Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 24, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJuly 18, 2017
July 1, 2017
6.3 years
August 24, 2014
July 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the consistency between EUS and pathologic determination of tumor depth
1 month （after careful examination by 2 pathologists）
Study Arms (4)
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
Eligibility Criteria
Patients with locally advanced upper GI carcinoma receive surgery as first treatment no previous surgery involved the upper GI tract
You may qualify if:
- Patients with upper GI carcinoma
- Receive surgery as first treatment
You may not qualify if:
- previous surgery involved the upper GI tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Yan, Doctor
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
August 24, 2014
First Posted
August 27, 2014
Study Start
June 1, 2014
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
July 18, 2017
Record last verified: 2017-07