Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD trial): A Multicenter Randomized Controlled Trial

Seiko Hirono^{1

2}, Yuji Kitahata¹, Hideki Motobayashi¹, Sohei Satoi³, Masayuki Sho⁴, Hideki Takami⁵, Keiko Kamei⁶, Kazuto Shibuya⁷, Masaaki Hidaka⁸, Kenichiro Uemura⁹, Kenjiro Kimura¹⁰, Yuko Mataki¹¹, Yuichi Nagakawa¹², Hiromitsu Hayashi¹³, Ryo Morimura¹⁴, Masafumi Nakamura¹⁵, Ke Wan¹⁶, Toshio Shimokawa¹⁶, Akimasa Nakao¹⁷, Hiroki Yamaue^{1

18}; MAPLE-PD trial investigators

Affiliations

¹ Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera, Wakayama city, Wakayama 641-8510, Japan.
² Division of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery, Hyogo Medical University. 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501, Japan.
³ Department of Pancreatobiliary Surgery, Kansai Medical University, 2-5-10, Shin-machi, Hirakata, Osaka 573-1010, Japan.
⁴ Department of Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8522, Japan.
⁵ Department of Gastroenterological Surgery, Nagoya University, Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
⁶ Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan.
⁷ Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan.
⁸ Department of Digestive and General Surgery, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan.
⁹ Department of Surgery, Institute of Biomedical and Health Science, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551 Japan.
¹⁰ Department of Hepato-Biliary-Pancreatic Surgery Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan.
¹¹ Department of Digestive surgery, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima city, Kagoshima 891-0175, Japan.
¹² Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
¹³ Department of Gastroenterology, Kumamoto University, Honjo, Kumamoto city, Kumamoto 860-8556, Japan.
¹⁴ Department of Digestive Surgery, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City, Kyoto 602-8566, Japan.
¹⁵ Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
¹⁶ Clinical Study Support Center, Wakayama Medical University, School of Medicine, 811-1 Kimiidera, Wakayama city, Wakayama 641-8509, Japan.
¹⁷ Department of Gastroenterological Surgery, Nagoya Central Hospital, 3-7-7 Taiko, Nakamura-ku, Nagoya, Aichi 453-0801, Japan.
¹⁸ Division of Gastroenterological & General Surgery, Department of Surgery, School of Medicine, Showa Medical University, 1-5-8 Hatanodai, Shinagawa-Ku, Tokyo 142-8555, Japan.

PMID: 40772617
DOI: 10.1097/SLA.0000000000006900

Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD trial): A Multicenter Randomized Controlled Trial

Seiko Hirono et al. Ann Surg. 2025.

. 2025 Aug 7.

doi: 10.1097/SLA.0000000000006900. Online ahead of print.

Authors

Affiliations

¹ Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera, Wakayama city, Wakayama 641-8510, Japan.
² Division of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery, Hyogo Medical University. 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501, Japan.
³ Department of Pancreatobiliary Surgery, Kansai Medical University, 2-5-10, Shin-machi, Hirakata, Osaka 573-1010, Japan.
⁴ Department of Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8522, Japan.
⁵ Department of Gastroenterological Surgery, Nagoya University, Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
⁶ Department of Surgery, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan.
⁷ Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan.
⁸ Department of Digestive and General Surgery, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan.
⁹ Department of Surgery, Institute of Biomedical and Health Science, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551 Japan.
¹⁰ Department of Hepato-Biliary-Pancreatic Surgery Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan.
¹¹ Department of Digestive surgery, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima city, Kagoshima 891-0175, Japan.
¹² Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
¹³ Department of Gastroenterology, Kumamoto University, Honjo, Kumamoto city, Kumamoto 860-8556, Japan.
¹⁴ Department of Digestive Surgery, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City, Kyoto 602-8566, Japan.
¹⁵ Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
¹⁶ Clinical Study Support Center, Wakayama Medical University, School of Medicine, 811-1 Kimiidera, Wakayama city, Wakayama 641-8509, Japan.
¹⁷ Department of Gastroenterological Surgery, Nagoya Central Hospital, 3-7-7 Taiko, Nakamura-ku, Nagoya, Aichi 453-0801, Japan.
¹⁸ Division of Gastroenterological & General Surgery, Department of Surgery, School of Medicine, Showa Medical University, 1-5-8 Hatanodai, Shinagawa-Ku, Tokyo 142-8555, Japan.

PMID: 40772617
DOI: 10.1097/SLA.0000000000006900

Abstract

Objective: This multicenter randomized controlled trial investigated whether the mesenteric approach, which is an infracolic superior mesenteric artery (SMA)-first approach during pancreatoduodenectomy (PD), can improve survival in patients with pancreatic ductal adenocarcinoma (PDAC), compared to the Kocher-first conventional approach.

Summary background data: The mesenteric approach might improve surgical outcomes through a non-touch isolation technique for PDAC.

Methods: This trial was conducted in 24 Japanese high-volume centers. Patients who were scheduled to undergo PD for resectable PDAC or borderline resectable PDAC with portal vein invasion (BR-PV PDAC) were randomly assigned (1:1) via a central web-based application to the conventional or mesenteric approach. The primary endpoint was overall survival (OS). We also analyzed circulating tumor cell (CTC) DNA in the PV blood obtained during surgery. This trial is registered with ClinicalTrials.gov. NCT03317886, and UMIN Clinical Trials UMIN000029615.

Results: Between 2018 and 2021, 360 patients were randomly assigned to conventional (n=181) and mesenteric groups (n=179). With a median follow-up of 39.3 months, the median OS was comparable between conventional and mesenteric groups (41.7 vs. 39.3 months; hazard ratio 1.02, 95% confidence interval: 0.76-1.37, P =0.897). CTC analysis showed that the mean change in CTC DNA copy number in PV obtained at laparotomy and just before removal of the specimen was significantly different between the conventional (10.1±2.7) and mesenteric (-7.3±2.6) groups ( P <0.001).

Conclusions: The mesenteric approach does not improve survival in patients with resectable or BR-PV PDAC, although it might prevent spread of cancer cells via vessels during surgery through the non-touch isolation procedure.

Keywords: Mesenteric approach; artery-first approach; conventional approach; pancreatic ductal adenocarcinoma; pancreatoduodenectomy; superior mesenteric artery.

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Conflict of interest statement

[ Conflicts of Interest and source of funding]: The authors have no conflicts of interest to declare.

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Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD trial): A Multicenter Randomized Controlled Trial

Affiliations

Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD trial): A Multicenter Randomized Controlled Trial

Authors

Affiliations

Abstract

Conflict of interest statement

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical