The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
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|ClinicalTrials.gov Identifier: NCT02762227|
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Polyp of Gallbladder||Device: Abdominal high resolution CT Device: Contrast-enhanced ultrasonography (CEUS) Procedure: Cholecystectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Cholecystectomy is performed by method of either laparoscopic cholecystectomy or open cholecystectomy.
- Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others） [ Time Frame: intraoperative ]
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
|Contact: TAO CHEN, M.D.||+firstname.lastname@example.org|
|Contact: YUNHE ZHANG, M.D.||+email@example.com|
|Principal Investigator:||JIAN WANG, M.D.||Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University|