Sentinel lymph node detection in uterine cervix carcinoma

Not Applicable

Completed

• Conditions: Patients with cervical carcinoma, stages Ia or Ib1 including IIA1 with small vaginal lesion, who planned to undergo a radical hysterectomy and a total pelvic lymphadenectomy

• Registration Number: JPRN-jRCT1090220202
• Lead Sponsor: Masaaki Ando

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1) Patients with cervical carcinoma, stages Ia or Ib1 including IIA1 with small vaginal lesion, who are planned to undergo a radical hysterectomy and a total pelvic lymphadenectomy.
2) Patients should be histologically diagnosed as adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma. 3) Patients should be proven that the diameter of tumor is less than 4cm and they don't have any enlarged lymph nodes by MRI and CT. 4) Patients age is between 20 - 75 years old. 5) Performance status should be 0 or 1. 6) Patients should not have any presurgical treatment such as radiation therapy, chemotherapy, and surgery excluding conization. 7) Principal organs of patients are working healthy. 8) Patients should provide written informed consent.

Exclusion Criteria

Patients, who are diagnosed not to participate in this study by doctors or have some problems such as psychiatric illness, should be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sentinel lymph node detection rate, sensitivity, specificity and negative predictive value

Secondary Outcome Measures

Name	Time	Method
Operative time, total blood loss, transfusion, injure to pelvic nerves, postoperative complications that are caused by a total pelvic lymphadenectomy such as lymphedema, lymphocyst, and intestinal obstruction