Clinical trial NCT02226224: Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro
Official title: Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Neoplasms
Keywords: gastrointestinal neoplasms
endosonography
in vitro
Staging
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* previous surgery involved the upper GI tract

Primary outcomes:
measure: the consistency between EUS and pathologic determination of tumor depth
timeFrame: 1 month （after careful examination by 2 pathologists）
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Yan Yan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: