Endometrial NeoplasmsNCT02690259
Sentinel Lymph Node Detection in Endometrial Cancer
A study testing Sentinel node procedure in people with Endometrial Neoplasms, run by Region Skane at 1 site in Sweden.
Trial summary
In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas no lymphadenectomy is recommended in low risk groups despite 5% LNM. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- Sentinel node procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2014to 30 May 2018
- 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
- Planned robotic operation due to endometrial carcinoma
- Patient suitable for laparoscopic surgery
- Signed consent
Who cannot join
- No consent
- Inability to understand study information
- surgical or anesthesiological contraindication for laparoscopic surgery
- previous lymphatic problems
- iodine allergy iodine
- disseminated disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near Infrared Fluorescent Technique for Sentinel Lymph Node Mapping in Endometrial Cancer
In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative risk group allocation is known to be erroneous in up to 15% of patients.
A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential to spare extensive surgery in 80% of high risk patients, identify low risk patients with nodal metastases, diminish side effects caused by full lymphadenectomy and render some expensive preoperative risk group allocation measures unnecessary.
Read more
A clinically useful SLN technique requires a high technical success rate, a clear definition of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of colored/ signaling nodes. Therefore, a definition of a SLN requires identification of efferent/afferent lymph vessels.
Several publications describe sentinel node techniques in EC with a variety of tracers (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as "radioactive nodes" or "colored nodes" only with no further discrimination. No study relate to an anatomical description of lymphatic pathways.
The aims of this study is to systematically display the major anatomical pathways with the use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on lymphatic anatomy and identification of efferent lymph vessels.
Read the detailed description
Endometrial cancer is an increasingly common gynecologic malignancy. The cumulative 5-year survival rate for node negative patients is 94%, 75% in those with metastatic pelvic lymph nodes only and 38% in patients with pelvic and paraaortic metastases. The proportion of node positive patients in adequately staged patient materials (usually high risk groups) is reported in the range of 15-21%. Depending on used risk criteria lymph node metastases occur in 1.5-7.8% in low risk patients. Some studies show better overall survival after pelvic and paraaortic lymphadenectomy, whereas other studies show increased complications with no survival benefit from the lymphadenectomy. Recent articles recommend paraaortic and pelvic lymp node metastases (LND) in high risk EC but the therapeutic value related to potential complications of nodal staging in EC is debated as well as how to define risk groups. An incidence of 0.9-5.2% severe lymphedema and 3.1% chylous ascites requiring treatment has been described after robotic pelvic and paraaortic lymphadenectomy.
The Sentinel node concept has been studied extensively in other cancer forms, for example breast and vulvar cancer. With the above mentioned controversy, patients with EC would benefit tremendously from a functioning Sentinel node concept. Studies using patent blue or radioactive tracer have not shown satisfactory results. The Da Vinci system (da Vinci® Surgical System, Intuitive Surgical Inc., Sunnyvale, Ca, USA) with Firefly technique could make a new concept possible in which major lymphatic drainage can be displayed and learned, hence allowing a standardization of SLN definitions. In our pilot studies, a reproducible surgical algorithm has been defined, overcoming and compensating the fact that ICG spreads quickly to several nodes.
Purpose: To develop a reliable Sentinel node Concept using the Firefly system with ICG in EC patients based on a defined lymphatic anatomy, a clear definition of a sentinel node and a reproducible surgical algorithm.
Hypothesis: The Firefly system using ICG enables the use of a Sentinel node concept in EC patients regardless risk group, so that only patients with pathologically proven lymph nodes metastases undergo a pelvic and paraaortic lymphadenectomy.
Methods of Research:
375 consecutive EC patients planned for robotic hysterectomy, bilateral salpingo-oophorectomy and in high risk patients also pelvic and paraaortic lymphadenectomy at Skane University Hospital, Lund, Sweden are enrolled in this study prospectively after giving written consent. The study is approved by the regional Institutional Review Board. With extended funding, the study will be expanded to another University Hospital in Sweden. Data on operative outcome, operative and postoperative complications, pathology reports and follow up for 24 months are prospectively collected. The use of Indocyanine green (ICG) and the Firefly system has the advantage of a fast uptake to lymphatic vessels and lymph nodes. Pilot studies have resulted in a new surgical method, standardization of operative technique and a clear definition of the Sentinel lymph node which now enables this study.
