Clinical Trial: A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction

Brief Summary:

Patients who present with obstructive jaundice due to a malignant stricture often undergo a battery of tests for diagnosis, treatment options, and prognosis. An endoscopic retrograde cholangiopancreatography (ERCP) is often performed with biliary stent placement for symptom relief as well as brushings for cytology. An endoscopic ultrasound is performed as well for fine needle aspiration (FNA) of the pancreas to aid in diagnosis. However, since EUS is not available at many centers, patients often undergo an initial ERCP procedure with stent placement (which is more widely available) prior to referral for EUS. It has been reported that biliary stents can disturb EUS visualization due to inflammation, acoustic shadowing, and pneumobilia which may lessen the accuracy of diagnosis.1 The cytological yield from the EUS with FNA procedure may also be compromised in patients with biliary stents. As such, diagnosis and treatment options may be delayed. One retrospective study of 65 subjects showed a significant difference in the number of correctly staged pancreatic head cancers (mainly T stage) in patients without stents versus those with biliary stents (85% vs 47%).2 A second retrospective study concluded that tissue diagnosis is not influenced in patients with stents placed greater than 24 hours before the EUS; however, patients with stents placed just prior to the EUS (less than 24 hours) were more likely to have indeterminate results.1 Although the findings are suggestive, the studies are limited by their retrospective design and these questions have not yet been addressed in a prospective study.

Both procedures require anesthesia, and when performed sequentially in the same setting, the duration of anesthesia is prolonged. This is concerning for the patient since complications may theoretically increase with prolonged anesthesia. However, a retrospective review at a tertiary

Detailed Summary:
Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Cytological yield (adequate versus inadequate for diagnosis) of EUS-FNA prior to stent placement vs post stent placement [ Time Frame: 1 day ]

Cytological yield will be defined by the ability of the pathologist to render a diagnosis based on the material supplied to them during the procedure (adequate vs inadequate tissue to make a diagnosis of malignant vs benign disease).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: January 12, 2012
Date Started: November 2011
Date Completion:
Last Updated: January 17, 2017
Last Verified: July 2015