Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer

NCT06870903 | Recruiting

• 1 other identifier: ENDOCA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (15)

• Total operation duration

  The total duration of the operation in minutes

  During surgery

• Duration of right and left lymphadenectomy

  The duration of lymphadenectomies in minutes

  During surgery

• Number of lymph nodes excised

  Lymph node count in the pathology report

  Postoperative second week

• number of positive lymph nodes

  Sentinel positive lymph nodes in the pathology report

  Postoperative second week

• Hospitalization duration

  Number of days patients stayed at the hospital postoperatively

  During hospital stay

• Total bleeding volume

  Measured by the suction bottle's volume and number of surgical gauzse used during surgery

  During surgery

• Difference between pre- and postoperative hemoglobin values

  Hemoglobin level (g/dL)

  Postoperative 1st day

• Surgical complications

  Clavien dindo scale of surgical complications

  During hospital stay

• Location o SLN

  The area that sentinel lymph node detected internal iliac, external iliac ,bifurcation or obturator fossa

  During surgery

• Preoperative and postoperative hematocrit values

  Hematocrit level (%)

  During hospital stay

• Tumor's patological features

  Histophatology, grade, lymphovascular invasion, tumor diameter(cm), myometrial invasion, stage, total positive lymph node count

  Postoperative second week

• Management of complications

  intraoperative and postoperative complication's management

  through study completion

• Duration of lateral colpotomy

  at transvaginal retroperitoneal procedure ; before the lymphadenectomy we are making and incision to the lateral of cervix .this time describes the time that to reach the obturator fossa to pick the nodes.

  During surgery

• Duration of hysterectomy

  minutes

  During surgery

• Sentinel lymphnode's side and number

  number

  Postoperative second week

Secondary Outcomes (7)

• Postoperative pain

  3rd and 6th month after operation

• Sexual function

  at postoperative 3rd and 6th month

• Timing of passing gas

  During hospital stay

• Demographic features

  Postoperative second week

• Previous abdominal surgery

  Preoperative day

Study Arms (2)

transvaginal paracervical sentinel lymphadenectomy group

EXPERIMENTAL

Surgical Procedure of transvaginal sentinel lymphadenectomy group: All patients will be operated in accordance with Memorial Sloan Kettering Cancer Center procedure. V-NOTES will consist of transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO). SLN Mapping: Under general anesthesia, subjects will be placed in supine lithotomy position. Methylene blue solution (BLUMET IV INJECTION INJECTABLE 50 mg/5 ml 1x5 ml) (1 mL submucosal to the cervix at the 3 and 9 o'clock positions and 1 mL at a depth of 1-2 cm, using a total volume of 2-4 mL. Monitoring of lymphatic ducts includes identification of structures stained with methylene blue dye in the expected anatomical location, typically between the internal and external iliac veins or in the obturator region. Bilateral and symmetrical structures believed to be sentinel lymph nodes (SLNs) will be removed. When unilate

Procedure: Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy

Transperitoneal lymphadenectomy

ACTIVE COMPARATOR

In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with methylene blue injection for sentinel lymph nodes. Methylene blue will be injected at the 3 and 9 o'clock positions on the cervix, first at a depth of 1 mm and then at 4 mm, with 1 cc administered at each point. This will result in a total of 4 cc (1 cc x 4). Then, the procedure will continue with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision.

Procedure: Transperitoneal lymphadenectomy

Interventions

Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy PROCEDURE

The procedure begins with a vaginal incision in the lateral vaginal fornices (on both sides), which is then extended to allow placement of the V-NOTES apparatus. By identifying an appropriate cleavage plane, the obturator fossa is accessed to excise the obturator lymph nodes. Following this, an anterior colpotomy is performed to access the vesicocervical space, and a posterior colpotomy is made to open the rectouterine pouch. The V-NOTES apparatus is then placed to continue with the hysterectomy and bilateral salpingo-oophorectomy (BSO).

transvaginal paracervical sentinel lymphadenectomy group

Transperitoneal lymphadenectomy PROCEDURE

In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision.

Transperitoneal lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Gazi Yasargil Training And Research Hospital

Diyarbakır, Baglar, 21090, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 37335988 BACKGROUND

• 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.

  PMID: 38316443 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

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

Study Officials

• Behzat Can, Assoc. Prof.

  Health Sciences University Gazi Yasargil Training and Research Hospital

  STUDY CHAIR

• Sedat Akgol, Assoc. Prof.

  Health Sciences University Gazi Yasargil Training and Research Hospital

  STUDY DIRECTOR

• Kevser Arkan, MD

  Health Sciences University Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevser Arkan, MD

CONTACT

+905536476838; kevser.toprak1989@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gynecology Oncology Department

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 11, 2025
• Study Start: March 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: It will be shared when the study is published.
• Access Criteria: When the study is published, the data will be shared by the corresponding author on request.

Locations

TU (1)