Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions
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Purpose
The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.
| Condition | Intervention |
|---|---|
|
Pancreatic Tumor Gastric Tumor Esophageal Tumor Lymphadenopathy Duodenal Tumor |
Procedure: Endoscopic ultrasound guided needle tissue acquisition. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial |
- Number of needle passes needed to obtain a pathologic diagnosis. [ Time Frame: Within 1 week of study enrollment ] [ Designated as safety issue: No ]
- Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB. [ Time Frame: By three months post-op in the pathology report ] [ Designated as safety issue: No ]
- Visible core specimens obtained and its correlation to obtaining a diagnostic sample. [ Time Frame: During the intervention itself ] [ Designated as safety issue: No ]
- Frequency of adverse side effects. [ Time Frame: Three months post-op ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Fine needle aspiration (FNA)
Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle
|
Procedure: Endoscopic ultrasound guided needle tissue acquisition.
Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.
Other Name: Echotip ProCore
|
|
Active Comparator: Fine needle biopsy (FNB)
Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy).
|
Procedure: Endoscopic ultrasound guided needle tissue acquisition.
Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.
Other Name: Echotip ProCore
|
Detailed Description:
When ultrasound is used during endoscopy, we are able to visualize the structures adjacent to the gastrointestinal tract in close detail. Once the mass is visualized, we use endoscopic ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a diagnosis.
The conventional method for obtaining a sample of tissue with endoscopic ultrasound is called fine needle aspiration (FNA). This involves the insertion of a thin needle into the mass and obtaining a small sample of tissue which the pathologist can examine. An alternative technique is called fine needle biopsy (FNB), and involves the insertion of a thin double-edged needle into the mass. This double-edged needle may potentially provide a larger sample of tissue to examine.
Both of these techniques are commonly used, and both methods are equally safe. However, it is not known if one of these techniques is more effective at obtaining a sample of tissue or if one of these techniques is more cost-effective than the other. The purpose of this study is to determine if one method is more efficacious and cost-effective than the other while maintaining diagnostic accuracy. The results of this study may alter the way gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility of the exam and reducing unnecessary healthcare costs.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Consecutive adult patients who require endoscopic ultrasound and tissue sampling of either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus, stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located adjacent to the esophagus, stomach, duodenum or rectum
- Ability to give consent
Exclusion Criteria:
- Inability to obtain informed consent
- Pregnant patients
- Patients under the age of 18
- Severe cardiopulmonary disease preventing a safe EUS procedure
- Patients unable to safely stop anti-coagulation therapy prior to EUS procedure
Contacts and Locations| Contact: Satish Nagula, M.D. | 631-444-2119 | satish.nagula@stonybrookmedicine.edu |
| United States, New York | |
| Stony Brook University Hospital | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Principal Investigator: Satish Nagula, M.D. | |
| Principal Investigator: | Satish Nagula, MD | Stony Brook University |
More Information
Publications:
| Responsible Party: | Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT01698190 History of Changes |
| Other Study ID Numbers: | SBUGI-2012 |
| Study First Received: | May 25, 2012 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Duodenal Neoplasms Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Pancreatic Neoplasms Lymphatic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Head and Neck Neoplasms Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013