- Conditions
- Endometrial Neoplasms
- Being tested
- Sentinel node procedure
- Keywords
- Sentinel Lymph Node Biopsy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node procedureProcedure or surgery
Also called Indocyanine green
Patients with Endometrial cancer undergo Sentinel node procedure using Indocyanine green
| Study group | Role | What they receive |
|---|---|---|
| Sentinel node procedure | Experimental | Enrolling all eligible endometrial cancer patient to the Sentinel node concept using indocyanine green. Receives: Procedure: Sentinel node procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of sentinel nodes
The study measures the sensitivity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
Measured: up to 2 months
Detection of Sentinel nodes
The study measures the specificity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
Measured: up to 2 months
Detection of Setinel nodes
The study measures the false negative rate of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
Measured: up to 2 months
Secondary outcomes (2)
Recurrence rates
The study measures the recurrence rate after concluded treatment including the Sentinel node concept
Measured: up to 24 months after inclusion
Lymphatic complications
Comparison of the incidence of lymphatic complications such as lymph cysts and lymph edema after Sentinel node biopsy and full pelvic and paraaortic lymphadenectomy.
Measured: up to 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start1 Jun 2014
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Endometrial NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Detection of SLN followed by a complete lymphadenectomy. In this way every patients will serve as her own control
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Persson, Ass Prof, Study director, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690259
- Sponsor's protocol ID
- RegionSkaneKKLund
- Status last verified
- Mar 2019
- First submitted
- 5 Nov 2015
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Geppert B, Persson J. Robotic infrarenal paraaortic and pelvic nodal staging for endometrial cancer: feasibility and lymphatic complications. Acta Obstet Gynecol Scand. 2015 Oct;94(10):1074-81. doi: 10.1111/aogs.12712. Epub 2015 Aug 25.
PubMed 26218968Schaafsma BE, van der Vorst JR, Gaarenstroom KN, Peters AA, Verbeek FP, de Kroon CD, Trimbos JB, van Poelgeest MI, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer. Gynecol Oncol. 2012 Oct;127(1):126-30. doi: 10.1016/j.ygyno.2012.07.002. Epub 2012 Jul 10.
PubMed 22796548Holloway RW, Bravo RA, Rakowski JA, James JA, Jeppson CN, Ingersoll SB, Ahmad S. Detection of sentinel lymph nodes in patients with endometrial cancer undergoing robotic-assisted staging: a comparison of colorimetric and fluorescence imaging. Gynecol Oncol. 2012 Jul;126(1):25-9. doi: 10.1016/j.ygyno.2012.04.009. Epub 2012 Apr 13.
PubMed 22507531van der Vorst JR, Hutteman M, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Kuppen PJ, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping in cervical cancer patients. Int J Gynecol Cancer. 2011 Nov;21(8):1472-8. doi: 10.1097/IGC.0b013e31822b451d.
PubMed 22027751Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11.
PubMed 21996262Rossi EC, Jackson A, Ivanova A, Boggess JF. Detection of sentinel nodes for endometrial cancer with robotic assisted fluorescence imaging: cervical versus hysteroscopic injection. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11. doi: 10.1097/IGC.0b013e3182a616f6.
PubMed 24177256Jewell EL, Huang JJ, Abu-Rustum NR, Gardner GJ, Brown CL, Sonoda Y, Barakat RR, Levine DA, Leitao MM Jr. Detection of sentinel lymph nodes in minimally invasive surgery using indocyanine green and near-infrared fluorescence imaging for uterine and cervical malignancies. Gynecol Oncol. 2014 May;133(2):274-7. doi: 10.1016/j.ygyno.2014.02.028. Epub 2014 Feb 28.
