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

NCT05318170 | Completed

• 1 other identifier: Yasargil-1
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Cancer

Keywords

Gynecological oncology; Gynecological cancers; Bulky lymph nodes; Laparoscopic ultra-radical lymph node debulking; Yasargil clamps; Complications; Surgical outcomes

Outcome Measures

Primary Outcomes (1)

• Complications

  Any complication occurred

  During the surgery and within 30 days after the surgery

Study Arms (1)

Women affected by gynecological cancer

Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)

Procedure: Laparoscopic ultra-radical lymph node debulking

Interventions

Laparoscopic ultra-radical lymph node debulking PROCEDURE

Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Women affected by gynecological cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women affected by gynecological cancer.

You may qualify if:

• 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

You may not qualify if:

• Disease-free interval \< 6 months and/or
• Performance status \> 2 according to Eastern Cooperative Oncology Group (ECOG) criteria

Sponsors & Collaborators

• University of Palermo: lead
• Fondazione Policlinico Universitario A. Gemelli, IRCCS: collaborator
• Universita di Verona: collaborator

Study Sites (1)

University of Palermo

Palermo, Sicily, 90133, Italy

Location

Related Publications (1)

• Di Donna MC, Sozzi G, Cucinella G, Giallombardo V, Gallotta V, Uccella S, Garzon S, Scambia G, Lagana AS, Chiantera V. Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies: Results from a Large, Multicenter, Retrospective Analysis. J Minim Invasive Gynecol. 2022 Sep;29(9):1083-1091. doi: 10.1016/j.jmig.2022.05.016. Epub 2022 May 29.

  PMID: 35649479 DERIVED

Study Officials

• Antonio Simone Laganà, M.D., Ph.D.

  University of Palermo

  STUDY CHAIR

• Vito Chiantera

  University of Palermo

  STUDY DIRECTOR

• Mariano Catello Di Donna

  University of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 8, 2022
• Study Start: April 1, 2022
• Primary Completion: April 8, 2022
• Study Completion: April 11, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

IT (1)