penile cancer
Conditions
Interventions
control group:traditional (robot assisted) laparoscopic inguinal lymphadenectomy
experimental group:indocyanine green fluorescence imaging guided (robot assisted) laparoscopic inguinal lymphadenectomy
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-80 at the time of enrollment; (2) Pathologically diagnosed with penile carcinoma without clinical diagnosis of distant metastasis (except for inguinal lymph node metastasis); (3) For patients requiring inguinal lymph node dissection, indications include but are not limited to: A. poorly differentiated penile carcinoma; B. grade G3 or above penile carcinoma; C. stage T2 or above penile carcinoma; D. tumor with vascular and lymphatic infiltration; (4) Without inguinal and pelvic lymph nodes surgery or radiotherapy , without chemotherapy; (5) The patients or their authorized immediate family members have signed the informed consent for the clinical trial.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of other cancer diagnoses except non-melanoma skin cancer; (2) Patients with chronic pyelonephritis, urolithiasis or uremia; (3) Patients who are not fitted for surgery with severe systemic diseases (including but not limited to the following conditions: severe heart disease and pulmonary insufficiency, uncontrolled diabetes and hypertension, active tuberculosis, etc.) ; (4) Indocyanine green or iodine allergy; (5) In the opinion of the investigator, subjects may not be able to complete the study or comply with the requirements of the study (due to poor management, compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dissected number of lymph nodes;complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rates of recurrence and metastasis;Lymph node positive rate ; | — |
Countries
China
Contacts
Public ContactLong Wang
Department of Urology, The Third Xiangya Hospital of Central South University
Outcome results
None listed