Sentinel Node Mapping in Women With Cervical and Endometrial Cancer
Completed
- Conditions
- Uterine Cervical NeoplasmsUterine Neoplasms
- Registration Number
- NCT02825355
- Lead Sponsor
- University of Southern Denmark
- Brief Summary
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 512
Inclusion Criteria
- Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size < 2 cm
- Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, > 50% myometrial invasion
Exclusion Criteria
- Prior PL
- Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- Women included in other studies affecting outcome-measures of the present study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of lymphedema 3 years Incidence of lymphedema will be assessed using patient reported outcome measures.
Severity of lymphedema 3 years Severity of lymphedema will be assessed using patient reported outcome measures.
- Secondary Outcome Measures
Name Time Method Detection rate of sentinel lymph node 2 years Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally
Mapping of SLN in different types of lymph node stations 2 years Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy
Trial Locations
- Locations (3)
Herlev Hospital
🇩🇰Herlev, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark