Study of sentinel lymph node for uterine cancer

JRCT ID: jRCTs071200026

Registered date:24/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: uterine cancer
• Date of first enrollment: 06/11/2020
• Target sample size: 540
• Study type: Interventional
• Intervention(s): In this study, the sentinel lymph node of uterine cancer is identified and biopsied, and the presence or absence of metastasis is diagnosed intraoperatively by cytology and histology, so that reduction treatment that individually omits lymph node dissection is performed.

Outcome(s)

• Primary Outcome: Complication due to pelvic lymphadenectomy (lower extremity lymphedema, lymphocele, and ileus)

Secondary Outcome

1. Operation time, blood loss, transfusion, nerve injury
2. Recurrence rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Cervical cancer FIGO stage IA - IB 1
Endometrial cancer FIGO stage IA
2. pathological type (cervical cancer) : SCC, adenocarcinoma, adenosquamous cell carcinoma
pathological type (endometrial cancer) : endometrioid carcinoma,G1 or 2
3. no lymph node swelling (preoperative CT or MRI)
4. patients age : 20age old over
5. ECOG Performance Status, PS: 0 or 1
6. no radiotherapy, chemotherapy and surgery (not including conization)
7. Patients who have no major organs dysfunction
8. Patients who have written consent from the patient

Exclude criteria

1. Psychosis or psychiatric symptoms were judged to be difficult to participate in the study
2. Other cases inappropriate judged by medical doctor

Related Information

• Primary Sponsor: KOBAYASHI Hiroaki