Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

Conditions:Colorectal Cancer, Skin Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Lymphoma, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Age Range:18 - 80
Start Date:June 2009
End Date:June 2018

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

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.

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 incidence of wound complications after minimally invasive lymphadenectomy. This is
expected predominantly for two reasons: 1. The wounds for this procedure are outside of
the groin, in contrast being located on the thigh, a less difficult area for healing; and 2.
The wounds are markedly shorter in length, making wound healing easier. The investigators
would expect recurrence patterns to be identical in the two groups. The investigators have
performed 20 procedures using the minimally invasive approach, and our experience to this
point has demonstrated that the mean and median number of nodes harvested was 9 and 10.5
respectively. Median procedure duration has been 147 minutes and there have been 3 patients
(15%) with complications (1 seroma, 2 with superficial cellulitis) but there have been no
wound dehiscences or superficial breakdowns.

While the investigators do not have immediate access to the entire dataset of patients
treated at Emory with the open approach, the investigators do have complete data on the 40
patients most recently treated (over the last 2 years). Of these 40 patients, 17 (43%) had
complications other than lymphedema. Of these, 5 required hospitalization and two had
complete wound dehiscences requiring management with a wound VAC. This data is not
complete, but reasonably reflects the Emory experience and allows us to conclude that our
data is similar to that reported in the literature historically.

While many minimally invasive approaches to open procedures have been applied without
randomized trials proving their efficacy (splenectomy, hepatectomy, pancreatectomy, partial
gastrectomy, to name a few), the investigators believe it is prudent when adopting a new
approach for a cancer operation to study it in a prospective fashion. This is the only
trial of its kind and the investigators are one of only a few centers in the world that has
the minimally invasive knowledge and expertise and the volume of urologic and melanoma
patients to have the potential to perform such a trial. It is incumbent upon us to complete
this study.

The goal of this study is to determine if a videoscopic approach to a standard procedure
offers a better outcome for patients with respect to wound complications and to prove that
there is no inferiority between the videoscopic approach and the traditional open approach
from a cancer outcome standpoint, specifically time to recurrence and nodal yield.

Patients will be considered for this study if they are between age 18 and 80, have either
metastatic melanoma or merkel cell carcinoma diagnosed by sentinel lymph node biopsy or have
indications for inguinal lymphadenectomy for urological malignancy.

The study will be designed as a randomized, prospective trial, analyzing wound complications
as the primary endpoint and recurrence-free survival as a secondary endpoint. Our sample
size calculation (see section 8.0 below) indicate that a sample size of 73 patients in the
study arm and 37 patients in the control arm will be sufficient to detect a
moderate-to-strong effect with an 80% power and a 95% level of statistical significance.

Inclusion Criteria:

- Patients will be considered for this study if they are between age 18 and 80,

- 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,
vulvar carcinoma or other cutaneous malignancy.

Exclusion Criteria:

- Patients with unresectable metastatic disease,

- Those who are pregnant or lactating, patients with prohibitive cardiac or pulmonary
comorbidities, and

- 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.
We found this trial at
Atlanta, GA
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