Research on Laparoscopic Fertility-Sparing Surgery in Early-Stage Cervical Cancer

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT06489171
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Purpose: To evaluate the oncological and obstetrical outcomes of women with early-stage cervical cancer who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT). All women with early-stage cervical cancer who planned to undergo fertility-preserved radical trachelectomy. The obstetric outcome evaluation was restricted to women with ≥12 months of follow-up and an active desire to conceive. The oncological outcome was evaluated in all patients.

Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.

Detailed Description

This retrospective cohort study reported the reproductive intentions and outcomes of cervical cancer patients who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT) .The LAVRT procedure began with laparoscopic pelvic lymphadenectomy, and all lymph nodes were removed for frozen pathological analysis. The laparoscopic-assisted vaginal radical trachelectomy procedure was continued only if the nodes were negative. The pararectal pouch was revealed, and the uterine arteries were divided from their origin to the internal iliac artery. The ureters were freed from the posterior leaf of the broad ligament down to the level where they entered the ureteral tunnel and then displaced laterally. The uterosacral ligaments, cardinal ligaments, and parametrial portions were then divided and dissected. The section of the procedure was performed laparoscopically. The vaginal epithelium was circumferentially incised approximately 3 cm distal to the endocervix. Frozen section analysis confirmed no cancer involvement at the endocervical or vaginal margin. The vaginal mucosa was sutured to the cervical stump to form a "new cervical os".

Postoperative adjuvant chemotherapy is indicated when women have at least one of 3 intermediate risk factors: stromal invasion of more than half of the cervix, lymphovascular space invasion (LVSI), or a tumor diameter of 4 cm or greater. Platinum-based chemotherapy (combination of paclitaxel and cisplatin or carboplatin for 3 courses) was used for these women.

Women attended follow-up visits every 3 months for the first 2 years, every 6 months for the next 3 years, and annually every year thereafter. At each follow-up visit, a physical and gynecological examination and a conventional Pap smear combined with an HPV test were performed. Abdominal (including both kidneys) and pelvic ultrasound (US) and serum tumor marker (SCC antigen or CA125 for adenocarcinoma) data were also included.

When tumor recurrence was suspected based on clinical findings or imaging studies, a positron emission tomography (PET)-CT scan was performed to investigate the extent of disease. Recurrence was confirmed by a lesion on biopsy or a positive PET-CT scan. The follow-up duration was measured from the day of the operation to the day of the last follow-up, death or loss to follow-up.

Study Timeline

• Study Start: 2003-01-01
• Primary Completion: 2013-01-01
• Study Completion: 2023-10-31
• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

• (i) were younger than 45 years old; (ii) strong desired to preserve fertility; (iii) had International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymphovascular space invasion (LVSI) positivity) to IB2; (iv) pathologically confirmed invasive cervical cancer; (v)had histology indicative of squamous cell carcinoma, adenosquamous cancer or adenocarcinoma; (vi) lacked evidence of pelvic lymph node or distant metastasis according to pelvic MRI and serum tumor markers (SCC and CA125) levels.

Exclusion Criteria

• (i) diagnosis of cervical gastric adenocarcinoma, cervical neuroendocrine carcinoma and other special types; (ii) invasion of cervical internal orifice; (iii) had contraindication of pregnancy; (iv) incomplete clinical data; (v) radiotherapy or hysterectomy was performed after diagnostic conization.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate after surgery	5 years	Postoperative patients who have successfully conceived
Recurrence rate	20years	The ratio of recurrent patients to the total enrolled patients
Progression-Free Survival	5-10 years	the date of the treatment to the date of disease progression or death from any cause in the absence of progression

Secondary Outcome Measures

Name	Time	Method
Average operation time	Intraoperative	The length of the surgery
bleeding volume	Intraoperative	the amount of blood loss in the patient