Inguinal Lymphadenectomy for Penile Cancer

NCT05887921 | Completed

• 1 other identifier: 00025/2020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Penile Cancer; Lymph Node Metastasis; Sentinel Lymph Node; Surgical Complication

Outcome Measures

Primary Outcomes (1)

• Surgical outcomes of lymph drainage (ml)

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

  24 months

Study Arms (2)

Open inguinal Lymphadenectomy

ACTIVE COMPARATOR

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

Procedure: Inguinal Lymphadenectomy

Laparoscopic inguinal Lymphadenectomy

ACTIVE COMPARATOR

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

Procedure: Inguinal Lymphadenectomy

Interventions

Inguinal Lymphadenectomy PROCEDURE

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

Laparoscopic inguinal Lymphadenectomy; Open inguinal Lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Male with a diagnosis of penile cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of patients \[45-80\], CCI ≤ 3. Penile tumour with inguinal lymphadenectomy indication, according to EAU 2019 guidelines. Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

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

Turin, 10126, Italy

Location

Related Publications (1)

• Falcone M, Gul M, Peretti F, Preto M, Cirigliano L, Scavone M, Sedigh O, Oderda M, Gontero P. Inguinal Lymphadenectomy for Penile Cancer: An Interim Report from a Trial Comparing Open Versus Videoendoscopic Surgery Using a Within-patient Design. Eur Urol Open Sci. 2024 Mar 21;63:31-37. doi: 10.1016/j.euros.2024.02.007. eCollection 2024 May.

  PMID: 38558767 DERIVED

MeSH Terms

Conditions

Penile Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Surgical, observational, prospective, monocentric study.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: June 5, 2023
• Study Start: April 30, 2019
• Primary Completion: December 22, 2022
• Study Completion: May 24, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)