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Sentinel lymph node biopsy in early stage cervical cancer (stage IB2,IIA1): a randomized controlled trial

Sentinel lymph node biopsy in early stage cervical cancer (stage IB2,IIA1): a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035567
Enrollment
Unknown
Registered
2020-08-13
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Cervical cancer

Interventions

Part-I Arm1:No pelvic lymphadenectomy
Part-I Arm 2:Pelvic lymphadenectomy
Part-II Arm1:No pelvic lymphadenectomy
Part-II Arm 2:Pelvic lymphadenectomy

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Newly treated cervical cancer patients aged 18-65 years; (2) Stage IB2 or IIA1 cerivical cancer(FIGO stage, 2018); (3) Preoperative imaging showed no lymph node metastasis; (4) The pathological types were squamous cell carcinoma, adenocarcinoma (common type) or squamous cell adenocarcinoma; (5) There is cervical tissue available for injection.

Exclusion criteria

Exclusion criteria: (1) Patients who have received neoadjuvant chemotherapy or radiotherapy; (2) a history of myocardial infarction or stroke, unstable angina pectoris, decompensated heart failure, or deep vein thrombosis; (3) liver insufficiency; (4) renal insufficiency; (5) A history of chronic pulmonary disease with limited respiratory dysfunction.

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival time;Recurrence rate of retroperitoneal lymph nodes;

Secondary

MeasureTime frame
Overall survival time;quality of life;postoperative complications;Sentinel lymph node technical indexes;Rule of lymph node metastasis of early cervical cancer;

Countries

China

Contacts

Public ContactKeqin Hua

Obstetrics and Gynecology Hospital of Fudan University

huakeqin@126.com+86 15921515900

Outcome results

None listed

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