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Endosonography-Guided Fine-Needle Aspiration versus "Key-Hole Biopsy" in the diagnostics of upper gastrointestinal subepithelial tumors. A prospective randomized interventional study
V. Zoundjiekpon, P. Falt, P. Fojtik, E. Kundratova, O. Mikolajek, M. Hanousek, K. Reiterova, D. Ziak, M. Bolek, A. Tchibozo, M. Kliment, O. Urban
Language English Country Czech Republic
Document type Comparative Study, Journal Article, Randomized Controlled Trial
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PubMed
31025658
DOI
10.5507/bp.2019.013
Knihovny.cz E-resources
- MeSH
- Endoscopic Ultrasound-Guided Fine Needle Aspiration * MeSH
- Endosonography * MeSH
- Gastrointestinal Neoplasms diagnostic imaging pathology MeSH
- Gastrointestinal Stromal Tumors diagnostic imaging pathology MeSH
- Middle Aged MeSH
- Humans MeSH
- Mitotic Index MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Feasibility Studies MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Geographicals
- Czech Republic MeSH
BACKGROUND: The management and prognosis of subepithelial tumors (SETs) of the upper gastrointestinal tract depend on the correct preoperative evaluation, including tissue diagnosis in selected cases. Several methods providing deep tissue sampling for cytological and/or histological examinations have been described but their diagnostic yield and precise position in the diagnostic algorithm remain to be established. This prospective randomized study aims to compare the Endosonography-Guided Fine-Needle Aspiration (EUS-FNA) to Key-Hole Biopsy (KHB) in cytological or histological diagnostics of upper gastrointestinal SETs. PATIENTS AND METHODS: This study was conducted in a single tertiary endoscopy center in Ostrava, Czech Republic between November 2010 and October 2015. Patients with endoscopically detected SETs of the upper gastrointestinal tract with a diameter ≥ 2 cm, were randomized to either the EUS-FNA with 22G needle, or to the Key Hole biopsy (forceps biopsy through mucosal incision) groups. The main study outcomes were success rate of tissue diagnostics and, in the cases of Gastrointestinal Stromal Tumours (GIST), possibility of determining mitotic activity. A cross-over examination was performed in situations where the first method had failed. RESULTS: A total of 46 consecutive patients were randomized. Of these, 24 (52%) and 22 (48%) were randomized to EUS-FNA group and KHB arm, respectively. 5 SETs (11%) were detected in the esophagus, 40 (87%) in the stomach and 1 (2%) in the duodenum. The definitive diagnosis was established by the first sampling method in 42 (91%) patients, including 22 (92%) in the EUS-FNA group and 20 (91%) in the KHB group (P=0.999), and after a cross-over in another 3 (7%) patients. The most prevalent SET was GIST (70%). Although some mitotic activity could be observed in 11 patients, the mitotic index could be diagnosed in none of them. Of a total of 20 surgically treated patients, preoperative and postoperative tissue diagnosis corresponded in 19/20 (95%) cases, including 100% in FNA group and 91% in KHB group (P=0.999). No adverse events of tissue sampling occurred in the study. CONCLUSIONS: Deep tissue sampling by EUS-FNA and KHB are equally effective in the diagnostics of SETs of the upper gastrointestinal tract ≥ 2 cm. However, neither EUS-FNA nor KHB provided adequate tissue sample to determine mitotic index. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02025244).
Biopsy and Cytology Department Agel Laboratories Novy Jicin Czech Republic
CGB Laboratories Ostrava Czech Republic
Department of Internal Medicine Gastroenterology and Hepatology Vivantes Clinic Berlin Germany
Department of Surgery Vitkovice Hospital Ostrava Czech Republic
Digestive Diseases Center Vitkovice Hospital Ostrava Czech Republic
Faculty of Medicine Charles University in Hradec Kralove Czech Republic
StatMed Health Analytics and Business Intelligence Saint Jean Sur Richelieu Quebec Canada
References provided by Crossref.org
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- $a BACKGROUND: The management and prognosis of subepithelial tumors (SETs) of the upper gastrointestinal tract depend on the correct preoperative evaluation, including tissue diagnosis in selected cases. Several methods providing deep tissue sampling for cytological and/or histological examinations have been described but their diagnostic yield and precise position in the diagnostic algorithm remain to be established. This prospective randomized study aims to compare the Endosonography-Guided Fine-Needle Aspiration (EUS-FNA) to Key-Hole Biopsy (KHB) in cytological or histological diagnostics of upper gastrointestinal SETs. PATIENTS AND METHODS: This study was conducted in a single tertiary endoscopy center in Ostrava, Czech Republic between November 2010 and October 2015. Patients with endoscopically detected SETs of the upper gastrointestinal tract with a diameter ≥ 2 cm, were randomized to either the EUS-FNA with 22G needle, or to the Key Hole biopsy (forceps biopsy through mucosal incision) groups. The main study outcomes were success rate of tissue diagnostics and, in the cases of Gastrointestinal Stromal Tumours (GIST), possibility of determining mitotic activity. A cross-over examination was performed in situations where the first method had failed. RESULTS: A total of 46 consecutive patients were randomized. Of these, 24 (52%) and 22 (48%) were randomized to EUS-FNA group and KHB arm, respectively. 5 SETs (11%) were detected in the esophagus, 40 (87%) in the stomach and 1 (2%) in the duodenum. The definitive diagnosis was established by the first sampling method in 42 (91%) patients, including 22 (92%) in the EUS-FNA group and 20 (91%) in the KHB group (P=0.999), and after a cross-over in another 3 (7%) patients. The most prevalent SET was GIST (70%). Although some mitotic activity could be observed in 11 patients, the mitotic index could be diagnosed in none of them. Of a total of 20 surgically treated patients, preoperative and postoperative tissue diagnosis corresponded in 19/20 (95%) cases, including 100% in FNA group and 91% in KHB group (P=0.999). No adverse events of tissue sampling occurred in the study. CONCLUSIONS: Deep tissue sampling by EUS-FNA and KHB are equally effective in the diagnostics of SETs of the upper gastrointestinal tract ≥ 2 cm. However, neither EUS-FNA nor KHB provided adequate tissue sample to determine mitotic index. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02025244).
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