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

NCT03679169 | Unknown DMC

• 1 other identifier: REMIND-01-IPC 2017-050
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (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.

  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.

  Day of surgery (1 day)

Study Arms (2)

Group RAMPS

EXPERIMENTAL

Radical antegrade modular pancreatosplenectomy

Procedure: pancreatosplenectomy

Group SPS

ACTIVE COMPARATOR

standard pancreatosplenectomy

Procedure: pancreatosplenectomy

Interventions

pancreatosplenectomy PROCEDURE

standard or radical anterograde modularpancreatosplenectomy

Group RAMPS; Group SPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

GENRE

Marseille, 13273, France

RECRUITING

Related Links

• Institut PAOLI-CALMETTES

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• DELPERO Jean-Robert, MD, PhD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GENRE Dominique, MD

CONTACT

+ 33 4 91 22 37 78; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: January 17, 2020
• Primary Completion: September 17, 2022
• Study Completion: September 17, 2024
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)