PubMed 24582865How J, Gotlieb WH, Press JZ, Abitbol J, Pelmus M, Ferenczy A, Probst S, Gotlieb R, Brin S, Lau S. Comparing indocyanine green, technetium, and blue dye for sentinel lymph node mapping in endometrial cancer. Gynecol Oncol. 2015 Jun;137(3):436-42. doi: 10.1016/j.ygyno.2015.04.004. Epub 2015 Apr 12.
PubMed 25870917Plante M, Touhami O, Trinh XB, Renaud MC, Sebastianelli A, Grondin K, Gregoire J. Sentinel node mapping with indocyanine green and endoscopic near-infrared fluorescence imaging in endometrial cancer. A pilot study and review of the literature. Gynecol Oncol. 2015 Jun;137(3):443-7. doi: 10.1016/j.ygyno.2015.03.004. Epub 2015 Mar 11.
PubMed 25771495Sinno AK, Fader AN, Roche KL, Giuntoli RL 2nd, Tanner EJ. A comparison of colorimetric versus fluorometric sentinel lymph node mapping during robotic surgery for endometrial cancer. Gynecol Oncol. 2014 Aug;134(2):281-6. doi: 10.1016/j.ygyno.2014.05.022. Epub 2014 Jun 2.
PubMed 24882555Luhrs O, Ekdahl L, Geppert B, Lonnerfors C, Persson J. Resection of the upper paracervical lymphovascular tissue should be an integral part of a pelvic sentinel lymph node algorithm in early stage cervical cancer. Gynecol Oncol. 2021 Nov;163(2):289-293. doi: 10.1016/j.ygyno.2021.08.031. Epub 2021 Sep 9.
PubMed 34509298Luhrs O, Ekdahl L, Lonnerfors C, Geppert B, Persson J. Combining Indocyanine Green and Tc99-nanocolloid does not increase the detection rate of sentinel lymph nodes in early stage cervical cancer compared to Indocyanine Green alone. Gynecol Oncol. 2020 Feb;156(2):335-340. doi: 10.1016/j.ygyno.2019.11.026. Epub 2019 Nov 26.
PubMed 31780237
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Fluorescent Technique for Sentinel Lymph Node Mapping in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02690259
- Acronym / sponsor ID
- RegionSkaneKKLund
- Conditions
- Endometrial Neoplasms
- Keywords
- Sentinel Lymph Node Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative risk group allocation is known to be erroneous in up to 15% of patients.
A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential to spare extensive surgery in 80% of high risk patients, identify low risk patients with nodal metastases, diminish side effects caused by full lymphadenectomy and render some expensive preoperative risk group allocation measures unnecessary.
A clinically useful SLN technique requires a high technical success rate, a clear definition of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of colored/ signaling nodes. Therefore, a definition of a SLN requires identification of efferent/afferent lymph vessels.
Several publications describe sentinel node techniques in EC with a variety of tracers (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as "radioactive nodes" or "colored nodes" only with no further discrimination. No study relate to an anatomical description of lymphatic pathways.
The aims of this study is to systematically display the major anatomical pathways with the use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on lymphatic anatomy and identification of efferent lymph vessels.
Detailed description
Endometrial cancer is an increasingly common gynecologic malignancy. The cumulative 5-year survival rate for node negative patients is 94%, 75% in those with metastatic pelvic lymph nodes only and 38% in patients with pelvic and paraaortic metastases. The proportion of node positive patients in adequately staged patient materials (usually high risk groups) is reported in the range of 15-21%. Depending on used risk criteria lymph node metastases occur in 1.5-7.8% in low risk patients. Some studies show better overall survival after pelvic and paraaortic lymphadenectomy, whereas other studies show increased complications with no survival benefit from the lymphadenectomy. Recent articles recommend paraaortic and pelvic lymp node metastases (LND) in high risk EC but the therapeutic value related to potential complications of nodal staging in EC is debated as well as how to define risk groups. An incidence of 0.9-5.2% severe lymphedema and 3.1% chylous ascites requiring treatment has been described after robotic pelvic and paraaortic lymphadenectomy.
