Status:
UNKNOWN
Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease
Lead Sponsor:
Region Skane
Conditions:
Sentinel Lymph Node
Endometrial Cancer
Eligibility:
FEMALE
18-85 years
Phase:
NA
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 remo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT03838055
Start Date
February 1 2019
End Date
December 1 2023
Last Update
February 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Gynecology and Obstetrics
Lund, Sweden, 22185