Correlation of Pelvic Sentinel Lymph Node with Superficial Vein

NCT ID: NCT06741007

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-22
• Study Completion Date: 2026-09-15

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

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.

Conditions

Sentinel Lymph Node; Superficial Uterine Vein; Deep Uterine Vein

Keywords

sentinel lymph node; uterine vein; uterine artery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Retroperitoneal pelvic lymphatic and uterine vessel dissection

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

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• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Albayrak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mustafa Albayrak, MD,Gynecologic Oncology Fellow

Role: CONTACT

Phone: +90 532 6871051

Email: mustafaalbayrak@icloud.com

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

Role: CONTACT

Phone: +905053574361

Email: yagmurminareci@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 29787938 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38401483 (View on PubMed)

Other Identifiers

2828083

Identifier Type: -

Identifier Source: org_study_id