Endoscopic Ultrasound Versus Endoscopic Retrograde Cholangiopancreatography (ERCP) Tissue Sampling for the Diagnosis of Suspected Pancreatico-Biliary Cancer
NCT ID: NCT01356030
Last Updated: 2013-07-09
Study Results
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Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2011-05-31
2012-05-31
Brief Summary
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Detailed Description
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Several studies have reported high sensitivity of EUS-FNA for detecting pancreaticobiliary cancers that are causing bile duct obstruction and jaundice (80-90%). The sensitivity for ERCP brushings and biopsies to detect the same types of tumors is reportedly lower (30-80%), but there have been no direct comparisons of these techniques.
Few centers use both technologies (EUS and ERCP) for patient care, or often perform EUS and ERCP at separate sessions. At CPMC, the investigators routinely perform EUS and ERCP together for patients needing these procedures. Thus the investigators are in a unique position to directly compare EUS-FNA to ERCP brushings for tissue diagnosis of suspected pancreaticobiliary tumors.
The proposed study will be the 1st direct comparison of EUS-FNA to ERCP tissue sampling for patients with suspected pancreaticobiliary cancers. Study results will highlight the best approach to obtain a biopsy diagnosis of pancreatic and biliary tract cancers.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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EUS-FNA
EUS FNA
Endoscopic ultrasound (EUS) is a procedure in which a flexible tube with a tiny camera and ultrasound probe at the tip is placed through the mouth, down the esophagus, and into the stomach and duodenum (first part of the small intestine where bile flows from the bile duct into the intestine). This allows the doctor performing the EUS to get a much closer view of your pancreas and bile duct. If a suspicious mass is seen, a small sample of the mass (biopsy) is taken using fine needle aspiration (FNA). FNA involves the use of a thin hollow needle to extract cells for diagnostic purposes and is considered safer and less invasive than surgical biopsies.
ERCP Brushing and Biopsy
ERCP
Endoscopic retrograde cholangiopancreatography (ERCP) is usually clinically indicated to place a stent (a plastic or metal tube) in the bile duct. The ERCP procedure is an endoscopic exam during which a small catheter or wire is placed into the bile duct from the point at which it connects to the small intestine. During such a procedure a stent can then be placed to help drain the bile across the site of blockage, and thereby treat your jaundice.
Interventions
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ERCP
Endoscopic retrograde cholangiopancreatography (ERCP) is usually clinically indicated to place a stent (a plastic or metal tube) in the bile duct. The ERCP procedure is an endoscopic exam during which a small catheter or wire is placed into the bile duct from the point at which it connects to the small intestine. During such a procedure a stent can then be placed to help drain the bile across the site of blockage, and thereby treat your jaundice.
EUS FNA
Endoscopic ultrasound (EUS) is a procedure in which a flexible tube with a tiny camera and ultrasound probe at the tip is placed through the mouth, down the esophagus, and into the stomach and duodenum (first part of the small intestine where bile flows from the bile duct into the intestine). This allows the doctor performing the EUS to get a much closer view of your pancreas and bile duct. If a suspicious mass is seen, a small sample of the mass (biopsy) is taken using fine needle aspiration (FNA). FNA involves the use of a thin hollow needle to extract cells for diagnostic purposes and is considered safer and less invasive than surgical biopsies.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients that do not require ERCP based on EUS findings (e.g. no mass seen, mass is not causing jaundice
* Patients in whom an additional 5 minutes of procedure time may increase the procedural/sedation risks:
* pregnant patients
* patients with severe medical co-morbidities (ASA class 4 or 5)
* Patients with significant bleeding risk precluding endoscopic tissue sampling
* INR \> 1.4 or Prothrombin time \> 5 sec more than control
* Platelet count \< 50,000
18 Years
ALL
No
Sponsors
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California Pacific Medical Center Research Institute
OTHER
Responsible Party
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Janak Shah, MD
Director of Pancreatic and Biliary Endoscopy
Principal Investigators
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Janak Shah, MD
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Locations
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California Pacific Medical Center
San Francisco, California, United States
Countries
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References
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Larghi A, Waxman I. Differentiating benign from malignant idiopathic biliary strictures: are we there yet? Gastrointest Endosc. 2007 Jul;66(1):97-9. doi: 10.1016/j.gie.2006.12.047. No abstract available.
Hollerbach S. EUS and ERCP: brothers in arms. Gastrointest Endosc. 2008 Sep;68(3):467-9. doi: 10.1016/j.gie.2008.01.022. No abstract available.
