Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) and Conventional Laparoscopy

NCT07583329 | Not Yet Recruiting DMC

• 1 other identifier: 164/61
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Endometrial Adenocarcinoma; Endometrial Cancer

Keywords

v-notes; sentinel lymph node; conventional laparoscopy

Outcome Measures

Primary Outcomes (1)

• Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

  Baseline (pre-procedure), perioperative/periprocedural period

Secondary Outcomes (4)

• 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

  Baseline (pre-procedure), perioperative/periprocedural period

• The Impact of Sentinel Lymph Node Applications on Progression-Free Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

  up to 5 years

• The Impact of Sentinel Lymph Node Applications on Overall Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

  Up to 10 years

• Evaluation of Surgical Complications in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

  Baseline (pre-procedure), perioperative/periprocedural period

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed endometrial cancer on preoperative endometrial biopsy

You may qualify if:

• 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

You may not qualify if:

• Presence of extrauterine disease
• Detection of distant metastasis
• Surgery performed via an open (laparotomy) approach
• Incomplete medical records
• History of prior pelvic radiotherapy

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova Univercity

Adana, 01000, Turkey (Türkiye)

Location

Related Publications (3)

• Odgers 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 BACKGROUND

• Baekelandt 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 BACKGROUND

• Nadaban 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 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Ghanim Khatib

CONTACT

+903223386060; ghanim.khatib@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 13, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2036
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)