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A Cohort Study on the Application of Sentinel-Lymph-Node Biopsy in Early-Stage Cervical Cancer

A Cohort Study on the Application of Sentinel-Lymph-Node Biopsy in Early-Stage Cervical Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116290
Enrollment
Unknown
Registered
2026-01-07
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Cervical Cancer

Interventions

Pelvic Lymphadenectomy Group (PLND):N/A
Sentinel lymph node biopsy (SLNB) Group:N/A

Sponsors

West China Second University Hospital of Sichuan University (WCSUH- SCU)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Pathological biopsy confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Preoperative assessment of general condition was performed, and tumor staging as well as lymph node metastasis status were clarified by combining imaging examinations. In accordance with guideline-based treatment protocols, radical hysterectomy combined with pelvic lymphadenectomy or sentinel lymph node biopsy (SLNB) was indicated; patients had signed the informed surgical consent form with the surgical approach clearly specified. 2.Clinical staging was IA1 with lymphovascular space invasion (LVSI), IA2, IB1, or IB2 (per International Federation of Gynecology and Obstetrics [FIGO] 2018 staging system). 3.Whole-body imaging assessment (contrast-enhanced computed tomography [CT] of the chest, abdomen, and pelvis or positron emission tomography-computed tomography [PET-CT]) confirmed no distant metastasis. 4.No significant chronic diseases of the heart, kidneys, or liver; no history of other malignant tumors, chemotherapy, or radiotherapy. 5.Age ranging from 18 to 70 years. 6.Voluntary participation in the study and signature of the informed consent form (waiver of informed consent was approved for the retrospective component).

Exclusion criteria

Exclusion criteria: 1.Severe preoperative medical or surgical comorbidities. 2.Patients with severe psychiatric disorders. 3.Residual cervical cancer. 4.Special pathological subtypes such as small cell carcinoma and neuroendocrine carcinoma. 5.Patients who received chemoradiotherapy prior to enrollment. 6.Patients with atopic diathesis or hypersensitivity to contrast agents (e.g., iodine-based contrast media). 7.Positive skin test result for indocyanine green (ICG). 8.Patients requesting preservation of fertility (who undergo radical trachelectomy instead of radical hysterectomy). 9.Patients for whom survival status cannot be obtained or with incomplete clinical information, confirmed via review of outpatient medical records and demographic data inquiry.

Design outcomes

Primary

MeasureTime frame
2-Year Disease-Free Survival (DFS);Total Sentinel Lymph Node Visualization Rate;Bilateral Detection Rate;Biopsy Sensitivity;

Secondary

MeasureTime frame
Incidence of Lymphedema Complications;1-year DFS;

Countries

China

Contacts

Public ContactYuedong He

West China Second University Hospital of Sichuan University (WCSUH- SCU)

He-yd@163.com+86 181 8060 9151

Outcome results

None listed

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