Clinical trial NCT06870903: Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
Official title: Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Lymphadenectomy
Sentinel Lymph Node Biopsy
Minimally Invasive Surgical Procedures
Natural Orifice Transluminal Endoscopic Surgery
Keywords: endometrial cancer
V-NOTES
lymphadenectomy
sentinel lymph node
transperitoneal
extraperitoneal
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare two types of lymphadenectomy (transperitoneal vs. paracervical) during the lymphadenectomy phase of endometrial cancer staging surgery performed using V-NOTES, a new and advanced technique. This study seeks to optimize the V-NOTES technique for endometrial cancer staging. This randomized, prospective, controlled study will include patients diagnosed with endometrial cancer via histology, following physical examination and imaging, and who are electively scheduled for the V-NOTES endometrial cancer staging procedure. Patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group. The parameters related with surgical and functional outcomes will be compared in both groups.

Detailed description: Surgical staging is often the primary management strategy for endometrial cancer. Sentinel lymph node (SLN) procedures are considered an alternative standard of care in the treatment of significant uterus-confined malignancy. Both accurately estimate nodal status and reduce the surgical morbidity associated with complete lymphadenectomy. Laparoscopic surgery for endometrial cancer has been associated with equal or better quality of life, less blood loss and similar cancer-related outcomes. A new innovation, natural orifice transluminal endoscopic surgery (NOTES), has been developed to further reduce morbidity and scarring associated with laparoscopic surgery. NOTES utilizes the natural orifices of the human body for access to the peritoneal cavity when performing endoscopic surgery.

However, there is no standardization in vNOTES SLN mapping and lymph tracers are diverse. Many procedures and tracers have been reported, such as intra- or retroperitoneal surgery, a range of vaginal surgeries, SLN exposure method, and indocyanine green or methylene blue injection, and they lack comparative studies. This study will evaluate feasibility and surgical outcomes by comparing transvaginal paracervical and transperitoneal mapping in vNOTES hysterectomy with SLN procedure in endometrial cancer.

The study is an observational study with a prospective design. It will be implemented in a single institution, specifically Diyarbakır Gazi Yaşargil Training and Research Hospital, which functions as a tertiary cancer treatment facility.

Between March 2025 and December 2025, patients with newly diagnosed clinical early stage (FIGO 2023 stages 1 and 2) endometrial cancer who will be treated with laparoscopic surgical staging with SLN mapping.

According to inclusion and exclusion criteria, the patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group.

Surgical Procedure of transvaginal paracervical sentinel lymphadenectomy group:

All patients(26) will receive V-NOTES with transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO).

Transperitoneal sentinel lenfadenectomy group's Surgical Procedure:

All patients (26) will receive vNOTES hysterectomy with bilateral salpingo-oophorectomy (BSO) followed by transperitoneal vNOTES sentinel lymph node (SLN) mapping.

Eligibility criteria: Patient Selection and Data Collection This study will be implemented in a single institution, Diyarbakır Gazi Yaşargil Training and Research Hospital, which functions as a tertiary cancer treatment facility.

Between March 2025 and December 2025, patients with newly diagnosed clinical early stage (FIGO 2023 stages 1 and 2) endometrial cancer who will be treated with laparoscopic surgical staging with SLN mapping at our institution will be randomized into groups. The research procedure has been approved by the ethics committee/institutional review board of Diyarbakır Gazi Yaşargil Training and Research Hospital and informed consent signed by the patient will be included in each table reviewed.

Eligible participants will be required to give informed consent to participate in the study.

Inclusion criteria will include

* Participants whose endometrial biopsy resulted in endometrial cancer and whose disease will be detected limited to the uterus using imaging modalities (computed tomography \[CT\], magnetic resonance imaging or Fluorine-18 fluorodeoxyglucose positron emission tomography/CT)
* Absence of synchronous malignancies.
* No neoadjuvant treatment before surgical intervention.

Exclusion criteria will include:

* Contraindications to using methylene blue dye or contraindications to the vNOTES procedure.
* Patients who have had previous malignancy surgery.
* Severe, deeply penetrating endometriosis or enlarged uterus that may require forced vaginal extraction
* Receiving neodajuvant therapy

Primary outcomes:
measure: Total operation duration
timeFrame: During surgery
measure: Duration of right and left lymphadenectomy
timeFrame: During surgery
measure: Number of lymph nodes excised
timeFrame: Postoperative second week
measure: number of positive lymph nodes
timeFrame: Postoperative second week
measure: Hospitalization duration
timeFrame: During hospital stay
measure: Total bleeding volume
timeFrame: During surgery
measure: Difference between pre- and postoperative hemoglobin values
timeFrame: Postoperative 1st day
measure: Surgical complications
timeFrame: During hospital stay
measure: Location o SLN
timeFrame: During surgery
measure: Preoperative and postoperative hematocrit values
timeFrame: During hospital stay
measure: Tumor's patological features
timeFrame: Postoperative second week
measure: Management of complications
timeFrame: through study completion
measure: Duration of lateral colpotomy
timeFrame: During surgery
measure: Duration of hysterectomy
timeFrame: During surgery
measure: Sentinel lymphnode's side and number
timeFrame: Postoperative second week
Secondary outcomes:
measure: Postoperative pain
timeFrame: 3rd and 6th month after operation
measure: Sexual function
timeFrame: at postoperative 3rd and 6th month
measure: Timing of passing gas
timeFrame: During hospital stay
measure: Demographic features
timeFrame: Postoperative second week
measure: Previous abdominal surgery
timeFrame: Preoperative day
measure: Initiation of mobilization
timeFrame: During hospital stay
measure: 6th hour and 24th hour VAS score
timeFrame: postoperatively 6th and 24th hours score
Other outcomes:
Locations:
city: Diyarbakir
country: Turkey
facility: Gazi Yasargil Training And Research Hospital
state: Baglar
Study officials:
affiliation: Health Sciences University Gazi Yasargil Training and Research Hospital
name: Behzat Can, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Health Sciences University Gazi Yasargil Training and Research Hospital
name: Sedat Akgol, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Health Sciences University Gazi Yasargil Training and Research Hospital
name: Kevser Arkan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deng L, Liu Y, Yao Y, Deng Y, Tang S, Sun L, Wang Y. Efficacy of vaginal natural orifice transluminal endoscopic sentinel lymph node biopsy for endometrial cancer: a prospective multicenter cohort study. Int J Surg. 2023 Oct 1;109(10):2996-3002. doi: 10.1097/JS9.0000000000000551.
citation: Can B, Akgol S, Adiguzel O, Kaya C. 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. Int J Gynecol Cancer. 2024 May 6;34(5):789-790. doi: 10.1136/ijgc-2023-005093. No abstract available.
citation: 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.