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Mar. 27, 2019 |
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April. 01, 2026 |
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jRCTs051180216 |
Sentinel node biopsy as minimally invasive surgery in uterine cancer (SNBUt) |
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Sentinel node biopsy in uterine cancer (SNBUt) |
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June. 30, 2025 |
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405 |
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Japanese female with uterine cancer who underwent laparoscopic or robotic hysterectomy with lymphadenectomy or sentinel lymph node biopsy were enrolled. Among 104 patients with cervical cancer, 52 underwent sentinel node biopsy and 52 underwent pelvic lymphadenectomy. The median age was 46 and 45 year-old in sentinel and lymphadenectomy group, respectively. The median tumor size was 12 mm and 20 mm in sentinel and lymphadenectomy group, respectively; the lymphadenectomy group had significant larger tumor then sentinel group. In the sentinel group, 8 patients had stage 1A2 disease, 43 patients had stage 1B1 disease and one patient had stage 2A1 disease. In lymphadenectomy group, 3 patients had stage 1A2 disease, 43 patients had stage 1B1 disease and 6 patients had stage 2A1 disease; most patients in both groups had stage 1B1 disease. Pathologically, 24 patients had squamous cell carcinoma and 28 patients had adenocarcinoma in sentinel group. In contrast, 27 patients had squamous cell carcinoma and 25 patients had adenocarcinoma in lypmphadenectomy group. Among 612 patients with endometrial cancer, 472 patients were matched the study category of low-risk endometrial cancer. Among them, there were 299 and 173 patients in sentinel and lymphadenectomy group, respectively. The median age was 56 and 57 year-old in sentinel and lymphadenectomy group, respectively. |
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Between 2013 and 2017, 311 patients with uterine cancer underwent sentinel node biopsy with pelvic lymphadenectomy; they were included into lymphadenectomy group. Between 2017 and 2025, 405 patients with uterine cancer underwent sentinel node biopsy alone; they were included into sentinel group. |
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No adverse events |
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Among 104 cervical cancer patients, there were 52 patients in the sentinel group and 52 patients in the lymphadenectomy group. The median follow up were 42 months in sentinel group and 82 months in the lymphadenectomy group. Three years disease free survival (3-y DFS) rate were significantly higher in the sentinel group (100% vs. 91.5%, p=0.04). Three years overall survival (3-y OS) rate was 100% in both groups. Among 472 endometrial cancer patients, there were 299 patients in the sentinel group and 173 patients in the lymphadenectomy group. The median follow up were 41 months in sentinel group and 95 months in the lymphadenectomy group. The 3-y DFS rate was not different between the groups (98.2% vs. 97.1%, p=0.96). The 3-y OS was not different between the groups (98.2% vs. 97.5%, p=0.96). The incidence of lower-extremity lymphedema was significantly lower in the sentinel group (2% vs.21.3%, p<0.01). |
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For patients with cervical and endometrial cancer, the prognosis was not different between sentinel node biopsy and lyphadenectomy. For the low risk cervical cancer (tumor size <2 cm) and endometrial cancer (stage of 1A, endometrioid adenocarcinoma of grade 1 or 2) patients, sentinel node biopsy was feasible. There were few patients who had lower extremity lymphedema after sentinel node biopsy. |
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April. 01, 2026 |
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July. 07, 2023 |
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https://www.mdpi.com/2077-0383/12/13/454 |
No |
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no |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs051180216 |
Tanaka Tomohito |
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Osaka Medical and Pharmaceutical University Hospital |
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2-7, Daigakumachi, Takatsuki, Osaka 569-8686, Japan |
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+81-72-683-1221 |
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tomohito.tanaka@ompu.ac.jp |
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Tanaka Tomohito |
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Osaka Medical and Pharmaceutical University Hospital |
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2-7, Daigakumachi, Takatsuki, Osaka 569-8686, Japan |
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+81-72-683-1221 |
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tomohito.tanaka@ompu.ac.jp |
Complete |
July. 10, 2017 |
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| Aug. 17, 2017 | ||
| 400 | ||
Interventional |
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single arm study |
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open(masking not used) |
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no treatment control/standard of care control |
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single assignment |
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treatment purpose |
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Cervical cancer of stage I with tumor diameter of less than 2 cm, endometrial cancer of stage IA with endometrioid carcinoma of grade 1 or 2 |
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Suspicious of lymph node metastasis on preoperative image findings |
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| 20age old over | ||
| 85age old under | ||
Female |
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Uterine cancer |
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Sentinel navigation surgery |
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Uterine cancer |
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Progression free survival |
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The rate of postoperative lymph edema and lymph node recurrence |
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| Osaka Medical and Pharmaceutical University Clinical Research Review Board | |
| 2-7, Daigakumachi, Takatsuki, Osaka 569-8686, Japan, Osaka | |
+81-72-684-6100 |
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| ompu_rinsyou@ompu.ac.jp | |
| Approval | |
Mar. 14, 2019 |
| UMIN000028524 | |
| University Hospital Medical Information Network |
none |