Clinical trial NCT02508909: Videoscopic Ilioinguinal Lymphadenectomy for Melanoma
Official title: Videoscopic Ilioinguinal Lymphadenectomy for Groin Lymph Node Metastases From Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Secondary Malignant Neoplasm of Lymph Node
Keywords: Videoassisted surgery
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Operative complications
timeFrame: 30 days
Secondary outcomes:
measure: Leg lymphedema
timeFrame: Up to 12 months
measure: Quality of life
timeFrame: Up to 12 months
measure: Recurrence
timeFrame: Up to 12 months
measure: Number of excised lymph nodes
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
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.
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.