Correlation of Pelvic Sentinel Lymph Node with Superficial Vein

NCT06741007 | Not Yet Recruiting DMC

• 1 other identifier: 2828083
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pelvic Sentinel Lymph Node (SLN) biopsy is an important integral part of endometrial surgery. Although SLN is usually found on internal iliac artery, location is variable. Lymphatic pathways in pelvis determines the location (Obturator, internal iliac or external iliac vessel locations). Since it is accepted that the lymphatic channel formation during embryologic life follows venous system formation investigators hypothesized that the presence or absence of superior or deep uterine vein may determine the location of sentinel lymph node

Conditions

Sentinel Lymph Node; Superficial Uterine Vein; Deep Uterine Vein

Keywords

sentinel lymph node; uterine vein; uterine artery

Outcome Measures

Primary Outcomes (1)

• Detection rate and localisation of SLN in correlation with the presence or absence of uterine veins bilaterally

  The location of SLN ( obturator, external iliac and internal iliac) will be defined in percentages for each side of pelvis in relation to presence or absence of uterine vessels.

  Two years

Study Arms (1)

Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancer

EXPERIMENTAL

Single arm study using ICG as a sentinel lymph node agent to detect the location of SLN in correlation with the presence or absence of superficial or deep uterine vein in early stage endometrial cancer

Procedure: Retroperitoneal pelvic lymphatic and uterine vessel dissection

Interventions

Retroperitoneal pelvic lymphatic and uterine vessel dissection PROCEDURE

ICG injection to cervix uteri at 3 and 9 o'clock followed by laparoscopic dissection of retroperitoneal space to detect uterine vessels (uterine arteries, SUVs and DUVs) bilaterally in addition to detect the location and biopsy of SLN stained by ICG.

Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancer

Eligibility Criteria

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

You may qualify if:

• all women with early stage endometrial cancer who will be operated for staging

You may not qualify if:

• Previous radiotheraphy Previous pelvic retropelvic LN dissection Women with any disease that precludes pelvic retropelvic LN dissection (such as peritoneal dialysis)

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (2)

• Ribatti D. Historical overview of lymphangiogenesis. Curr Opin Immunol. 2018 Aug;53:161-166. doi: 10.1016/j.coi.2018.04.027. Epub 2018 May 19.

  PMID: 29787938 BACKGROUND

• Kimmig R, Thangarajah F, Buderath P. Sentinel Lymph node detection in endometrial cancer - Anatomical and scientific facts. Best Pract Res Clin Obstet Gynaecol. 2024 Jun;94:102483. doi: 10.1016/j.bpobgyn.2024.102483. Epub 2024 Feb 15.

  PMID: 38401483 BACKGROUND

Central Study Contacts

Mustafa Albayrak, MD,Gynecologic Oncology Fellow

CONTACT

+90 532 6871051; mustafaalbayrak@icloud.com

Yagmur Minareci, M.D.,Gynec. Oncol Specialist

CONTACT

+905053574361; yagmurminareci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 18, 2024
• Study Start: December 22, 2024
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-08