Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)

Gynecologic Cancer Clinical Trial

Official title:

Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318170
• Other study ID #: Yasargil-1
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: April 11, 2022

Study information

• Verified date: July 2022
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable.

To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 11, 2022
• Est. primary completion date: April 8, 2022
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least one bulky lymph node with size = 25 mm

• Age > 18 years

• Body mass index (BMI) < 40 kg/m²

• Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation

Exclusion Criteria:

• Disease-free interval < 6 months and/or

• Performance status > 2 according to Eastern Cooperative Oncology Group (ECOG) criteria

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Procedure:
• Laparoscopic ultra-radical lymph node debulking
Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Locations

Country	Name	City	State
Italy	University of Palermo	Palermo	Sicily

Sponsors (3)

Lead Sponsor	Collaborator
University of Palermo	Fondazione Policlinico Universitario A. Gemelli, IRCCS, Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Any complication occurred	During the surgery and within 30 days after the surgery