NCT03478449

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

February 10, 2018

Last Update Submit

November 10, 2020

Conditions

Lymph Node MetastasesGastric CancerExanimation

Outcome Measures

Primary Outcomes (1)

  • 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.

    60 months

Study Arms (2)

Fine sorting lymph node group

EXPERIMENTAL
Procedure: lymph node sorting for pathological examination

Regional sorting lymph node group

NO INTERVENTION

Interventions

lymph node sorting for pathological examinationPROCEDURE

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.

Fine sorting lymph node group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Physical conditions compliance with the requirements for curative gastrectomy
  • \) Consent to undergo the D2 lymphadenectomy
  • \) Comply with the protocol during the whole study period
  • \) No neoadjuvant therapy administration
  • \) Sign informed consent and permission of withdraw in the whole study period
  • \) Consent to provide the tissue specimens after surgery for this study
  • \) Pathological examination confirmation the adenocarcinoma of stomach before surgery
  • \) Estimation the overall survival after surgery no less than 6 months
  • \) No anesthesia or operation contraindication disease
  • \) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
  • \) Negative cytological detection in operation
  • \) No seriously concomitance's diseases
  • \) Karnofsky Performance Scores (KPS) more than 60

You may not qualify if:

  • \) Women during pregnant stage and breast-feed stage
  • \) Women of childbearing age without any contraceptive measures
  • \) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
  • \) Immunosuppressive therapists for organ transplantation
  • \) Seriously uncontrolled recurrent infection
  • \) other malignant tumors
  • \) No abilities of self-knowledge or mental disorders
  • \) Participating in other clinical trials
  • \) Siewert I and II esophagogastric junction tumors
  • \) Serious internal diseases obstruction surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Tianjin Medical University

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Lymphatic MetastasisStomach NeoplasmsComa

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2018

First Posted

March 27, 2018

Study Start

April 1, 2018

Primary Completion

November 2, 2020

Study Completion

December 30, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)