Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma
Abstract Aim To clarify and evaluate the long‐term outcomes of laparoscopic surgery for clinical stage 0/I rectal carcinoma patients. Methods This single‐arm phase II trial involved accredited surgeons from 43 Japanese institutions. Patients were registered preoperatively. The planned sample size wa...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2020-05-01
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| Series: | Annals of Gastroenterological Surgery |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/ags3.12333 |
| _version_ | 1818675311399665664 |
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| author | Masaaki Ito Seiichiro Yamamoto Junji Okuda Shoichi Fujii Shigeki Yamaguchi Koki Otsuka Kenichi Yoshimura Masahiko Watanabe for the Japan Society of Laparoscopic Colorectal Surgery |
| author_facet | Masaaki Ito Seiichiro Yamamoto Junji Okuda Shoichi Fujii Shigeki Yamaguchi Koki Otsuka Kenichi Yoshimura Masahiko Watanabe for the Japan Society of Laparoscopic Colorectal Surgery |
| author_sort | Masaaki Ito |
| collection | DOAJ |
| description | Abstract Aim To clarify and evaluate the long‐term outcomes of laparoscopic surgery for clinical stage 0/I rectal carcinoma patients. Methods This single‐arm phase II trial involved accredited surgeons from 43 Japanese institutions. Patients were registered preoperatively. The planned sample size was 490. The primary endpoint was overall survival, and long‐term outcomes were evaluated. Results A total of 495 patients were registered between February 2008 and August 2010. Eight patients (1.6%) required conversion to open surgery. Sphincter‐preserving procedures were performed in 477 (97%) patients. Positive radial resection margin was found in two (0.4%) patients. Of 490 patients, 22, 314, 38, 115, and one patient had final pathological stages (p‐stage) 0, I, II, III, and IV, respectively. Pathologically, 31.4% (154/490) of the patients did not have p‐stage 0/I. The 5‐year overall survival (OS) rates in p‐stages 0, I, II, and III were 100%, 98%, 97%, and 94%, respectively. The 5‐year OS of all patients at 96.6% (95% CI 94.6‐97.9) was significantly better than the expected 5‐year OS of 81.1% (P < .0001). The 5‐year relapse‐free survival in p‐stages 0, I, II, and III were 100%, 93%, 81%, and 79%, respectively. The 5‐year relapse‐free survival of all patients was 90.1%. Fifty patients (10.2%) had recurrence; lung recurrence was found in 22 patients, local recurrence in 14, liver in seven, distant lymph node in nine, and bone in three. Conclusions Laparoscopic surgery for clinical stage 0/I rectal carcinoma has feasible long‐term outcomes. (ClinicalTrials.gov No.NCT00635466.) |
| first_indexed | 2024-12-17T08:25:34Z |
| format | Article |
| id | doaj.art-4d0fd736dec843e1b0920ca02c0fdef9 |
| institution | Directory Open Access Journal |
| issn | 2475-0328 |
| language | English |
| last_indexed | 2024-12-17T08:25:34Z |
| publishDate | 2020-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | Annals of Gastroenterological Surgery |
| spelling | doaj.art-4d0fd736dec843e1b0920ca02c0fdef92022-12-21T21:56:48ZengWileyAnnals of Gastroenterological Surgery2475-03282020-05-014329430010.1002/ags3.12333Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinomaMasaaki Ito0Seiichiro Yamamoto1Junji Okuda2Shoichi Fujii3Shigeki Yamaguchi4Koki Otsuka5Kenichi Yoshimura6Masahiko Watanabe7for the Japan Society of Laparoscopic Colorectal SurgeryDepartment of Colorectal Surgery National Cancer Center Hospital East Kashiwa JapanDepartment of Surgery Tokai University School of Medicine Hiratsuka JapanDepartment of Generl and Gastroenterological Surgery Osaka Medical College Takatsuki JapanDepartment of Surgery Sunkokai Koga Community Hospital Yaizu JapanDepartment of Gastroenterological Surgery Saitama Medical University International Medical Center Hidaka JapanDepartment of Surgery Iwate Medical University School of Medicine Morioka JapanCenter for Integrated Medical Research Hiroshima University Hospital Higashihiroshima JapanDepartment of Surgery Kitasato Institute Hospital Kitasato University Tokyo JapanAbstract Aim To clarify and evaluate the long‐term outcomes of laparoscopic surgery for clinical stage 0/I rectal carcinoma patients. Methods This single‐arm phase II trial involved accredited surgeons from 43 Japanese institutions. Patients were registered preoperatively. The planned sample size was 490. The primary endpoint was overall survival, and long‐term outcomes were evaluated. Results A total of 495 patients were registered between February 2008 and August 2010. Eight patients (1.6%) required conversion to open surgery. Sphincter‐preserving procedures were performed in 477 (97%) patients. Positive radial resection margin was found in two (0.4%) patients. Of 490 patients, 22, 314, 38, 115, and one patient had final pathological stages (p‐stage) 0, I, II, III, and IV, respectively. Pathologically, 31.4% (154/490) of the patients did not have p‐stage 0/I. The 5‐year overall survival (OS) rates in p‐stages 0, I, II, and III were 100%, 98%, 97%, and 94%, respectively. The 5‐year OS of all patients at 96.6% (95% CI 94.6‐97.9) was significantly better than the expected 5‐year OS of 81.1% (P < .0001). The 5‐year relapse‐free survival in p‐stages 0, I, II, and III were 100%, 93%, 81%, and 79%, respectively. The 5‐year relapse‐free survival of all patients was 90.1%. Fifty patients (10.2%) had recurrence; lung recurrence was found in 22 patients, local recurrence in 14, liver in seven, distant lymph node in nine, and bone in three. Conclusions Laparoscopic surgery for clinical stage 0/I rectal carcinoma has feasible long‐term outcomes. (ClinicalTrials.gov No.NCT00635466.)https://doi.org/10.1002/ags3.12333clinical stage Iclinical triallaparoscopylong‐term outcomerectal cancer |
| spellingShingle | Masaaki Ito Seiichiro Yamamoto Junji Okuda Shoichi Fujii Shigeki Yamaguchi Koki Otsuka Kenichi Yoshimura Masahiko Watanabe for the Japan Society of Laparoscopic Colorectal Surgery Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma Annals of Gastroenterological Surgery clinical stage I clinical trial laparoscopy long‐term outcome rectal cancer |
| title | Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma |
| title_full | Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma |
| title_fullStr | Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma |
| title_full_unstemmed | Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma |
| title_short | Long‐term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma |
| title_sort | long term survival outcomes following laparoscopic surgery for clinical stage 0 i rectal carcinoma |
| topic | clinical stage I clinical trial laparoscopy long‐term outcome rectal cancer |
| url | https://doi.org/10.1002/ags3.12333 |
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