Comparative analysis of the usefulness of endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and mucosal incision assisted biopsy (MIAB) in the diagnosis of gastrointestinal stromal tumors (GIST) of the stomach.
- Conditions
- gastrointestinal stromal tumor
- Registration Number
- JPRN-UMIN000012169
- Lead Sponsor
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Results: A total of 47 patients were randomized to the MIAB group (n = 23) and EUS-FNA group (n = 24). There was no significant difference in the diagnostic yield of MIAB and EUSFNA (91.3% vs 70.8%, P = 0.0746). The complication rates of MIAB and EUS-FNA did not differ to a statistically significant extent. The mean procedure time in the MIAB group was significantly longer than that in the EUS-FNA group (34 vs 26 min, P = 0.0011).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
(1) Patients who are not candidates for upper gastrointestinal endoscopy including ileus, gastrointestinal perforation, critical respiratory ailment, cardiovascular diseases, etc. (2) Patients taking antithrombotic treatment (3) Patients with bleeding tendency (4) Patients judged by the principal or sub-investigator to be unsuitable for the study (5) Patients without written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of successful tissue extraction rates of FNA and MIAB for pathological diagnosis of gastric GIST by H.E and immunohistochemistry staining.
- Secondary Outcome Measures
Name Time Method (1) Comparison of the diagnostic yield of EUS-FNA and MIAB. (2) Comparison of safety of EUS-FNA and MIAB. (3) Comparison of procedure time and biopsy frequency of EUS-FNA and MIAB