Endoscopic Ultrasound Versus Endoscopic Retrograde Cholangiopancreatography (ERCP) Tissue Sampling for the Diagnosis of Suspected Pancreatico-Biliary Cancer

NCT01356030 | Completed

• 1 other identifier: 2011.048
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The two most commonly used methods to biopsy suspected pancreaticobiliary masses are (1) endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) and (2) cytology brush biopsies obtained during endoscopic retrograde cholangiopancreatography (ERCP). At most centers, the specific method used depends on the availability of the technology and local expertise. Although it is believed that EUS-FNA is more accurate than ERCP brushings, there have been no head-to-head comparisons. The investigators' hypothesis is that EUS-FNA is superior to ERCP in obtaining tissue biopsies of pancreaticobiliary tumors, and the investigators aim to directly compare the two techniques.

Conditions

Pancreaticobiliary Cancers; Jaundice; Bile Duct Obstruction

Outcome Measures

Primary Outcomes (1)

• Direct comparison of tissue sampling techniques for patients with suspected pancreaticobiliary cancers.

  Diagnostic yield from EUS-FNA samples will be compared to yield from ERCP tissue sampling methods (brushings and forceps biopsies).

  One year

Study Arms (2)

EUS-FNA

ACTIVE COMPARATOR

Procedure: EUS FNA

ERCP Brushing and Biopsy

ACTIVE COMPARATOR

Procedure: ERCP

Interventions

ERCP PROCEDURE

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.

ERCP Brushing and Biopsy

EUS FNA PROCEDURE

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.

EUS-FNA

Eligibility Criteria

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

You may qualify if:

• Patients age \>18 years that are scheduled for EUS and possible ERCP for the evaluation of jaundice from suspected pancreaticobiliary tumors.

You may not qualify if:

• Patients that do not provide consent for EUS and ERCP (for standard clinical reasons)
• 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

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Related Publications (15)

• 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.

  PMID: 17591480 BACKGROUND

• 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.

  PMID: 18760174 BACKGROUND

• 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.

  PMID: 18384788 BACKGROUND

• 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.

  PMID: 17643700 BACKGROUND

• 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.

  PMID: 19179135 BACKGROUND

• 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.

  PMID: 16377319 BACKGROUND

• 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.

  PMID: 12397282 BACKGROUND

• 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.

  PMID: 14687140 BACKGROUND

• 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.

  PMID: 15017604 BACKGROUND

• 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.

  PMID: 16923477 BACKGROUND

• 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.

  PMID: 15332029 BACKGROUND

• 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.

  PMID: 15180727 BACKGROUND

• 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.

  PMID: 19249043 BACKGROUND

• 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.

  PMID: 18279866 BACKGROUND

• 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.

  PMID: 24559784 DERIVED

MeSH Terms

Conditions

Jaundice; Cholestasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Investigative Techniques

Study Officials

• Janak Shah, MD

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pancreatic and Biliary Endoscopy

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 19, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

US (1)