The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer
NCT ID: NCT03478449
Last Updated: 2020-11-13
Study Results
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.
UNKNOWN
NA
276 participants
INTERVENTIONAL
2018-04-01
2020-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fine sorting lymph node group
lymph node sorting for pathological examination
In this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis.
Regional sorting lymph node group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
lymph node sorting for pathological examination
In this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2\) Consent to undergo the D2 lymphadenectomy
* 3\) Comply with the protocol during the whole study period
* 4\) No neoadjuvant therapy administration
* 5\) Sign informed consent and permission of withdraw in the whole study period
* 6\) Consent to provide the tissue specimens after surgery for this study
* 7\) Pathological examination confirmation the adenocarcinoma of stomach before surgery
* 8\) Estimation the overall survival after surgery no less than 6 months
* 9\) No anesthesia or operation contraindication disease
* 10\) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
* 11\) Negative cytological detection in operation
* 12\) No seriously concomitance's diseases
* 13\) Karnofsky Performance Scores (KPS) more than 60
Exclusion Criteria
* 2\) Women of childbearing age without any contraceptive measures
* 3\) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
* 4\) Immunosuppressive therapists for organ transplantation
* 5\) Seriously uncontrolled recurrent infection
* 6\) other malignant tumors
* 7\) No abilities of self-knowledge or mental disorders
* 8\) Participating in other clinical trials
* 9\) Siewert I and II esophagogastric junction tumors
* 10\) Serious internal diseases obstruction surgery
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Hospital of Tianjin Medical University
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DJY001
Identifier Type: -
Identifier Source: org_study_id