Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer
2 other identifiers
interventional
29
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 28, 2012
CompletedFirst Posted
Study publicly available on registry
February 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMay 6, 2015
May 1, 2015
3.7 years
January 28, 2012
May 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Complication profile
The primary objective is to assess wound infection, wound dehiscence and other wound complications.
30 days
Length of stay
Hospital length of stay.
1- 7 days
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
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
Secondary Outcomes (2)
Readmission
30 days
Oncologic outcomes--survival
5 years
Study Arms (2)
Videoscopic (Minimally invasive)
EXPERIMENTALPatients in this arm will have the procedure done through the three port minimally invasive approach.
Open (traditional approach)
ACTIVE COMPARATORPatients in this arm will have the traditional, open approach in conjunction with a sartorius muscle transposition.
Interventions
Minimally invasive, three port approach, (using a laparoscope to perform a procedure previously performed through open surgery).
Open surgical procedure, with sartorius muscle transfer.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with unresectable metastatic disease
- Patients who are pregnant or lactating
- Patients with prohibitive cardiac or pulmonary comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory University Hospital-Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Related Publications (4)
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.
PMID: 21184190BACKGROUNDDelman 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: 20183910BACKGROUNDMaster 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: 19640633BACKGROUNDTobias-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: 17153511BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith Delman, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
January 28, 2012
First Posted
February 6, 2012
Study Start
June 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
May 6, 2015
Record last verified: 2015-05