Ross WA, Wasan SM, Evans DB, Wolff RA, Trapani LV, Staerkel GA, Prindiville T, Lee JH. Combined EUS with FNA and ERCP for the evaluation of patients with obstructive jaundice from presumed pancreatic malignancy. Gastrointest Endosc. 2008 Sep;68(3):461-6. doi: 10.1016/j.gie.2007.11.033. Epub 2008 Apr 2.
Savides TJ, Donohue M, Hunt G, Al-Haddad M, Aslanian H, Ben-Menachem T, Chen VK, Coyle W, Deutsch J, DeWitt J, Dhawan M, Eckardt A, Eloubeidi M, Esker A, Gordon SR, Gress F, Ikenberry S, Joyce AM, Klapman J, Lo S, Maluf-Filho F, Nickl N, Singh V, Wills J, Behling C. EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement. Gastrointest Endosc. 2007 Aug;66(2):277-82. doi: 10.1016/j.gie.2007.01.017.
Sanchez MV, Pujol B, Napoleon B. Linear array EUS in bile-duct lesions. Gastrointest Endosc. 2009 Feb;69(2 Suppl):S121-4. doi: 10.1016/j.gie.2008.12.016. No abstract available.
Fogel EL, deBellis M, McHenry L, Watkins JL, Chappo J, Cramer H, Schmidt S, Lazzell-Pannell L, Sherman S, Lehman GA. Effectiveness of a new long cytology brush in the evaluation of malignant biliary obstruction: a prospective study. Gastrointest Endosc. 2006 Jan;63(1):71-7. doi: 10.1016/j.gie.2005.08.039.
de Bellis M, Sherman S, Fogel EL, Cramer H, Chappo J, McHenry L Jr, Watkins JL, Lehman GA. Tissue sampling at ERCP in suspected malignant biliary strictures (Part 2). Gastrointest Endosc. 2002 Nov;56(5):720-30. doi: 10.1067/mge.2002.129219. No abstract available.
Fritscher-Ravens A, Broering DC, Knoefel WT, Rogiers X, Swain P, Thonke F, Bobrowski C, Topalidis T, Soehendra N. EUS-guided fine-needle aspiration of suspected hilar cholangiocarcinoma in potentially operable patients with negative brush cytology. Am J Gastroenterol. 2004 Jan;99(1):45-51. doi: 10.1046/j.1572-0241.2003.04006.x.
Eloubeidi MA, Chen VK, Jhala NC, Eltoum IE, Jhala D, Chhieng DC, Syed SA, Vickers SM, Mel Wilcox C. Endoscopic ultrasound-guided fine needle aspiration biopsy of suspected cholangiocarcinoma. Clin Gastroenterol Hepatol. 2004 Mar;2(3):209-13. doi: 10.1016/s1542-3565(04)00005-9.
DeWitt J, Misra VL, Leblanc JK, McHenry L, Sherman S. EUS-guided FNA of proximal biliary strictures after negative ERCP brush cytology results. Gastrointest Endosc. 2006 Sep;64(3):325-33. doi: 10.1016/j.gie.2005.11.064.
Rosch T, Hofrichter K, Frimberger E, Meining A, Born P, Weigert N, Allescher HD, Classen M, Barbur M, Schenck U, Werner M. ERCP or EUS for tissue diagnosis of biliary strictures? A prospective comparative study. Gastrointest Endosc. 2004 Sep;60(3):390-6. doi: 10.1016/s0016-5107(04)01732-8.
Lee JH, Salem R, Aslanian H, Chacho M, Topazian M. Endoscopic ultrasound and fine-needle aspiration of unexplained bile duct strictures. Am J Gastroenterol. 2004 Jun;99(6):1069-73. doi: 10.1111/j.1572-0241.2004.30223.x.
Uehara H, Tatsumi K, Masuda E, Kato M, Kizu T, Ishida T, Takakura R, Takano Y, Nakaizumi A, Ishikawa O, Takenaka A. Scraping cytology with a guidewire for pancreatic-ductal strictures. Gastrointest Endosc. 2009 Jul;70(1):52-9. doi: 10.1016/j.gie.2008.09.059. Epub 2009 Feb 26.
DeWitt J, McGreevy K, Sherman S, LeBlanc J. Utility of a repeated EUS at a tertiary-referral center. Gastrointest Endosc. 2008 Apr;67(4):610-9. doi: 10.1016/j.gie.2007.09.037. Epub 2008 Feb 14.
Weilert F, Bhat YM, Binmoeller KF, Kane S, Jaffee IM, Shaw RE, Cameron R, Hashimoto Y, Shah JN. EUS-FNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study. Gastrointest Endosc. 2014 Jul;80(1):97-104. doi: 10.1016/j.gie.2013.12.031. Epub 2014 Feb 19.
Other Identifiers
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2011.048
Identifier Type: -
Identifier Source: org_study_id
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