Endometrial Carcinoma, Lymphadenectomy
Conditions
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.
Detailed description
The clinical data including surgical procedure, the situation of sentinel lymph node imaging and pathological results of patients with endometrial carcinoma treated in our hospitals between April 2019 and April 2021 will be analyzed in this study to clarify the homogeneity of imaging evaluation, sentinel lymph node development evaluation and pathological results.
Interventions
PROCEDUREPelvic and Peritoneal Lymphadenectomy
Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma.
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Females who are diagnosed with endometrial carcinoma; 2. Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease; 3. Patients who are agreed to participated in this prospective cohort study.
Exclusion criteria
1. Patients who still have the will to have pregnancy; 2. Patients who have other diseases or heavy injuries that will interfere with the results; 3. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number (s) of pelvic and abdominal lymph node metastasis | 1 year during the perioperative period | the specific number of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma |
| the percentage (%) of pelvic and abdominal lymph node metastasis | 1 year during the perioperative period | the specific percentage of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma |
| the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis | 1 year during the perioperative period | by performing chi-square test by SPSS 17.0，we plan to calculate the coincidence rate of three clinical examination |
| the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients | 1 year during the perioperative period | 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 |
Contacts
Primary ContactYu ZHAO, Ph.D
Outcome results
None listed