Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer

Sun Yat-sen University

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)

Study type: Observational

Funder types: Other

Identifiers

NCT05904977

SYSKY-2022-446-01

Details and patient eligibility

About

The purpose of this study is to preliminarily explore the metastatic rate and clinical significance of the anterior leaf of vesicouterine ligament resection for early stage cervical cancer, so as to further improve the postoperative quality of life of patients and reduce the incidence of postoperative urinary complications.

Full description

The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter). The anterior leaf of the VUL in the type C resection group was sent to pathological biopsy separately, and the metastasis rate was further clarified by the pathological "ultrastaging" method. By comparing the clinicopathological characteristics of patients with metastasis and non-metastasis, the potential risk factors of VUL metastasis were analyzed. The oncological outcomes of patients with different resection range of the anterior VUL were compared. At the same time, the Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table was used to evaluate cervical cancer patients after surgery. The relevant factors that may affect the quality of life score are included in the multiple linear regression analysis to obtain independent risk factors that affect the quality of life of the patient after surgery.

Enrollment: 460 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical carcinoma (even neuroendocrine or clear cell carcinoma)
2. Radiographically confirmed tumor limited to the cervix or upper third vagina, but without evidence of lymph node metastasis
3. Stage IA2-IIA2 ( FIGO 2018)
4. Treated initially or just underwent cervical conization before
5. Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic lymph node dissection by the same team
6. Underwent the bilateral type C AL-VUL resection during the surgery
7. The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

1. Not stage IA2-IIA2 ( FIGO 2018)
2. History of abdominal or pelvic radiotherapy
3. Evidence of metastatic disease detected by PECT, MRI or CT
4. The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy or the patient as refusing abdominal surgery
5. Patients with other mailgnant tumors except cervical cancer
6. Incompetence of the clinical, surgical and pathological data

Trial design

460 participants in 2 patient groups

Type B resection

Description:

The patients reviced type B resection of the antierior leaf of vesicouterine ligament

Treatment:

Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)

Type C resection

Description:

The patients reviced type C resection of the antierior leaf of vesicouterine ligament

Treatment:

Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)