Sentinel Lymph NodeNCT06741007
Correlation of Pelvic Sentinel Lymph Node With Superficial Vein
A study testing Retroperitoneal pelvic lymphatic and uterine vessel dissection in people with Sentinel Lymph Node and Superficial Uterine Vein, run by Istanbul University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sentinel Lymph Node, Superficial Uterine Vein, Deep Uterine Vein
- What is being tested?
- Retroperitoneal pelvic lymphatic and uterine vessel dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2024to 15 Sep 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all women with early stage endometrial cancer who will be operated for staging
Who cannot join
- Previous radiotheraphy Previous pelvic retropelvic LN dissection Women with any disease that precludes pelvic retropelvic LN dissection (such as peritoneal dialysis)
- -
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Being tested
- Retroperitoneal pelvic lymphatic and uterine vessel dissection
- Keywords
- sentinel lymph node, uterine vein, uterine artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroperitoneal pelvic lymphatic and uterine vessel dissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancer | Experimental | 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 Receives: Procedure: Retroperitoneal pelvic lymphatic and uterine vessel dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate and localisation of SLN in correlation with the presence or absence of uterine veins bilaterally
The location of SLN ( obturator, external iliac and internal iliac) will be defined in percentages for each side of pelvis in relation to presence or absence of uterine vessels.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start22 Dec 2024 (estimated)
- Primary completion22 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Albayrak, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741007
- Sponsor's protocol ID
- 2828083
- Status last verified
- Aug 2024
- First submitted
- 15 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29787938Kimmig 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.
PubMed 38401483
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Pelvic Sentinel Lymph Node With Superficial Vein
- ClinicalTrials.gov ID
- NCT06741007
- Acronym / sponsor ID
- 2828083
- Keywords
- sentinel lymph node, uterine vein, uterine artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 22 Dec 2024 (estimated)
- Primary completion
- 22 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 18 Dec 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancer | Experimental | Procedure: Retroperitoneal pelvic lymphatic and uterine vessel dissectionSingle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all women with early stage endometrial cancer who will be operated for staging
Key exclusion criteria (2 listed)
- Previous radiotheraphy Previous pelvic retropelvic LN dissection Women with any disease that precludes pelvic retropelvic LN dissection (such as peritoneal dialysis)
- -
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 |
|---|---|---|
| Retroperitoneal pelvic lymphatic and uterine vessel dissectionICG 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. | Procedure or surgery | Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancer |
Primary outcome
Detection rate and localisation of SLN in correlation with the presence or absence of uterine veins bilaterally
Time frame: Two years
The location of SLN ( obturator, external iliac and internal iliac) will be defined in percentages for each side of pelvis in relation to presence or absence of uterine vessels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Results publication: PubMed 29787938Ribatti 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.
- Results publication: PubMed 38401483Kimmig 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Retroperitoneal pelvic lymphatic and uterine vessel dissection in people with Sentinel Lymph Node and Superficial Uterine Vein, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Albayrak, MD,Gynecologic Oncology Fellow (+90 532 6871051, mustafaalbayrak@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate and localisation of SLN in correlation with the presence or absence of uterine veins bilaterally (time frame: Two years). 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 NCT06741007, which also lists 2 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 18 Dec 2024.