NCT02508909

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Status
completed

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

September 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

July 16, 2015

Last Update Submit

July 23, 2015

Conditions

MelanomaSecondary Malignant Neoplasm of Lymph Node

Keywords

Videoassisted surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Secondary Outcomes (4)

  • Leg lymphedema

    Up to 12 months

  • Quality of life

    Up to 12 months

  • Recurrence

    Up to 12 months

  • Number of excised lymph nodes

    30 days

Study Arms (1)

Videoscopic ilioinguinal lymphadenectomy for melanoma

EXPERIMENTAL

Melanoma groin lymph node metastasis.

Procedure: Videoscopic ilioinguinal dissection

Interventions

Videoscopic ilioinguinal dissectionPROCEDURE

Inguinal dissection is performed after subcutaneous inflation via three ports. Iliac dissection is obtained through a pro-peritoneal access.

Also known as: Videoscopic groin lymphadenectomy
Videoscopic ilioinguinal lymphadenectomy for melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25583458BACKGROUND

  • 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.

    PMID: 24560569BACKGROUND

MeSH Terms

Conditions

MelanomaLymphatic Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 27, 2015

Study Start

September 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 27, 2015

Record last verified: 2015-07