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Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer

Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer - Phase II trial of sentinel lymph node navigation surgery for patients with early stage endometrial cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032222
Enrollment
26
Registered
2018-04-13
Start date
2018-05-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial cancer

Interventions

Sentinel lymph node navigation surgery

Sponsors

Department of Obstetrics and Gynecology, Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) patients aged 20 years and over 2) patients who obtained written consent from the patient herself 3) patients diagnosed pathologically with G1 or G2 endometrioid canrcinoma by preoperative endometrial biopsy (or endometrial curettage) 4) patients who have no extrauterine lesions, no cervical stromal invasion, and less than half of myometrial invasion by preoperative pelvic MRI 5) patients who have no extrauterine lesions (including regional lymph node metastasis) in chest to pelvic CT. 6) patients agreeing to perform a standard operation procedure including retroperitoneal lymph node dissection in two stages when SN was positive. 7) patient with Performance Status (PS) 0-1. 8) patients with systemic function maintained and undergoing uterine malignant surgery (laparoscopy or laparotomy) under general anesthesia

Exclusion criteria

Exclusion criteria: 1) patients who are considered to be regional lymph node metastasis in preoperative diagnostic imaging 2) patients whith atypical endometrial hyperplasia 3) patients who are thought to be unbearable by standard surgery including retroperitoneal lymph node dissection due to elderly, past history, complications. 4) patients with double cancer 5) patients who have a history of other malignancies. However, excluding cancer patients who do not have cervical carcinoma in situ or who have 5 years or more RFS. 6) patients who have undergone adnexectomy due to ovarian disease etc. 7) patients who have undergone surgery for the retroperitoneal region and irradiation of the pelvic and para-aortic regions due to malignant pelvic tumors 8) patients who are allergic to indocyanine green (ICG) or RI tracer. 9) patients who had radiotherapy to the abdomen / pelvic area 10) patients who had a history of oophorectomy, salpingo-oophorectomy, salpingectomy due to ovarian or fallopian tube disease 11) patients who recognize systemic edema and lower limb edema from preoperative period 12) patients with medical complications with systemic edema 13) Patients who are difficult to follow up at our hospital.

Design outcomes

Primary

MeasureTime frame
incidence of lymphedema

Secondary

MeasureTime frame
2-year PFS, OS, recurrence rate, sentinel node detection rate , number of sentinel node, site of sentinel node,, recurrence site, recurrence period, operation time, bleeding volume, adverse event, quality of life

Countries

Japan

Contacts

Public ContactWataru Yamagami

Keio University School of Medicine Department of Obstetrics and Gynecology

gami@z8.keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026