Endometrial CancerNCT05191212
Real-time Lymphatic Channel Visualization Improves Bilateral Sentinel Lymph Node Detection in Endometrial Cancer
A study testing indocyanine green in people with Endometrial Cancer and Endometrial Neoplasms, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Neoplasms, Sentinel Lymph Node Biopsy (SLNB)
- What is being tested?
- indocyanine green
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2021to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Lymphatic Channel Visualization Compared With Conventional Cervical Indocyanine Green Injection for Sentinel Lymph Node Mapping in Early-stage Endometrial Cancer
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.
Read the 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.
- Being tested
- indocyanine green
- 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
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine greenProcedure or surgery
Cervical indocyanine green injection for the detection of sentinel lymph node
| Study group | Role | What they receive |
|---|---|---|
| Experimental injection | Experimental | Cervical indocyanine green injections until real-time visualization of the afferent lymphatic channels bilaterally. Receives: Procedure: indocyanine green |
| Standart injection | Active comparator | Cervical indocyanine green injections group Receives: Procedure: indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral sentinel lymph node detection rate
Proportion of patients in whom sentinel lymph nodes are successfully identified bilaterally.
Measured: Intraoperative (during surgery)
Secondary outcomes (6)
Unilateral Sentinel Lymph Node Detection Rate
Proportion of patients in whom SLNs are detected unilaterally
Measured: Intraoperative
Overall Sentinel Lymph Node Detection Rate (bilateral + unilateral)
Proportion of patients with any SLN detected
Measured: Intraoperative
Operative Time
Total surgical duration measured in minutes
Measured: From skin incision to skin closure
Time Required for Bilateral Sentinel Lymph Node Removal
The duration in minutes from the first cervical indocyanine green (ICG) injection to the successful removal of bilateral sentinel lymph nodes. This measure evaluates the efficiency of the mapping technique
Measured: Intraoperative (measured during surgery)
Estimated Blood Loss
Amount of blood loss measured intraoperatively (mL)
Measured: During surgery
Intraoperative and Postoperative Complications
Any complications observed intraoperatively or within 30 days postoperatively
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start13 Jul 2021
- Primary completion1 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Demirayak, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191212
- Sponsor's protocol ID
- 2021/455
- Status last verified
- Sep 2025
- First submitted
- 29 Dec 2021
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy concerns and institutional regulations; however, de-identified aggregate data will be available upon reasonable request.
Publications
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.
PubMed 319129022- NCCN Clinical Practice Guidelines in Oncology. Uterine Neoplasms Version 4.2021 -September 3, 2021 https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf
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.
PubMed 25004343Maramai 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.
PubMed 33906784
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Lymphatic Channel Visualization Compared With Conventional Cervical Indocyanine Green Injection for Sentinel Lymph Node Mapping in Early-stage Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05191212
- Acronym / sponsor ID
- 2021/455
- Keywords
- Endometrial cancer, Sentinel lymph node, İndocyanine green, Lymphatic channel, Lymphatic Channel Visualization, Uterine cancer, Da Vinci Surgical System, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental injection | Experimental | Procedure: indocyanine greenCervical indocyanine green injections until real-time visualization of the afferent lymphatic channels bilaterally. |
| Standart injection | Active comparator | Procedure: indocyanine greenCervical indocyanine green injections group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indocyanine greenCervical indocyanine green injection for the detection of sentinel lymph node | Procedure or surgery | Experimental injection, Standart injection |
Primary outcome
Bilateral sentinel lymph node detection rate
Time frame: Intraoperative (during surgery)
Proportion of patients in whom sentinel lymph nodes are successfully identified bilaterally.
6 secondary outcomes
Unilateral Sentinel Lymph Node Detection Rate
Time frame: Intraoperative
Overall Sentinel Lymph Node Detection Rate (bilateral + unilateral)
Time frame: Intraoperative
Operative Time
Time frame: From skin incision to skin closure
Time Required for Bilateral Sentinel Lymph Node Removal
Time frame: Intraoperative (measured during surgery)
Estimated Blood Loss
Time frame: During surgery
Intraoperative and Postoperative Complications
Time frame: Up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Results publication: PubMed 31912902Siegel 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.
- Results publication2- NCCN Clinical Practice Guidelines in Oncology. Uterine Neoplasms Version 4.2021 -September 3, 2021 https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf
- Results publication: PubMed 25004343Yost 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.
- Results publication: PubMed 33906784Maramai 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy concerns and institutional regulations; however, de-identified aggregate data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indocyanine green in people with Endometrial Cancer and Endometrial Neoplasms, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral sentinel lymph node detection rate (time frame: Intraoperative (during surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191212, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.