Compares two lymph node removal methods during vaginal surgery for endometrial cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with newly diagnosed early stage endometrial cancer who are scheduled for keyhole staging surgery through the vagina (v-NOTES) with sentinel lymph node mapping.

Age

18 to 85 years

Sex

Women only

Disease stage

Newly diagnosed early stage endometrial cancer (FIGO 2023 stages 1 and 2), shown by imaging to be limited to the uterus.

Earlier treatment

No treatment before surgery (no neoadjuvant treatment). No earlier surgery for a cancer.

Main reasons for not taking part

• Another cancer at the same time
• Cannot have methylene blue dye or the vNOTES procedure
• Earlier surgery for a cancer
• Severe, deep endometriosis or an enlarged uterus that may need forced removal through the vagina
• Treatment given before surgery (neoadjuvant therapy)

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 85 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• transvaginal paracervical sentinel lymphadenectomy groupTreatment being tested

  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

  Treatment: Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy

• Transperitoneal lymphadenectomyExisting treatment, for comparison

  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.