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

NCT02762227 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2020-02-11

No results posted yet for this study

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.

Conditions

  • Polyp of Gallbladder

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • JIAN WANG, M.D. · Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762227 on ClinicalTrials.gov