penile cancer
Conditions
Interventions
56 patients at left side versus 56 patients at right side:laparoscopic surgery versus open surgery in modified radical inguinal lymph node dissection
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Routine physical examination and imaging evaluation of patients with penile cancer without distant metastasis (cN0-2); Preoperative primary focal point and Sentinel lymph node biopsy were identified with pathological staging and classification. Penile squamous cell carcinoma; Patients with pTxN0-2M0; 2. Aged 18-80, life expectancy greater than 2 years, Karnofsky score = 60 points(see schedule 2); 3. Blood routine: WBC = 3.5 × 10^9/L, the absolute value of centrocytes = 2.0 × 10^9/L, PLT = 100.0 × 10^9/L, HGb = 90g/L; Liver function: bilirubin, gamma-GT, ALP and LDH are all below the upper limit of normal values; SGOT and SGPT are 2.5 times lower than the upper limit of normal values; Kidney function: Creatinine is 1.25 times lower than the upper limit of the normal value; Heart function 0-2; 4. Voluntary participation in the study and signature of informed consent. (* Total number of single lymph nodes cleared requires at least 8 or more).
Exclusion criteria
Exclusion criteria: 1. Non-squamous cell carcinoma, such as adenocarcinoma, malignant melanoma, etc.; 2. Preoperative primary focal and desorption with lymph node biopsy confirmed pN3M1 patients 3. Can touch unilateral or bilateral inactive lymph nodes or pelvic lymph node metastasis(cN3 phase); Skin ulceration; 4. Preoperative pathological stage and classification are not clear, lymph node biopsy pathology is unknown; The pathological examination of lymph nodes did not meet the prescribed requirements(unilateral clearance and pathological examination of lymph nodes less than 8, pathology can not define N0), can not accurately determine the postoperative pathological N stage; 5. Neoadjuvant chemotherapy was performed within 3 months before operation. In the 6 months before surgery, the original focal or ventral zone radiotherapy = 30Gy; 6. Severe liver and kidney dysfunction; Merge other serious diseases; Cardiac insufficiency, or angina, arrhythmias, and uncontrolled hypertension, with a history of myocardial infarction within one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival;Disease free survival time; | — |
Countries
China
Contacts
Public ContactZhang Xueqi
Shenzhen People's Hospital
Outcome results
None listed