Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

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Brief Title

Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer

Official Title

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

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.
    

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


Primary Outcome

Complication profile

Secondary Outcome

 Readmission

Condition

Melanoma

Intervention

Videoscopic procedure

Study Arms / Comparison Groups

 Videoscopic (Minimally invasive)
Description:  Patients in this arm will have the procedure done through the three port minimally invasive approach.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

29

Start Date

June 2009

Completion Date

February 2013

Primary Completion Date

February 2013

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Keith Delman, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01526486

Organization ID

IRB00012329

Secondary IDs

WCI1585-08

Responsible Party

Principal Investigator

Study Sponsor

Emory University


Study Sponsor

Keith Delman, MD, Principal Investigator, Emory University


Verification Date

May 2015