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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02762227
Other study ID # RenJiH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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