Efficacy of vaginal natural orifice transluminal endoscopic sentinel lymph node biopsy for endometrial cancer: a prospective multicenter cohort study.
Li Deng, Yi Liu, Yuanyan Yao...
https://pubmed.ncbi.nlm.nih.gov/37335988Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
FEMALE
ID06870903
Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
Led by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Updated on 2025-03-20
52
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of lymphadenectomy—transperitoneal and transvaginal paracervical—during the lymphadenectomy phase of endometrial cancer staging surgery using V-NOTES, a new and advanced surgical approach. This randomized, prospective, controlled study aims to optimize the V-NOTES technique for staging early-stage endometrial cancer by comparing surgical and functional outcomes between the two methods. Patients diagnosed with endometrial cancer through biopsy and imaging are enrolled and randomly assigned to one of the two lymphadenectomy groups. In the transvaginal paracervical lymphadenectomy group, patients undergo V-NOTES surgery beginning with methylene blue dye injection around the cervix, followed by sentinel lymph node mapping, hysterectomy, and removal of ovaries and fallopian tubes. The transperitoneal lymphadenectomy group receives V-NOTES surgery starting with methylene blue injection, anterior and posterior colpotomies, placement of the V-NOTES device, hysterectomy, and then lymph node removal through peritoneal dissection. Both groups receive similar surgical procedures with differences in lymphadenectomy approach. Participants will be assessed during surgery and hospitalization for operation duration, bleeding, lymph node removal, and complications. Follow-up evaluations include postoperative pain and sexual function at 3 and 6 months. Tumor pathology and other surgical outcomes are monitored up to the study completion. The study duration covers recruitment from March to December 2025 with ongoing follow-up through early 2026. Data will be collected on surgical safety, effectiveness of lymph node mapping, and recovery measures.
CONDITIONS
Brief Title
Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
Who Can Participate
Age: 18Years - 85Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 85 years
- Histologically confirmed endometrial cancer limited to the uterus by imaging
- Newly diagnosed clinical early stage (FIGO 2023 stages 1 and 2) endometrial cancer
- No neoadjuvant treatment before surgery
- Electively scheduled for V-NOTES endometrial cancer staging surgery
- Able to provide informed consent
You will not qualify if you...
- Contraindications to methylene blue dye or V-NOTES procedure
- History of previous malignancy surgery
- Severe, deeply penetrating endometriosis or enlarged uterus requiring forced vaginal extraction
- Receiving neoadjuvant therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgical procedure day
Participants undergo surgical staging with V-NOTES surgery, including sentinel lymph node (SLN) mapping and hysterectomy with bilateral salpingo-oophorectomy. They are randomized to either transvaginal paracervical lymphadenectomy or transperitoneal lymphadenectomy approach.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 6 months
Participants are monitored during their hospital stay and have follow-up assessments including surgical outcomes, complications, and recovery.
Approximately 3 follow-up visits (including postoperative day 1, second week, and months 3 and 6)
Trial Site Locations
Total: 1 location
1
Gazi Yasargil Training And Research Hospital
Diyarbakır, Baglar, Turkey (Türkiye), 21090
Actively Recruiting
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Research Team
K
Kevser Arkan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A new, less invasive approach for retroperitoneal pelvic and para-aortic lymphadenectomy combining the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique and single-port laparoscopy.
Behzat Can, Sedat Akgöl, Özgür Adıgüzel...
https://pubmed.ncbi.nlm.nih.gov/38316443vNOTES retroperitoneal sentinel lymph node dissection for endometrial cancer staging: First multicenter, prospective case series.
Jan Baekelandt, Astrid Jespers, Daniela Huber...
https://pubmed.ncbi.nlm.nih.gov/38623778