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

Primary Purpose

Lymph Node Metastases, Gastric Cancer, Exanimation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lymph node sorting for pathological examination
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymph Node Metastases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital of Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fine sorting lymph node group

Regional sorting lymph node group

Arm Description

Outcomes

Primary Outcome Measures

Migration of pN stage in gastric cancer patients
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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2018
Last Updated
November 10, 2020
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03478449
Brief Title
The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer
Official Title
A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymph Node Metastases, Gastric Cancer, Exanimation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fine sorting lymph node group
Arm Type
Experimental
Arm Title
Regional sorting lymph node group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
lymph node sorting for pathological examination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Migration of pN stage in gastric cancer patients
Description
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.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cancer Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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