MAPLE-PD trial (Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer during Pancreaticoduodenectomy): study protocol for a multicenter randomized controlled trial of 354 patients with pancreatic ductal adenocarcinoma.
BACKGROUND
The mesenteric approach is an artery-first approach to pancreaticoduodenectomy for pancreatic cancer, which starts with the dissection of connective tissues around the superior mesenteric artery. The procedure aims for early confirmation of resectability by checking the surgical margin around the superior mesenteric artery first during the operation. It also aims to decrease intraoperative blood loss by early ligation of the inferior pancreaticoduodenal artery and to increase R0 rate by complete clearance of the lymph nodes around the superior mesenteric artery and pancreatic head plexus II, the most favorable positive margin site for pancreatic ductal adenocarcinoma. Furthermore, it aims to avoid the spread of cancer cells during operation (nontouch isolation technique). The MAPLE-PD (Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer during Pancreaticoduodenectomy) trial investigates whether the mesenteric approach can prolong the survival of patients with pancreatic ductal adenocarcinoma who undergo pancreaticoduodenectomy compared with the conventional approach.


METHODS/DESIGN
The MAPLE-PD trial is a Japanese multicenter randomized controlled trial that compares the surgical outcomes between the mesenteric and conventional approaches to pancreaticoduodenectomy. Patients with pancreatic ductal adenocarcinoma scheduled to undergo pancreaticoduodenectomy are randomized before operation to either a conventional approach (arm A) or a mesenteric approach (arm B). In arm A, the operation starts with Kocher's maneuver. At the final step of the removal procedure, the connective tissues around the superior mesenteric artery are dissected. In arm B, the operation starts with dissection of the connective tissues around the superior mesenteric artery and ends with Kocher's maneuver. In total, 354 patients from 15 Japanese high-volume centers will be randomized. The primary endpoint is overall survival by intention-to-treat analysis. Secondary endpoints include intraoperative blood loss, R0 rate, and recurrence-free survival.


DISCUSSION
If the MAPLE-PD trial shows the oncological benefits of the mesenteric approach for patients with pancreatic ductal adenocarcinoma, this procedure may become a standard approach to pancreaticoduodenectomy.


TRIAL REGISTRATION
ClinicalTrials.gov, NCT03317886 . Registered on 23 October 2017. University Hospital Medical Information Network Clinical Trials Registry, UMIN000029615 . Registered on 15 January 2018.
['Hirono|Seiko|S|', 'Kawai|Manabu|M|', 'Okada|Ken-Ichi|KI|', 'Fujii|Tsutomu|T|', 'Sho|Masayuki|M|', 'Satoi|Sohei|S|', 'Amano|Ryosuke|R|', 'Eguchi|Hidetoshi|H|', 'Mataki|Yuko|Y|', 'Nakamura|Masafumi|M|', 'Matsumoto|Ippei|I|', 'Baba|Hideo|H|', 'Tani|Masaji|M|', 'Kawabata|Yasunari|Y|', 'Nagakawa|Yuichi|Y|', 'Yamada|Suguru|S|', 'Murakami|Yoshiaki|Y|', 'Shimokawa|Toshio|T|', 'Yamaue|Hiroki|H|http://orcid.org/0000-0002-6982-3457']
D000230:Adenocarcinoma D021441:Carcinoma, Pancreatic Ductal D003238:Connective Tissue D032984:Ethics, Research D006801:Humans D017538:Mesenteric Artery, Superior D015337:Multicenter Studies as Topic D010190:Pancreatic Neoplasms D016577:Pancreaticoduodenectomy D016032:Randomized Controlled Trials as Topic D018401:Sample Size
Mesenteric approach Conventional approach Pancreaticoduodenectomy Pancreatic ductal adenocarcinoma Artery-first approach Superior mesenteric artery Borderline resectable pancreatic cancer R0 resection Resectable pancreatic cancer