arm

FB-CB study arm PROCEDURE

Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session

FB-CB study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (4)

• Yarmus L, Akulian J, Gilbert C, Illei P, Shah P, Merlo C, Orens J, Feller-Kopman D. Cryoprobe transbronchial lung biopsy in patients after lung transplantation: a pilot safety study. Chest. 2013 Mar;143(3):621-626. doi: 10.1378/chest.12-2290.

  PMID: 23328889 RESULT

• Fruchter O, Fridel L, Rosengarten D, Raviv Y, Rosanov V, Kramer MR. Transbronchial cryo-biopsy in lung transplantation patients: first report. Respirology. 2013 May;18(4):669-73. doi: 10.1111/resp.12037.

  PMID: 23294256 RESULT

• Roden AC, Kern RM, Aubry MC, Jenkins SM, Yi ES, Scott JP, Maldonado F. Transbronchial Cryobiopsies in the Evaluation of Lung Allografts: Do the Benefits Outweigh the Risks? Arch Pathol Lab Med. 2016 Apr;140(4):303-11. doi: 10.5858/arpa.2015-0294-OA. Epub 2015 Oct 21.

  PMID: 26488148 RESULT

• Gershman E, Ridman E, Fridel L, Shtraichman O, Pertzov B, Rosengarten D, Rahman NA, Shitenberg D, Kramer MR. Efficacy and safety of trans-bronchial cryo in comparison with forceps biopsy in lung allograft recipients: Analysis of 402 procedures. Clin Transplant. 2018 Apr;32(4):e13221. doi: 10.1111/ctr.13221. Epub 2018 Feb 28.

  PMID: 29436115 RESULT

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Carolin Steinack

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 16, 2021
• Study Start: May 7, 2021
• Primary Completion: January 31, 2024
• Study Completion: February 28, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)