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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janak Shah, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01356030
First received: May 12, 2011
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Pancreaticobiliary Cancers
Jaundice
Bile Duct Obstruction
Procedure: ERCP
Procedure: EUS FNA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
Official Title: Prospective Comparison of EUS-guided FNA and ERCP Tissue Sampling for the Diagnosis of Suspected Pancreato-biliary Neoplasms

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Direct comparison of tissue sampling techniques for patients with suspected pancreaticobiliary cancers. [ Time Frame: One year ] [ Designated as safety issue: No ]
    Diagnostic yield from EUS-FNA samples will be compared to yield from ERCP tissue sampling methods (brushings and forceps biopsies).


Enrollment: 51
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS-FNA Procedure: 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.
Active Comparator: ERCP Brushing and Biopsy Procedure: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356030

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Janak Shah, MD California Pacific Medical Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janak Shah, MD, Director of Pancreatic and Biliary Endoscopy, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01356030     History of Changes
Other Study ID Numbers: 2011.048
Study First Received: May 12, 2011
Last Updated: July 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 21, 2014