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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01514058
First received: January 12, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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 referral center showed that combined EUS and ERCP yielded a complication rate no higher than that of the component procedures.3

At our institution, the current practice is to sequentially perform both EUS and ERCP in the same setting for patients with suspected malignant biliary obstruction. Typically, EUS-FNA is performed first, followed by ERCP.

Hypothesis We hypothesize that performing ERCP with biliary stenting immediately prior to EUS-FNA will decrease the diagnostic yield of EUS-FNA and diminish the ability of EUS to accurately stage pancreas tumors. Conversely, performing EUS-FNA prior to ERCP will increase biliary cannulation time and increase success rate.

The objectives of this study are as follows:

  1. Determine the diagnostic yield of EUS-FNA (for diagnosis of cancer vs benign process) when performed either immediately before or after ERCP with biliary stenting (primary outcome)
  2. Determine the ability of EUS to accurately stage pancreatic masses (T and N staging) when performed either immediately before or after ERCP with biliary stenting (secondary outcome) in comparison to the gold standard of surgical pathology post resection or in comparison to CT findings (in those patients who are not surgical candidates)
  3. Determine the biliary cannulation time (the time it takes to successfully pass a wire into the common bile duct from the start of the procedure) and success rate of placing a biliary stent during ERCP when performed either immediately before or after EUS-FNA (secondary outcome)

Condition Intervention Phase
Jaundice
Procedure: EUS-FNA first, followed by CRCP with bilinary stenting
Procedure: ERCP with stent placement, followed by EUS-FNA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Cytological yield (adequate versus inadequate for diagnosis) of EUS-FNA prior to stent placement vs post stent placement [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 166
Study Start Date: November 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS-FNA First
Patients will undergo EUS-FNA first, followed by ERCP with biliary stenting (using a plastic stent).
Procedure: EUS-FNA first, followed by CRCP with bilinary stenting
EUS-FNA first, followed by CRCP with bilinary stenting (using a plastic stent)
Active Comparator: ERCP with stent placement first
Patients will undergo ERCP with stent placement first, followed by EUS-FNA.
Procedure: ERCP with stent placement, followed by EUS-FNA
ERCP with stent placement, followed by EUS-FNA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be able to review and sign informed consent.
  • Subjects must require biliary stenting for the relief of their symptoms as well as FNA biopsy for proper diagnosis.
  • Suspected mass should be located in the head, uncinate, or neck of the pancreas.

Exclusion Criteria:

  • Cannot give and sign informed consent.
  • The suspected mass is located in the body or tail of the pancreas.
  • The patient may be a candidate for palliative biliary stenting (in which a metal stent would be placed)
  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: NCT01514058

Locations
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: John A Evans, MD Wake Forest Baptist Health
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01514058     History of Changes
Other Study ID Numbers: CCCWFU 01711
Study First Received: January 12, 2012
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014