Clinical trial · Interventional
Real-time Lymphatic Channel Visualization Improves Bilateral Sentinel Lymph Node Detection in Endometrial Cancer
Real-time Lymphatic Channel Visualization Compared With Conventional Cervical Indocyanine Green Injection for Sentinel Lymph Node Mapping in Early-stage Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indocyanine green | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental injection
- description
- Cervical indocyanine green injections until real-time visualization of the afferent lymphatic channels bilaterally.
- interventionNames
- Procedure: indocyanine green
- type
- ACTIVE_COMPARATOR
- label
- Standart injection
- description
- Cervical indocyanine green injections group
- interventionNames
- Procedure: indocyanine green
Primary outcomes (1)
- measure
- Bilateral sentinel lymph node detection rate
- timeFrame
- Intraoperative (during surgery)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTSiegel 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
- RESULT2- NCCN Clinical Practice Guidelines in Oncology. Uterine Neoplasms Version 4.2021 -September 3, 2021 https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf
- RESULTYost 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
- RESULTMaramai 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