Pilot clinical study on the prevention of complications after lung biopsy by the MIPP kit PNX device.
Percutaneous lung biopsy (PLB)
complications
lung cancer diagnosis
pneumothorax (PNX)
Journal
Translational cancer research
ISSN: 2219-6803
Titre abrégé: Transl Cancer Res
Pays: China
ID NLM: 101585958
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
received:
29
04
2022
accepted:
25
09
2022
entrez:
16
1
2023
pubmed:
17
1
2023
medline:
17
1
2023
Statut:
ppublish
Résumé
Pneumothorax (PNX), pulmonary hemorrhage, hemothorax and chest wall hematoma are the most commonly reported complications of percutaneous lung biopsy (PLB). Sealing the biopsy tract with different types of materials is an emerging way to prevent PLB complications. To investigate the safety and efficacy of a new device, Minimally Invasive Percutaneous Procedure Kit for Pneumothorax (MIPP-Kit PNX), when used in association with a resorbable bio-compatible glue in the prevention of PLB complications. A prospective, multicenter, open-label, single-arm study was performed to evaluate the complication rate after glue administration by the new investigational device during PLBs. Fourty-three patients were enrolled after informed consent signature (40 underwent PLB, while three were screening failures). Only 3 patients (7.5%, 95% CI: 0.0-15.7%) developed complications within 48 h after glue injection during PLB: two developed minor pneumothoraces and one a pulmonary hemorrhage. No patients who showed procedural complications before glue administration were reported with any recurrent or new complications after glue administration. In comparison with the data reported in the literature, this trial results support the safe and effective use of the MIPP kit PNX in the prevention of PLB complications. These promising preliminary results warrant further confirmation in larger clinical trials. ClinicalTrials.gov identifier: NCT04071509.
Sections du résumé
Background
UNASSIGNED
Pneumothorax (PNX), pulmonary hemorrhage, hemothorax and chest wall hematoma are the most commonly reported complications of percutaneous lung biopsy (PLB). Sealing the biopsy tract with different types of materials is an emerging way to prevent PLB complications.
Methods
UNASSIGNED
To investigate the safety and efficacy of a new device, Minimally Invasive Percutaneous Procedure Kit for Pneumothorax (MIPP-Kit PNX), when used in association with a resorbable bio-compatible glue in the prevention of PLB complications. A prospective, multicenter, open-label, single-arm study was performed to evaluate the complication rate after glue administration by the new investigational device during PLBs.
Results
UNASSIGNED
Fourty-three patients were enrolled after informed consent signature (40 underwent PLB, while three were screening failures). Only 3 patients (7.5%, 95% CI: 0.0-15.7%) developed complications within 48 h after glue injection during PLB: two developed minor pneumothoraces and one a pulmonary hemorrhage. No patients who showed procedural complications before glue administration were reported with any recurrent or new complications after glue administration.
Conclusions
UNASSIGNED
In comparison with the data reported in the literature, this trial results support the safe and effective use of the MIPP kit PNX in the prevention of PLB complications. These promising preliminary results warrant further confirmation in larger clinical trials.
Trial Registration
UNASSIGNED
ClinicalTrials.gov identifier: NCT04071509.
Identifiants
pubmed: 36644169
doi: 10.21037/tcr-22-1203
pii: tcr-11-12-4338
pmc: PMC9834579
doi:
Banques de données
ClinicalTrials.gov
['NCT04071509']
Types de publication
Journal Article
Langues
eng
Pagination
4338-4348Commentaires et corrections
Type : CommentIn
Informations de copyright
2022 Translational Cancer Research. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tcr.amegroups.com/article/view/10.21037/tcr-22-1203/coif). PLC has been VP Clinical Operations at Betaglue after the study started until its completion. AA has been CEO/CMO at Betaglue for the entire duration of the study. The other authors have no conflicts of interest to declare.
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