The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps

Not Applicable

• Conditions: Polyp of Gallbladder
• Interventions: Device: Abdominal high resolution CT; Device: Contrast-enhanced ultrasonography (CEUS); Procedure: Cholecystectomy

• Registration Number: NCT02762227
• Lead Sponsor: RenJi Hospital

Brief Summary

This prospective cohort study is designed to investigate and to compare the diagnostic performance of contrast-enhanced ultrasonography (CEUS) and multidetector computed tomography (CT) for gallbladder cholesterol polyps, adenoma and gallbladder cancer.

Detailed Description

In this study, investigators aimed to investigate the diagnostic performance of CEUS and high resolution CT (HRCT) for the preoperative differential diagnostic accuracies of gallbladder polypoid lesions.

Study Timeline

• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Study Start: 2016-08
• Status Verified: 2019-10
• Last Update Submitted: 2020-02-09
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US.

Exclusion Criteria

• Gallbladder polyp with a diameter less than 10 mm.
• Lesions highly suspected to be cancer due to visible metastasis.
• Allergy to contrast agents and cannot received CT or CEUS examination.
• Women in pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gallbladder polyps patients	Cholecystectomy	All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US, were enrolled in this study. Of these patients, we excluded: (1) gallbladder polyp with a diameter less than 10 mm. (2) lesions highly suspected to be cancer due to visible metastasis. (3) allergy to contrast agents and cannot received CT or CEUS examination. (4) women in pregnancy or lactation. All patients received transabdominal US, abdominal high resolution CT and contrast-enhanced ultrasonography (CEUS) before the cholecystectomy.
gallbladder polyps patients	Contrast-enhanced ultrasonography (CEUS)	All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US, were enrolled in this study. Of these patients, we excluded: (1) gallbladder polyp with a diameter less than 10 mm. (2) lesions highly suspected to be cancer due to visible metastasis. (3) allergy to contrast agents and cannot received CT or CEUS examination. (4) women in pregnancy or lactation. All patients received transabdominal US, abdominal high resolution CT and contrast-enhanced ultrasonography (CEUS) before the cholecystectomy.
gallbladder polyps patients	Abdominal high resolution CT	All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US, were enrolled in this study. Of these patients, we excluded: (1) gallbladder polyp with a diameter less than 10 mm. (2) lesions highly suspected to be cancer due to visible metastasis. (3) allergy to contrast agents and cannot received CT or CEUS examination. (4) women in pregnancy or lactation. All patients received transabdominal US, abdominal high resolution CT and contrast-enhanced ultrasonography (CEUS) before the cholecystectomy.

Primary Outcome Measures

Name	Time	Method
Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others）	intraoperative

Trial Locations

Locations (1)

RenJi Hospital; 🇨🇳 Shanghai, Shanghai, China