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Real world study on retroperitoneal lymph tracing and lymph node metastasis prediction in early cervical cancer under fluorescence endoscopy guidance

Real world study on retroperitoneal lymph tracing and lymph node metastasis prediction in early cervical cancer under fluorescence endoscopy guidance

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078917
Enrollment
Unknown
Registered
2023-12-21
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical carcinoma

Interventions

Case series (Intraoperative application of ICG for tracing retroperitoneal lymph nodes and predicting lymph node metastasis in early cervical cancer):None

Sponsors

Sichuan Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age at diagnosis = 18 years old, = 65 years old 2. Early cervical (clinical IA1 (LVSI+), IA2, IB1 stages) squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma 3. After clinical examination and magnetic resonance imaging, the maximum diameter of the tumor is = 20mm 4. MRI examination shows no suspicious lymph node metastasis 5. Those who meet the indications for laparoscopic radical cervical cancer surgery and are determined to require intraoperative lymph node dissection 6. The patient and their family members understand and are willing to participate in this clinical study, sign an informed consent form, and undergo follow-up

Exclusion criteria

Exclusion criteria: 1. Allergy to ICG (indocyanine green) or iodine 2. Pregnancy or history of pelvic or abdominal malignancies 3. If the maximum diameter of the tumor is greater than 20mm, and the tumor involves adjacent organs that require joint organ resection 4. Have a history of cervical cancer chemotherapy, external radiation therapy, and close range radiation therapy 5. Severe heart and lung diseases, or coagulation disorders, unsuitable for surgery and anesthesia 6. Researchers believe that patients with other conditions should not participate in this study 7. Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment

Design outcomes

Primary

MeasureTime frame
Imaging mode and quality evaluation of retroperitoneal lymph after cervical injection;Development rate, negative predictive value, false negative rate, accuracy of paraaortic, obturator lymph nodes, and common iliac lymph nodes;

Secondary

MeasureTime frame
Laparoscopic radical hysterectomy, pelvic lymphadenectomy, and paraaortic lymph node sampling were performed. Under the guidance of fluorescence laparoscopy, the excised lymph nodes were divided into two categories: developed and non developed according to their location, and were sent for routine pathological examination or pathological staging examination.;Follow up the incidence of postoperative complications (ureterovaginal fistula and vesicovaginal fistula, venous embolism, bleeding, urinary retention, lymphedema, etc.);

Countries

China

Contacts

Public Contactwang gang

Sichuan Maternal and Child Health Hospital

wallace1971@163.com+86 139 2992 8768

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026