Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02825355

Acronym

SENTIREC I

Enrollment

512

Registered

2016-07-07

Start date

2017-02-27

Completion date

2022-05-01

Last updated

2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasms, Uterine Neoplasms

Keywords

robotic surgery procedure, indocyanine green, sentinel lymph node mapping

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Denmark

Outcome results