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Trial registered on ANZCTR


Registration number
ACTRN12619000979156
Ethics application status
Approved
Date submitted
28/05/2019
Date registered
9/07/2019
Date last updated
5/11/2019
Date data sharing statement initially provided
9/07/2019
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] 296301 0
none
Universal Trial Number (UTN)
U1111-1222-0614
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial cancer 309992 0
Condition category
Condition code
Cancer 308758 308758 0 0
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] 312631 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320206 0
Detection rate of monolateral sentinel lymph nodes, verified by histology.
Timepoint [1] 320206 0
Final histological verification 14 days after surgery.
Primary outcome [2] 320207 0
Detection rate of bilateral sentinel lymph nodes, verified by histology.
Timepoint [2] 320207 0
Final histological verification 14 days after surgery.
Primary outcome [3] 320209 0
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] 320209 0
2 years of longitudinal evaluation of separate surgeons
Secondary outcome [1] 370860 0
Detection rate of micrometastasis and isoloated tumour cells (ITC) in sentinel lymph nodes, assessed by final histology.
Timepoint [1] 370860 0
FInal histological report including protocol for micrometastasis and ITC up to 3 months after surgery.
Secondary outcome [2] 370861 0
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] 370861 0
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
Gender
Females
Can healthy volunteers participate?
No
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20912 0
Lithuania
State/province [1] 20912 0

Funding & Sponsors
Funding source category [1] 300894 0
Hospital
Name [1] 300894 0
Lithuanian University of Health Sciences Hospital
Address [1] 300894 0
2 Eiveniu str., Kaunas, LT - 50161
Country [1] 300894 0
Lithuania
Primary sponsor type
University
Name
Lithuanian University of Health sciences
Address
9 Mickeviciaus str. Kaunas; LT - 44307
Country
Lithuania
Secondary sponsor category [1] 300463 0
None
Name [1] 300463 0
Address [1] 300463 0
Country [1] 300463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301667 0
Kaunas Regional bioethics Commitee
Ethics committee address [1] 301667 0
Lithuanian University of Health Sciences
A. Mickeviciaus str. 9, Kaunas, LT- 44307; Lithuania
Ethics committee country [1] 301667 0
Lithuania
Date submitted for ethics approval [1] 301667 0
Approval date [1] 301667 0
07/02/2019
Ethics approval number [1] 301667 0
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 87722 0
A/Prof Adrius Gaurilcikas
Address 87722 0
Lithuanian University of Health Sciences Hospital
Obstetrics and Gynaecology Department
Eiveniu str. 4; Kaunas; LT - 50161
Country 87722 0
Lithuania
Phone 87722 0
+37063989530
Fax 87722 0
Email 87722 0
adrius.gaurilcikas@kaunoklinikos.lt
Contact person for public queries
Name 87723 0
Ms Migle Gedgaudaite
Address 87723 0
Lithuanian University of Health Sciences Hospital
Obstetrics and Gynaecology Department
Eiveniu str. 4; Kaunas; LT - 50161
Country 87723 0
Lithuania
Phone 87723 0
+37067222104
Fax 87723 0
Email 87723 0
migle.gedgaudaite@lsmuni.lt
Contact person for scientific queries
Name 87724 0
Ms Migle Gedgaudaite
Address 87724 0
Lithuanian University of Health Sciences Hospital
Obstetrics and Gynaecology Department
Eiveniu str. 4; Kaunas; LT - 50161
Country 87724 0
Lithuania
Phone 87724 0
+37067222104
Fax 87724 0
Email 87724 0
migle.gedgaudaite@lsmuni.lt

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results