False positive (FP) results by computer-aided detection (CADe) hamper the efficiency of colonoscopy by extending examination time. Our aim was to develop a classification of the causes and clinical ...relevance of CADe FPs, and to assess the relative distribution of FPs in a real-life setting.
In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe colonoscopy videos. Using a modified Delphi process, 4 expert endoscopists identified the main domains for the reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP and classified it according to the proposed domains. The analysis was limited to the withdrawal phase.
The 2 main domains for the causes of CADe FPs were identified as artifacts due to either the mucosal wall or bowel content, and clinical relevance was defined as the time spent on FPs and the FP rate per minute. The mean number of FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) were due to artifacts in the bowel wall and bowel content, respectively. Of the 27.3 FPs per colonoscopy, 1.6 (5.7%) required additional exploration time of 4.8 ± 6.2 seconds per FP (ie, 0.7% of the mean withdrawal time). In detail, 15 (24.2%), 33 (53.2%), and 14 (22.6%) FPs were classified as being of mild, moderate, or severe clinical relevance. The rate of FPs per minute of withdrawal time was 2.4 ± 1.2, and was higher for FPs due to artifacts from the bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, P < .001).
FPs by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase in the total withdrawal time because most of them are immediately discarded by the endoscopist.
The natural history of autoimmune gastritis (AIG) has been poorly described. In this study, we report the long-term natural history and clinical clustering of the full spectrum of AIG, from the ...potential to the complicated stage.
Prospective single-center study conducted in a tertiary referral center. Patients with AIG at any stage (0 = potential; 1 = early; 2 = florid; 3 = severe; and 4 = complicated) were enrolled (January 2000-December 2022). The histopathological evolution, the clinical presentation, and the correlates of evolution of potential AIG were assessed.
Four hundred ninety-eight patients with AIG (mean age 56.7 ± 15.2 years, F:M ratio 2.5:1) were included, of whom 93 experienced potential AIG. The maximum disease duration was 27 years (median 18, interquartile range 14-23), while the overall median follow-up was 52 months (interquartile range 12-95). Age was significantly lower in stage 0 compared with that in the other stages. Accidental histologic evidence and hematologic findings were the most common clusters of diagnosis. The overall median rate of progression was 7.29 per 100 persons/yr (95% confidence interval CI 6.19-8.59), while the stage-specific rates of progression were 10.85 (stage 0; 95% CI 7.75-15.18), 14.83 (stages 1-2; 95% CI 11.89-18.49), and 2.68 (stage 3; 95% CI 1.88-3.84). Newly onset neoplastic complications at follow-up occurred in 41/483 patients (8.5%; 23 neuroendocrine tumors and 18 epithelial dysplasia). No cases of adenocarcinoma were noticed. Male sex was associated with a greater likelihood of evolving from potential AIG to overt AIG.
AIG is a progressive disorder, with a virtually absent risk of gastric adenocarcinoma. Patients with potential AIG should be monitored because they carry a high risk of evolving into overt AIG.
In recent years, the feasibility and safety of endoscopic placement of different biodegradable biliary stents have been investigated. New, helicoidally shaped, biliary and pancreatic biodegradable ...stents have been developed for endoscopic use. Stents are provided in different sizes and with 3 expected speeds of degradation: slow (11 weeks), medium (20 days), and fast (12 days). The aim of this study was to evaluate degradation time, technical outcomes, and safety of these stents.
This was a single-center, prospective, pilot study (August 2018 to January 2019) of consecutive patients with indication for biliary or pancreatic plastic stent positioning during ERCP. The primary outcome was the evaluation of degradation time of the stents, which was controlled by abdominal radiograph. Secondary outcomes were the evaluation of specific stent-related technical features (loadability, pushability, and fluoroscopic visibility) as compared with commonly used plastic stents and adverse events (AEs).
Thirty-eight patients (11 women 28.9%; median age, 68.05 ± 10.74 years) who received 53 biodegradable stents (34 64.2% biliary and 19 35.8% pancreatic stents) were enrolled in the study. Thirty-five (66%) slow-degrading stents, 6 (11.3%) medium-degrading stents, and 12 (22.6%) fast-degrading stents were used. At time 1, partial degradation of the stents was present in 48 cases (90.6%). Five stents (9.4%) prematurely migrated. At the subsequent time 2 evaluation, complete degradation occurred in 100% of cases. Stent loadability was defined as excellent in all cases. Pushability of the stent was scored as excellent in 48 cases (90.5%), good in 4 cases (7.5%), and fair in 1 case (1.9%). Fluoroscopic visualization was excellent in 11 cases (20.8%), good in 39 cases (73.6%), and fair in 3 (5.6%). Only 1 AE of mild post-ERCP pancreatitis occurred.
The results of our study suggest that the biodegradation of the new biliary and pancreatic stents is reliable and in line with expected times and technically successful in a variety of indications. Further randomized multicenter studies are required to validate our preliminary findings. (Clinical trial registration number: NCT03767166.)
EUS-guided biopsy sampling is the method of choice for obtaining pancreatic tissue. Next-generation sequencing (NGS) has been applied to EUS-guided biopsy sampling and may classify patients based on ...specific molecular profiles. Our study aimed to compare side-by-side the diagnostic yield achievable by genetic identification of somatic mutations detected with NGS versus histologic and cytologic typing in locally advanced pancreatic carcinoma (LAPC) in samples acquired under EUS guidance.
