NCT03317886

Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer During Pancreaticoduodenectomy (MAPLE-PD Trial)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (estimated)
• Sponsor: Wakayama Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the advantage of mesenteric approach during pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). The design of this study is multicenter randomized clinical trial, comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.

Detailed description

Mesenteric approach starts from dissection of lymph nodes around the superior mesenteric artery (SMA) and finally performs Kocher's maneuver during PD. The aims of this approach are 1) decrease of intraoperative blood loss volume, 2) increase of R0 rate, and 3) prevention of squeezing cancer cells out into the vessels. However, there have been no evidence of the efficacy of this procedure. Therefore, the aim of this study is to evaluate the efficacy of mesenteric approach during PD for PDAC, by multicenter randomized clinical trial comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Pancreaticoduodenectomy
• Mesenteric Approach

Interventions

Type	Name	Description
PROCEDURE	pancreaticoduodenectomy	pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2017-10-23
• Last updated: 2017-10-24

Locations

15 sites across 1 country: Japan