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

Primary Purpose

Polyp of Gallbladder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Abdominal high resolution CT
Contrast-enhanced ultrasonography (CEUS)
Cholecystectomy
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polyp of Gallbladder focused on measuring CEUS, CT, gallbladder cholesterol polyps, adenoma, gallbladder cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RenJi HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gallbladder polyps patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2016
Last Updated
February 9, 2020
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02762227
Brief Title
The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
Official Title
The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Gallbladder
Keywords
CEUS, CT, gallbladder cholesterol polyps, adenoma, gallbladder cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gallbladder polyps patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Abdominal high resolution CT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Contrast-enhanced ultrasonography (CEUS)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cholecystectomy
Intervention Description
Cholecystectomy is performed by method of either laparoscopic cholecystectomy or open cholecystectomy.
Primary Outcome Measure Information:
Title
Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others)
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TAO CHEN, M.D.
Phone
+8613601779874
Email
dr_chentao78@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YUNHE ZHANG, M.D.
Phone
+8613917908722
Email
zyhe31@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIAN WANG, M.D.
Organizational Affiliation
Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
RenJi Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAO CHEN, MD
Phone
+8613601779874
Email
dr_chentao78@163.com
First Name & Middle Initial & Last Name & Degree
YUNHE ZHANG, MD
Phone
+8613917908722
Email
zyhe31@163.com
First Name & Middle Initial & Last Name & Degree
TAO CHEN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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