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Evaluation of Complete microscopicE Resection Margin (R0) and Lymph Node Involvement After Standard Pancreatosplenectomy (SPS) Versus Radical Anterograde Modular Pancreatosplenectomy (REMIND-01)

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ClinicalTrials.gov Identifier: NCT03679169
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:

Resection with negative margins (R0) followed by adjuvant chemotherapy is today the standard of care and the only chance of cure for patients with pancreatic ductal adenocarcinoma (PDA). Incomplete microscopic resection margin (R1) after pancreatic resection has been reported to occur in 17 to >80% of cases depending on the nonconsensual definition of R1 status. This discrepancy is reflected in conflicting reports regarding the prognostic relevance of R1 resection. Currently, neither the definition of the margin involvement nor the surgical technique to clear the margins is consistently applied, resulting in conflicting data in the literature. The Radical Antegrade Modular Pancreatosplenectomy (RAMPS) was described by Strasberg et al. in 2003 to increase the rate of R0 resection for left PDA. However, there is no grade A recommendation and surgical practices still remain heterogeneous as many surgeons still consider the "retrograde" technique as the standard procedure. The invasion of the resection margins is often poorly evaluated, including in large clinical trials. The surgical specimens are not systematically inked and the microscopic invasion of the splenic vessels is underreported, leading to inaccurate pathologic evaluation.

A French prospective multicenter study (Delpero JR et al; ClinicalTrials.gov: NCT00918853) was previously conducted for pancreaticoduodenectomy specimens. A recent update (Ann Surg 2017, in press) has emphasized the value of a standardized pathology protocol to accurately assess the impact of R0 resection and improve patient's stratification.

Today, no recommendations are available regarding the surgical procedure and histological analysis for DP specimen 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. 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: pancreatosplenectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial for the Evaluation of Complete Microscopic Resection Margin (R0) and Lymph Node Involvement After Standard Pancreatosplenectomy (SPS) Versus Radical Anterograde Modular Pancreatosplenectomy (RAMPS)
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : September 17, 2022
Estimated Study Completion Date : September 17, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group RAMPS
Radical antegrade modular pancreatosplenectomy
Procedure: pancreatosplenectomy
standard or radical anterograde modularpancreatosplenectomy

Active Comparator: Group SPS
standard pancreatosplenectomy
Procedure: pancreatosplenectomy
standard or radical anterograde modularpancreatosplenectomy




Primary Outcome Measures :
  1. Rate of resection margins involvement and lymph node involvement between RAMPS and SPS performed for pancreatic adenocarcinoma of the body and tail, using a standardized pathology protocol. [ Time Frame: Day of surgery (1 day) ]
    Comparison of the rate of resection margins involvement and lymph node involvement between RAMPS (radical anterograde modular pancreatosplenectomy) and SPS (standard pancreatosplenectomy) performed for pancreatic adenocarcinoma of the body and tail, using a standardized pathology protocol.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679169


Contacts
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Contact: GENRE Dominique, MD + 33 4 91 22 37 78 drci.up@ipc.unicancer.fr

Locations
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France
GENRE Recruiting
Marseille, France, 13273
Contact: GENRE Dominique, MD    + 33 4 91 22 37 78    drci.up@ipc.unicancer.fr   
Principal Investigator: Jean Robert DELPERO, Md PhD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: DELPERO Jean-Robert, MD, PhD Institut Paoli-Calmettes

Additional Information:
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03679169    
Other Study ID Numbers: REMIND-01-IPC 2017-050
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No