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NCT Number: NCT01356030

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

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.

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Key information

Conditions

Pancreaticobiliary Cancers Bile Duct Diseases Bile Duct Obstruction Biliary Tract Diseases Cholestasis Digestive System Diseases Hyperbilirubinemia Jaundice Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Pacific Medical Center

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: One year

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

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Registry information

Official study title

Prospective Comparison of EUS-guided FNA and ERCP Tissue Sampling for the Diagnosis of Suspected Pancreato-biliary Neoplasms

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 19, 2011
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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