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

NCT05904977 | Unknown

• 1 other identifier: SYSKY-2022-446-01
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Cervical cancer; Radical hysterectomy; Ultrastaging; Vesicouterine ligament

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of postoperative adjuvant therapy in patients with metastasis in the anterior leaf of VUL

  1 year after surgery

• Incidence of postoperative urinary dysfunction in two groups

  1 year after surgery

• Postoperative quality of life scores in two groups

  1，2，3 years after surgery

• DFS

  3 years after surgery

Study Arms (2)

Type B resection

The patients reviced type B resection of the antierior leaf of vesicouterine ligament

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

Type C resection

The patients reviced type C resection of the antierior leaf of vesicouterine ligament

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

Interventions

Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C) PROCEDURE

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).

Type B resection; Type C resection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical carcinoma (even neuroendocrine or clear cell carcinoma)
• Radiographically confirmed tumor limited to the cervix or upper third vagina, but without evidence of lymph node metastasis
• Stage IA2-IIA2 ( FIGO 2018)
• Treated initially or just underwent cervical conization before
• Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic lymph node dissection by the same team
• Underwent the bilateral type C AL-VUL resection during the surgery
• The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• Not stage IA2-IIA2 ( FIGO 2018)
• History of abdominal or pelvic radiotherapy
• Evidence of metastatic disease detected by PECT, MRI or CT
• The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy or the patient as refusing abdominal surgery
• Patients with other mailgnant tumors except cervical cancer
• Incompetence of the clinical, surgical and pathological data

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Huaiwu Lu

Guangzhou, Guangdong, 520120, China

RECRUITING

Related 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.

  PMID: 31812369 BACKGROUND

• 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.

  PMID: 32925291 BACKGROUND

• 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.

  PMID: 28785898 BACKGROUND

• 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.

  PMID: 23694985 BACKGROUND

• 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.

  PMID: 20837355 BACKGROUND

• 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.

  PMID: 19805678 BACKGROUND

• 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.

  PMID: 15655537 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Huaiwu Lu

CONTACT

18688395806; luhuaiwu@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: April 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-05

Locations

CN (1)