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

NCT02762227 | Unknown DMC

• 1 other identifier: RenJiH
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyp of Gallbladder

Keywords

CEUS; CT; gallbladder cholesterol polyps; adenoma; gallbladder cancer

Outcome Measures

Primary Outcomes (1)

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

  intraoperative

Study Arms (1)

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.

Device: Abdominal high resolution CT; Device: Contrast-enhanced ultrasonography (CEUS); Procedure: Cholecystectomy

Interventions

Abdominal high resolution CT DEVICE

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.

gallbladder polyps patients

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.

gallbladder polyps patients

Cholecystectomy PROCEDURE

Cholecystectomy is performed by method of either laparoscopic cholecystectomy or open cholecystectomy.

gallbladder polyps patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Adenoma; Gallbladder Neoplasms

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• JIAN WANG, M.D.

  Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TAO CHEN, M.D.

CONTACT

+8613601779874; dr_chentao78@163.com

YUNHE ZHANG, M.D.

CONTACT

+8613917908722; zyhe31@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: May 4, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 11, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)