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

• Conditions: Gastrointestinal Neoplasms

• Registration Number: NCT02226224
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-24
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-18
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• previous surgery involved the upper GI tract

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the consistency between EUS and pathologic determination of tumor depth	1 month （after careful examination by 2 pathologists）

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China