Transabdominal Gastric Contrast Ultrasound

Application Value of Transabdominal Gastric Contrast Ultrasound in the Diagnosis and Staging Evaluation of Gastric Cancer

In this study, the clinical data of patients diagnosed with gastric cancer who were ready for surgery were examined by contrast-enhanced ultrasonography and gastric-enhanced CT before surgery. Based on the results of postoperative pathological examinations, the diagnostic accuracy of gastric filling contrast-enhanced ultrasonography and gastric contrast-enhanced CT in different stages of gastric cancer was compared and analyzed. Provide better guidance for follow-up clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Transabdominal Gastric Contrast Ultrasound
• Intervention / Treatment: Diagnostic test: gastric contrast ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Wei Li, Prof.; Phone Number: 13596157865; Email: weili8308@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with gastric cancer who are ready for surgery

Description

Inclusion Criteria:

1. Age: 18~80 years old, male or female;
2. Diagnosed with gastric cancer by histology or cytology;
3. No distant multiple metastasis;
4. ECOG score 0-2;
5. Heart, lung, liver and kidney function can tolerate surgery;
6. Patients and their families can understand and be willing to participate in this clinical study, and sign the informed consent.

Exclusion Criteria:

1. Previous history of malignant tumor or recent diagnosis combined with other malignant tumors;
2. Patients with gastrointestinal perforation, gastrointestinal bleeding, etc. requiring emergency surgery;
3. Patients with previous gastroduodenal surgery;
4. Preoperative neoadjuvant therapy;
5. Patients and their families refuse surgical treatment;
6. ASA grade ≥ IV and/or ECOG performance status score > 2;
7. Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases who cannot tolerate surgery;
8. Have a history of serious mental illness;
9. Pregnant or lactating women;
10. Patients with other clinical and laboratory conditions considered by the researchers should not participate in this trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Experimental group; Patients with gastric cancer underwent contrast-enhanced CT scan and gastric filling ultrasound, respectively.

Diagnostic test: gastric contrast ultrasound; Gastric contrast ultrasound (GCUS) refers to that the patient fills the stomach cavity with oral water, contrast agent and ultrasound contrast agent before the examination to remove the gas in the stomach cavity and fill the stomach cavity to become a homogeneous echo area and form a good acoustic sound. Interface contrast, more clearly showing the gastric wall hierarchy and the ultrasound examination method of the lesions. In this way, not only the changes of the gastrointestinal mucosa can be found, but also the submucosal tumors of the gastrointestinal tract can be clearly displayed, the internal structural characteristics of the tumor, the extent of the lesions, the depth of infiltration, the TNM staging of the tumor, and the lesions of the surrounding organs can be displayed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity, specificity and accuracy of gastric contrast ultrasound in judging gastric cancer staging.	one month after surgery

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Wei Li, Prof., The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (ACTUAL): October 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CUS-GC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No