Submucosal injection is generally required for both endoscopic-mucosal resection (EMR) and submucosal dissection (ESD). SIC-8000 (Eleview™) is a new FDA 510(k) cleared and CE marked liquid ...composition for submucosal injection, containing a biocompatible polymer as a cushioning agent.
The aim of this randomized study was to compare Eleview with saline solution when performing upper- and lower-GI EMR/ESD in a porcine model.
EMR/ESD procedures were performed in a total of 10 white domestic pigs comparing Eleview vs. NaCl 0.9% containing methylene blue at 0.001% (control solution) as submucosal solution to be injected. Animals were randomized between EMR (22 procedures) and ESD (22 procedures) and between upper- (8 animals) and lower-(2 animals) GI procedures. All procedures were performed aiming for a resection size of 1 cm × 1 cm for EMR and 2 cm × 2 cm for ESD. Volume of injected fluid, number of injections, time of resection, technical success, en-bloc resection, and adverse events were collected. Endoscopic surveillance was conducted each week for 4 weeks after the EMR/ESD, including biopsies on the margins of resection sites at week-1 of follow-up. After four weeks, pigs were sacrificed and necropsy performed.
Overall, 22 EMR and 22 ESD were performed in 10 live pigs. The average total volume needed for EMR and ESD was statistically significantly lower with Eleview as compared with control solution for both of the techniques (EMR: 5.6 ± 3.4 ml vs. 11.5 ± 6.7 ml; p = 0.02; ESD: 19.0 ± 10.0 ml vs. 36.3 ± 16.9 ml; p = 0.02). The rate of adverse events was statistically significantly lower in the Eleview than in the control group (2/26, 7.7% vs. 6/18, 33.3%; p = 0.03), but most of them were minor. No difference between Eleview and control solution was found in the rate of technical success (EMR: 11/13, 84.6% vs. 7/9, 77.8%; p = 0.7; ESD: 13/13, 100% vs. 9/9, 100%; p = 1), en-bloc resection (EMR: 6/13, 46.2% vs. NaCl: 5/9, 55.6%; p = 0.06; ESD: 12/13, 92.3% vs. 8/9, 88.9%; p = 0.8), and time of resection (EMR: 9.1 ± 7.75 min vs. 9.4 ± 9.6 min; p = NS; ESD: 38.4 ± 17.2 min vs. 40.2 ± 19.1 min; p = NS). At endoscopic follow up and necropsy, no difference in the process of healing of post-endoscopic ulcer and in the histological inflammation at the site of resection was shown between the two groups.
The new submucosal injection composition Eleview appeared to be an effective alternative to saline solution for submucosal injection for EMR/ESD, resulting in a substantial reduction of the volume administered to achieve an adequate lifting. No signs of adverse local or distant tissue reaction to Eleview were found at long-term follow up.
Abstract
Background
It is unknown whether there is an advantage to using the wet-suction or slow-pull technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) with new-generation ...needles. We aimed to compare the performance of each technique in EUS-FNB.
Methods
This was a multicenter, randomized, single-blind, crossover trial including patients with solid lesions of ≥ 1 cm. Four needle passes with 22 G fork-tip or Franseen-type needles were performed, alternating the wet-suction and slow-pull techniques in a randomized order. The primary outcome was the histological yield (samples containing an intact piece of tissue of at least 550 μm). Secondary end points were sample quality (tissue integrity and blood contamination), diagnostic accuracy, and adequate tumor fraction.
Results
Overall, 210 patients with 146 pancreatic and 64 nonpancreatic lesions were analyzed. A tissue core was retrieved in 150 (71.4 %) and 129 (61.4 %) cases using the wet-suction and the slow-pull techniques, respectively (
P
= 0.03). The mean tissue integrity score was higher using wet suction (
P
= 0.02), as was the blood contamination of samples (
P
< 0.001). In the two subgroups of pancreatic and nonpancreatic lesions, tissue core rate and tissue integrity score were not statistically different using the two techniques, but blood contamination was higher with wet suction. Diagnostic accuracy and tumor fraction did not differ between the two techniques.
Conclusion
Overall, the wet-suction technique in EUS-FNB resulted in a higher tissue core procurement rate compared with the slow-pull method. Diagnostic accuracy and the rate of samples with adequate tumor fraction were similar between the two techniques.
BACKGROUND : The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not ...been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. METHODS : This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. RESULTS : 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % 95 %CI 84.8 %-93.9 % vs. 87.8 % 95 %CI 82.1 %-92.2 %;
= 0.49), sample adequacy (93.1 % 95 %CI 88.6 %-96.3 % vs. 95.5 % 95 %CI 91.4 %-98 %;
= 0.31), and rate of adverse events (2.6 % vs. 1.1 %;
= 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3;
< 0.001). CONCLUSIONS : The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.
