Comparison of Chemotherapy Combined with Percutaneous Electroporation and Chemotherapy Alone in the Management of Locally Advanced Gallbladder Carcinoma (GBC): A Study Protocol.
Ablation
Chemotherapy
Irreversible electroporation
Unresectable gallbladder carcinoma
Journal
Cardiovascular and interventional radiology
ISSN: 1432-086X
Titre abrégé: Cardiovasc Intervent Radiol
Pays: United States
ID NLM: 8003538
Informations de publication
Date de publication:
27 Sep 2024
27 Sep 2024
Historique:
received:
03
01
2024
accepted:
29
08
2024
medline:
28
9
2024
pubmed:
28
9
2024
entrez:
27
9
2024
Statut:
aheadofprint
Résumé
This study aims to evaluate the feasibility and efficacy of chemotherapy combined with irreversible electroporation (IRE) in patients with locally advanced gallbladder carcinoma (GBC) presenting as gallbladder masses. Patients with unresectable GBC masses of size greater than 2 cm and less than 6 cm without evidence of distant metastases and with no contraindication to general anaesthesia will be enrolled in the study. They will be randomized using computer generated table into two arms with 1:1 allocation ratio to include 15 patients in each group. Group I will be the chemotherapy alone arm and Group II will be the combined image-guided irreversible electroporation of the tumour and chemotherapy arm. The primary outcome assessed shall be the clinical benefit rate (complete response, CR; partial response, PR and stable disease, SD) based on the mRECIST criteria and overall survival. The secondary outcome shall be feasibility and safety of the procedure and quality of life pre and post procedure. The quality of life will be assessed by a questionnaire as given by EORTC-Quality of Life Group before starting therapy and 4 weeks after completion of therapy. The combined local and systemic effects of irreversible electroporation and systemic chemotherapy respectively may improve the outcomes in inoperable cases of gallbladder carcinoma. Clinical Trials Registry - India ( https://ctri.nic.in/Clinicaltrials/advancesearchmain.php ). Identifier: CTRI/2021/05/033803. Primary Register of the International Clinical Trials Registry Platform (WHO ICTRP) ( http://www.who.int/ictrp/search/en/ ).
Identifiants
pubmed: 39333372
doi: 10.1007/s00270-024-03856-0
pii: 10.1007/s00270-024-03856-0
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
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