Real-time Lymphatic Channel Visualization Improves Bilateral Sentinel Lymph Node Detection in Endometrial Cancer

NCT05191212 | Completed

• 1 other identifier: 2021/455
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Endometrial cancer is the most common malignancy of the female genital tract. Standard treatment for early-stage disease includes hysterectomy, bilateral salpingo-oophorectomy, and lymph node assessment. Sentinel lymph node (SLN) mapping with indocyanine green (ICG) has become widely used as an alternative to systematic lymphadenectomy due to lower morbidity and high detection rates. This randomized clinical trial was designed to compare conventional cervical ICG injection with a modified technique, in which injection is continued until real-time lymphatic channels are visualized intraoperatively, for bilateral SLN detection in patients with clinical early-stage endometrial cancer undergoing robotic surgery.

Conditions

Endometrial Cancer; Endometrial Neoplasms; Sentinel Lymph Node Biopsy (SLNB)

Keywords

Endometrial cancer; Sentinel lymph node; İndocyanine green; Lymphatic channel; Lymphatic Channel Visualization; Uterine cancer; Da Vinci Surgical System; Robotic Surgery; Real-time Visualization; Fluorescence Imaging; Near-Infrared Fluorescence; Gynecologic Oncology; Endometrial neoplasms

Outcome Measures

Primary Outcomes (1)

• Bilateral sentinel lymph node detection rate

  Proportion of patients in whom sentinel lymph nodes are successfully identified bilaterally.

  Intraoperative (during surgery)

Secondary Outcomes (6)

• Unilateral Sentinel Lymph Node Detection Rate

  Intraoperative

• Overall Sentinel Lymph Node Detection Rate (bilateral + unilateral)

  Intraoperative

• Operative Time

  From skin incision to skin closure

• Time Required for Bilateral Sentinel Lymph Node Removal

  Intraoperative (measured during surgery)

• Estimated Blood Loss

  During surgery

Other Outcomes (3)

• Length of Hospital Stay

  From immediately after surgery through hospital discharge (expected average of 2 days)

• Need for Blood Transfusion

  Perioperative period

• Need for ICU Admission

  From ICU admission through ICU discharge, an average of 1 day

Study Arms (2)

Experimental injection

EXPERIMENTAL

Cervical indocyanine green injections until real-time visualization of the afferent lymphatic channels bilaterally.

Procedure: indocyanine green

Standart injection

ACTIVE COMPARATOR

Cervical indocyanine green injections group

Procedure: indocyanine green

Interventions

indocyanine green PROCEDURE

Cervical indocyanine green injection for the detection of sentinel lymph node

Experimental injection; Standart injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Eligibility is limited to biologic females, as the study population is patients with endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Gökhan Demirayak

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (4)

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

  PMID: 31912902 RESULT

• 2- NCCN Clinical Practice Guidelines in Oncology. Uterine Neoplasms Version 4.2021 -September 3, 2021 https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf

  RESULT

• Yost KJ, Cheville AL, Al-Hilli MM, Mariani A, Barrette BA, McGree ME, Weaver AL, Dowdy SC. Lymphedema after surgery for endometrial cancer: prevalence, risk factors, and quality of life. Obstet Gynecol. 2014 Aug;124(2 Pt 1):307-315. doi: 10.1097/AOG.0000000000000372.

  PMID: 25004343 RESULT

• Maramai M, Achilarre MT, Aloisi A, Betella I, Bogliolo S, Garbi A, Maruccio M, Quatrale C, Aletti GD, Mariani A, Colombo N, Maggioni A, Multinu F, Zanagnolo V. Cervical re-injection of indocyanine green to improve sentinel lymph node detection in endometrial cancer. Gynecol Oncol. 2021 Jul;162(1):38-42. doi: 10.1016/j.ygyno.2021.04.026. Epub 2021 Apr 24.

  PMID: 33906784 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. This is an open-label surgical trial; no parties were masked.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor of Gynecologic Oncology, University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Model Details: A prospective, randomized, parallel-group study in which patients with clinical early-stage endometrial cancer are assigned to either conventional cervical indocyanine green (ICG) injection or real-time lymphatic channel-guided ICG injection for sentinel lymph node mapping. Each participant undergoes only one technique according to randomization.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: July 13, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 15, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)