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

NCT06489171CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

132

Start Date

2003-01-01

Completion Date

2013-01-01

Study Type

OBSERVATIONAL

Official Title

Oncological and Obstetrical Outcomes for Fertility Preservation in Early Cervical Cancer Patient With Laparoscopic-assisted Vaginal Radical Trachelectomy

Interventions

Received laparoscopic-assisted vaginal radical trachelectomy

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years – 45 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Progression-Free Survival

the date of the treatment to the date of disease progression or death from any cause in the absence of progression

Time frame: 5-10 years

Pregnancy rate after surgery

Postoperative patients who have successfully conceived

Time frame: 5 years

Recurrence rate

The ratio of recurrent patients to the total enrolled patients

Time frame: 20years

Secondary Outcomes

Average operation time

The length of the surgery

Time frame: Intraoperative

bleeding volume

the amount of blood loss in the patient

Time frame: Intraoperative

Linked Papers

Conization and lymph node evaluation as a fertility-sparing treatment for early stage cervical cancer

To evaluate oncological and obstetrical outcomes of early stage cervical cancer patients who underwent conservative management to retain childbearing potential. Data of women (aged <40 years) who underwent fertility sparing treatment for International Federation of Gynecology and Obstetrics (FIGO) stage IA1 with lymphovascular invasion (LVSI) and IB1 cervical cancer were prospectively collected. All patients underwent cervical conization/s and laparoscopic nodal evaluation (pelvic lymphadenectomy/sentinel node mapping). Oncological and obstetrical outcomes were assessed. Overall, 39 patients met inclusion criteria; 36 (92.3%) women were nulliparous. There were: 3 (7.7%) IA1-LVSI+; 11 (28.2%) IA2; and 25 (64.1%) IB1 cervical cancers, according to 2018 FIGO stage classification. Histological types were 22 (56.4%) squamous carcinoma and 17 (43.6%) adenocarcinoma. Pelvic lymphadenectomy was performed in 29 (74.4%) patients, while 10 (25.6%) patients had only sentinel node mapping. In 4 (10.3%) patients conservative treatment was discontinued due to nodal involvement and 2 (5.1%) patients requested definitive treatment (hysterectomy) after a negative lymph node evaluation. Among 33 (84.6%) patients who retained their childbearing potential, 17 (51.5%) had a second conization. 2 (6.1%) patients relapsed and underwent definitive treatment. After a median follow-up of 51 months (range 1-184) no deaths were reported. 22 (70.9%) patients attempted to conceive. There were 13 natural pregnancies among 12 (54.5%) women who got pregnant. Live birth rate was 76.9%: 9 (69.2%) term and 1 (7.7%) preterm (at 32 weeks) deliveries. 2 (15.4%) miscarriages (first and second trimester) and 1 (7.7%) termination of pregnancy for medical reasons were recorded. Conization plus laparoscopic nodal evaluation may be a safe and feasible conservative option in the setting of fertility-sparing treatment for early-stage cervical cancer patients.

Terminology for cone dimensions after local conservative treatment for cervical intraepithelial neoplasia and early invasive cervical cancer: 2022 consensus recommendations from ESGO, EFC, IFCPC, and ESP

Local cervical treatment for squamous intraepithelial lesion (SIL) or cervical intraepithelial neoplasia (CIN) removes or ablates a cone-shaped or dome-shaped part of the cervix that contains abnormal cells. This Series paper introduces the 2022 terminology for cone dimensions after local conservative treatment for SIL, CIN, or early invasive cervical cancer. The terminology was prepared by the Nomenclature Committee of the European Society of Gynaecologic Oncology, the European Federation for Colposcopy, the International Federation of Cervical Pathology and Colposcopy, and the European Society of Pathology. Cone length should be tailored to the type of transformation zone. Treatment of SIL or CIN is associated with an increased risk of preterm birth, which escalates with increasing cone length. There is a lack of agreement regarding terms used to report excised specimen dimensions both intraoperatively and in the pathology laboratory. Consensus is needed to make studies addressing effectiveness and safety of SIL or CIN treatment comparable, and to facilitate their use to improve accuracy of antenatal surveillance and management. This Series paper summarises the current terminology through a review of existing literature, describes new terminology as agreed by a group of experts from international societies in the field of cervical cancer prevention and treatment, and recommends use of the new terminology that will facilitate communication between clinicians and foster more specific treatment guidelines that balance obstetrical harm against therapeutic effectiveness.

Linked Investigators

Daniele Vinti

Fabio Martinelli

Fabio Martinelli is the Director of the Gynecologic Oncology Surgical Division at Humanitas San Pio X and tenure-track Assistant Professor of Gynecology and Obstetrics at Humanitas University. Former attending physician in the Department of Gynecologic Oncology at IRCCS Foundation - National Cancer Institute of Milan –Italy since 2012, when he graduated residency in Obstetrics and Gynecology from the University of Milan. During his training attended at The University of Texas MD Anderson Cancer Center - Gynecologic Oncology and Reproductive Medicine Department, at the Department of Gynaecology and Gynaecological Oncology of Kliniken-Essen-Mitte and at the Universidad Autonoma of Madrid. His area of interest are: Gynecological Oncology, Gynecologic Malignancies Treatment (cervical, endometrial, ovarian and vulvar cancer and pre-invasive disease), Minimally invasive surgery in ob/gyn (Laparoscopy, Hysteroscopy), Cytoreductive surgery, Surgical techniques in gynecology, Sentinel node procedures, Laser surgery, Oncofertility, Fertility preservation in gynecologic cancers, HPV and colposcopy. He is a European Society of Gynaecological Oncology (ESGO) certified European Gynaecological Oncologist. He was awarded the National Scientific Qualification for Associate and Full Professorship in Gynecology and Obstetric - Ministry of Education, University and Research (Italy) He has been the 2021-2023 Italian National Representative (NATREP) at ENYGO (European Network of Young Gynaecologic Oncologists). He is an Expert Evaluator EX2021D431400 at the European Commission Funding & Tenders and Member of the panel of Expert in Medical Devices at the European Commission (EU), since 2021. He is an European Society of Gynaecological Oncology (ESGO) member, an AAGL member and a participant in the AAGL’s oncology special interest group, past member of Mario Negri Gynecologic Oncology Group (MaNGO), and member of the Multicenter Italian Trials in Ovarian Cancer and gynecologic malignancies (MITO) group and board member of the Italian Society of Gynecologic Oncology (SIOG). He is Principal Investigator and investigator in several national and international research studies and protocols. He has authored and co-authored more than 150 articles in peer-reviewed journals as well as various book chapters. He is a member of several editorial boards as well as a reviewer for indexed journals.

Giorgio Bogani