Effects of the superior mesenteric artery approach versus the no-touch approach during pancreatoduodenectomy on the mobilization of circulating tumour cells and clusters in pancreatic cancer (CETUPANC): randomized clinical trial.


Journal

BJS open
ISSN: 2474-9842
Titre abrégé: BJS Open
Pays: England
ID NLM: 101722685

Informations de publication

Date de publication:
29 Oct 2024
Historique:
received: 09 02 2024
revised: 02 08 2024
accepted: 21 08 2024
medline: 2 11 2024
pubmed: 2 11 2024
entrez: 1 11 2024
Statut: ppublish

Résumé

Patients with pancreatic ductal adenocarcinoma present early postoperative systemic metastases, despite complete oncological resection. The aim of this study was to assess two pancreatoduodenectomy approaches with regard to intraoperative circulating tumour cells and cluster mobilization and their potential association with the development of distant metastasis. Patients with periampullary tumours who underwent open pancreatoduodenectomy were randomly allocated to either the no-touch approach or the superior mesenteric artery approach. A total of four intraoperative portal vein samples (at the beginning of the intervention, after portal vein disconnection from the tumour, after tumour resection, and before abdominal closure) were collected to measure circulating tumour cells and cluster numbers. Primary outcomes were the intraoperative number of circulating tumour cells and cluster mobilization. Further, their potential impact on 3-year distant metastasis disease-free survival and overall survival was assessed. A total of 101 patients with periampullary tumours were randomized (51 in the superior mesenteric artery group and 50 in the no-touch group) and 63 patients with pancreatic ductal adenocarcinoma (34 in the superior mesenteric artery group and 29 in the no-touch group) were analysed. Circulating tumour cells and cluster mobilization were similar in both the no-touch group and the superior mesenteric artery group at all time points. There were no significant differences between surgical groups with regard to the median metastasis disease-free survival (12.4 (interquartile range 6.1-not reached) months in the superior mesenteric artery group and 18.1 (interquartile range 12.1-not reached) months in the no-touch group; P = 0.730). Patients with intraoperative cluster mobilization from the beginning to the end of surgery developed significantly more distant metastases within the first year after surgery (P = 0.023). Two intraoperative factors (the superior mesenteric artery approach (P = 0.025) and vein resection (P < 0.001)) were predictive factors for cluster mobilization. Patients undergoing pancreatoduodenectomy using either the no-touch approach or the superior mesenteric artery approach had similar circulating tumour cells and cluster mobilization and similar overall survival and metastasis disease-free survival. A high intraoperative cluster dissemination during pancreatoduodenectomy was a predictive factor for early metastases in patients with pancreatic ductal adenocarcinoma. NCT03340844 (http://www.clinicaltrials.gov)-CETUPANC trial.

Sections du résumé

BACKGROUND BACKGROUND
Patients with pancreatic ductal adenocarcinoma present early postoperative systemic metastases, despite complete oncological resection. The aim of this study was to assess two pancreatoduodenectomy approaches with regard to intraoperative circulating tumour cells and cluster mobilization and their potential association with the development of distant metastasis.
METHODS METHODS
Patients with periampullary tumours who underwent open pancreatoduodenectomy were randomly allocated to either the no-touch approach or the superior mesenteric artery approach. A total of four intraoperative portal vein samples (at the beginning of the intervention, after portal vein disconnection from the tumour, after tumour resection, and before abdominal closure) were collected to measure circulating tumour cells and cluster numbers. Primary outcomes were the intraoperative number of circulating tumour cells and cluster mobilization. Further, their potential impact on 3-year distant metastasis disease-free survival and overall survival was assessed.
RESULTS RESULTS
A total of 101 patients with periampullary tumours were randomized (51 in the superior mesenteric artery group and 50 in the no-touch group) and 63 patients with pancreatic ductal adenocarcinoma (34 in the superior mesenteric artery group and 29 in the no-touch group) were analysed. Circulating tumour cells and cluster mobilization were similar in both the no-touch group and the superior mesenteric artery group at all time points. There were no significant differences between surgical groups with regard to the median metastasis disease-free survival (12.4 (interquartile range 6.1-not reached) months in the superior mesenteric artery group and 18.1 (interquartile range 12.1-not reached) months in the no-touch group; P = 0.730). Patients with intraoperative cluster mobilization from the beginning to the end of surgery developed significantly more distant metastases within the first year after surgery (P = 0.023). Two intraoperative factors (the superior mesenteric artery approach (P = 0.025) and vein resection (P < 0.001)) were predictive factors for cluster mobilization.
CONCLUSION CONCLUSIONS
Patients undergoing pancreatoduodenectomy using either the no-touch approach or the superior mesenteric artery approach had similar circulating tumour cells and cluster mobilization and similar overall survival and metastasis disease-free survival. A high intraoperative cluster dissemination during pancreatoduodenectomy was a predictive factor for early metastases in patients with pancreatic ductal adenocarcinoma.
REGISTRATION NUMBER BACKGROUND
NCT03340844 (http://www.clinicaltrials.gov)-CETUPANC trial.

