Clinical trial · Observational
Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)
Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic ultra-radical lymph node debulking | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women affected by gynecological cancer
- description
- Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)
- interventionNames
- Procedure: Laparoscopic ultra-radical lymph node debulking
Primary outcomes (1)
- measure
- Complications
- timeFrame
- During the surgery and within 30 days after the surgery
- description
- Any complication occurred
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDi 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