Clinical trial NCT06656949: Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer
Official title: A Prospective, Randomized Trial Comparing the Different Injection Sites of Indocyanine Green (ICG) in Sentinel Lymph Node Mapping in Patients With Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a two-arm, randomized, controlled trial.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: paraaortic Sentinel lymph node detection rates
timeFrame: intraoperative day0
measure: Sentinel lymph node technique accuracy
timeFrame: postoperative up to day7
Secondary outcomes:
measure: Optimizing Sentinel lymph node detection procedure in endometrium cancer
timeFrame: intraoperative day 0
measure: The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site
timeFrame: intraoperative day 0
measure: Postoperative complications
timeFrame: postoperative up to day 30
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital，Shandong University
state: Shandong
Study officials:
References: