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

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

NCT ID: NCT02226224

Condition: Gastrointestinal Neoplasms

Conditions: Official terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms

Conditions: Keywords:
gastrointestinal neoplasms
endosonography
in vitro
Staging

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

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

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - Patients with upper GI carcinoma - Receive surgery as first treatment Exclusion Criteria: - previous surgery involved the upper GI tract

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Status: Recruiting

Contact:
Last name: Yan Yan, Doctor

Phone: 861088196168
Email: dr.yan@outlook.com

Investigator:
Last name: Yan Yan, Doctor
Email: Principal Investigator

Start date: June 2014

Completion date: October 2020

Lead sponsor:
Agency: Peking University Cancer Hospital & Institute
Agency class: Other

Source: Peking University Cancer Hospital & Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02226224