The prevalence of inflammatory bowel disease (IBD) has been described in 5% to 40% of autoimmune pancreatitis (AIP) patients. The aim of our study was to evaluate the prevalence, endoscopic features, ...and outcome of IBD in association with AIP.A retrospective analysis including all consecutive patients with AIP and a histological diagnosis of IBD from 2010 to 2020 was performed. Demographical data, AIP, and IBD features, as well as clinical course, were recorded.Among 267 AIP patients, 45 were diagnosed with ulcerative colitis (UC) (27 men, mean age 31.6), all with a diagnosis of type 2 AIP. The most frequent presentation of AIP was acute pancreatitis (55.5%). Both diffuse (51.1%) and focal (48.9%) pancreatic involvement were observed. The AIP relapse rate was 11.1% over a mean follow-up of 55 months. In 69% of patients, the interval time between the diagnosis of AIP and UC was <1 year. When UC was present at AIP onset, UC was in clinical remission in 50% of patients. Fecal calprotectin levels, when available, were elevated in 86.6% of these patients. Mostly, mild-moderate pancolitis was initially diagnosed (55.5%). During follow-up, escalation therapy for UC was required in 40% of patients after a mean time of 45 months. Two patients (4.4%) underwent colectomy.The prevalence of UC in AIP patients was 17%. Mild pancolitis with a low rate of colectomy was found. Greater awareness is needed to avoid a delayed diagnosis of UC, and the dosage of fecal calprotectin levels could have a role in this setting.
The diagnostic role of endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of pelvic masses has not been well established. We aimed to evaluate the diagnostic ...accuracy of EUS plus FNA/FNB in suspected local recurrence of pelvic masses.
All consecutive patients with a history of lower gastrointestinal and pelvic mass undergone EUS-FNA/FNB were included in the study.
In total 34 patients who underwent EUS-guided FNA or FNB of a perirectal mass were enrolled. The sampled lesion was a mass in 22 patients (64.7%) and a lymph node in 10 patients (29.4%). The univariate logistic regression analysis for diagnostic accuracy showed lesion size as a significant predictor of diagnostic accuracy odds ratio (OR), 1.61; 1.08-2.27; P = 0.02. Diagnostic sensitivity was 100% (71.5-100%) with EUS-FNB and 75% (34.9-96.8%) with EUS-FNA ( P = 0.12); specificity was 100% in both groups ( P = 1.0). Sample adequacy was 94.1% in the whole cohort, with 20/20 adequacy rate (100%) in the EUS-FNB group and 12/14 (85.7%) in the EUS-FNA group ( P = 0.28).
This is the first study demonstrating the diagnostic yield of EUS plus FNA/FNB in patients with pelvic masses comparing the two needles. Our results highlight the relevance of this technique, especially in undefined masses during oncological follow-up.
Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools ...compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial.
Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision ECV; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time.
From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00–1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04–1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69–1.14; P = .38).
The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone. ClinicalTrials.gov, Number: NCT04676308.
Including a mucosal exposure device in artificial intelligence–assisted colonoscopy examinations increased detection of adenomas without affecting safety in a randomized controlled study.
A direct comparison between endoscopic ultrasound (EUS) fine-needle biopsy (FNB) and current endoscopic biopsy techniques in patients with subepithelial lesions (SELs) is still lacking. Aim of this ...multicenter study was to compare the diagnostic performance and safety profile between EUS-FNB and bite-on-bite jumbo biopsy.
Out of 416 patients undergoing endoscopic sampling of SELs between 2017 and 2021, after propensity score matching two groups were compared: 120 undergoing EUS-FNB and 120 sampled with bite-on-bite jumbo biopsy. Primary outcome was sample adequacy. Secondary outcomes were diagnostic accuracy, sensitivity, specificity, and adverse events.
Median age was 61 years and most patients were male in both groups. Final diagnosis was GIST in 65 patients (54.1%) in the EUS-FNB group and 62 patients in the bite-on-bite biopsy group (51.6%; p = 0.37). Sample adequacy was significantly higher in the EUS-FNB group as compared to the bite-on-bite biopsy group (94.1% versus 77.5%, p<0.001). EUS-FNB outperformed bite-on-bite biopsy also in terms of diagnostic accuracy (89.3% versus 67.1%, p<0.001) and sensitivity (89% vs 64.5%; p<0.001), whereas specificity was 100% in both groups (p = 0.89). These findings were confirmed in subgroup analysis according to SEL location, final diagnosis, and wall layers of the sampled SEL. Adverse event rate was 6.6% in the EUS-FNB group and 30% in the bite-on-bite biopsy group (p<0.001).
EUS-FNB outperforms bite-on-bite biopsy both in terms of diagnostic yield and safety profile.
PDF
