Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

This study has suspended participant recruitment.
(Under review by the clinical trials office at Emory University)
Sponsor:
Information provided by (Responsible Party):
Keith A Delman, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01526486
First received: January 28, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Melanoma
Merkel Cell Carcinoma
Squamous Cell Carcinoma
Penile Carcinoma
Urethral Carcinoma
Extramammary Paget's Disease
Scrotal Carcinoma
Anal Cancer
Vulvar Cancer
Skin Cancer
Lymphadenopathy
Procedure: Videoscopic procedure
Procedure: Open, traditional approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Videoscopic Versus Open Inguinal Lymphadenectomy for Sentinel Node Positive Cutaneous Malignancies and Genitourinary Staging Procedures

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Complication profile [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    The primary objective is to assess wound infection, wound dehiscence and other wound complications.

  • Length of Stay [ Time Frame: 1- 7 days ] [ Designated as safety issue: No ]
    Hospital length of stay

  • Lymphedema [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This will characterize, as a surrogate of completeness of surgery, the number of nodes retrieved at the surgical procedure via either approach.


Secondary Outcome Measures:
  • Readmission [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    To assess differences in readmission rates between the two groups.

  • Oncologic outcomes--survival [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
    Recurrence free and overall survival will be measured in patients undergoing the procedure to determine if the procedure impacts survival at all.


Estimated Enrollment: 110
Study Start Date: June 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 sartorious muscle transfer.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526486

Locations
United States, Georgia
Emory University Hospital-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
  More Information

Additional Information:
Publications:
Responsible Party: Keith A Delman, MD, Associate Professor of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT01526486     History of Changes
Other Study ID Numbers: IRB00012329
Study First Received: January 28, 2012
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
melanoma
urology
inguinal
lymph nodes
groin
lymphadenectomy
groin dissection
skin cancer
penile cancer
urethral cancer
scrotal cancer
Paget's disease

Additional relevant MeSH terms:
Anus Neoplasms
Carcinoma
Skin Neoplasms
Carcinoma, Merkel Cell
Carcinoma, Squamous Cell
Melanoma
Paget Disease, Extramammary
Vulvar Neoplasms
Lymphatic Diseases
Urethral Neoplasms
Penile Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Skin Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on July 31, 2014