Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

Patients with melanoma, some other rare skin cancers, and some cancers of the penis and scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called the groin. Medically, this area is called the inguinal area. At present, for melanomas and skin cancers this type of spread is usually found with a special test called a "sentinel lymph node biopsy". This procedure can find spread of even a few cells in a single lymph node-allowing the treating doctor to find the spread very early. Treatment for patients with skin cancer in the lymph nodes in this area is to remove all of the lymph nodes in this area. In patients with cancers of the penis and scrotum who do hot have any evidence of cancer having spread either by physical examination or by radiology tests, the lymph nodes in this area are removed to check and see if there is cancer in them. This is called staging. At present, the standard way to remove all of the lymph nodes in the groin is by a large incision, approximately 8-10 inches in length. For patients who have this operation, there is a very high incidence of infection after surgery: as many as 50% as patients can have a problem after surgery. These infections range from a low grade skin infection needing oral antibiotics to deep infections requiring the wound to be opened and occasionally needing readmission to the hospital and antibiotics given via the vein. With the advent of new technology and new equipment, the ability to perform this procedure through small incisions away from the groin and further down the leg has become possible. This procedure has never been performed routinely nor compared side by side to the standard open approach. The investigators propose to perform this protocol in two phases. The investigators have performed procedures in 20 groins to this point and have confirmed the number of lymph nodes and visually verified that the procedure is identical to the open procedure. The investigators performed these procedures in order to insure that the investigators were offering an equivalent option regardless of which procedure the patient is randomized to. The study will involve the randomization of patients undergoing the procedure. The investigators will randomize the next 110 patients in a 2:1 fashion (two people will get the videoscopic procedure for every one who gets the open procedure) until 73 patients are included in the video arm and 37 in the open arm. Outcomes including recurrence rate, duration of drain requirements, and incidence of lymphedema will be followed. Patients will be followed using standard of care processes, including regular office visits, physical exams, and radiographic imaging, when indicated. Patients will be followed for 5 years.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Patients will be considered for this study if they are between age 18 and 80
* Patients have either metastatic melanoma or merkel cell carcinoma diagnosed by sentinel lymph node biopsy or are candidates for a staging procedure for either a penile or scrotal carcinoma

Exclusion Criteria:

* Patients with unresectable metastatic disease
* Patients who are pregnant or lactating
* Patients with prohibitive cardiac or pulmonary comorbidities
* Patients with other contraindications for general anesthesia as determined by the anesthesia preoperative evaluation will not be considered enrolled in the trial although they may undergo randomization prior to exclusion from surgery

• BACKGROUNDDelman KA, Kooby DA, Rizzo M, Ogan K, Master V. Initial experience with videoscopic inguinal lymphadenectomy. Ann Surg Oncol. 2011 Apr;18(4):977-82. doi: 10.1245/s10434-010-1490-5. Epub 2010 Dec 24. PMID 21184190
• BACKGROUNDDelman KA, Kooby DA, Ogan K, Hsiao W, Master V. Feasibility of a novel approach to inguinal lymphadenectomy: minimally invasive groin dissection for melanoma. Ann Surg Oncol. 2010 Mar;17(3):731-7. doi: 10.1245/s10434-009-0816-7. PMID 20183910
• BACKGROUNDMaster V, Ogan K, Kooby D, Hsiao W, Delman K. Leg endoscopic groin lymphadenectomy (LEG procedure): step-by-step approach to a straightforward technique. Eur Urol. 2009 Nov;56(5):821-8. doi: 10.1016/j.eururo.2009.07.003. Epub 2009 Jul 15. PMID 19640633
• BACKGROUNDTobias-Machado M, Tavares A, Molina WR Jr, Zambon JP, Medina JA, Forseto PH Jr, Juliano RV, Wroclawski ER. Video endoscopic inguinal lymphadenectomy (VEIL): initial case report and comparison with open radical procedure. Arch Esp Urol. 2006 Oct;59(8):849-52. doi: 10.4321/s0004-06142006000800020. PMID 17153511