Videoscopic Ilioinguinal Lymphadenectomy for Melanoma

NCT ID: NCT02508909

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-01-31

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

Conditions

Melanoma; Secondary Malignant Neoplasm of Lymph Node

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Videoscopic ilioinguinal lymphadenectomy for melanoma

Melanoma groin lymph node metastasis.

Group Type: EXPERIMENTAL

Videoscopic ilioinguinal dissection

Intervention Type: PROCEDURE

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

Interventions

Videoscopic ilioinguinal dissection

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

Intervention Type: PROCEDURE

Other Intervention Names

Videoscopic groin lymphadenectomy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 25583458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24560569 (View on PubMed)

Other Identifiers

VIDEO SIIO trial, 2011/41

Identifier Type: -

Identifier Source: org_study_id