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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic diagnosis of gallbladder polyp after cholecystectomy | Pathologic diagnosis of gallbladder polyps or masses in cholecystectomy specimen | within 10 days after operation |
| Difference of strain ratio | Differences in strain ratio between non-neoplastic and neoplastic gallbladder polyps. | Within two years of starting the study |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal cut-off valve of strain ratio | Optimal cut-off valve of strain ratio for differential diagnosis between cholesterol polyps and adenomatous polyps | Within two years of starting the study |
| Diagnostic value of EUS-elastography |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have GB polyps and are recommended cholecystectomy due to large size of polyp (8-10 mm or larger).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Hyub Lee, MD., PhD. | Contact | +082 2-2072-4892 | gidoctor@snuh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 101 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20697115 | Background | 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. | |
| 23233003 | Background | 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. |
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Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of EUS-elastography for diagnosis of cholesterol polyps.
| Within two years of starting the study |
| 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. | Within two years of starting the study |
| 7127263 | Background | 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. |
| 7617866 | Background | 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. |
| 10968853 | Background | 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. |
| Background | Practical Guidelines for Management of Gallbladder Polyps. Korean Journal of HBP Surgery Vol. 14, No. 3, September 2010 |
| 28185005 | Background | 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. |
| 25463882 | Background | 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. |
| 21464584 | Background | 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. |
| 38431102 | Derived | 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. |