The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma

NCT03877627 | Unknown

• 1 other identifier: SAHoWMU-CR2019-07-102
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management.

Conditions

Endometrial Carcinoma; Lymphadenectomy

Outcome Measures

Primary Outcomes (4)

• the number (s) of pelvic and abdominal lymph node metastasis

  the specific number of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma

  1 year during the perioperative period

• the percentage (%) of pelvic and abdominal lymph node metastasis

  the specific percentage of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma

  1 year during the perioperative period

• the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis

  by performing chi-square test by SPSS 17.0，we plan to calculate the coincidence rate of three clinical examination

  1 year during the perioperative period

• the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients

  by setting up the control group and experimental group and conducting follow-up，we are determined to know whether pelvic lymphadenectomy would influence the prognosis of endometrial carcinoma

  1 year during the perioperative period

Study Arms (2)

Negative 1

NO INTERVENTION

Patients in this arm will not undergo Pelvic and Peritoneal Lymphadenectomy.

Negative 2

EXPERIMENTAL

Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy.

Procedure: Pelvic and Peritoneal Lymphadenectomy

Interventions

Pelvic and Peritoneal Lymphadenectomy PROCEDURE

Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma.

Negative 2

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Females who are diagnosed with endometrial carcinoma;
• Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease;
• Patients who are agreed to participated in this prospective cohort study.

You may not qualify if:

• Patients who still have the will to have pregnancy;
• Patients who have other diseases or heavy injuries that will interfere with the results;
• Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yu ZHAO, Ph.D

CONTACT

13777760306; zhaoyu196035@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 15, 2019
• Study Start: April 1, 2022
• Primary Completion: March 15, 2023
• Study Completion: April 1, 2023
• Last Updated: October 29, 2020

Record last verified: 2020-10