Identifiants

pubmed: 39485887
pii: 7863330
doi: 10.1093/bjsopen/zrae123
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03340844']

Types de publication

Journal Article Randomized Controlled Trial Comparative Study

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Instituto de Salud Carlos III

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.

Auteurs

Javier Padillo-Ruiz (J)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Cristóbal Fresno (C)

Health and Sciences Research Centre, Health and Sciences Faculty, Anahuac University, Huixquilucan, Mexico.

Gonzalo Suarez (G)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Gerardo Blanco (G)

Department of Surgery, Badajoz University Hospital, University of Extremadura, Badajoz, Spain.

Luis Muñoz-Bellvis (L)

Department of Surgery, University Hospital of Salamanca, Salamanca Biosanitary Institute, University of Salamanca, Salamanca, Spain.

Iago Justo (I)

Department of Surgery, University Hospital October 12 in Madrid, Madrid, Spain.

Maria I García-Domingo (MI)

Department of Surgery, Terrassa Mutual University Hospital, Terrassa, Spain.

Fabio Ausania (F)

Hospital-Clinic, August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Barcelona, Spain.

Elena Muñoz-Forner (E)

Department of Surgery, Valencia Clinical Hospital, University of Valencia, Biomedical Research Institute, INCLIVA, Valencia, Spain.

Alejandro Serrablo (A)

Department of Surgery, Miguel Servet University Hospital, Zaragoza, Spain.

Elena Martin (E)

Department of Surgery, Princess University Hospital, Madrid, Spain.

Luis Díez (L)

Department of Surgery, Clinical Hospital, Madrid, Spain.

Carmen Cepeda (C)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Luis Marin (L)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Jose Alamo (J)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Carmen Bernal (C)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Sheila Pereira (S)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Francisco Calero (F)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Jose Tinoco (J)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Sandra Paterna (S)

Department of Surgery, Miguel Servet University Hospital, Zaragoza, Spain.

Esteban Cugat (E)

Department of Surgery, Terrassa Mutual University Hospital, Terrassa, Spain.

Constantino Fondevila (C)

Hospital-Clinic, August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Barcelona, Spain.

Elisa Diego-Alonso (E)

Department of Surgery, University Hospital of Salamanca, Salamanca Biosanitary Institute, University of Salamanca, Salamanca, Spain.

Diego López-Guerra (D)

Department of Surgery, Badajoz University Hospital, University of Extremadura, Badajoz, Spain.

Miguel Gomez (M)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Valeria Denninghoff (V)

Department of Surgery, Virgen del Rocío University Hospital, IBIS, University of Seville, Seville, Spain.

Luis Sabater (L)

Department of Surgery, Valencia Clinical Hospital, University of Valencia, Biomedical Research Institute, INCLIVA, Valencia, Spain.

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