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AzTrials

Gallbladder Polyps or Masses Greater Than 8-10 mm in SizeNCT04416763

Diagnostic Value of Endoscopic Ultrasound Elastography and Contrast Enhanced Endoscopic Ultrasound for Differential Diagnosis of Gallbladder Polyp

An observational study of Gallbladder Polyps or Masses Greater Than 8-10 mm in Size, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gallbladder polyps are often detected incidentally by ultrasonography. The most of gallbladder polyps are non-neoplastic such as cholesterol polyps and do not need further treatments. However, neoplastic polyps, which need additional treatments to prevent malignancy, show the same appearance on ultrasound. Read more about this study

Who is it for?
Ages 19 years and older
How many people
30 participants
Where
1 siteSouth Korea
Study dates
1 Jun 2020to Jun 2022
How long will I take part?
2 Years
Phase
Observational
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who have GB polyps and are recommended cholecystectomy due to large size of polyp (8-10 mm or larger).

  1. Inclusion Criteria:
  2. Gallbladder polyp of 8-10mm or more in size confirmed by imaging tests
  3. Must be 19 years old or older
  4. With voluntary agreement to participate in the study after be informed about the necessity of EUS due to the clinical necessity
  5. Exclusion Criteria:
  6. Unable to confirm histological diagnosis (ex. Patients did not underwent cholecystectomy)
  7. Younger than 18 year-old
  8. Without agreement with this study or informed consent

Trial locations and contacts

1 site in 1 country.

Sang Hyub Lee, MD., PhD. contact

+082 2-2072-4892

gidoctor@snuh.org

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 101

    Sang Hyub Lee, MD PhD

    Sang Hyub Lee, MD PhD

    Recruiting

Other trials in South Korea

About this study

Gallbladder polyps are often detected incidentally by ultrasonography. The most of gallbladder polyps are non-neoplastic such as cholesterol polyps and do not need further treatments. However, neoplastic polyps, which need additional treatments to prevent malignancy, show the same appearance on ultrasound. Clinically, the differential diagnosis between cholesterol polyps and adenomatous polyps is very important for patient follow-up and treatment. However, differential diagnosis between these two conditions is difficult using conventional trans-abdominal ultrasound.

Endoscopic ultrasound (EUS) is less affected and disturbed by subcutaneous fat or intraabdominal air, so a clearer image of pancreatobiliary system can be obtained. In addition, EUS elastography and contrast enhanced EUS are recently introduced. EUS elastography enables practitioners to evaluate the stiffness of a target lesion and compare it with surrounding tissues (strain ratio). Also, contrast enhanced EUS is used widely with additional information such as presence of vessels and enhancement pattern of soft tissues. Several studies have been published that EUS elastography can help in the differential diagnosis of pancreatic solid lesions.

Although studies have been conducted to confirm the usefulness of transabdomnial ultrasound with elastography or contrast enhancement at differentiating gallbladder polyps, no prospective studies have been conducted to evaluate the usefulness of EUS elastography or contrast enhanced EUS for gallbladder polyp. Therefore, with this prospective study, we would like to evaluate the diagnostic value of EUS elastography and contrast enhanced EUS for differential diagnosis of gallbladder polyps.

Keywords
Gallbladder polyp, Endoscopic ultrasound, Elastography, contrast enhanced endoscopic ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic diagnosis of gallbladder polyp after cholecystectomy

    Pathologic diagnosis of gallbladder polyps or masses in cholecystectomy specimen

    Measured: within 10 days after operation

  2. Difference of strain ratio

    Differences in strain ratio between non-neoplastic and neoplastic gallbladder polyps.

    Measured: Within two years of starting the study

Secondary outcomes (3)

  1. Optimal cut-off valve of strain ratio

    Optimal cut-off valve of strain ratio for differential diagnosis between cholesterol polyps and adenomatous polyps

    Measured: Within two years of starting the study

  2. Diagnostic value of EUS-elastography

    Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of EUS-elastography for diagnosis of cholesterol polyps.

    Measured: Within two years of starting the study

  3. Diagnostic value of contrast enhanced EUS

    Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of contrast enhanced EUS for diagnosis of cholesterol polyps.

    Measured: Within two years of starting the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completionApr 2022 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04416763
Sponsor's protocol ID
H-2005-135-1124
Status last verified
Feb 2022
First submitted
2 Jun 2020
Last updated
15 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Corwin MT, Siewert B, Sheiman RG, Kane RA. Incidentally detected gallbladder polyps: is follow-up necessary?--Long-term clinical and US analysis of 346 patients. Radiology. 2011 Jan;258(1):277-82. doi: 10.1148/radiol.10100273. Epub 2010 Aug 9.

    PubMed 20697115

  • Park CH, Chung MJ, Oh TG, Park JY, Bang S, Park SW, Kim H, Hwang HK, Lee WJ, Song SY. Differential diagnosis between gallbladder adenomas and cholesterol polyps on contrast-enhanced harmonic endoscopic ultrasonography. Surg Endosc. 2013 Apr;27(4):1414-21. doi: 10.1007/s00464-012-2620-x. Epub 2012 Dec 12.

    PubMed 23233003

  • Kozuka S, Tsubone N, Yasui A, Hachisuka K. Relation of adenoma to carcinoma in the gallbladder. Cancer. 1982 Nov 15;50(10):2226-34. doi: 10.1002/1097-0142(19821115)50:103.0.co;2-3.

    PubMed 7127263

  • Sugiyama M, Atomi Y, Kuroda A, Muto T, Wada N. Large cholesterol polyps of the gallbladder: diagnosis by means of US and endoscopic US. Radiology. 1995 Aug;196(2):493-7. doi: 10.1148/radiology.196.2.7617866.

    PubMed 7617866

  • Choi WB, Lee SK, Kim MH, Seo DW, Kim HJ, Kim DI, Park ET, Yoo KS, Lim BC, Myung SJ, Park HJ, Min YI. A new strategy to predict the neoplastic polyps of the gallbladder based on a scoring system using EUS. Gastrointest Endosc. 2000 Sep;52(3):372-9. doi: 10.1067/mge.2000.108041.

    PubMed 10968853

  • Practical Guidelines for Management of Gallbladder Polyps. Korean Journal of HBP Surgery Vol. 14, No. 3, September 2010

  • Wiles R, Thoeni RF, Barbu ST, Vashist YK, Rafaelsen SR, Dewhurst C, Arvanitakis M, Lahaye M, Soltes M, Perinel J, Roberts SA. Management and follow-up of gallbladder polyps : Joint guidelines between the European Society of Gastrointestinal and Abdominal Radiology (ESGAR), European Association for Endoscopic Surgery and other Interventional Techniques (EAES), International Society of Digestive Surgery - European Federation (EFISDS) and European Society of Gastrointestinal Endoscopy (ESGE). Eur Radiol. 2017 Sep;27(9):3856-3866. doi: 10.1007/s00330-017-4742-y. Epub 2017 Feb 9.

    PubMed 28185005

  • Teber MA, Tan S, Donmez U, Ipek A, Ucar AE, Yildirim H, Aslan A, Arslan H. The use of real-time elastography in the assessment of gallbladder polyps: preliminary observations. Med Ultrason. 2014 Dec;16(4):304-8. doi: 10.11152/mu.201.3.2066.164.1mat.

    PubMed 25463882

  • Kitano M, Kudo M, Sakamoto H, Komaki T. Endoscopic ultrasonography and contrast-enhanced endoscopic ultrasonography. Pancreatology. 2011;11 Suppl 2:28-33. doi: 10.1159/000323493. Epub 2011 Apr 5.

    PubMed 21464584

  • Cho IR, Lee SH, Choi JH, Chun JW, Lee MW, Lee MH, Kim J, Lee TS, Paik WH, Ryu JK, Kim YT. Diagnostic performance of EUS-guided elastography for differential diagnosis of gallbladder polyp. Gastrointest Endosc. 2024 Sep;100(3):449-456.e1. doi: 10.1016/j.gie.2024.02.015. Epub 2024 Feb 29.

    PubMed 38431102

Questions about this trial

What is this clinical trial studying?

An observational study of Gallbladder Polyps or Masses Greater Than 8-10 mm in Size, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 15 Mar 2022. 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 South Korea. 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 Sang Hyub Lee, MD., PhD. (+082 2-2072-4892, gidoctor@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic diagnosis of gallbladder polyp after cholecystectomy (time frame: within 10 days after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04416763, which also lists 10 linked publications.

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 15 Mar 2022.

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