ClinicalTrials.gg
Status unknownNCT03478449Updated Nov 13, 2020

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

An interventional study of lymph node sorting for pathological examination in Lymph Node Metastases, Gastric Cancer and Exanimation, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lymph Node Metastases
  • Gastric Cancer
  • Exanimation
03

In context

Lymphatic Metastasis

213 studies on the registry are indexed under Lymphatic Metastasis; 77 are open to participants now.

This study's planned enrollment of 276 is above the median of 97 across 109 interventional studies indexed under Lymphatic Metastasis.

Browse Lymphatic Metastasis studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

    1. Women during pregnant stage and breast-feed stage
    1. Women of childbearing age without any measures
    1. Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
    1. therapists for organ transplantation
    1. Seriously uncontrolled recurrent infection
    1. other malignant tumors
    1. No abilities of self-knowledge or mental disorders
    1. Participating in other clinical trials
    1. Siewert I and II esophagogastric junction tumors
    1. Serious internal diseases obstruction surgery
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
276 participants (estimated)

Study arms

  • Experimental
    Fine sorting lymph node group

    Procedure: lymph node sorting for pathological examination

  • No intervention
    Regional sorting lymph node group

Interventions

  • Procedurelymph 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.

06

What researchers measure

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.

    Time frame: 60 months

07

Study locations

1 site
  • Cancer Hospital of Tianjin Medical University
    Tianjin, 300060, China
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03478449
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Apr 1, 2018
Primary completion
Nov 2, 2020
Completion
Dec 30, 2020 (estimated)
Last update
Nov 13, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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