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

Gastrointestinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02226224
• Other study ID #: EC1001
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2014
• Last updated: July 17, 2017
• Start date: June 2014
• Est. completion date: October 2020

Study information

• Verified date: July 2017
• Source: Beijing Cancer Hospital
• Contact: Yan Yan, Doctor
• Phone: 861088196168
• Email: dr.yan[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with upper GI carcinoma

• Receive surgery as first treatment

Exclusion Criteria:

• previous surgery involved the upper GI tract

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the consistency between EUS and pathologic determination of tumor depth		1 month (after careful examination by 2 pathologists)