The Sentinel node concept has been studied extensively in other cancer forms, for example breast and vulvar cancer. With the above mentioned controversy, patients with EC would benefit tremendously from a functioning Sentinel node concept. Studies using patent blue or radioactive tracer have not shown satisfactory results. The Da Vinci system (da Vinci® Surgical System, Intuitive Surgical Inc., Sunnyvale, Ca, USA) with Firefly technique could make a new concept possible in which major lymphatic drainage can be displayed and learned, hence allowing a standardization of SLN definitions. In our pilot studies, a reproducible surgical algorithm has been defined, overcoming and compensating the fact that ICG spreads quickly to several nodes.
Purpose: To develop a reliable Sentinel node Concept using the Firefly system with ICG in EC patients based on a defined lymphatic anatomy, a clear definition of a sentinel node and a reproducible surgical algorithm.
Hypothesis: The Firefly system using ICG enables the use of a Sentinel node concept in EC patients regardless risk group, so that only patients with pathologically proven lymph nodes metastases undergo a pelvic and paraaortic lymphadenectomy.
Methods of Research:
375 consecutive EC patients planned for robotic hysterectomy, bilateral salpingo-oophorectomy and in high risk patients also pelvic and paraaortic lymphadenectomy at Skane University Hospital, Lund, Sweden are enrolled in this study prospectively after giving written consent. The study is approved by the regional Institutional Review Board. With extended funding, the study will be expanded to another University Hospital in Sweden. Data on operative outcome, operative and postoperative complications, pathology reports and follow up for 24 months are prospectively collected. The use of Indocyanine green (ICG) and the Firefly system has the advantage of a fast uptake to lymphatic vessels and lymph nodes. Pilot studies have resulted in a new surgical method, standardization of operative technique and a clear definition of the Sentinel lymph node which now enables this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Detection of SLN followed by a complete lymphadenectomy. In this way every patients will serve as her own control
| Arm | Type | Receives |
|---|---|---|
| Sentinel node procedure | Experimental | Procedure: Sentinel node procedureEnrolling all eligible endometrial cancer patient to the Sentinel node concept using indocyanine green. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned robotic operation due to endometrial carcinoma
- Patient suitable for laparoscopic surgery
- Signed consent
Key exclusion criteria (6 listed)
- No consent
- Inability to understand study information
- surgical or anesthesiological contraindication for laparoscopic surgery
- previous lymphatic problems
- iodine allergy iodine
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 |
|---|---|---|
| Sentinel node procedureAlso: Indocyanine greenPatients with Endometrial cancer undergo Sentinel node procedure using Indocyanine green | Procedure or surgery | Sentinel node procedure |
Primary outcome
Detection of sentinel nodes
Time frame: up to 2 months
The study measures the sensitivity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
Detection of Sentinel nodes
Time frame: up to 2 months
The study measures the specificity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
Detection of Setinel nodes
Time frame: up to 2 months
The study measures the false negative rate of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
2 secondary outcomes
Recurrence rates
Time frame: up to 24 months after inclusion
Lymphatic complications
Time frame: up to 24 months after inclusion
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 22 Mar 2019.
- Background: PubMed 26218968Geppert B, Persson J. Robotic infrarenal paraaortic and pelvic nodal staging for endometrial cancer: feasibility and lymphatic complications. Acta Obstet Gynecol Scand. 2015 Oct;94(10):1074-81. doi: 10.1111/aogs.12712. Epub 2015 Aug 25.
- Background: PubMed 22796548Schaafsma BE, van der Vorst JR, Gaarenstroom KN, Peters AA, Verbeek FP, de Kroon CD, Trimbos JB, van Poelgeest MI, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer. Gynecol Oncol. 2012 Oct;127(1):126-30. doi: 10.1016/j.ygyno.2012.07.002. Epub 2012 Jul 10.
