Clinical trial NCT03838055: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sentinel Lymph Node
Endometrial Cancer
Lymphedema
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 362
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Detection rate of pelvic metastatic disease in endometrial cancer
timeFrame: 3 years from start inclusion with an interim analysis after 150 patients
measure: Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
timeFrame: 3 years from start inclusion
Secondary outcomes:
measure: Incidence of lymphedema after removal of sentinel lymph nodes
timeFrame: 4 years including at least one year follow up
measure: intraoperative adverse events associated with the study intervention
timeFrame: 3 years from start inclusion or after 150 patients if study stopped at interim analysis
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Gynecology and Obstetrics
Study officials:
affiliation: RegionSkane, department of OB&G, Skåne university hospital, Lund
name: Jan Persson, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: