Clinical trial · Observational
Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) and Conventional Laparoscopy
Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With V-NOTES and Conventional Laparoscopy: A Multicenter Prospective Observational Study
- 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)
Endometrial cancer is a common cancer in women, and surgery is usually the first step in treatment. During surgery, doctors often check nearby lymph nodes to see if the cancer has spread. A newer method called sentinel lymph node (SLN) mapping allows doctors to examine only the first few lymph nodes most likely to contain cancer. This can reduce the need for removing many lymph nodes and may lower the risk of complications. Minimally invasive surgery is commonly performed using small abdominal incisions (laparoscopy). A newer technique, called vaginal natural orifice transluminal endoscopic surgery (vNOTES), allows the surgery to be performed through the vagina without any cuts on the abdomen. This approach may lead to less pain, quicker recovery, and no visible scars. This study will compare these two surgical methods-laparoscopy and vNOTES-in patients with early-stage endometrial cancer. Researchers will look at how safe and effective each method is, how patients recover after surgery, and how well the sentinel lymph node procedure works with each technique. The study will also examine how quickly surgeons become experienced with the newer vNOTES method. The goal of this research is to determine whether vNOTES can be a safe and effective alternative to standard laparoscopic surgery, while offering potential benefits for patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
- timeFrame
- Baseline (pre-procedure), perioperative/periprocedural period
Secondary outcomes (4)
- measure
- The Relationship Between Case Volume and the Learning Curve of Surgeons for Sentinel Lymph Node Procedures in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
- timeFrame
- Baseline (pre-procedure), perioperative/periprocedural period
- measure
- The Impact of Sentinel Lymph Node Applications on Progression-Free Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
- timeFrame
- up to 5 years
- description
- The impact of sentinel lymph node applications on progression-free survival in endometrial cancer cases performed with V-NOTES and conventional laparoscopy will be evaluated over a follow-up period of 5 years. Progression-free survival is defined as the time from surgery to the first documented disease recurrence, progression, or death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histologically confirmed endometrial cancer on preoperative endometrial biopsy * Disease confirmed to be confined to the uterus based on clinical evaluation and imaging * No evidence of lymphatic or distant metastasis on positron emission tomography/computed tomography(PET/CT) or magnetic resonance imaging (MRI) * Surgical staging with sentinel lymph node biopsy recommended by a multidisciplinary tumor board * Surgical treatment performed using either conventional laparoscopy or the vNOTES approach Exclusion Criteria: * Presence of extrauterine disease * Detection of distant metastasis * Surgery performed via an open (laparotomy) approach * Incomplete medical records * History of prior pelvic radiotherapy
References
Publications (3)
- BACKGROUNDOdgers H, Lin A, Tejada-Berges T. Comparison of laparoscopic vs. robotic sentinel lymph node mapping and biopsy in endometrial cancer. J Robot Surg. 2025 Apr 24;19(1):173. doi: 10.1007/s11701-025-02300-w. PMID 40272600
- BACKGROUNDBaekelandt J, Jespers A, Huber D, Badiglian-Filho L, Stuart A, Chuang L, Ali O, Burnett A. vNOTES retroperitoneal sentinel lymph node dissection for endometrial cancer staging: First multicenter, prospective case series. Acta Obstet Gynecol Scand. 2024 Jul;103(7):1311-1317. doi: 10.1111/aogs.14843. Epub 2024 Apr 16. PMID 38623778
- BACKGROUNDNadaban M, Balint O, Secosan C, Furau AM, Olaru F, Pirtea L. V-Notes Sentinel Lymph Node Staging for Endometrial Cancer: A Systematic Review. J Clin Med. 2025 Sep 12;14(18):6451. doi: 10.3390/jcm14186451. PMID 41010655