Correlation of Pelvic Sentinel Lymph Node with Superficial Vein

December 15, 2024 updated by: Mustafa Albayrak, Istanbul University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometrial cancer is the most common gynecologic cancer. Treatment and prognosis depends on the surgical staging of the apparently early stage disease including the evaluation of lymphatic status of the disease. Detection of positive lymph node upstages the apparently early stage endometrial cancer. However, systematic lymphadenectomy carries immediate and long term risks for patients including bleeding, massive transfusions, prolongation of operation time, serious major vessel and major abdominal organ injury and death.

Sentinel lymph node biopsy (SLNB) procedure is the biopsy of one or two lymph node(s) which represents the lymph node basin draining the area of malignancy. This biopsy may potentially eliminate the need systemic pelvic / para-aortic lymphadenectomy which harbours potential complications. Although SLNB became an standard procedure in endometrial cancer, available data on the SLNB in endometrial cancer is variable. The relevant literature suggests that the detection rate of sentinel lymph node using various tracer agents are between %70-98, even with lower for bilateral pelvic detection and para-aortic sentinel lymph node(s). The most commonly used tracer agent is fluorescent indocyanine green (ICG). Although SLN is usually found on internal iliac artery during surgery, location is variable. Lymphatic pathways in pelvis determines the location (Obturator, internal iliac or external iliac 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 right or left superior (SUV) or deep uterine vein (DUV), which actually are highly variable, may determine the location of sentinel lymph node.

So investigators aims to find any correlation between the location of SLN (obturator, external iliac and internal iliac) and the presence of SUV or DUV unilaterally or bilaterally.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancer
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate and localisation of SLN in correlation with the presence or absence of uterine veins bilaterally
Time Frame: Two years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 22, 2024

Primary Completion (Estimated)

August 22, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2828083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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