NCT03838055

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

3.8 years

First QC Date

December 21, 2018

Last Update Submit

February 8, 2019

Conditions

Sentinel Lymph NodeEndometrial CancerLymphedema

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Incidence of lymphedema after removal of sentinel lymph nodes

    4 years including at least one year follow up

  • intraoperative adverse events associated with the study intervention

    3 years from start inclusion or after 150 patients if study stopped at interim analysis

Study Arms (1)

SLN only

EXPERIMENTAL

Pelvic SLN's defined by ICG injected cervically

Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes

Interventions

Injection of tracer ( ICG) and detection of sentinel lymph nodesPROCEDURE

Pelvic SLN's defined by ICG injected cervically

SLN only

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology and Obstetrics

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Endometrial NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jan Persson, Ass Prof

    RegionSkane, department of OB&G, Skåne university hospital, Lund

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Persson, Ass prof

CONTACT

0046733522080jan.persson@med.lu.se

Michele Bollino, MD

CONTACT

0046723059274michele.bollino@med.lu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2018

First Posted

February 12, 2019

Study Start

February 1, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

February 12, 2019

Record last verified: 2019-01

Locations

SE(1)