1. Impact of EUS-guided Microforceps Biopsy Sampling (MFB) and Needle-Based Confocal Laser Endomicroscopy (nCLE) on the Diagnostic Yield and Clinical Management of Pancreatic Cystic Lesions (PCLs)
Cheesman AR, et al. Gastrointest Endosc. 2020;91(5):1095-1104. doi:10.1016/j.gie.2019.12.022
- The aim of this study was to assess diagnostic outcomes and changes in clinical management resulting from MFB and nCLE use in PCLs compared with the current “composite standard” (CS) obtained by combining clinical, morphologic, cyst fluid cytology, and chemical analysis.
- Retrospective study; 44 patients included.
- Technical success was 100% for EUS-FNA, 88.6% for MFB, and 97.7% for nCLE. There was 1 (2.4%) adverse event (infected pseudocyst).
- Diagnostic yield was 34.1% for CS, 75.0% for MFB (P<0.05 vs CS) and 84.1% for nCLE (P<0.05 vs CS). Diagnostic yield for combined tests was 79.5% for CS/MFB, 88.6% for CS/nCLE and 93.2% for CS/MFB/nCLE.
- Compared with CS, MFB, nCLE and their combination changed clinical management in 38.6%, 43.2% and 52.3% of cases, respectively.
- The use of combined EUS-guided FNA, MFB and nCLE in PCL diagnosis is safe and may have a major impact in clinical management.
Background and aims: EUS-guided microforceps biopsy sampling (MFB) and needle-based confocal laser endomicroscopy (nCLE) are emerging diagnostic tools for pancreatic cystic lesions (PCLs). There is a paucity of data regarding their performance and impact. The aim of this study was to compare diagnostic outcomes and changes in clinical management resulting from MFB and nCLE use in PCLs.
Methods: This was a single-center retrospective study of patients with PCLs who underwent combined EUS-guided FNA, MFB, and nCLE. Primary outcomes included diagnostic yield (specific PCL type) and change in clinical management for each modality compared with the current “composite standard” (CS) obtained by combining clinical, morphologic, cyst fluid cytology, and chemical analysis.
Results: Forty-four cysts were studied in 44 patients. Technical success was 100% for EUS-FNA, 88.6% for MFB, and 97.7% for nCLE. Of 44 procedures, there was 1 adverse event (2.3%, an infected pseudocyst). Diagnostic yield for each individual modality was 34.1% for CS, 75.0% for MFB (P < .05 vs CS), and 84.1% for nCLE (P < .05 vs CS). Diagnostic yield for combined tests was 79.5% for CS/MFB, 88.6% for CS/nCLE, and 93.2% for CS/MFB/nCLE (P = not significant). Compared with the CS, the use of MFB, nCLE, and their combination led to overall change in clinical management in 38.6%, 43.2%, and 52.3% of cases, respectively. MFB and nCLE led to an overall increase in discontinuation of surveillance (MFB, 34.1% [P < .05]; nCLE, 31.8% [P < .05]), led by a reduction in the indication for follow-up radiologic or endoscopic studies (MFB, 34.1% [P < .05]; nCLE, 38.6% [P < .05]). Based on MFB and nCLE, 2 of 28 (7.1%) and 3 of 28 (10.7%) patients who would have undergone further surveillance were referred for surgery.
Conclusions: In the evaluation of PCLs, the use of combined EUS-guided FNA, MFB, and nCLE is safe. MFB and nCLE led to significant improvements in specific PCL diagnosis, which in turn has major impacts in clinical management.
2. Repeat EUS-FNA (rFNA) of pancreatic masses after nondiagnostic or inconclusive results: systematic review and meta-analysis
Lisotti A, et al. Gastrointest Endosc. 2020;91(6):1234-1241.e4. doi:10.1016/j.gie.2020.01.034
- The aim of this study was to evaluate the diagnostic accuracy of rEUS-FNA after a nondiagnostic result.
- Systematic review and meta-analysis; 505 patients included (12 studies).
- Sensitivity, specificity, PPV and NPV were 77%, 98%, 99% and 61%, respectively.
- When ROSE was available, sensitivity and specificity were 83% and 98%, respectively, and the number of correctly diagnosed cases increased from 6 to 8 of 10 patients.
- After a nondiagnostic result, rEUS-FNA has an added value for the diagnosis of solid pancreatic masses and ROSE may be particularly beneficial in this setting.
Background and Aims: EUS-guided FNA (EUS-FNA) is the criterion standard for the diagnosis of solid pancreatic lesions. Several studies assessed the role of repeat EUS-FNA (rEUS-FNA) after an inconclusive examination. Our aim was to evaluate the diagnostic accuracy of rEUS-FNA after a nondiagnostic result.
Methods: We conducted systematic research on electronic databases (Medline, PubMed, EMBASE) and a meta-analysis to obtain pooled sensitivity, specificity, positive and negative likelihood ratio, and diagnostic odds ratio. A summary receiver operating characteristic curve was used to calculate area under the curve. Subgroup analysis was used to assess the role of rapid on-site evaluation (ROSE).
Results: Twelve studies (505 patients) were included. Sensitivity was 77% (66%-86%), specificity 98% (78%-100%), and positive and negative predictive values 99% (98%-100%) and 61 (60%-63%), respectively. At 73% of disease prevalence (pretest probability), positive rEUS-FNA increased the disease probability to 99%, whereas a negative result decreased the disease probability to 39%. The sensitivity was 83% (64%-93%) and specificity 98% (80%-100%) when ROSE was available and 65% (57%-73%) and 94% (31%-100%) when not available. The number needed to diagnose was 1.2 (1.1-2.3) and 1.7 (1.4-8.3) in ROSE-positive and ROSE-negative cases, respectively. The number of correctly diagnosed cases increased from 6 (1-7) to 8 (4-9) of 10 patients without and with ROSE, respectively.
Conclusions: This study objectively substantiated the added value of rEUS-FNA for the diagnosis of solid pancreatic masses in cases of a previous nondiagnostic or inconclusive result. Moreover, our data suggested that ROSE may be beneficial in this setting, because it increased the proportion of definitive diagnoses.
3. Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial
Colán-Hernández J, et al. Gastroenterology. 2020;158(6):1642-1649.e1. doi:10.1053/j.gastro.2020.01.025
- The aim of this study was to compare prophylaxis with ciprofloxacin vs placebo (saline solution) in patients with a pancreatic cyst requiring EUS-FNA.
- Multicenter, randomized, noninferiority trial. 226 patients included: ciprofloxacin n=112; placebo n=114.
- Between ciprofloxacin and placebo groups, there were no differences in the incidente of infection (0% vs 0.87%), fever (1.78% vs 1.76%) and other events (5.4% vs 7%).
- EUS-FNA of pancreatic cystic lesions has a very low risk of infection and its incidence did not differ significantly with vs without ciprofloxacin prophylaxis.
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.
4. Efficacy and Safety of Endoscopic Ultrasound-Guided Therapy Versus Direct Endoscopic (END) Glue Injection Therapy for Gastric Varices: Systematic Review and Meta-Analysis
Mohan BP, et al. Endoscopy. 2020;52(4):259-267. doi:10.1055/a-1098-1817
- The aim of this study was to assess the role of EUS-guided therapy in the treatment of gastric varices.
- Systematic review and meta-analysis; 851 patients (23 studies) were treated with EUS-guided therapy and 3467 patients (28 studies) were treated with direct END-glue injection.
- Except for obliteration which was significantly better with EUS-guided therapy (84.5%, P=0.02), this technique is comparable to END-glue therapy: treatment efficacy 93.7%, P=0.4; recurrence 9.1, P=0.06; and early and late rebleeding 7.0, P=0.7, and 11.6%, P=0.1, respectively.
- Compared to each EUS modality alone, EUS-coil/glue combination showed superior outcomes.
- EUS-guided therapy for the treatment of gastric varices is effective and may be superior to END-glue therapy.
Background: Gastric variceal bleeding carries significant mortality in the setting of portal hypertension. Among the endoscopic treatment options, endoscopic ultrasound (EUS)-guided glue and/or coil injection is a novel approach, but its role in the treatment of gastric varices is not established due to a lack of robust data.
Methods: We conducted a comprehensive search of several databases (inception to June 2019) to identify studies evaluating EUS in the treatment of gastric varices. Our primary goals were to estimate the pooled rates of treatment efficacy, obliteration and recurrence of gastric varices, early and late rebleeding, and adverse events with EUS-guided therapy in gastric varices. We also searched for studies that evaluated direct endoscopic glue (END-glue) injection for treatment of gastric varices, and used the pooled rates as comparators.
Results: 23 studies (851 patients) evaluating EUS-guided therapy were included. The pooled treatment efficacy was 93.7 % (95 % confidence interval [CI] 89.5 – 96.3, I 2 = 53.7), gastric varices obliteration was 84.4 % (95 %CI 74.8 – 90.9, I 2 = 77), gastric varices recurrence was 9.1 % (95 %CI 5.2 – 15.7, I 2 = 32), early rebleeding was 7.0 % (95 %CI 4.6 – 10.7, I 2 = 0), and late rebleeding was 11.6 % (95 %CI 8.8 – 15.1, I 2 = 22). The rates were comparable to END-glue therapy (28 studies, 3467 patients) except for obliteration, which was significantly better with EUS-guided therapy. On subgroup analysis, EUS-coil/glue combination showed superior outcomes.
Conclusions: EUS-guided therapy demonstrated clinical efficacy for treatment of gastric varices in terms of obliteration, recurrence, and long-term rebleeding, and may be superior to END-glue.