Clinical trial NCT01356030: Endoscopic Ultrasound Versus Endoscopic Retrograde Cholangiopancreatography (ERCP) Tissue Sampling for the Diagnosis of Suspected Pancreatico-Biliary Cancer
Official title: Prospective Comparison of EUS-guided FNA and ERCP Tissue Sampling for the Diagnosis of Suspected Pancreato-biliary Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreaticobiliary Cancers
Jaundice
Bile Duct Obstruction
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: Patients with pancreaticobiliary tumors usually present with painless jaundice due to bile duct obstruction. The standard clinical evaluation may include EUS and/or ERCP. At centers where EUS is available (like CPMC), it is usually used first as it is generally considered a better tool for tumor detection, staging, and performing biopsies (FNA). ERCP is then performed, if needed, to place a stent and relieve jaundice. As EUS is a relatively newer technology that has not widely disseminated, other centers use ERCP as the 1st modality to evaluate suspected malignant pancreaticobiliary obstruction. The role of ERCP in this setting is to not only place a stent to relieve jaundice, but to additionally obtain cytology brushings for tissue diagnosis.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Direct comparison of tissue sampling techniques for patients with suspected pancreaticobiliary cancers.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Janak Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.