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Trial Title:
Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer
NCT ID:
NCT06656949
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study design is a two-arm, randomized, controlled trial.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
injecting indocyanine green (ICG) dye Intraoperative
Description:
injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer
Arm group label:
sentinel lymph node mapping with One injection site (cervix) group
Arm group label:
sentinel lymph node mapping with two injection site (cervix-uterus) group
Summary:
The primary goal of this prospective study is to define the efficacy of the sentinel
lymph node biopsy (SLNB) procedure by comparing different method performed in patients
with endometrial cancer. The aim of this study is to investigate whether the detection
rate of sentinel lymph node (SLN) with two different injection sites may be increased
compared to the standard use with single site (cervix) injection in endometrial cancer.
Detailed description:
The primary treatment for endometrial cancer involves total hysterectomy and bilateral
salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for
patients with advanced disease or who have risk factors for relapse. The tumor is
confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to
perform systematic lymphadenectomy to all patients. The primary purpose of the present
study is the to investigate the feasibility of sentinel lymph node determination in
endometrial cancer patients operated via conventional laparoscopy. To determine sentinel
lymph nodes cervical indocyanine green will be injected prior to the surgery. During the
surgery using fluorescent imaging systems sentinel lymph nodes will be removed and
examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be
performed if sentinel lymph node is positive.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- • 1.Age >18 and <80 years old
-
2. The pathological diagnosis was epithelial ovarian cancer
- 3.Survival time is expected to exceed 3 months
- 4.Signed consent form
Exclusion Criteria:
-
1. Patients with myocardial infarction or stroke, or unstable angina pectoris or
decompensated heart function
- 2.Patients with a history of exhaustion or deep vein thrombosis;
-
3. Liver insufficiency (transaminase >2.5 times the upper limit of the standard);
-
4. Renal insufficiency (serum muscle liver >2 times the standard upper limit);
-
5. Pregnancy and perinatal patients;
-
6. History of major organ transplantation and immune disease;
-
7. Psychiatric condition or language barriers
-
8. Alcohol or drug abuser (current or previous)
-
9. Unable or unwilling to sign informed consent or comply with study requirements;
-
10. Patients with other malignant tumors.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital，Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Peng, PhD
Phone:
86-18560088205
Email:
jin_peng@outlook.com
Start date:
October 30, 2024
Completion date:
January 30, 2026
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06656949
