Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Neoplasm Metastasis

Lymphatic Metastasis

Penile Neoplasms

Neoplastic Processes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Penile Diseases

Male Urogenital Diseases

Penile Cancer

- Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery

Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery

arm A: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery arm B: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery

Inguinal Lymphadenectomy

The aim of the present study is to prospectively compare oncological and functional results of penile radical inguinal lymphadenectomy performed with an open versus videolaparoscopic technique.

The main questions it aims to answer are: evaluated the oncological and functional results of inguinal lymphadenectomy performed with minimally invasive techniques using videolaparoscopic instruments vs open inguinal lymphadenectomy according to the standard technique.

Participants will undergo treatment of the primary lesion and contextual inguinal lymphadenectomy:

* Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery
* Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery. The results of these procedures will be prospectively collected and compared.

Penile cancer represents, to date, a rare oncological pathology (1/100000 males in Europe). However, in tertiary reference centres, such as the SCU Urologia (Prof. P.

Gontero), the number of patients sent for this pathology is increasing. Although for the main lesion (T) there are now consolidated standards of care, increasingly aimed at a conservative "sexual sparing" approach where oncologically possible, the management of loco-regional lymph nodes is still not completely standardized. The European Guidelines (EAU) recommend bilateral inguinal radical lymphadenectomy for cN1/N2 (palpable lymph nodes mono/bilaterally, but not fixed) or high-risk tumour (\> T1G2). Lymph node management is the factor that most influences patient survival. For this reason, this must be entrusted to highly specialized centres. Some recent trials have shown that bilateral inguinal lymphadenectomy has a statistically significant superiority to radiotherapy and clinical surveillance in cN1/N2 patients. Despite this, inguinal lymphadenectomy has an important incidence of morbidity (up to 50% of cases) which often wrongly limits its indications. Main complications are: Lymphocele

* Prolonged lymphatic drainage
* Skin necrosis
* Dehiscence of the surgical wound
* Edema of lower limbs and genitals Only few studies have recently evaluated the oncological and functional results of inguinal lymphadenectomy performed with minimally invasive techniques using videolaparoscopic instruments. First results seem to support minimally invasive approach, that appears to have comparable oncological results and less post-operative morbidity.

However, evidences are still extremely limited, and no high-grade recommendations can be made. The aim of the present study is to prospectively compare oncological and functional results of penile radical inguinal lymphadenectomy performed with an open versus videolaparoscopic technique.

20 patients with indication for inguinal lymphadenectomy (according to EAU 2019 Guidelines - in case of primary lesion \> pT1G2 or in case of lymph node disease cN1/N2) will be enrolled. Each patient will undergo treatment of the primary lesion and contextual inguinal lymphadenectomy. The procedure will be performed in this way:

* Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery
* Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery The results of these procedures will be prospectively collected and compared. The main outcome will be the percentage of postoperative complications (lymphocele, prolonged lymph drainage, necrosis of the skin, dehiscence of the surgical wound, edema of lower limb, emergency admission from the ED, re-intervention/surgical revision).

Complications will be classified according to the international Clavien-Dindo classification. Additionally, secondary outcomes (number of lymph nodes, number of positive lymph nodes, surgical time) will be evaluated. After the operation, patients will attend a 24-month follow-up program, as reported in the flow chart, functional results and patient satisfaction will be evaluated during the visits.

The categorical variables will be described using frequency and percentage, and the continuous variables will be described using median and interquartile range (IQR) value.

Differences between groups will be assessed by the Student independent t test or the Mann-Whitney U test on the basis of their normal or not-normal distribution, respectively (normality of variables' distribution will be tested by the Kolmogorov-Smirnov test).

Surgical, observational, prospective, monocentric study.

Inguinal Lymphadenectomy for Penile Cancer

Inguinal Lymphadenectomy for Penile Cancer: an Interim Report From a Prospective Randomized Clinical Trial Comparing Open vs. Video-endoscopic Approach

All the data are anonymous and cannot be reconducted to patients if the legend is not available.

this legend is owned only by the principal investigator

Stratification of complications according to the international classification of Clavien-Dindo.

Azienda Ospedaliera Città della Salute e della Scienza di Torino

MD, PhD

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Inguinal Lymphadenectomy (IL) is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11 lymph nodes

Ilio-inguinal Lymphadenectomy (I-IL) is the removal of the same superficial groin lymp nodes (LN) removed during an IL but also combined with the more surgically complex removal of the ipsilateral pelvic LN. About twice as many LN are removed with I-IL compared to IL.

