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

Polyp of Gallbladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762227
• Other study ID #: RenJiH
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: RenJi Hospital
• Contact: TAO CHEN, M.D.
• Phone: +8613601779874
• Email: dr_chentao78[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polyp of Gallbladder
• Polyps

Intervention

Device:
• Abdominal high resolution CT
CT examinations were performed using a 64-slice CT scanner. Arterial phase scanning was triggered by bolus tracking technique after 100 to 120 mL nonionic contrast material was injected through the antecubital vein. With a delay of 60 and 140 s after the beginning of contrast medium injection, portal venous and equilibrium phase image scanning were followed.
• Contrast-enhanced ultrasonography (CEUS)
CEUS examinations were performed using a Philips iU 22 scanner with a 1-5 MHz(Mega Hertz, MHz)vector transducer. Traditional transabdominal ultrasound and CEUS were performed by the same investigator, one with more than 3 years experiences in CEUS. Traditional ultrasound was used initially to locate the lesion. The plane with the bottom of the lesion was selected for further examination. When multiple lesions were existed, the largest one was selected to evaluate. The target was placed in the center of the screen and was kept stable. Pulse inversion harmonic imaging with an index of 0.06 was used in CEUS examination. SonoVue, which contained sulfur hexafluoride microbubbles, was used as the contrast agent.

Procedure:
• Cholecystectomy
Cholecystectomy is performed by method of either laparoscopic cholecystectomy or open cholecystectomy.

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others)		intraoperative