Correlation of Pelvic Sentinel Lymph Node With Superficial Vein

ConditionsSentinel Lymph Node Superficial Uterine Vein Deep Uterine Vein

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorIstanbul University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Retroperitoneal pelvic lymphatic and uterine vessel dissection
Procedure/Surgery
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.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Two years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: