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

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ClinicalTrials.gov Identifier: NCT02226224
Recruitment Status : Recruiting
First Posted : August 27, 2014
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yan Yan, Beijing Cancer Hospital

Brief Summary:
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.

Condition or disease
Gastrointestinal Neoplasms

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro
Study Start Date : June 2014
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • previous surgery involved the upper GI tract

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226224


Contacts
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Contact: Yan Yan, Doctor 861088196168 dr.yan@outlook.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Yan Yan, Doctor    861088196168    dr.yan@outlook.com   
Principal Investigator: Yan Yan, Doctor         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: Yan Yan, Doctor Beijing Cancer Hospital

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Responsible Party: Yan Yan, Attending physician, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02226224     History of Changes
Other Study ID Numbers: EC1001
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Keywords provided by Yan Yan, Beijing Cancer Hospital:
gastrointestinal neoplasms
endosonography
in vitro
Staging
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases