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Inguinal Lymphadenectomy for Penile Cancer

Primary Purpose

Penile Cancer, Lymph Node Metastasis, Sentinel Lymph Node

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Inguinal Lymphadenectomy
Sponsored by
Azienda Ospedaliera Città della Salute e della Scienza di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penile Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Age of patients [45-80], CCI ≤ 3. Penile tumour with inguinal lymphadenectomy indication, according to EAU 2019 guidelines. Written informed consent. Exclusion Criteria: Age of patients> 80, CCI ≥ 3. Patients with lymphatic disorders of lower limbs. Patients with previous inguinal surgery/radiotherapy. Previous or concomitant diagnosis of other tumours.

Sites / Locations

  • A.O.U. Città della Salute e della Scienza di Torino

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open inguinal Lymphadenectomy

Laparoscopic inguinal Lymphadenectomy

Arm Description

- 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

Outcomes

Primary Outcome Measures

Surgical outcomes of lymph drainage (ml)
Stratification of complications according to the international classification of Clavien-Dindo.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2022
Last Updated
May 24, 2023
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT05887921
Brief Title
Inguinal Lymphadenectomy for Penile Cancer
Official Title
Inguinal Lymphadenectomy for Penile Cancer: an Interim Report From a Prospective Randomized Clinical Trial Comparing Open vs. Video-endoscopic Approach
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
May 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Cancer, Lymph Node Metastasis, Sentinel Lymph Node, Surgical Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Surgical, observational, prospective, monocentric study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open inguinal Lymphadenectomy
Arm Type
Active Comparator
Arm Description
- Groin 1: open lymphadenectomy performed by a surgical team with extensive experience in traditional surgery
Arm Title
Laparoscopic inguinal Lymphadenectomy
Arm Type
Active Comparator
Arm Description
Groin 2: laparoscopic lymphadenectomy performed by a surgical team with extensive experience in minimally invasive surgery
Intervention Type
Procedure
Intervention Name(s)
Inguinal Lymphadenectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Surgical outcomes of lymph drainage (ml)
Description
Stratification of complications according to the international classification of Clavien-Dindo.
Time Frame
24 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male with a diagnosis of penile cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of patients [45-80], CCI ≤ 3. Penile tumour with inguinal lymphadenectomy indication, according to EAU 2019 guidelines. Written informed consent. Exclusion Criteria: Age of patients> 80, CCI ≥ 3. Patients with lymphatic disorders of lower limbs. Patients with previous inguinal surgery/radiotherapy. Previous or concomitant diagnosis of other tumours.
Facility Information:
Facility Name
A.O.U. Città della Salute e della Scienza di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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

Learn more about this trial

Inguinal Lymphadenectomy for Penile Cancer

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