Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

May 4, 2015 updated by: Keith A Delman, MD, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 vacuum-assisted closure (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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital-Winship Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Videoscopic (Minimally invasive)
Patients in this arm will have the procedure done through the three port minimally invasive approach.
Procedure: Videoscopic procedure
Minimally invasive, three port approach, (using a laparoscope to perform a procedure previously performed through open surgery).
Active Comparator: Open (traditional approach)
Patients in this arm will have the traditional, open approach in conjunction with a sartorius muscle transposition.
Procedure: Open, traditional approach
Open surgical procedure, with sartorius muscle transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication profile
Time Frame: 30 days
The primary objective is to assess wound infection, wound dehiscence and other wound complications.
30 days
Length of stay
Time Frame: 1- 7 days
Hospital length of stay.
1- 7 days
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.
5 years
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.
5-7 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission
Time Frame: 30 days
To assess differences in readmission rates between the two groups.
30 days
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Keith Delman, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 28, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (Estimate)

February 6, 2012

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00012329
  • WCI1585-08 (Other Identifier: Winship Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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