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Prophylactic epinephrine for the prevention of transbronchial lung biopsy-related bleeding in lung transplant recipients (PROPHET) study: a protocol for a multicentre randomised, double-blind, placebo-controlled trial.

ABSTRACT: INTRODUCTION:Transbronchial lung biopsy (TBLB) is frequently performed in single-lung and double-lung transplant recipients for evaluation of clinical and radiological findings as well as routine surveillance for acute cellular rejection. While rates of clinically significant TBLB-related haemorrhage are <1% for all comers, the incidence in lung transplant recipients is reported to be higher, presumably due to persistent allograft inflammation and alterations in allograft blood flow. While routinely performed by some bronchoscopists, the efficacy and safety profile of prophylactic administration of topical intrabronchial diluted epinephrine for the prevention of TBLB-related haemorrhage has not been explored in a prospective manner. METHODS AND ANALYSIS:In this randomised, double-blind, placebo-controlled multicentre trial (PROPHET Study), single-lung and double-lung transplant adult recipients from participating institutions who are scheduled for bronchoscopy with TBLB for clinical indications will be identified. Potential participants who meet inclusion and exclusion criteria and sign an informed consent will be randomised to receive either diluted epinephrine or placebo prior to performance of TBLB. The degree of TBLB-related haemorrhage will be graded by the performing bronchoscopist as well as independent observers. The primary analysis will compare the rates of severe and very severe bleeding in participants treated with epinephrine or placebo. The study will also evaluate the safety profile of prophylactic topical epinephrine including the occurrence of serious cardiovascular and haemodynamic adverse events. Additional secondary outcomes to be explored include rates of non-severe TBLB-related haemorrhage, overall yield of the bronchoscopic procedure and non-serious cardiovascular and haemodynamic adverse effects. ETHICS AND DISSEMINATION:The study procedures were reviewed and approved by institutional review boards in participating institutions. This study is being externally monitored, and a data and safety monitoring committee has been assembled to monitor patient safety and to evaluate the efficacy of the intervention. The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences. TRIAL REGISTRATION NUMBER:NCT03126968; Pre-results.

SUBMITTER: Kalchiem-Dekel O

PROVIDER: S-EPMC6475255 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Prophylactic epinephrine for the prevention of transbronchial lung biopsy-related bleeding in lung transplant recipients (PROPHET) study: a protocol for a multicentre randomised, double-blind, placebo-controlled trial.

Kalchiem-Dekel Or O Iacono Aldo A Pickering Edward M EM Sachdeva Ashutosh A Shah Nirav G NG Sperry Mark M Tran Bich-Chieu BC Reed Robert M RM

BMJ open 20190323 3

<h4>Introduction</h4>Transbronchial lung biopsy (TBLB) is frequently performed in single-lung and double-lung transplant recipients for evaluation of clinical and radiological findings as well as routine surveillance for acute cellular rejection. While rates of clinically significant TBLB-related haemorrhage are <1% for all comers, the incidence in lung transplant recipients is reported to be higher, presumably due to persistent allograft inflammation and alterations in allograft blood flow. Whi ...[more]

