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Assessment of a randomized controlled trial on the safety of pre-placing bronchial balloons in transbronchial lung cryobiopsy for diagnosing interstitial lung disease.
Bian, Yiding; Zhou, Guowu; Gao, Qian; Deng, Mingming; Tong, Run; Xia, Yang; Lin, Jieru; Hou, Gang; Dai, Huaping.
Afiliación
  • Bian Y; National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China.
  • Zhou G; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, 2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China.
  • Gao Q; Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.
  • Deng M; National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China.
  • Tong R; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, 2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China.
  • Xia Y; National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China.
  • Lin J; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, 2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China.
  • Hou G; National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China.
  • Dai H; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, 2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China.
Eur J Med Res ; 29(1): 268, 2024 May 03.
Article en En | MEDLINE | ID: mdl-38702744
ABSTRACT
RATIONALE AND

OBJECTIVES:

Bleeding is a major complication of transbronchial lung cryobiopsy (TBLC), and pre-placing a bronchial balloon is one of the clinical practices used to prevent it, but with very weak evidence, which should be confirmed. This study aimed to conduct whether pre-placing a bronchial balloon in TBLC for diagnosing interstitial lung disease (ILD) is more safety. MATERIALS AND

METHODS:

In this prospective, single-center, randomized controlled trial, patients with suspected ILD were enrolled and randomly assigned to pre-placed balloon and none-pre-placed balloon groups. The primary outcome was incidence of moderate bleeding in each group. The secondary endpoints were the incidence of severe bleeding, pneumothorax, and other procedural complications.

RESULTS:

Exactly 250 patients were enrolled between August 2019 and March 2022, with 125 in each group. There were no significant differences in severe bleeding between the none-pre-placed balloon group and pre-placed balloon group (1.6% vs. 0.8%; adjusted p = 0.520), while more moderate bleeding occurred in the none-pre-placed balloon group (26.4% vs. 6.4%, adjusted p = 0.001), as well as more use of hemostatic drug (28.0% vs. 6.4%, adjusted p = 0.001). Three patients in the none-pre-placed balloon group used the bronchial balloon. More samples could be acquired in the pre-placed balloon group than in the none-pre-placed balloon group (3.8 ± 0.9 vs. 3.1 ± 0.9, p < 0.001). There were no significant differences in multidisciplinary discussion (MDD) between the two groups (89.6% vs. 91.2%, adjusted p = 0.182).

CONCLUSION:

A pre-placed bronchial balloon can reduce the incidence of moderate bleeding and increase the confidence of the bronchoscopists. However, it had no effect on increasing the diagnostic rate of MDD and reducing severe bleeding. REGISTRATION NUMBER NCT04047667 ( www. CLINICALTRIALS gov identifier).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Broncoscopía / Enfermedades Pulmonares Intersticiales / Criocirugía Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Med Res Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Broncoscopía / Enfermedades Pulmonares Intersticiales / Criocirugía Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Med Res Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido