A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study)
Abstract Background Minimally invasive distal pancreatectomy (MIDP), including laparoscopic and robotic distal pancreatectomy, has gained widespread acceptance over the last decade owing to its favorable short-term outcomes. However, evidence regarding its oncologic safety is insufficient. In March...
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BMC
2024-02-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-024-11957-9 |
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| author | Naoki Ikenaga Tadayoshi Hashimoto Junki Mizusawa Ryo Kitabayashi Yusuke Sano Haruhiko Fukuda Kohei Nakata Kazuto Shibuya Yuji Kitahata Minoru Takada Keiko Kamei Hiroshi Kurahara Daisuke Ban Shogo Kobayashi Hiroaki Nagano Hajime Imamura Michiaki Unno Amane Takahashi Shintaro Yagi Hiroshi Wada Hirofumi Shirakawa Naoto Yamamoto Seiko Hirono Naoto Gotohda Etsuro Hatano Masafumi Nakamura Makoto Ueno on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group |
| author_facet | Naoki Ikenaga Tadayoshi Hashimoto Junki Mizusawa Ryo Kitabayashi Yusuke Sano Haruhiko Fukuda Kohei Nakata Kazuto Shibuya Yuji Kitahata Minoru Takada Keiko Kamei Hiroshi Kurahara Daisuke Ban Shogo Kobayashi Hiroaki Nagano Hajime Imamura Michiaki Unno Amane Takahashi Shintaro Yagi Hiroshi Wada Hirofumi Shirakawa Naoto Yamamoto Seiko Hirono Naoto Gotohda Etsuro Hatano Masafumi Nakamura Makoto Ueno on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group |
| author_sort | Naoki Ikenaga |
| collection | DOAJ |
| description | Abstract Background Minimally invasive distal pancreatectomy (MIDP), including laparoscopic and robotic distal pancreatectomy, has gained widespread acceptance over the last decade owing to its favorable short-term outcomes. However, evidence regarding its oncologic safety is insufficient. In March 2023, a randomized phase III study was launched in Japan to confirm the non-inferiority of overall survival in patients with resectable pancreatic cancer undergoing MIDP compared with that of patients undergoing open distal pancreatectomy (ODP). Methods This is a multi-institutional, randomized, phase III study. A total of 370 patients will be enrolled from 40 institutions within 4 years. The primary endpoint of this study is overall survival, and the secondary endpoints include relapse-free survival, proportion of patients undergoing radical resection, proportion of patients undergoing complete laparoscopic surgery, incidence of adverse surgical events, and length of postoperative hospital stay. Only a credentialed surgeon is eligible to perform both ODP and MIDP. All ODP and MIDP procedures will undergo centralized review using intraoperative photographs. The non-inferiority of MIDP to ODP in terms of overall survival will be statistically analyzed. Only if non-inferiority is confirmed will the analysis assess the superiority of MIDP over ODP. Discussion If our study demonstrates the non-inferiority of MIDP in terms of overall survival, it would validate its short-term advantages and establish its long-term clinical efficacy. Trial registration This trial is registered with the Japan Registry of Clinical Trials as jRCT 1,031,220,705 [ https://jrct.niph.go.jp/en-latest-detail/jRCT1031220705 ]. |
| first_indexed | 2024-03-07T14:56:43Z |
| format | Article |
| id | doaj.art-af795692c0f54a44af1217f010e816e2 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-07T14:56:43Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-af795692c0f54a44af1217f010e816e22024-03-05T19:23:29ZengBMCBMC Cancer1471-24072024-02-012411710.1186/s12885-024-11957-9A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study)Naoki Ikenaga0Tadayoshi Hashimoto1Junki Mizusawa2Ryo Kitabayashi3Yusuke Sano4Haruhiko Fukuda5Kohei Nakata6Kazuto Shibuya7Yuji Kitahata8Minoru Takada9Keiko Kamei10Hiroshi Kurahara11Daisuke Ban12Shogo Kobayashi13Hiroaki Nagano14Hajime Imamura15Michiaki Unno16Amane Takahashi17Shintaro Yagi18Hiroshi Wada19Hirofumi Shirakawa20Naoto Yamamoto21Seiko Hirono22Naoto Gotohda23Etsuro Hatano24Masafumi Nakamura25Makoto Ueno26 on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu UniversityJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center HospitalJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center HospitalJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center HospitalJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center HospitalJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center HospitalDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu UniversityDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of ToyamaSecond Department of Surgery, Wakayama Medical UniversityDepartment of Surgery, Teine Keijinkai HospitalDepartment of Surgery, Kindai University Faculty of MedicineDepartment of Digestive Surgery, Kagoshima UniversityDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center HospitalDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka UniversityDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of MedicineDepartment of Surgery, Nagasaki University Graduate School of Biomedical SciencesDepartment of Surgery, Tohoku University Graduate School of MedicineDepartment of Gastroenterological Surgery, Saitama Cancer CenterDepartment of Hepato-Biliary-Pancreatic Surgery and Transplantation, Kanazawa UniversityDepartment of Gastroenterological Surgery, Osaka International Cancer InstituteDepartment of HepatoBiliary-Pancreatic Surgery, Tochigi Cancer CenterDepartment of Gastrointestinal Surgery, Kanagawa Cancer CenterDivision of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery, Hyogo Medical UniversityDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital EastDepartment of Surgery, Graduate School of Medicine, Kyoto UniversityDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu UniversityDepartment of Gastroenterology, Kanagawa Cancer CenterAbstract Background Minimally invasive distal pancreatectomy (MIDP), including laparoscopic and robotic distal pancreatectomy, has gained widespread acceptance over the last decade owing to its favorable short-term outcomes. However, evidence regarding its oncologic safety is insufficient. In March 2023, a randomized phase III study was launched in Japan to confirm the non-inferiority of overall survival in patients with resectable pancreatic cancer undergoing MIDP compared with that of patients undergoing open distal pancreatectomy (ODP). Methods This is a multi-institutional, randomized, phase III study. A total of 370 patients will be enrolled from 40 institutions within 4 years. The primary endpoint of this study is overall survival, and the secondary endpoints include relapse-free survival, proportion of patients undergoing radical resection, proportion of patients undergoing complete laparoscopic surgery, incidence of adverse surgical events, and length of postoperative hospital stay. Only a credentialed surgeon is eligible to perform both ODP and MIDP. All ODP and MIDP procedures will undergo centralized review using intraoperative photographs. The non-inferiority of MIDP to ODP in terms of overall survival will be statistically analyzed. Only if non-inferiority is confirmed will the analysis assess the superiority of MIDP over ODP. Discussion If our study demonstrates the non-inferiority of MIDP in terms of overall survival, it would validate its short-term advantages and establish its long-term clinical efficacy. Trial registration This trial is registered with the Japan Registry of Clinical Trials as jRCT 1,031,220,705 [ https://jrct.niph.go.jp/en-latest-detail/jRCT1031220705 ].https://doi.org/10.1186/s12885-024-11957-9Clinical trialLaparoscopyMinimally invasive surgical proceduresPancreatectomyPancreatic neoplasm |
| spellingShingle | Naoki Ikenaga Tadayoshi Hashimoto Junki Mizusawa Ryo Kitabayashi Yusuke Sano Haruhiko Fukuda Kohei Nakata Kazuto Shibuya Yuji Kitahata Minoru Takada Keiko Kamei Hiroshi Kurahara Daisuke Ban Shogo Kobayashi Hiroaki Nagano Hajime Imamura Michiaki Unno Amane Takahashi Shintaro Yagi Hiroshi Wada Hirofumi Shirakawa Naoto Yamamoto Seiko Hirono Naoto Gotohda Etsuro Hatano Masafumi Nakamura Makoto Ueno on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study) BMC Cancer Clinical trial Laparoscopy Minimally invasive surgical procedures Pancreatectomy Pancreatic neoplasm |
| title | A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study) |
| title_full | A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study) |
| title_fullStr | A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study) |
| title_full_unstemmed | A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study) |
| title_short | A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study) |
| title_sort | multi institutional randomized phase iii study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer japan clinical oncology group study jcog2202 lapan study |
| topic | Clinical trial Laparoscopy Minimally invasive surgical procedures Pancreatectomy Pancreatic neoplasm |
| url | https://doi.org/10.1186/s12885-024-11957-9 |
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