Pilot Study to standardize the surgical management of node negative groins in penile cancer patients.

Pilot Study to standardize the technique of Dynamic Sentinel Lymph Node Biopsy in management of penile cancer patients with clinically normal groin - MANOPEN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022248

Enrollment

Registered

2019-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C609- Malignant neoplasm of penis, unspecified Health Condition 2: C609- Malignant neoplasm of penis, unspecified

Interventions

Intervention1: Dynamic Sentinal Lymph Node Biopsy (DSNB): DSNB will be performed using three agents radioactive colloid, Indocyanin Green(ICG) and Methylene blue. Patients will have to undergo injecti

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To assess sensitivity of DSNB in detecting sentinel lymph nodes in penile cancerTimepoint: 24 hours	—

Secondary

Measure	Time frame
To assess the rate of complications among the patients undergoing the procedures.Timepoint: 24 hours;To assess the rate of false negatives of DSNBTimepoint: 24 hours	—

Countries

India

Contacts

Public ContactDr Gagan Prakash

Department of Surgical OncologyTata Memorial Hospital

gagan2311@gmail.com02224177176

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026