sentinel lymph node sampling (SLN): Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN).
1. The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines;
2. Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted;
3. Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted.
pelvic lymphonodectomy (PLN): Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling
Study summary
Aim To investigate the effect of sentinel lymph node (SLN) sampling on the prognosis of patients with middle-high risk endometrial cancer obviously confined to the uterus before surgery.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Older than 18 years old;
2. Clinically diagnosed (by pre-surgical pathology and radiology) as primary endometrial cancer confined to uterus with middle-high risk factors:
1. disease limited to the uterus on image study (MRI, CT or ultrasound);
2. including all histological types of endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma, and undifferentiated carcinoma); not including uterine sarcoma
3. excluding low-risk endometrial cancer (endometrioid G 1-2 with pre-surgical endometrial lesion≤2cm and myometrial invasion \<50%);
4. with one or more middle-high risk factors including: endometrioid endometrial cancer G3, myometrial invasion ≥50%, tumor size≥2cm, type II endometrial cancer, molecular classification of p53abn, LVSI;
5. diagnosis should be confirmed by at least two senior clinicians;
3. Be able to undergo staging surgery.
Exclusion Criteria:
1. During pregnancy or perinatal period;
2. With synchronous malignancies or other malignancies than endometrial cancer in 3 years, except for non-melanoma skin cancer;
3. With history of important organs transplantation;
4. With immune diseases requiring taking immunosuppressants
5. With severe mental illness or brain function disorders
6. With history of drug abuse;
7. Allergic to contrast agent;
8. Still participating in other clinical trials;
9. Not willing to accept surgery or trial protocol;
10. Not eligible for surgery;
11. Had hysterectomy, chemotherapy, radiotherapy, or hormone therapy before the trail;
12. Had retroperitoneum lymph node dissection for other reasons.
Primary outcome measure(s)
The 2-year progression-free survival (2-year PFS) — 2 years The percentage of patients who have first relapse within 2 years after surgery (SLN or LND)
Trial sites (1)
Facility
City
Region
Status
Tenth People's Hospital Affiliated to Tongji University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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