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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CB study arm | Procedure | Included patients are randomized to receive cryobiopsy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with treatment alteration due to the biopsy result | Impact on treatment decisions depending of the pathology results | up to 1 month |
| Incidence of treatment-emergent adverse events as assessed by pneumothorax rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolin Steinack | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Zurich | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23328889 | Result | 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. | |
| 23294256 | 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. |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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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.
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| FB-CB study arm |
| Procedure |
Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session |
|
data on safety
| up to 1 week |
| Incidence of treatment-emergent adverse events as assessed by bleeding events | data on safety | up to 1 week |
| interobserver agreement between 3 pathologists | The biopsies are assessed for acute cellular rejection by three pathologists. | up to 3 months |
| 26488148 | 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. |
| 29436115 | 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. |