Ilio-inguinal Lymphadenectomy

Andrew Spillane

BACKGROUND: Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event affecting about 350 people a year in Australia. Globally it has been shown that patients with involved groin LN, without proven pelvic LN disease on imaging receive 1 of 3 management strategies in equal proportions - inguinal lymphadenectomy (IL); ilio-inguinal lymphadenectomy (I-IL); or variable use of either depending on circumstances. Different experts have strong and polarised opinions favouring either IL or more extensive I-IL with existing cases series reporting conflicting data on best cancer outcomes. No high level evidence proves which operation is best. HYPOTHESIS: There will be no significant difference in DFS between patients having IL or I-IL, conditional on PET/CT scan showing no evidence of pelvic disease at the time of diagnosis of groin LN metastatic melanoma. AIMS: To provide a rational evidence base for management for melanoma to the groin LNs by randomly assessing the effect of each operation on DFS, distant DFS, overall survival (OS), morbidity - including early complications and longer-term rates of lymphedema as well as comprehensively assessed QOL. Also to clarify the reliability of PET/CT scans for staging pelvic LNs and evaluate any health economic benefits of I-IL over IL. TARGET POPULATION: To recruit 634 patients in 5 years. DESIGN: An Australian led, international, multi-centre, non-inferiority, phase III, prospective, randomised clinical trial comparing IL or I-IL for patients with metastatic melanoma to groin LNs and no evidence of pelvic disease on PET/CT. ENDPOINTS: DFS, Distant DFS, OS and QOL at 5 years. Accuracy of PET/CT for pelvic LN metastases.

OUTCOMES: International standardization of care, improved cancer outcomes, improved QOL for patients with groin metastatic melanoma. Proof of principle about extent of surgery when PET/CT is clear in adjacent LN areas, leading to clinical trials investigating management of other lymph node fields.

Background and Rationale

Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event for patients with melanoma. In melanoma treatment centres around the world, patients without demonstrated pelvic LN disease receive 1 of 3 strategies of management in relatively equal proportions (Pasquali, Spillane et al. 2012):

i. Inguinal Lymphadenectomy (IL) ii. Ilio-inguinal Lymphadenectomy (I-IL) iii. Variable use of either IL or I-IL surgery.

Some larger melanoma centres have an institutional policy that all patients have either IL or I-IL for metastatic inguinal node involvement. Nearly all centres would agree that patients with pelvic LN involvement without distant metastatic disease should have I-IL.

Study Objectives This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS), distant disease-free survival (DDFS), overall survival (OS), morbidity, and quality of life. In addition, the study will clarify the reliability of PET (Positron Emission Tomography) / CT (Computed Tomography) scans for staging pelvic LNs, clarify morbidity differences between the operations in a balanced cohort, evaluate any health economic benefits of I-IL over IL and provide a tissue and serum resource to be used to identify biological markers of recurrence and progression after inguinal metastases.

Study Hypothesis There will be no significant difference in DFS between patients having IL or I-IL, conditional on PET/CT scan showing no evidence of pelvic disease at the time of diagnosis of groin LN metastatic melanoma.

Study Population The aim is to recruit 634 patients in 5 years who are 15 years or older with cytologically or histologically confirmed metastatic melanoma in inguinal LNs (H\&E \& IHC); specifically with no evidence of pelvic node involvement or distant spread of melanoma clinically or on PET/CT staging scans. To be eligible patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 at randomisation.

Study Treatments Eligible patients will be randomised 1:1 to undergo an IL or I-IL.

Study Design This is an international, multi-centre, phase III, non-inferiority, prospective, randomised clinical trial.

Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma

Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)

The difference between IL and I-IL surgery in DFS 5 years after randomisation

time from randomisation to death from any cause

time to new regional lymph node recurrence

This includes lymphoedema, wound complications (wound infections, dehiscence/necrosis, and seroma) chronic pain, and restriction in mobility

Quality Of Life questionnaires completed by patients

The diagnostic accuracy of PET/CT and CT for detecting pelvic lymph nodes positive for metastatic melanoma as confirmed by histopathology will be assessed in the sub-group of patients screened and shown to have a positive pelvic LN on PET/CT and those patients who had negative pelvic LN on PET/CT and randomised for I-IL treatment.

Resource use will be identified from the trial case report forms, and valued according the relevant Australian Refined Diagnosis Related Groups and Medicare Benefits Schedule item numbers.The cost-effectiveness and cost-utility analyses will calculate total costs and mean per patient costs per surgical group allocation, as well as total and mean benefits per group allocation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Inguinal Lymphadenectomy for Penile Cancer	NCT05887921	Penile Cancer Lymph Node Meta... Sentinel Lymph ... Surgical Compli...	Inguinal Lympha...	18 Years - 80 Years	Azienda Ospedaliera Città della Salute e della Scienza di Torino
Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma	NCT02166788	Metastatic Mela...	Inguinal Lympha... Ilio-inguinal L...	15 Years -	Melanoma and Skin Cancer Trials Limited

Spots Global Cancer Trial Database for inguinal lymphadenectomy