The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer

November 10, 2020 updated by: Tianjin Medical University Cancer Institute and Hospital

A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer

The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300060
        • Cancer Hospital of Tianjin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) Physical conditions compliance with the requirements for curative gastrectomy
  • 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:

  • 1) Women during pregnant stage and breast-feed stage
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fine sorting lymph node group
Procedure: 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.
No Intervention: Regional sorting lymph node group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migration of pN stage in gastric cancer patients
Time Frame: 60 months
According to the overall survival of all included patients, we will evaluate the optimal lymph node sorting method to obtain the accurately pathological stage of lymph node metastatic counts (pN stage) for prediction the prognosis of patients after curative surgery for gastric cancer.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

November 2, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

February 10, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DJY001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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