MedDataX Logo

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

NCT ID: NCT03877627

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Carcinoma Lymphadenectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Negative 1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Negative 2

Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy.

Group Type EXPERIMENTAL

Pelvic and Peritoneal Lymphadenectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pelvic and Peritoneal Lymphadenectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yu ZHAO, Ph.D

Role: CONTACT

[email protected]
13777760306

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAHoWMU-CR2019-07-102

Identifier Type: -

Identifier Source: org_study_id