A pilot study to assess the safety of the ICG angiography for the evaluation of lymph duct morphology and function before and after pelvic lymphadenectomy in patients with gynecologic cancers.
- Conditions
- cervical cancer, corpus cancer, ovarian cancer
- Registration Number
- JPRN-jRCTs031200114
- Lead Sponsor
- Hirayama Takashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
1) Age>20 years old, Sex: female
2) Cervical cancer or Corpus cancer or Ovarian cancer
3) Pelvic lymphadenectomy is scheduled.
4) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
5) Written informed consent
6) Adequate organ function (especially in bone marrow, liver and kidney): Meet the criteria as below within 14 days before registration.
1. WBC >= 3000 /mm3 and Neutrophil > 1500mm3
2. Platelet > 100,000/ mm3
3. AST, ALT < 2.5 times lower than the normal range
4. Total bilirubin < 1.5 times lower than the normal range
5. Serum albumin > 2.8g/dl
6. Serum creatinine < 1.5 times lower than the normal range
1)History of radiation therapy
2)History of chemotherapy
3)Allergy to ICG
4)Allergy to iodine
5)Others who are not suitable for this research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation of subcutaneous ICG injection (Adverse events, vital signs, clinical examination and clinical symptoms)
- Secondary Outcome Measures
Name Time Method 1. The comparison of lymph duct morphology and function between pre-surgery and 1.3,9 month after surgery<br>2. The relationship between the rate of lymphedema and the lymph duct morphology and function at 1.3 and 9 month after surgery<br>3. The morphological and functional changes after surgery (1.3 and 9 months), compared to the pre-operative condition <br>4. The relationship between the pre-operative background and the rate of lymphedema at 1.3 and 9 month after surgery<br>5. The relationship between the operative findings and the rate of lymphedema at 1.3 and 9 month after surgery