Etude : REMIND-01 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : REMIND-01

Situation thérapeutique :

Traitement : Chirurgie

Cadre réglementaire : RIPH1

Dernière MÀJ : 06/12/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai randomisé évaluant le taux de résection complète R0 et d'envahissement ganglionnaire après splénopancréatectomie standard (SPS) versus splénopancréatectomie antérograde radicale (RAMPS) (REsection MargINs for Distal pancreatectomy)

Spécialité : Organes digestifs
Localisation : C25 - Tumeur maligne du pancréas
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Patients enrolled in this study will be randomized (standard resection procedure versus the RAMPS technique) in 20 participating centers. Inclusions are planned over a 3 years-period.
Margin resection will be assessed using a standardized histopathologic protocol which will involve axial specimen slicing, extensive tissue sampling and multicolor staining. Specimens will be inked systematically in the operative room. Five margins will be studied: the retroperitoneal margin (with the anterior renal fascia in the "RAMPS" group); the celio-mesenteric artery interface; the portal vein groove; the anterior margin; the pancreatic transection margin. Thus, the inking will identify each face of the "circumferential margin". The splenic vessels involvement will be independently identified and analyzed. The distance between tumor cells and each inked margin (ie: the clearance) will be precisely defined from 0 to 2mm with increments of 0.5mm. The invasion of the splenic vessels will be assessed both on the preoperative CT-scan and the specimens. A second centralized histopathological review of the specimens will be performed by a committee of referents pathologists in pancreatic specimens handling.

- The primary endpoint of this multicenter randomized control trial (RCT) is to investigate the benefit of the RAMPS procedure in comparison to standard distal pancreatosplenectomy (SDPS) on the R0-resection rate using a high-quality pathology protocol.
- Secondary outcome measures will be: a) survival (overall, relapse and progression free survival) according to the two surgical techniques; b) evaluation of the independent determinants of post-resection survival: R1 for each margin at each increment; splenic vessels invasion; LN involvement (and LN ratio).

To date, there are no prospective data assessing the superiority of the RAMPS technique over standard resection. This study will be the first RCT on the subject.

This study could improve the surgical practices and define a surgical standard of care. The pathology protocol used for the study could help to standardize histopathology report on margin status. It could also provide a better evaluation of the impact of adjuvant and neoadjuvant therapies on local control. This study should lead to improved selection of patients for upfront surgery and give appropriate perioperative treatment tailored to a well-defined disease stage. Furthermore, guidelines for surgical practices and standardization of histological examination may represent a significant step forward in the design of future trials to assess perioperative strategies.

STUDY ARMS:
- Experimental: Group RAMPS = Radical antegrade modular pancreatosplenectomy
- Active Comparator: Group SPS = Standard pancreatosplenectomy

Phase : NA

Stade : Localisé

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age> 18 years
- Tumor of the body or tail of the pancreas compatible with pancreatic ductal adenocarcinoma before surgery
- Intraductal papillary mucinous neoplasms (IPMN) with invasive carcinoma
- Resectable tumor
- Absence of medical contraindication
- Borderline* resectable tumors with preoperative treatment could be enlisted in the protocol

Critères de non-inclusion : - Patients with legal protection
- Pregnancy
- Preoperative distant metastasis and unresectable tumor (ie tumor interface with the celiac axis and superior mesenteric artery > 180°, aortic involvement or unreconstructible superior mesenteric venous resection due to tumor involvement or occlusion)
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03679169
Promoteur :
INSTITUT PAOLI-CALMETTES
Type de sponsor : Institutionnel
INSTITUT PAOLI-CALMETTES - INSTITUT PAOLI-CALMETTES
13009 MARSEILLE 09

Coordonnateur :
Professeur Jean-Robert DELPERO
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Guillaume PIESSEN

TEC / ARC / IDE :
Justine LEROOY
justine.lerooy@
chru-lille.fr
Tel: 03 20 44 47 86 (ou 03 20 44 59 62) Fax: 03 20 44 59 14

Statut de l'essai : OUVERT

MAJ : 04/09/2020

Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Stéphanie TRUANT

TEC / ARC / IDE :
Katia LECOLLE
Katia.LECOLLE@
CHRU-LILLE.FR
03 20 44 42 60-poste 29254

Statut de l'essai : OUVERT

MAJ : 04/09/2020