Melanoma Clinical Trial
Official title:
Videoscopic Versus Open Inguinal Lymphadenectomy for Sentinel Node Positive Cutaneous Malignancies and Genitourinary Staging Procedures
Verified date | May 2015 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital-Winship Cancer Institute | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Delman 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. — View Citation
Delman 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. — View Citation
Master 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. — View Citation
Tobias-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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complication profile | The primary objective is to assess wound infection, wound dehiscence and other wound complications. | 30 days | Yes |
Primary | Length of stay | Hospital length of stay. | 1- 7 days | No |
Primary | Lymphedema | 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. | 5 years | No |
Primary | Nodal yield | This will characterize, as a surrogate of completeness of surgery, the number of nodes retrieved at the surgical procedure via either approach. | 5-7 days post procedure | No |
Secondary | Readmission | To assess differences in readmission rates between the two groups. | 30 days | No |
Secondary | Oncologic outcomes--survival | Recurrence free and overall survival will be measured in patients undergoing the procedure to determine if the procedure impacts survival at all. | 5 years | No |
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