We conducted a prospective comparative pilot study at Humanitas Research Hospital. The study included 33 patients referred for LAPC who underwent EUS-guided tissue acquisition using a 22-gauge Franseen needle. Material was obtained for both pathologic diagnosis and DNA extraction and targeted NGS analysis with the AmpliSeq Comprehensive Panel v3 (Illumina Inc, San Diego, Calif, USA). Twenty-one genes were prioritized for somatic mutation detection.
The final diagnosis was pancreatic ductal adenocarcinoma (PDAC) in all patients (100%). A macroscopic core was obtained in 30 patients (91%). In 3 lesions no cores adequate for histologic analysis were obtained, but cytologic analysis revealed tumoral cells from PDAC. DNA was extracted from 32 of 33 samples (97%), most of which (27/32) carried at least 2 clearly pathogenic mutations in different genes. Detection of K-ras mutation allowed for molecular diagnosis of PDAC in most of the patients (30/32).
In our study we demonstrated that proper tissue specimens obtained under EUS guidance allowed DNA sample extraction and subsequent NGS analysis in 97% of cases. These results support the potential role of NGS as a complementary diagnostic test to be implemented in association with standard diagnostic modalities. (Clinical trial registration number: NCT03578939.)
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Over the years, digestive endoscopy has gone through a revolution. With different technological improvements, its diagnostic role is indeed becoming more and more sophisticated and is even moving ...closer to pathological evaluation. Above all, its therapeutic purpose is to date the first line of treatment for several gastrointestinal diseases. Importantly, the role of digestive endoscopy is also crossing over the mere concept of the GI tract and digestive diseases and will probably find a place in a more holistic concept of health. In this Special Issue, several emerging techniques are addressed, highlighting how endoscopy is emerging as a minimally invasive treatment procedure for several gastrointestinal diseases and post-surgical complications. However, crucial to this is the safety of all endoscopic processes, starting from endoscopic suites to the management of intra- and post-procedural complications.
EUS elastography is useful in characterizing solid pancreatic lesions (SPLs), and fractal analysis–based technology has been used to evaluate geometric complexity in oncology. The aim of this study ...was to evaluate EUS elastography (strain ratio) and fractal analysis for the characterization of SPLs.
Consecutive patients with SPLs were prospectively enrolled between December 2015 and February 2017. Elastographic evaluation included parenchymal strain ratio (pSR) and wall strain ratio (wSR) and was performed with a new compact US processor. Elastographic images were analyzed using a computer program to determine the 3-dimensional histogram fractal dimension. A composite cytology/histology/clinical reference standard was used to assess sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve.
Overall, 102 SPLs from 100 patients were studied. At final diagnosis, 69 (68%) were malignant and 33 benign. At elastography, both pSR and wSR appeared to be significantly higher in malignant as compared with benign SPLs (pSR, 24.5 vs 6.4 P < .001; wSR, 56.6 vs 15.3 P < .001). When the best cut-off levels of pSR and wSR at 9.10 and 16.2, respectively, were used, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve were 88.4%, 78.8%, 89.7%, 76.9%, and 86.7% and 91.3%, 69.7%, 86.5%, 80%, and 85.7%, respectively. Fractal analysis showed a significant statistical difference (P = .0087) between the mean surface fractal dimension of malignant lesions (D = 2.66 ± .01) versus neuroendocrine tumor (D = 2.73 ± .03) and a statistical difference for all 3 channels red, green, and blue (P < .0001).
EUS elastography with pSR and fractal-based analysis are useful in characterizing SPLs. (Clinical trial registration number: NCT02855151.)
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Background
Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our ...study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date.
Methods
This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events.
Results
A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction.
Conclusions
This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.
Multiple therapeutic modalities including surgery and rigid and flexible endoscopy have been adopted to manage Zenker's diverticulum (ZD). Minimally invasive flexible endoscopic septotomy (FES) ...techniques have been increasingly favored over the past 20 years; however, long-term data are still scanty. The aim of this study is to evaluate early and long-term outcomes of FES for naive ZD in a single-center setting.
From 2010 to 2017, ZD patients treated with FES were included in a prospectively maintained database (NCT03948438). Those who had already been treated surgically or endoscopically were excluded from the analysis. The Dakkak and Bennett dysphagia scale was used to rate the dysphagia. Persistent complete or near-complete resolution of symptoms (Dakkak and Bennett 0 or 1) was defined as clinical success. Postprocedural adverse events were reported according to ASGE lexicon.
Overall, 256 consecutive patients were treated. Mean pouch size was 29.8 ± 11.3 mm. The procedure was successfully completed in all scheduled patients, with an early clinical success of 96.1%. Adverse events occurred in 3.5% (9/256) of patients. Eight of them were mild/moderate with no fatal events, whereas one patient required surgery. Recurrences occurred in 31.3% (80/256) of treated patients after a mean time of 9 ± 3 months and 95% of recurrences were treated by a second FES. At an average follow-up of 5.5 years, 95.3% of patients were asymptomatic after a mean number of 1.3 procedures.
FES is a safe and effective treatment modality for patients with ZD. Recurrence rate is significant; however, endoscopic reintervention is associated with long-term relief of dysphagia.
