Brief Title
Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease
Official Title
Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study
Brief Summary
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node
metastases in high risk and low risk endometrial cancer.
Detailed Description
Consecutive patients with- and low risk endometrial cancer will be approached for eligibility
for inclusion in a study evaluating the detection rates of pelvic metastatic disease by
detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.
A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant
treatment.
The detection rate will be evaluated from a non-inferiority perspective against the expected
rate of nodal metastases based on detailed final histological data.
Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel
nodes), time for the intervention, and an objective evaluation of lymphatic complications
(lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL
questionnaire.
Study Type
Interventional
Primary Outcome
Detection rate of pelvic metastatic disease in endometrial cancer
Secondary Outcome
Incidence of lymphedema after removal of sentinel lymph nodes
Condition
Sentinel Lymph Node
Intervention
Injection of tracer ( ICG) and detection of sentinel lymph nodes
Study Arms / Comparison Groups
SLN only
Description: Pelvic SLN's defined by ICG injected cervically
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
362
Start Date
February 2019
Completion Date
December 2023
Primary Completion Date
December 2022
Eligibility Criteria
Inclusion Criteria:
- Women of age 18 years and older at the time of informed consent.
- Women with a pathologically proven endometrial carcinoma of any histologic subtype or
grade, clinically stage I-II planned for primary surgery
- A uterine size allowing minimally invasive surgery
- Women must be able to understand and sign an informed consent in Swedish language.
- Absence of any exclusion criteria
Exclusion Criteria:
- Non consenting patients
- Ongoing pregnancy
- Inability to understand written and/or oral study information
- WHO performance status or conditions contraindicating adjuvant oncological treatment
(WHO III or more)
- Previous lower limb lymphedema ( only for the lymphedema part of study)
- Evidence of locally advanced disease or intraabdominal/distant metastases at
preoperative CT, MRI or ultrasonography.
- Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons
discretion.
- Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's
discretion
- Allergy to Iodine
- Patients with a known liver disease
- Patients with a bleeding disorder or mandatory antithrombotic treatment.
Gender
Female
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Jan Persson, Ass Prof, 0046733522080, [email protected]
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT03838055
Organization ID
RegionSkaneKKLund3
Responsible Party
Sponsor
Study Sponsor
Region Skane
Study Sponsor
Jan Persson, Ass Prof, Principal Investigator, RegionSkane, department of OB&G, Skåne university hospital, Lund
Verification Date
January 2019