- Background: PubMed 22507531Holloway RW, Bravo RA, Rakowski JA, James JA, Jeppson CN, Ingersoll SB, Ahmad S. Detection of sentinel lymph nodes in patients with endometrial cancer undergoing robotic-assisted staging: a comparison of colorimetric and fluorescence imaging. Gynecol Oncol. 2012 Jul;126(1):25-9. doi: 10.1016/j.ygyno.2012.04.009. Epub 2012 Apr 13.
- Background: PubMed 22027751van der Vorst JR, Hutteman M, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Kuppen PJ, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping in cervical cancer patients. Int J Gynecol Cancer. 2011 Nov;21(8):1472-8. doi: 10.1097/IGC.0b013e31822b451d.
- Background: PubMed 21996262Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11.
- Background: PubMed 24177256Rossi EC, Jackson A, Ivanova A, Boggess JF. Detection of sentinel nodes for endometrial cancer with robotic assisted fluorescence imaging: cervical versus hysteroscopic injection. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11. doi: 10.1097/IGC.0b013e3182a616f6.
- Background: PubMed 24582865Jewell EL, Huang JJ, Abu-Rustum NR, Gardner GJ, Brown CL, Sonoda Y, Barakat RR, Levine DA, Leitao MM Jr. Detection of sentinel lymph nodes in minimally invasive surgery using indocyanine green and near-infrared fluorescence imaging for uterine and cervical malignancies. Gynecol Oncol. 2014 May;133(2):274-7. doi: 10.1016/j.ygyno.2014.02.028. Epub 2014 Feb 28.
- Background: PubMed 25870917How J, Gotlieb WH, Press JZ, Abitbol J, Pelmus M, Ferenczy A, Probst S, Gotlieb R, Brin S, Lau S. Comparing indocyanine green, technetium, and blue dye for sentinel lymph node mapping in endometrial cancer. Gynecol Oncol. 2015 Jun;137(3):436-42. doi: 10.1016/j.ygyno.2015.04.004. Epub 2015 Apr 12.
- Background: PubMed 25771495Plante M, Touhami O, Trinh XB, Renaud MC, Sebastianelli A, Grondin K, Gregoire J. Sentinel node mapping with indocyanine green and endoscopic near-infrared fluorescence imaging in endometrial cancer. A pilot study and review of the literature. Gynecol Oncol. 2015 Jun;137(3):443-7. doi: 10.1016/j.ygyno.2015.03.004. Epub 2015 Mar 11.
- Background: PubMed 24882555Sinno AK, Fader AN, Roche KL, Giuntoli RL 2nd, Tanner EJ. A comparison of colorimetric versus fluorometric sentinel lymph node mapping during robotic surgery for endometrial cancer. Gynecol Oncol. 2014 Aug;134(2):281-6. doi: 10.1016/j.ygyno.2014.05.022. Epub 2014 Jun 2.
- Derived from this study: PubMed 34509298Luhrs O, Ekdahl L, Geppert B, Lonnerfors C, Persson J. Resection of the upper paracervical lymphovascular tissue should be an integral part of a pelvic sentinel lymph node algorithm in early stage cervical cancer. Gynecol Oncol. 2021 Nov;163(2):289-293. doi: 10.1016/j.ygyno.2021.08.031. Epub 2021 Sep 9.
- Derived from this study: PubMed 31780237Luhrs O, Ekdahl L, Lonnerfors C, Geppert B, Persson J. Combining Indocyanine Green and Tc99-nanocolloid does not increase the detection rate of sentinel lymph nodes in early stage cervical cancer compared to Indocyanine Green alone. Gynecol Oncol. 2020 Feb;156(2):335-340. doi: 10.1016/j.ygyno.2019.11.026. Epub 2019 Nov 26.
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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.
Jan Persson, Ass Prof study director
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node procedure in people with Endometrial Neoplasms, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 22 Mar 2019. 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 Sweden. 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?
Detection of sentinel nodes (time frame: up to 2 months). The study lists 3 primary outcomes in all. 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 NCT02690259, which also lists 12 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 22 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.