ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619000979156

Ethics application status

Approved

Date submitted

28/05/2019

Date registered

9/07/2019

Date last updated

11/01/2023

Date data sharing statement initially provided

9/07/2019

Date results provided

11/01/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

The value of sentinel lymphnode mapping with ICG in endometrial cancer

Scientific title

Sentinel lymphnode mapping with indocyanine green (ICG) in endometrial cancer: detection rate of sentinel lympnodes and learning curve of surgical procedure.

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1222-0614

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Endometrial cancer

Condition category

Condition code

Cancer

Womb (Uterine or endometrial cancer)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

For patients undergoing surgical treatment for endometrial cancer - total laparoscopic hysterectomy with bilateral adnexectomy and pelvic lymphadenectomy - indocyanine green dye (ICG) will be used to map sentinel lymph nodes: 1ml of ICG will be injected in 4 points of uterine cervix mucosa and stroma. Durign laparoscopic surgery in near infrared light a sentinel lymph nodes will be visualised and resected before proceeding with next surgery steps - total pelvic lymphadenectomy and hysterectomy. Duration of mapping procedure and sentinel lymphonode resection is aproximately 50 - 60 minutes.
This procedure will be performed by the surgeon.
Sentinel lymph nodes will be examined by pathologist using ultrastaging protocol to find micrometasis and isolated tumur cells (ITC)

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Detection rate of monolateral sentinel lymph nodes, verified by histology.

Timepoint [1]

Final histological verification 14 days after surgery.

Primary outcome [2]

Detection rate of bilateral sentinel lymph nodes, verified by histology.

Timepoint [2]

Final histological verification 14 days after surgery.

Primary outcome [3]

Surgeons learning curve, assessed by longitudinal evaluation of the duration of surgery, time of SLB procedure, blood loss.
This data will be collected from the surgery report that is completed by the surgeon after the surgery.

Timepoint [3]

2 years of longitudinal evaluation of separate surgeons

Secondary outcome [1]

Detection rate of micrometastasis and isoloated tumour cells (ITC) in sentinel lymph nodes, assessed by final histology.

Timepoint [1]

FInal histological report including protocol for micrometastasis and ITC up to 3 months after surgery.

Secondary outcome [2]

Performance of surgery comparing SLB with pelvic lymphadenectomy and conventional pelvic lymphadenectomy.
The duration of surgery, blood loss, the number of lymphnodes removed will be assessed and compared. This data will be collected from reports of the surgery completed by the surgeon performing operation.
The number of removed lymphnodes will be collected from the final histological report.
It is composite secondary outcome.

Timepoint [2]

Duration of surgery and blood loss will be assessed after the surgery and number of removed lymphnodes will be assessed after final histological verification 14 days after the surgery.

Eligibility

Key inclusion criteria

Patients who are diagnosed with:
1. Histologically confirmed high risk uterine endometrial carcinoma (G 2 -3) or non-endometrioid carcinoma;
2. Clinically staged >/- FIGO stage I B uterine carcinoma
Type of surgery planned: totally laproscopic histerectomy/ laparoscopic asssisted vaginal hysterectomy and full systemic lymphadenectomy

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Planned surgery - laparotomy

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/09/2019

Actual

6/09/2019

Date of last participant enrolment

Anticipated

Actual

28/10/2022

Date of last data collection

Anticipated

Actual

28/10/2022

Sample size

Target

100

Accrual to date

Final

212

Recruitment outside Australia

Country [1]

Lithuania

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Lithuanian University of Health Sciences Hospital

Address [1]

2 Eiveniu str., Kaunas, LT - 50161

Country [1]

Lithuania

Primary sponsor type

University

Name

Lithuanian University of Health sciences

Address

9 Mickeviciaus str. Kaunas; LT - 44307

Country

Lithuania

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Kaunas Regional bioethics Commitee

Ethics committee address [1]

Lithuanian University of Health Sciences
A. Mickeviciaus str. 9, Kaunas,  LT- 44307; Lithuania

Ethics committee country [1]

Lithuania

Date submitted for ethics approval [1]

Approval date [1]

07/02/2019

Ethics approval number [1]

BE-2-12

Summary

Brief summary

HYPTOHESIS: Sentinel lymph node biopsy (SLB) with Indocyanine green (ICG) mapping is a valuable tool in endometrial cancer patients for pathological staging of the disease which improves short-term and long-term outcomes.

AIM: To determine the value of SLB in endometrial cancer staging and to evaluate short and long - term treatment outcomes.

TASKS:
1. To determine the influence of body mass index (BMI) and uterine or uterine cervix comorbidities on the detection rate of sentinel lymph node mapped with ICG.
2. To evaluate the incidence rate of micro-metastasis and isolated tumour cells (ITC) in SLB and its coherency with local spread of the endometrial cancer.
3. To evaluate the surgeons learning curve in detecting and resecting SLB mapped with ICG.

METHODS:
It is a prospective interventional study that is carried out in Lithuanian University of Health Sciences Hospital, Obstetrics and gynaecology Department. 
Inclusion criteria:
- histologically confirmed high risk endometrial carcinoma of the uterus (G 2-3), non-endometrioid carcinoma, carcinosarcoma;
- clinically staged non less than stage I B (FIGO) uterine carcinoma.
Exclusion criteria:
- surgery is done by laparotomy.
For patients undergoing surgical treatment for endometrial cancer - total laparoscopic hysterectomy with bilateral adnexectomy and pelvic lymphadenectomy - indocyanine green dye (ICG) will be used to map sentinel lymph nodes: 1ml of ICG will be injected in 4 points of uterine cervix mucosa and stroma. During laparoscopic surgery in near-infrared light sentinel lymph nodes will be visualised and resected before proceeding with next steps of the surgery  - total pelvic lymphadenectomy and hysterectomy.
Sentinel lymph nodes will be examined by pathologist using ultra-staging protocol to find micro-metastasis and isolated tumour cells (ITC).

Trial website

Trial related presentations / publications

Public notes

First participant was excluded from analysis for the purposes of prospective registration, Kaunas Regional Bioethics Committee was adviced of this on 31/07/2019

Contacts

Principal investigator

Name

A/Prof Adrius Gaurilcikas

Address

Lithuanian University of Health Sciences Hospital
Obstetrics and Gynaecology Department
Eiveniu str. 4; Kaunas; LT - 50161

Country

Lithuania

Phone

+37063989530

Fax

adrius.gaurilcikas@kaunoklinikos.lt

Contact person for public queries

Name

Migle Gedgaudaite

Address

Lithuanian University of Health Sciences Hospital
Obstetrics and Gynaecology Department
Eiveniu str. 4; Kaunas; LT - 50161

Country

Lithuania

Phone

+37067222104

Fax

migle.gedgaudaite@lsmuni.lt

Contact person for scientific queries

Name

Migle Gedgaudaite

Address

Lithuanian University of Health Sciences Hospital
Obstetrics and Gynaecology Department
Eiveniu str. 4; Kaunas; LT - 50161

Country

Lithuania

Phone

+37067222104

Fax

migle.gedgaudaite@lsmuni.lt

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18010					Gedgaudaite M, Sukovas A, Paskauskas S, et al 202... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically