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Recruiting NCT06656949

Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer

No phase Interventional Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: injecting indocyanine green (ICG) dye Intraoperative.
Who it may be relevant to
Registry conditions: Endometrial Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
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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

Overview

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.

Interventions

  • Procedure injecting indocyanine green (ICG) dye Intraoperative
    injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer

Primary outcome measures

  • paraaortic Sentinel lymph node detection rates [Time frame: intraoperative day0]
  • Sentinel lymph node technique accuracy [Time frame: postoperative up to day7]
Secondary outcome measures (3)
  • Optimizing Sentinel lymph node detection procedure in endometrium cancer [Time frame: intraoperative day 0]
  • The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site [Time frame: intraoperative day 0]
  • Postoperative complications [Time frame: postoperative up to day 30]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Qilu Hospital，Shandong University — Jinan

Identifiers

NCT: NCT06656949 · KYLL-202404-005-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