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

Recruiting

• Conditions: Cervical Cancer
• Interventions: Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)

• Registration Number: NCT05904977
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2023-05
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type B resection	Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)	The patients reviced type B resection of the antierior leaf of vesicouterine ligament
Type C resection	Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)	The patients reviced type C resection of the antierior leaf of vesicouterine ligament

Primary Outcome Measures

Name	Time	Method
Metastatic rate of the anterior leaf of vesicouterine ligament	1 year (Postoperative pathological confirmation date)	The metastasis rate of anterior leaf of VUL (%) = (case number of positive metastatic lesion detected by H\&E staining + case number of positive metastatic lesion diagnosed by "ultrastaging") / Total number of the patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the samesurgical team ×100%

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative adjuvant therapy in patients with metastasis in the anterior leaf of VUL	1 year after surgery	Clinical data
Incidence of postoperative urinary dysfunction in two groups	1 year after surgery	Follow-up and subjective description
Postoperative quality of life scores in two groups	1，2，3 years after surgery	The Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table
DFS	3 years after surgery	Disease-free survival

Trial Locations

Locations (1)

Huaiwu Lu; 🇨🇳 Guangzhou, Guangdong, China