Clinical trial NCT05318170: Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)
Official title: Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Keywords: Gynecological oncology
Gynecological cancers
Bulky lymph nodes
Laparoscopic ultra-radical lymph node debulking
Yasargil clamps
Complications
Surgical outcomes
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Universita di Verona
First posted: 2022-04-08
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women affected by gynecological cancer.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complications
timeFrame: During the surgery and within 30 days after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University of Palermo
state: Sicily
Study officials:
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: University of Palermo
name: Vito Chiantera
role: STUDY_DIRECTOR
affiliation: University of Palermo
name: Mariano Catello Di Donna
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.