ABSTRACT
BACKGROUND AND AIMS: Endoscopic necrosectomy through lumen apposition metal stents (LAMS) is increasingly being used for complicated walled-off pancreatic necrosis (WOPN), but the need for necrosectomy after stent placement is not well understood. The aim of this study was to evaluate clinical, endoscopic, and radiologic predictors of the need for necrosectomy in patients treated with LAMS. METHODS: We retrospectively reviewed patients with WOPN treated with LAMS from 2014 to 2017. Necrosectomy was performed only in patients who had recurrent fever or hemodynamic instability during follow-up. Univariate and multivariate analyses were performed. RESULTS: We included 15 patients, 67% men and median age was 75 (54-76) years. Two (13%) presented adverse events, one immediate and one delayed. In the first case, the stent migrated to the gastric cavity during deployment but was relocated in the same procedure. In the second case, the patient presented bleeding on day 36 due to a pseudoaneurysm that was successfully treated with embolization. Clinical success was 100%, but five patients (33%) required endoscopic necrosectomy (4 mechanical and 1 irrigation) and one (7%) required surgical necrosectomy of distant collections. The percentage of necrosis in the collection detected in a previous CT scan (45 [35-66]% vs 10 [5-17]%) was the only factor to predict the need for necrosectomy in the multivariate analysis (OR 1.18 [1.01-1.39]). CONCLUSION: LAMS is efficient to treat WOPN but more than a third will need necrosectomy. The percentage of necrosis in the collection detected in the CT scan seems to predict the need for necrosectomy.
Subject(s)
Pancreatitis, Acute Necrotizing , Aged , Drainage/methods , Endoscopy/methods , Female , Humans , Male , Middle Aged , Necrosis/etiology , Necrosis/surgery , Pancreatitis, Acute Necrotizing/surgery , Retrospective Studies , Stents/adverse effectsABSTRACT
BACKGROUND & AIMS: Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether performing the procedure without antimicrobial prophylaxis increases the incidence of infection. METHODS: We performed a multicenter, randomized, noninferiority trial to compare prophylaxis with ciprofloxacin vs placebo in patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain. From September 2014 to June 2018, patients were randomly assigned to groups that received the prophylaxis with ciprofloxacin (n = 112) or saline solution (n = 114, placebo). We recorded patients' demographic data, lesion characteristics, and procedure data and followed patients for 21 days. A total of 205 patients completed the trial (90.7%), receiving ciprofloxacin or the control, with no statistically significant differences in demographics, baseline data, or procedure characteristics between groups. The primary outcome was FNA-related infection. Secondary outcomes were incidence of fever, procedure complications, and medication-related adverse events. RESULTS: The only case of FNA-related infection (0.44%) occurred in a patient in the placebo group (0.87%); this patient developed acute pancreatitis and bacteremia after the procedure. Prevention of infection was not inferior in the control group; the difference between proportions was 0.87% (95% confidence interval, -0.84% to 2.59%). There were no differences between groups in fever (2 patients in each group: 1.78% vs 1.76%; P = 1.00) or other adverse events. CONCLUSIONS: In a randomized trial of patients undergoing EUS-FNA for pancreatic cyst evaluation, we found the risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. (ClinicalTrials.gov, Number: NCT02261896).
Subject(s)
Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis/standards , Endoscopic Ultrasound-Guided Fine Needle Aspiration/adverse effects , Pancreatic Cyst/diagnosis , Postoperative Complications/prevention & control , Preoperative Care/standards , Aged , Ciprofloxacin/administration & dosage , Female , Humans , Incidence , Male , Middle Aged , Pancreas/diagnostic imaging , Pancreas/pathology , Pancreatic Cyst/pathology , Placebos/administration & dosage , Postoperative Complications/epidemiology , Postoperative Complications/microbiology , Practice Guidelines as Topic , Preoperative Care/methods , SpainABSTRACT
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