Polyp of GallbladderNCT02762227
The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
A study testing Abdominal high resolution CT, Contrast-enhanced ultrasonography (CEUS) and Cholecystectomy in people with Polyp of Gallbladder, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Polyp of Gallbladder
- What is being tested?
- Abdominal high resolution CT, Contrast-enhanced ultrasonography (CEUS) and Cholecystectomy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200127
TAO CHEN, MD, +8613601779874, dr_chentao78@163.com
YUNHE ZHANG, MD, +8613917908722, zyhe31@163.com
About this study
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.
Read the 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.
- Conditions
- Polyp of Gallbladder
- Being tested
- Abdominal high resolution CT, Contrast-enhanced ultrasonography (CEUS), Cholecystectomy
- Keywords
- CEUS, CT, gallbladder cholesterol polyps, adenoma, gallbladder cancer
- Medical subject headings
- Adenoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal high resolution CTDevice
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)Device
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.
CholecystectomyProcedure or surgery
Cholecystectomy is performed by method of either laparoscopic cholecystectomy or open cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| gallbladder polyps patients | Experimental | 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. Receives: Device: Abdominal high resolution CT; Device: Contrast-enhanced ultrasonography (CEUS); Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others）
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp of GallbladderStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIAN WANG, M.D., Principal investigator, Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762227
- Sponsor's protocol ID
- RenJiH
- Status last verified
- Oct 2019
- First submitted
- 28 Mar 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
- ClinicalTrials.gov ID
- NCT02762227
- Acronym / sponsor ID
- RenJiH
- Conditions
- Polyp of Gallbladder
- Keywords
- CEUS, CT, gallbladder cholesterol polyps, adenoma, gallbladder cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gallbladder polyps patients | Experimental | Device: Abdominal high resolution CT, Device: Contrast-enhanced ultrasonography (CEUS), Procedure: CholecystectomyAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal high resolution CTCT 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 | gallbladder polyps patients |
| 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. | Device | gallbladder polyps patients |
| CholecystectomyCholecystectomy is performed by method of either laparoscopic cholecystectomy or open cholecystectomy. | Procedure or surgery | gallbladder polyps patients |
Primary outcome
Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others）
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIAN WANG, M.D. principal investigator
Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal high resolution CT, Contrast-enhanced ultrasonography (CEUS) and Cholecystectomy in people with Polyp of Gallbladder, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAO CHEN, M.D. (+8613601779874, dr_chentao78@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others） (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.