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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02762227
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Polyp of Gallbladder Device: Abdominal high resolution CT Device: Contrast-enhanced ultrasonography (CEUS) Procedure: Cholecystectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
Actual Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: gallbladder polyps patients

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.

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.




Primary Outcome Measures :
  1. Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others) [ Time Frame: intraoperative ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762227


Contacts
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Contact: TAO CHEN, M.D. +8613601779874 dr_chentao78@163.com
Contact: YUNHE ZHANG, M.D. +8613917908722 zyhe31@163.com

Locations
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China, Shanghai
RenJi Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: TAO CHEN, MD    +8613601779874    dr_chentao78@163.com   
Contact: YUNHE ZHANG, MD    +8613917908722    zyhe31@163.com   
Principal Investigator: TAO CHEN, MD         
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: JIAN WANG, M.D. Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02762227    
Other Study ID Numbers: RenJiH
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by RenJi Hospital:
CEUS
CT
gallbladder cholesterol polyps
adenoma
gallbladder cancer
Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical