Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro

July 17, 2017 updated by: Yan Yan, Peking University Cancer Hospital & Institute
In our era of personalized treatment, both the prognosis and the choice of therapy for upper GI malignancies depend on the staging before any treatment. Most experts recommend EUS (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in clinical practice varies in different centers according to the published data. Neither the discrepancy between EUS and histological findings nor the variation between centers well explained. So the investigators designed this prospective study. In the present study, the investigators performed EUS on the resected specimen after surgery before fixation in formalin, evaluated the invasion of the GI wall, and marked the deepest location with sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy between EUS and histologic findings.

Study Overview

Status

Unknown

Conditions

Detailed Description

- EUS Examination After the surgery, the specimen is filled with 0.9%NS (normal saline ) without cut open，and put into a container filled with 0.9%NS before fixation in formalin. EUS will be performed on the resected specimen.The endoscopy move from the distal to proximal side along the longitudinal axis of stomach, evaluate the invasion of gastric wall, and mark the deepest point with sutures under the EUS guided. The images were stored .

EUS images the are reviewed by two endoscopists. They are asked to stage the tumor according to the AJCC(American Joint Committee on Cancer) staging system (7th edition) , assign a level of confidence to the staging, and score the quality of the EUS image .

  • Histologic Preparations and Examination Carcinoma invasion into each layer of the gastric wall is diagnosed by an experienced pathologist (L.ZW) who is unaware of the findings of the EUS imaging. The marked section will be assessed separately.
  • Data analysis The diagnosis between the pathologic findings and EUS prediction will be compared. Whether the marked point was the deepest in pathologic findings is recorded. And the histological section and the EUS image of the marked point is compared.

Study Type

Observational

Enrollment (Anticipated)

120

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
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yan Yan, Doctor

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with locally advanced upper GI carcinoma receive surgery as first treatment no previous surgery involved the upper GI tract

Description

Inclusion Criteria:

  • Patients with upper GI carcinoma
  • Receive surgery as first treatment

Exclusion Criteria:

  • previous surgery involved the upper GI tract

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

Cohorts and Interventions

Group / Cohort
early gastric cancer
EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen
Locally Advanced Gastric Cancer
EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen
early esophagus cancer
EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen
locally advanced esophagus cancer
EUS examination on the specimen right after surgery mark the deepest invasive site on the specimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the consistency between EUS and pathologic determination of tumor depth
Time Frame: 1 month （after careful examination by 2 pathologists）
1 month （after careful examination by 2 pathologists）

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Yan Yan, Doctor, Peking University Cancer Hospital & Institute

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

June 1, 2014

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 24, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC1001

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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