Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients

Lung Transplant Rejection Clinical Trial

— Kryo-LUTPL  

Official title:

Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients: A Prospective Analysis for Acute Cellular Rejection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006742
• Other study ID #: ID 2021-00466
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: University of Zurich
• Contact: Carolin Steinack
• Phone: +41767713779
• Email: Carolin.steinack[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Transplant Failure and Rejection
• Lung Transplant Rejection

Intervention

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

Locations

Country	Name	City	State
Switzerland	University hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

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 Trans — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	% of patients with treatment alteration due to the biopsy result	Impact on treatment decisions depending of the pathology results	up to 1 month
Secondary	Incidence of treatment-emergent adverse events as assessed by pneumothorax rate	data on safety	up to 1 week
Secondary	Incidence of treatment-emergent adverse events as assessed by bleeding events	data on safety	up to 1 week
Secondary	interobserver agreement between 3 pathologists	The biopsies are assessed for acute cellular rejection by three pathologists.	up to 3 months