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

NCT ID: NCT05191212

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-13
• Study Completion Date: 2025-09-15

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.

Detailed Description

Primary treatment of clinical early-stage endometrial cancer consists of total hysterectomy, bilateral salpingo-oophorectomy, and lymph node assessment for staging. Sentinel lymph node (SLN) biopsy using indocyanine green (ICG) has been recommended in international guidelines as an alternative to systematic lymphadenectomy.

Conventional cervical ICG injection achieves bilateral SLN detection rates of approximately 73-75%. Re-injection may increase detection but prolongs the procedure. To optimize this approach, the investigators developed a modified technique in which ICG injection is continued until real-time lymphatic channels are visualized intraoperatively using the Firefly fluorescence mode of the robotic system.

The trial was designed as a prospective, randomized study comparing the conventional method with the modified technique in patients with clinical early-stage endometrial cancer undergoing robotic surgery. Participants were randomized in a 1:1 ratio to either the conventional cervical ICG injection group or the real-time lymphatic channel-guided ICG injection group. Randomization was performed using a computer-generated random sequence.

Initially, a sample size of 24 participants per group was planned, assuming bilateral detection rates of 75% (conventional) and 99% (modified). During the course of the study, the observed rates were 82.5% and 97.5%, respectively. A revised power analysis indicated the need for 40 participants per group, and the protocol was amended accordingly.

The study was completed with 40 participants in each group. The primary outcome was the rate of bilateral SLN detection. Secondary outcomes included operative parameters and perioperative complications.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental injection

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

Group Type: EXPERIMENTAL

indocyanine green

Intervention Type: PROCEDURE

Cervical indocyanine green injection for the detection of sentinel lymph node

Standart injection

Cervical indocyanine green injections group

Group Type: ACTIVE_COMPARATOR

indocyanine green

Intervention Type: PROCEDURE

Cervical indocyanine green injection for the detection of sentinel lymph node

Interventions

indocyanine green

Cervical indocyanine green injection for the detection of sentinel lymph node

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: Patients with clinical stage 1-2 endometrial cancer ASA 1-3 patients. Ability to provide written informed consent

Exclusion Criteria: Patients with clinical stage 3-4 endometrial cancer Patients who are not suitable for robotic surgery due to their comorbidities (such as glaucoma, COPD, asthma) ASA 4-5 patients. Patients unable or unwilling to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gokhan Demirayak, MD

Assoc. Professor of Gynecologic Oncology, University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gökhan Demirayak

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 31912902 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 25004343 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33906784 (View on PubMed)

Other Identifiers

2021/455

Identifier Type: -

Identifier Source: org_study_id