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

Primary Purpose

Endometrial Carcinoma, Lymphadenectomy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic and Peritoneal Lymphadenectomy
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Carcinoma

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Negative 1

    Negative 2

    Arm Description

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

    Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2019
    Last Updated
    October 27, 2020
    Sponsor
    Second Affiliated Hospital of Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03877627
    Brief Title
    The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma
    Official Title
    The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    March 15, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital of Wenzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Carcinoma, Lymphadenectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Negative 1
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm will not undergo Pelvic and Peritoneal Lymphadenectomy.
    Arm Title
    Negative 2
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pelvic and Peritoneal Lymphadenectomy
    Intervention Description
    Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma.
    Primary Outcome Measure Information:
    Title
    the number (s) of pelvic and abdominal lymph node metastasis
    Description
    the specific number of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
    Time Frame
    1 year during the perioperative period
    Title
    the percentage (%) of pelvic and abdominal lymph node metastasis
    Description
    the specific percentage of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
    Time Frame
    1 year during the perioperative period
    Title
    the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis
    Description
    by performing chi-square test by SPSS 17.0，we plan to calculate the coincidence rate of three clinical examination
    Time Frame
    1 year during the perioperative period
    Title
    the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients
    Description
    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
    Time Frame
    1 year during the perioperative period

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu ZHAO, Ph.D
    Phone
    13777760306
    Email
    zhaoyu196035@163.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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