Clinical Trial: Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Videoscopic Versus Open Inguinal Lymphadenectomy for Sentinel Node Positive Cutaneous Malignancies and Genitourinary Staging Procedures

Brief Summary:

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.

Inguinal lymphadenectomy is the standard procedure used to treat patients with metastatic lymphadenopathy to the groin. For melanoma, the majority of these patients are diagnosed via sentinel lymph node biopsy, which identifies disease at a very early stage. In up to 80% of patients no additional disease is identified in the lymphadenectomy specimen1,2, which is performed at a separate setting from the initial biopsy, unlike in breast cancer. Unfortunately, due to the nature of the incision and the location, inguinal lymphadenectomy is associated with an extremely high incidence of postoperative wound complications. As many as 50% of patients will develop wound infections ranging from simple cellulitis to significant wound abscesses requiring a reopening of the incision and considerable wound care, sometimes necessitating rehospitalization.3 These data are associated with an open procedure, generally requiring a 10-15 cm incision. Recently, a videoscopic approach to this procedure has been described.4 It has been well-proven that a minimally invasive approach to cancer surgery does not have a negative impact on outcomes from cancer treatment.5 Emory has long been at the forefront of minimally invasive surgery and it is only appropriate that the investigators continue to lead the field. As one of the busiest melanoma centers in the country, the investigators have the opportunity to demonstrate the utility of this approach and continue to lead the field in both cancer therapy and minimally invasive surgery.

The trial will randomize patients to either videoscopic or open lymphadenectomy to determine if there is any difference in wound complication rate and as a secondary endpoint, time to recurrence. It is expected that there will be a substantial (approximately 25% incidence versus traditional 50% incidence or half of the number of wound complications) decrease in the incid
Sponsor: Emory University

Current Primary Outcome:

• Complication profile [ Time Frame: 30 days ]
  The primary objective is to assess wound infection, wound dehiscence and other wound complications.
• Length of stay [ Time Frame: 1- 7 days ]
  Hospital length of stay.
• Lymphedema [ Time Frame: 5 years ]
  Assessment of lymphedema will be determined in all patients to identify if there is a difference in all patients undergoing either videoscopic or open inguinal lymphadenectomy.
• Nodal yield [ Time Frame: 5-7 days post procedure ]
  This will characterize, as a surrogate of completeness of surgery, the number of nodes retrieved at the surgical procedure via either approach.

Original Primary Outcome:

• Complication profile [ Time Frame: 30 days ]
  The primary objective is to assess wound infection, wound dehiscence and other wound complications.
• Length of stay [ Time Frame: 1- 7 days ]
  Hospital length of stay
• Lymphedema [ Time Frame: 5 years ]
  Assessment of lymphedema will be determined in all patients to identify if there is a difference in all patients undergoing either videoscopic or open inguinal lymphadenectomy
• Nodal yield [ Time Frame: 5-7 days post procedure ]
  This will characterize, as a surrogate of completeness of surgery, the number of nodes retrieved at the surgical procedure via either approach.

Current Secondary Outcome:

• Readmission [ Time Frame: 30 days ]
  To assess differences in readmission rates between the two groups.
• Oncologic outcomes--survival [ Time Frame: 5 years ]
  Recurrence free and overall survival will be measured in patients undergoing the procedure to determine if the procedure impacts survival at all.

Original Secondary Outcome:

• Readmission [ Time Frame: 30 days ]
  To assess differences in readmission rates between the two groups.
• Oncologic outcomes--survival [ Time Frame: 5 yr ]
  Recurrence free and overall survival will be measured in patients undergoing the procedure to determine if the procedure impacts survival at all.

Information By: Emory University

Dates:
Date Received: January 28, 2012
Date Started: June 2009
Date Completion:
Last Updated: May 4, 2015
Last Verified: May 2015