ObjectiveAlthough lumen-apposing metal stents (LAMS) are increasingly used for drainage of walled-off necrosis (WON), their advantage over plastic stents is unclear. We compared efficacy of LAMS and plastic stents for WON drainage.DesignPatients with WON were randomised to endoscopic ultrasound-guided drainage using LAMS or plastic stents. Primary outcome was comparing total number of procedures to achieve treatment success defined as symptom relief in conjunction with WON resolution on CT at 6 months. Secondary outcomes were treatment success, procedure duration, clinical/stent-related adverse events, readmissions, length of hospital stay (LOS) and costs.Results60 patients underwent LAMS (n=31) or plastic stent (n=29) placement. There was no significant difference in total number of procedures performed (median 2 (range 2–7) LAMS vs 3 (range 2–7) plastic, p=0.192), treatment success, clinical adverse events, readmissions, LOS and overall treatment costs between cohorts. Although procedure duration was shorter (15 vs 40 min, p<0.001), stent-related adverse events (32.3% vs 6.9%, p=0.01) and procedure costs (US$12 155 vs US$6609, p<0.001) were higher with LAMS. Significant stent-related adverse events were observed ≥3 weeks postintervention in LAMS cohort. Interim audit resulted in protocol amendment where CT scan was obtained at 3 weeks postintervention followed by LAMS removal if WON had resolved. After protocol amendment, there was no significant difference in adverse events between cohorts.ConclusionExcept for procedure duration, there was no significant difference in treatment outcomes between LAMS and plastic stents. To minimise adverse events with LAMS, patients should undergo follow-up imaging and stent removal at 3 weeks if WON has resolved.Trial registration numberNCT02685865.
Background:
To overcome limitations of cytology, biopsy needles have been developed to procure histologic samples during EUS.
Objective:
To compare 22-gauge (G) FNA and 22G biopsy needles (FNB) for EUS-guided sampling of solid pancreatic masses.
Design:
Randomized trial.
Setting:
Tertiary-care medical center.
Patients:
This study involved 56 patients with solid pancreatic masses.
Intervention:
Sampling of pancreatic masses by using 22G FNA or 22G FNB devices.
Main Outcome Measurements:
Compare the median number of passes required to establish the diagnosis, diagnostic sufficiency, technical performance, complication rates, procurement of the histologic core, and quality of the histologic specimen.
Results:
A total of 28 patients were randomized to the FNA group and 28 to the FNB group. There was no significant difference in median number of passes required to establish the diagnosis (1 [interquartile range 1-2.5] vs 1 [interquartile range 1-1]; P = .21), rates of diagnostic sufficiency (100% vs 89.3%; P = .24), technical failure (0 vs 3.6%; P = 1.0), or complications (3.6% for both) between FNA and FNB needles, respectively. Patients in whom diagnosis was established in passes 1, 2, and 3 were 64.3% versus 67.9%, 10.7% versus 17.9%, and 25% versus 3.6%, respectively, for FNA and FNB cohorts. There was no significant difference in procurement of the histologic core (100% vs 83.3%; P = .26) or the presence of diagnostic histologic specimens (66.7% vs 80%; P = .66) between FNA and FNB cohorts, respectively.
Limitations:
Only pancreatic masses were evaluated.
Conclusion:
Diagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles are comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types. (Clinical trial registration number: AQ:NCT01394159.) (Gastrointest Endosc 2012;76:321-7.)
Background and study aims: To overcome the limitations associated with cytology, a uniquely designed needle (ProCore) was introduced in an effort to obtain a core of tissue under endoscopic ultrasound (EUS) guidance. However, studies comparing the sample quality between ProCore and standard-design fine-needle aspiration (FNA) needles have yielded varying results. A systematic review and meta-analysis was therefore conducted to compare the performance of the ProCore and standard FNA needles when performing EUS-guided tissue acquisition.
Patients and methods: MEDLINE and EMBASE were searched to identify all published manuscripts that compared the ProCore needle with standard FNA needles. Noncomparative and technical feasibility studies were excluded. The main outcome measures were diagnostic adequacy, diagnostic accuracy, acquisition of histological core tissue, and mean number of passes required to achieve a diagnosis when sampling solid lesions.
Results: Nine studies (total 576 patients) met the inclusion criteria. There was no significant difference in diagnostic adequacy (75.2?% vs. 89.0?%, odds ratio [OR] 0.39, P?=?0.23), diagnostic accuracy (85.8?% vs. 86.2?%, OR 0.88, P?=?0.53) or rate of histological core specimen acquisition (77.7?% vs. 76.5?%, OR 0.94, P?=?0.85) between the ProCore and standard FNA needles, respectively. The mean number of passes required for diagnosis, however, was significantly lower when using the ProCore needle (standardized mean difference ??1.2, P?0.001).
Conclusions: Current data do not demonstrate a significant difference between the ProCore and standard FNA needles for sample adequacy, diagnostic accuracy or acquisition of a core specimen. However, the ProCore needle establishes the diagnosis with fewer passes.
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