Diagnostic Value of Endoscopic Ultrasound Elastography and Contrast Enhanced Endoscopic Ultrasound for Differential Diagnosis of Gallbladder Polyp

• Conditions: Gallbladder Polyps or Masses Greater Than 8-10 mm in Size

• Registration Number: NCT04416763
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Gallbladder polyps are often detected incidentally by ultrasonography. The most of gallbladder polyps are non-neoplastic such as cholesterol polyps and do not need further treatments. However, neoplastic polyps, which need additional treatments to prevent malignancy, show the same appearance on ultrasound. Clinically, the differential diagnosis between cholesterol polyps and adenomatous polyps is very important for patient follow-up and treatment. However, differential diagnosis between these two conditions is difficult using conventional trans-abdominal ultrasound.

Endoscopic ultrasound (EUS) is less affected and disturbed by subcutaneous fat or intraabdominal air, so a clearer image of pancreatobiliary system can be obtained. In addition, EUS elastography and contrast enhanced EUS are recently introduced. EUS elastography enables practitioners to evaluate the stiffness of a target lesion and compare it with surrounding tissues (strain ratio). Also, contrast enhanced EUS is used widely with additional information such as presence of vessels and enhancement pattern of soft tissues. Several studies have been published that EUS elastography can help in the differential diagnosis of pancreatic solid lesions.

Although studies have been conducted to confirm the usefulness of transabdomnial ultrasound with elastography or contrast enhancement at differentiating gallbladder polyps, no prospective studies have been conducted to evaluate the usefulness of EUS elastography or contrast enhanced EUS for gallbladder polyp. Therefore, with this prospective study, we would like to evaluate the diagnostic value of EUS elastography and contrast enhanced EUS for differential diagnosis of gallbladder polyps.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-04
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Gallbladder polyp of 8-10mm or more in size confirmed by imaging tests 2. Must be 19 years old or older 3. With voluntary agreement to participate in the study after be informed about the necessity of EUS due to the clinical necessity

Exclusion Criteria

1. Unable to confirm histological diagnosis (ex. Patients did not underwent cholecystectomy) 2. Younger than 18 year-old 3. Without agreement with this study or informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic diagnosis of gallbladder polyp after cholecystectomy	within 10 days after operation	Pathologic diagnosis of gallbladder polyps or masses in cholecystectomy specimen
Difference of strain ratio	Within two years of starting the study	Differences in strain ratio between non-neoplastic and neoplastic gallbladder polyps.

Secondary Outcome Measures

Name	Time	Method
Optimal cut-off valve of strain ratio	Within two years of starting the study	Optimal cut-off valve of strain ratio for differential diagnosis between cholesterol polyps and adenomatous polyps
Diagnostic value of EUS-elastography	Within two years of starting the study	Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of EUS-elastography for diagnosis of cholesterol polyps.
Diagnostic value of contrast enhanced EUS	Within two years of starting the study	Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of contrast enhanced EUS for diagnosis of cholesterol polyps.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of