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

U

University of Palermo

Status

Completed

Conditions

Gynecologic Cancer

Treatments

Procedure: Laparoscopic ultra-radical lymph node debulking

Study type

Observational

Funder types

Other

Identifiers

NCT05318170
Yasargil-1

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

43 participants in 1 patient group

Women affected by gynecological cancer
Description:
Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)
Treatment:
Procedure: Laparoscopic ultra-radical lymph node debulking

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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