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

• Sponsor: University of Palermo (Other)
• Overall Status: Completed
• CT.gov ID: NCT05318170
• Collaborator: Fondazione Policlinico Universitario A. Gemelli, IRCCS (Other), Universita di Verona (Other)
• Enrollment: 43
• Location: 1
• Actual Duration (Days): 10
• Patients Per Site Per Month: 130.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer	Procedure: Laparoscopic ultra-radical lymph node debulking

Study Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies
• Actual Study Start Date: Apr 1, 2022
• Actual Primary Completion Date: Apr 8, 2022
• Actual Study Completion Date: Apr 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Women affected by gynecological cancer Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)	Procedure: Laparoscopic ultra-radical lymph node debulking; Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Outcome Measures

Primary Outcome Measures

1. Complications [During the surgery and within 30 days after the surgery]

   Any complication occurred

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Palermo	Palermo	Sicily	Italy	90133

Sponsors and Collaborators

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

Investigators

• Study Chair: Antonio Simone Laganà, M.D., Ph.D., University of Palermo
• Study Director: Vito Chiantera, University of Palermo
• Principal Investigator: Mariano Catello Di Donna, University of Palermo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio Simone Laganà, Principal Investigator, University of Palermo
• ClinicalTrials.gov Identifier: NCT05318170
• Other Study ID Numbers: Yasargil-1
• First Posted: Apr 8, 2022
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antonio Simone Laganà, Principal Investigator, University of Palermo: Gynecological oncology; Gynecological cancers; Bulky lymph nodes; Laparoscopic ultra-radical lymph node debulking; Yasargil clamps; Complications; Surgical outcomes

Study Results

No Results Posted as of Jul 18, 2022