PMID: 30904852

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Project description:BACKGROUND:Bronchoscopic cryobiopsy is a new method of bronchoscopic tissue sampling in interstitial lung disease. In case of transbronchial biopsies, the resultant tissue samples are of high quality, and the lung parenchyma seen in the samples is adequate for a histological diagnosis in most cases. Bleeding after transbronchial biopsy is the most important procedure- associated complication and may be life threatening. This study addresses the risk of bleeding of transbronchial cryobiopsy. METHODS:In this prospective, randomized, controlled multicentre study 359 patients with interstitial lung disease requiring diagnostic bronchoscopic tissue sampling were included. Both conventional transbronchial forceps biopsy and transbronchial cryobiopsy were undertaken in each patient. The sequence of the procedures was randomized. Bleeding severity was evaluated semi-quantitatively as "no bleeding", "mild" (suction alone), "moderate" (additional intervention) or "severe" (prolonged monitoring necessary or fatal outcome), for each intervention. RESULTS:In 359 patients atotal of 1160 cryobiopsies and 1302 forceps biopsies were performed. Bleeding was observed after forceps biopsy in 173 patients (48.2%) and after cryobiopsy in 261 patients (72.7%). Bleeding was significantly greater in the cryobiopsy group (cryobiopsy/forceps biopsy: no bleeding 27.3%/51.8%; mild 56.5%/44.0%; moderate 15.0%/4.2%; severe 1.2%/0%; p?<?0.001). The rate of clinically relevant bleeding (moderate or severe) was higher after the cryobiopsy procedures compared to the forceps biopsies (16.2% vs. 4.2%, p?<?0.05). No fatal bleeding complications occurred. CONCLUSIONS:Compared to transbronchial forceps biopsy, transbronchial cryobiopsy was associated with an increased risk of bleeding which is of clinical relevance. Therefore training and additional precautions for bleeding control should be considered. TRIAL REGISTRATION:The study was registered with clinicaltrials.gov ( NCT01894113 ).

Project description:BACKGROUND:Radial endobronchial ultrasound (R-EBUS) transbronchial lung biopsy (TBLB) improves the diagnostic yield from peripheral pulmonary lesions (PPLs). However, the small specimens obtained using small forceps through a guide sheath (GS) may impede diagnosis and molecular analysis. Here, we investigated the diagnostic significance of additional conventional TBLB with standard forceps after R-EBUS-GS-guided TBLB. METHODS:We retrospectively reviewed data from 55 patients who underwent conventional TBLB after R-EBUS-GS-guided TBLB for PPL diagnosis. Procedures were performed on single PPLs with no visible lesions on bronchoscopy. In cases with inconclusive pathologic confirmation, final diagnoses were made based on pathologic specimens or clinical observations. RESULTS:The median size of the target lesions was 28?mm. The appearances on computed tomography images were solid (n = 45, 81.8%), part-solid (n = 7, 12.7%), and cavitary nodules (n = 3, 5.5%). A computed tomography bronchus sign was present in 35 (63.6%) cases, and a radial probe was positioned within target lesion in 32 (58.2%) cases. R-EBUS-GS-guided TBLB was diagnostic in 30 (54.5%) patients, and subsequent conventional TBLB yielded additional diagnostic information in 8 (14.5%) patients. Probe positioning within target lesions and the outer margin of PPLs more than 1 cm from pleura were significantly associated with enhanced diagnostic yield from the combined procedures. In conventional TBLB, probe positioning within target lesions (75.0% vs. 11.8%, P = 0.004) and characteristic of nonsolid nodules (83.3% vs. 15.8%, P = 0.006) were significantly associated with additional diagnostic utility. CONCLUSIONS:Conventional TBLB following R-EBUS-GS-guided TBLB could be a useful procedure for diagnosing PPLs, especially for nonsolid nodules. KEY POINTS:Significant findings of the study: Additional conventional TBLB with standard forceps after R-EBUS-GS-guided TBLB yielded an additional 14.5% diagnostic utility for peripheral pulmonary lesions. For conventional TBLB, probe positioning within target lesions and nonsolid nodules were significantly associated with additional diagnostic utility. WHAT THIS STUDY ADDS:Conventional TBLB with standard forceps after R-EBUS-GS-guided TBLB is an effective and economically accessible diagnostic tool for peripheral pulmonary lesions.

Dataset Information

Prophylactic epinephrine for the prevention of transbronchial lung biopsy-related bleeding in lung transplant recipients (PROPHET) study: a protocol for a multicentre randomised, double-blind, placebo-controlled trial.

Publications

Prophylactic epinephrine for the prevention of transbronchial lung biopsy-related bleeding in lung transplant recipients (PROPHET) study: a protocol for a multicentre randomised, double-blind, placebo-controlled trial.

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