- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163963
Sentinel Lymph Node in Early-Stage Endometrium Cancer
Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer
Study Overview
Status
Conditions
Detailed Description
Endometrial cancer is the most common gynecologic cancer. Although 85-90% of women are diagnosed at early stage, about 10-15% are diagnosed at advanced stages. 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. These risks are especially increased in para-aortic lymphadenectomy which is a part of staging procedure in apparently early stage endometrial cancer.
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 agents are methylene blue, radiolabeled colloid technetium 99 (Tc99), isosulfan blue and fluorescent indocyanine green. Although subserosal, intramyometrial uterine injections and peritumoral injections using hysteroscopy with different tracers and different detection rates have been used, cervical injection with ICG is the most favoured and standard technique with highest pelvic SLN detection rates. However, the para-aortic SLN detection rates are not satisfactory with a single tracer injected into cervix which may be critical especially in high grade endometrioid, serous and clear cell histological types.
So, we aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer.
Technically, 2 mL indocyanine green with sterile water is injected at 3 and 9 o'clocks (each 1 mL) of cervix before the start of laparoscopic operation. Additionally, 2-4 mL of sterile charcoal carbon black dye is carefully injected just beneath the serosal layer at uterine fundus bilaterally avoiding intravascular injection This is done classically during laparoscopy by a spinal needle introduced under optical supervision after all optical and operative instruments are entered. 10-15 minute interval is allowed before the start of harvesting sentinel lymph nodes in pelvic and paraaortic region.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mustafa ALBAYRAK, MD
- Phone Number: +905326871051
- Email: mustafaalbayrak@icloud.com
Study Contact Backup
- Name: Yagmur MINARECI, MD
- Phone Number: +905053574361
- Email: yagmurminareci@gmail.com
Study Locations
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Istanbul / Turkey
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Istanbul, Istanbul / Turkey, Turkey, 34093
- Recruiting
- Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology
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Contact:
- Mustafa ALBAYRAK, MD
- Phone Number: +905326871051
- Email: mustafaalbayrak@icloud.com
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Contact:
- Yagmur MINARECI, MD
- Phone Number: +905053574361
- Email: yagmurminareci@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must have preoperative histologic diagnosis of endometrial carcinoma
- Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically
- Must have written informed consent
Exclusion Criteria:
- Possible allergic reaction to commonly used drugs
- Medical or surgical contraindications for comphrensive staging
- Preoperative or intraoperative findings of advanced endometrial cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sentinel Lymph Node Mapping With Double Tracer in Endometrium Cancer (Single Arm)
Sentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer (Single Arm)
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This is a single arm interventional prospective study.
Sentinel lymph node detection rate of the tracer injected in cervix (ICG- indocyanine green) before operation and the second tracer injected in uterine fundal subserosa (sterile charcoal black) at the start of operation are investigated.
It is anticipated that additional tracer used in the uterine serosa may overcome the insufficiency (or increase the detection rate) of the standard single tracer injected in cervix for detection rate of sentinel lymph nodes, especially in paraaortic sentinel lymph nodes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinoma
Time Frame: From the day of surgery to final pathology report (2 weeks)
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Detection rates of sentinel lymph nodes for both tracers in every pelvic and paraaortic lymph node basin are the primary outcome of the study.Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.
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From the day of surgery to final pathology report (2 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Samet TOPUZ, PROF. DR., ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC ONCOLOGY
Publications and helpful links
General Publications
- Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
- Cibula D, Oonk MH, Abu-Rustum NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol. 2015 Feb;27(1):66-72. doi: 10.1097/GCO.0000000000000133.
- Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. Lancet. 2022 Apr 9;399(10333):1412-1428. doi: 10.1016/S0140-6736(22)00323-3.
- Lee YC, Lheureux S, Oza AM. Treatment strategies for endometrial cancer: current practice and perspective. Curr Opin Obstet Gynecol. 2017 Feb;29(1):47-58. doi: 10.1097/GCO.0000000000000338.
- van den Heerik ASVM, Horeweg N, de Boer SM, Bosse T, Creutzberg CL. Adjuvant therapy for endometrial cancer in the era of molecular classification: radiotherapy, chemoradiation and novel targets for therapy. Int J Gynecol Cancer. 2021 Apr;31(4):594-604. doi: 10.1136/ijgc-2020-001822. Epub 2020 Oct 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/2015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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