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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904977
• Other study ID #: SYSKY-2022-446-01
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Huaiwu Lu
• Phone: 18688395806
• Email: luhuaiwu[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Huaiwu Lu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (7)

Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4. Erratum In: Lancet Glob Health. 2022 Jan;10(1):e41. — View Citation

Cao TT, Wen HW, Gao YN, Lyu QB, Liu HX, Wang S, Wang SY, Sun HX, Yu N, Wang HB, Li Y, Wang ZQ, Chang OH, Sun XL, Wang JL. Urodynamic assessment of bladder storage function after radical hysterectomy for cervical cancer. Chin Med J (Engl). 2020 Oct 5;133(19):2274-2280. doi: 10.1097/CM9.0000000000001014. — View Citation

Kim CH, Soslow RA, Park KJ, Barber EL, Khoury-Collado F, Barlin JN, Sonoda Y, Hensley ML, Barakat RR, Abu-Rustum NR. Pathologic ultrastaging improves micrometastasis detection in sentinel lymph nodes during endometrial cancer staging. Int J Gynecol Cancer. 2013 Jun;23(5):964-70. doi: 10.1097/IGC.0b013e3182954da8. — View Citation

Kornblith AB, Huang HQ, Walker JL, Spirtos NM, Rotmensch J, Cella D. Quality of life of patients with endometrial cancer undergoing laparoscopic international federation of gynecology and obstetrics staging compared with laparotomy: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Nov 10;27(32):5337-42. doi: 10.1200/JCO.2009.22.3529. Epub 2009 Oct 5. Erratum In: J Clin Oncol. 2010 Jun 1;28(16):2805. — View Citation

Narayansingh GV, Miller ID, Sharma M, Welch CJ, Sharp L, Parkin DE, Cruickshank ME. The prognostic significance of micrometastases in node-negative squamous cell carcinoma of the vulva. Br J Cancer. 2005 Jan 31;92(2):222-4. doi: 10.1038/sj.bjc.6602343. — View Citation

Querleu D, Cibula D, Abu-Rustum NR. 2017 Update on the Querleu-Morrow Classification of Radical Hysterectomy. Ann Surg Oncol. 2017 Oct;24(11):3406-3412. doi: 10.1245/s10434-017-6031-z. Epub 2017 Aug 7. — View Citation

Zand B, Euscher ED, Soliman PT, Schmeler KM, Coleman RL, Frumovitz M, Jhingran A, Ramondetta LM, Ramirez PT. Rate of para-aortic lymph node micrometastasis in patients with locally advanced cervical cancer. Gynecol Oncol. 2010 Dec;119(3):422-5. doi: 10.1016/j.ygyno.2010.08.012. Epub 2010 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastatic rate of the anterior leaf of vesicouterine ligament	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%	1 year (Postoperative pathological confirmation date)
Secondary	Incidence of postoperative adjuvant therapy in patients with metastasis in the anterior leaf of VUL	Clinical data	1 year after surgery
Secondary	Incidence of postoperative urinary dysfunction in two groups	Follow-up and subjective description	1 year after surgery
Secondary	Postoperative quality of life scores in two groups	The Functional Assessment of Cancer Therapy-Cervical(FACT-Cx)cervical cancer patient quality of life score table	1,2,3 years after surgery
Secondary	DFS	Disease-free survival	3 years after surgery