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Videoscopic Ilioinguinal Lymphadenectomy for Melanoma

Primary Purpose

Melanoma, Secondary Malignant Neoplasm of Lymph Node

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Videoscopic ilioinguinal dissection
Sponsored by
Istituto Oncologico Veneto IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Videoassisted surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Melanoma patients without distant metastasis and either positive SLNB or clinically positive inguinal lymph nodes

Exclusion Criteria:

American Society of Anaesthesiologists (ASA) classification III-IV Severe chronic obstructive pulmonary disease (COPD) and other restrictive lung disease, Severe ischemic heart disease and chronic heart failure Previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), History of deep vein thrombosis (DVT) Childbearing state Severe hip functional limitation Previous hip/knee arthroplasty. Previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Videoscopic ilioinguinal lymphadenectomy for melanoma

    Arm Description

    Melanoma groin lymph node metastasis.

    Outcomes

    Primary Outcome Measures

    Operative complications
    Frequency, type and severity of operative complications according to the Clavien-Dindo classification. Grade I: no intervention required; Grade II: medical therapy resolved the complication; Grade III A: intervention without general anaesthesia; Grade III B: intervention under general anaesthesia.

    Secondary Outcome Measures

    Leg lymphedema
    Lymphedema is measured pre-operatively at 3, 6 and 12 months after surgery. Number of patients with lymphedema according to the definition of the percent change > or = 7% of the sum of circumferences of the lower limb.
    Quality of life
    Quality of life was evaluated with European Organization Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ-C30) administered pre-operatively and after 3-6 and 9-12 months after surgery.This questionnaire is made up of 30 items to be later summarized in 5 functional scales, 3 symptom scales, 6 single items and a global health status scale. All of the scores are standardized using linear transformation and converted onto a 0-100 scale. Thus, a higher score for a functional scale and the global health status scale mean a high level of functioning/quality of life. Conversely, a high score for a symptom scale/item means a worse quality of life due to the symptoms perceived.
    Recurrence
    Patients were re-evaluated 1, 3, 6, 9 and 12 months after surgery and every 6 months thereafter. Whole body CT scan and inguinal ultrasonography were performed every six months. Local, in-transit, regional and distant recurrences were recorded. Number of patients with histology confirmed local recurrence
    Number of excised lymph nodes
    Information extracted from pathology report. Implications for quality assurance monitoring.

    Full Information

    First Posted
    July 16, 2015
    Last Updated
    July 23, 2015
    Sponsor
    Istituto Oncologico Veneto IRCCS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02508909
    Brief Title
    Videoscopic Ilioinguinal Lymphadenectomy for Melanoma
    Official Title
    Videoscopic Ilioinguinal Lymphadenectomy for Groin Lymph Node Metastases From Melanoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Oncologico Veneto IRCCS

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.
    Detailed Description
    Videoscopic ilioinguinal dissection is a two-stage procedure. Dissection is performed using an ultrasound dissector. The inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the Sartorius muscle). After subcutaneous inflation, a formal inguinal lymph node (LN) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. The specimen is extracted using an endobag from the incision of SLNB, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive LNs. The iliac step starts with open insertion in the pro-peritoneal space of a Hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. After creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac LNs removed. Afterwards, the obturator LNs are dissected off the obturator nerve. LNs are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. Two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. Intra-operative and early post-operative outcome (lenght of stay, complications, number of LNs) is recorded. Follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melanoma, Secondary Malignant Neoplasm of Lymph Node
    Keywords
    Videoassisted surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Videoscopic ilioinguinal lymphadenectomy for melanoma
    Arm Type
    Experimental
    Arm Description
    Melanoma groin lymph node metastasis.
    Intervention Type
    Procedure
    Intervention Name(s)
    Videoscopic ilioinguinal dissection
    Other Intervention Name(s)
    Videoscopic groin lymphadenectomy
    Intervention Description
    Inguinal dissection is performed after subcutaneous inflation via three ports. Iliac dissection is obtained through a pro-peritoneal access.
    Primary Outcome Measure Information:
    Title
    Operative complications
    Description
    Frequency, type and severity of operative complications according to the Clavien-Dindo classification. Grade I: no intervention required; Grade II: medical therapy resolved the complication; Grade III A: intervention without general anaesthesia; Grade III B: intervention under general anaesthesia.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Leg lymphedema
    Description
    Lymphedema is measured pre-operatively at 3, 6 and 12 months after surgery. Number of patients with lymphedema according to the definition of the percent change > or = 7% of the sum of circumferences of the lower limb.
    Time Frame
    Up to 12 months
    Title
    Quality of life
    Description
    Quality of life was evaluated with European Organization Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ-C30) administered pre-operatively and after 3-6 and 9-12 months after surgery.This questionnaire is made up of 30 items to be later summarized in 5 functional scales, 3 symptom scales, 6 single items and a global health status scale. All of the scores are standardized using linear transformation and converted onto a 0-100 scale. Thus, a higher score for a functional scale and the global health status scale mean a high level of functioning/quality of life. Conversely, a high score for a symptom scale/item means a worse quality of life due to the symptoms perceived.
    Time Frame
    Up to 12 months
    Title
    Recurrence
    Description
    Patients were re-evaluated 1, 3, 6, 9 and 12 months after surgery and every 6 months thereafter. Whole body CT scan and inguinal ultrasonography were performed every six months. Local, in-transit, regional and distant recurrences were recorded. Number of patients with histology confirmed local recurrence
    Time Frame
    Up to 12 months
    Title
    Number of excised lymph nodes
    Description
    Information extracted from pathology report. Implications for quality assurance monitoring.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Melanoma patients without distant metastasis and either positive SLNB or clinically positive inguinal lymph nodes Exclusion Criteria: American Society of Anaesthesiologists (ASA) classification III-IV Severe chronic obstructive pulmonary disease (COPD) and other restrictive lung disease, Severe ischemic heart disease and chronic heart failure Previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), History of deep vein thrombosis (DVT) Childbearing state Severe hip functional limitation Previous hip/knee arthroplasty. Previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25583458
    Citation
    Sommariva A, Pasquali S, Rossi CR. Video endoscopic inguinal lymphadenectomy for lymph node metastasis from solid tumors. Eur J Surg Oncol. 2015 Mar;41(3):274-81. doi: 10.1016/j.ejso.2014.10.064. Epub 2014 Dec 27.
    Results Reference
    background
    PubMed Identifier
    24560569
    Citation
    Martin BM, Etra JW, Russell MC, Rizzo M, Kooby DA, Staley CA, Master VA, Delman KA. Oncologic outcomes of patients undergoing videoscopic inguinal lymphadenectomy for metastatic melanoma. J Am Coll Surg. 2014 Apr;218(4):620-6. doi: 10.1016/j.jamcollsurg.2013.12.016. Epub 2013 Dec 24.
    Results Reference
    background

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    Videoscopic Ilioinguinal Lymphadenectomy for Melanoma

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