Pilot Study to standardize the surgical management of node negative groins in penile cancer patients.
- Conditions
- Health Condition 1: C609- Malignant neoplasm of penis, unspecifiedHealth Condition 2: C609- Malignant neoplasm of penis, unspecified
- Registration Number
- CTRI/2019/12/022248
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion criteria
1.Age: Adult patients between 18 yrs and 70 years of age.
2.All patients should have histologically proven penile cancer and clinically normal groins bilaterally. If surgery for primary has been already done the histopathological T stage and grade of tumor should be known. If surgery for primary has not been done the grade of tumor as reported on biopsy and T stage as assessed clinically should be known.
3.Patient should have intermediate (T1G2) or high risk disease (any T G3, T or higher with any G , presence of LVI)
4.Patients should have no nodes in groin clinically palpable or seen on USG .The clinical assessment will be done by one of the investigators from surgical oncology department.
5.No evidence of distant metastasis including para-aortic nodal metastasis.
6.KPS >= 70
7.No major co morbidities preventing radical treatment
8.Signed study specific consent form
9.Adequate hepatic, renal and hematologic parameters
1.Low risk primary disease(Tis,Ta, T1G1)
2.Previous groin surgery
3.Uncontrolled diabetes or hypertension
4.Uncontrolled cardiac or respiratory co morbidity
5.Patient unwilling and reliable for follow up and QoL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess sensitivity of DSNB in detecting sentinel lymph nodes in penile cancerTimepoint: 24 hours
- Secondary Outcome Measures
Name Time Method To assess the rate of complications among the patients undergoing the <br/ ><br>procedures.Timepoint: 24 hours;To assess the rate of false negatives of DSNBTimepoint: 24 hours