Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489171
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Research on Laparoscopic Fertility-Sparing Surgery in Early-Stage Cervical Cancer
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Oncological and Obstetrical Outcomes for Fertility Preservation in Early Cervical Cancer Patient With Laparoscopic-assisted Vaginal Radical Trachelectomy
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None