A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study).
BMC Cancer
; 24(1): 231, 2024 Feb 19.
Article
em En
| MEDLINE
| ID: mdl-38373949
ABSTRACT
BACKGROUND:
Minimally invasive distal pancreatectomy (MIDP), including laparoscopic and robotic distal pancreatectomy, has gained widespread acceptance over the last decade owing to its favorable short-term outcomes. However, evidence regarding its oncologic safety is insufficient. In March 2023, a randomized phase III study was launched in Japan to confirm the non-inferiority of overall survival in patients with resectable pancreatic cancer undergoing MIDP compared with that of patients undergoing open distal pancreatectomy (ODP).METHODS:
This is a multi-institutional, randomized, phase III study. A total of 370 patients will be enrolled from 40 institutions within 4 years. The primary endpoint of this study is overall survival, and the secondary endpoints include relapse-free survival, proportion of patients undergoing radical resection, proportion of patients undergoing complete laparoscopic surgery, incidence of adverse surgical events, and length of postoperative hospital stay. Only a credentialed surgeon is eligible to perform both ODP and MIDP. All ODP and MIDP procedures will undergo centralized review using intraoperative photographs. The non-inferiority of MIDP to ODP in terms of overall survival will be statistically analyzed. Only if non-inferiority is confirmed will the analysis assess the superiority of MIDP over ODP.DISCUSSION:
If our study demonstrates the non-inferiority of MIDP in terms of overall survival, it would validate its short-term advantages and establish its long-term clinical efficacy. TRIAL REGISTRATION This trial is registered with the Japan Registry of Clinical Trials as jRCT 1,031,220,705 [ https//jrct.niph.go.jp/en-latest-detail/jRCT1031220705 ].Palavras-chave
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Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Pancreáticas
/
Laparoscopia
/
Procedimentos Cirúrgicos Robóticos
Limite:
Humans
País como assunto:
Asia
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article