Endometrial Cancer Clinical Trial
Official title:
Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.
Status | Not yet recruiting |
Enrollment | 362 |
Est. completion date | December 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Gynecology and Obstetrics | Lund |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection rate of pelvic metastatic disease in endometrial cancer | The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases | 3 years from start inclusion with an interim analysis after 150 patients | |
Primary | Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes | Exact measurements of time allocated for the SLN procedure as such. | 3 years from start inclusion | |
Secondary | Incidence of lymphedema after removal of sentinel lymph nodes | Objective measurement lymphedema defined by of leg volume before and after surgery | 4 years including at least one year follow up | |
Secondary | intraoperative adverse events associated with the study intervention | Detailed registration of adverse events associated with the SLN procedure as such | 3 years from start inclusion or after 150 patients if study stopped at interim analysis |
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