Publications by authors named "Marco Spadaccini"

74 Publications

Long-Term Outcomes of Per-Oral Endoscopic Myotomy (POEM) for Achalasia: a Systematic Review and Meta-analysis.

Endoscopy 2022 Jul 7. Epub 2022 Jul 7.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

Background: The long-term outcomes of esophageal peroral endoscopic myotomy (POEM) are still unknown.

Methods: We searched electronic databases (Medline/Pubmed, EMBASE, Scopus) for studies assessing outcomes after POEM for esophageal achalasia, with a minimum median follow-up duration of 36 months. Pooled rates of clinical success and post-operative reflux were calculated and compared with the same values at 12/24/36 months when available. Sub-group analyses were also performed to explore the inter-study heterogeneity.

Results: From 1528 initial records, 11 studies (2017-2021) satisfied all the eligibility criteria for inclusion. A total of 2342 (48.1 ± 6.8 years; 50.1% males) patients were analyzed with a median follow-up of 48 (IQR, 45-60) months. Pooled clinical success rate was 87.3% (95% CI, 86.3%-91.0%; I2= 73.1%). Symptomatic reflux pooled rate was 22.0% (95% CI, 14.4%-29.5%, I2= 92.7%). Three cases of peptic strictures and one Barrett's esophagus were reported. Pooled rate of severe adverse events was 1.5% (95% CI, 0.5%-2.5%, I2= 52.8%).

Conclusions: Long-term clinical efficacy of POEM persists in nearly 87% of patients with achalasia. Post-POEM symptomatic reflux seems to remain stable over time. Risk for Barrett's esophagus and peptic strictures appears minimal.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/a-1894-0147DOI Listing
July 2022

Percutaneous endoscopic gastrostomy and jejunostomy: Indications and techniques.

World J Gastrointest Endosc 2022 May;14(5):250-266

Division of Gastroenterology and Digestive Endoscopy, Department of Gastroenterology, Humanitas Research Hospital - IRCCS, Rozzano 20089, Milan, Italy.

Nutritional support is essential in patients who have a limited capability to maintain their body weight. Therefore, oral feeding is the main approach for such patients. When physiological nutrition is not possible, positioning of a nasogastric, nasojejunal tube, or other percutaneous devices may be feasible alternatives. Creating a percutaneous endoscopic gastrostomy (PEG) is a suitable option to be evaluated for patients that need nutritional support for more than 4 wk. Many diseases require nutritional support by PEG, with neurological, oncological, and catabolic diseases being the most common. PEG can be performed endoscopically by various techniques, radiologically or surgically, with different outcomes and related adverse events (AEs). Moreover, some patients that need a PEG placement are fragile and are unable to express their will or sign a written informed consent. These conditions highlight many ethical problems that become difficult to manage as treatment progresses. The aim of this manuscript is to review all current endoscopic techniques for percutaneous access, their indications, postprocedural follow-up, and AEs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4253/wjge.v14.i5.250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9157691PMC
May 2022

Dye-based chromoendoscopy for the detection of colorectal neoplasia: meta-analysis of randomized controlled trials.

Gastrointest Endosc 2022 May 16. Epub 2022 May 16.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Endoscopy Unit, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.

Background And Aims: Dye-based chromoendoscopy (DBC) could be effective in increasing the adenoma detection rate (ADR) in patients undergoing colonoscopy, but the technique is time-consuming and its uptake is limited. We aimed to assess the effect of DBC on ADR based on available randomized controlled trials (RCTs).

Methods: Four databases were searched up to April 2022 for RCTs comparing DBC with conventional colonoscopy (CC) in terms of ADR, advanced ADR, and sessile serrated adenoma detection rate as well as the mean adenomas per patient and non-neoplastic lesions. Relative risk (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes were calculated using random-effect models. The I test was used for quantifying heterogeneity. Risk of bias was evaluated with the Cochrane tool.

Results: Overall, 10 RCTs (5334 patients) were included. Indication for colonoscopy was screening or surveillance (3 studies) and mixed (7 studies). Pooled ADR was higher in the DBC group versus the CC group (95% CI, 48.1% [41.4%-54.8%] vs 39.3% [33.5%-46.4%]; RR, 1.20 [1.11-1.29]), with low heterogeneity (I = 29%). This effect was consistent for advanced ADR (RR, 1.21 [1.03-1.42]; I = .0%), sessile serrated adenomas (6.1% vs 3.5%; RR, 1.68 [1.15-2.47]; I = 9.8%), and mean adenomas per patient (MD, .24 [.17-.31]) overall and in the right-sided colon (MD, .28 [.14-.43]). A subgroup analysis considering only trials using high-definition white-light endoscopy reduced the heterogeneity while still showing a significant increase in adenoma detection with DBC: 51.6% (95% confidence interval [CI], 47.1%-56.1%) and 59.1% (95% CI, 54.7-63.3%), RR = 1.14 (95% CI, 1.06-1.23), P = .0004, I = .0%, P = .50.

Conclusions: Meta-analysis of RCTs showed that DBC increases key quality parameters in colonoscopy, supporting its use in everyday clinical practice.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.gie.2022.05.002DOI Listing
May 2022

Peroral endoscopic myotomy (POEM) for achalasia developing after vertical banded gastroplasty with asymptomatic gastro-gastric fistula.

VideoGIE 2022 May 14;7(5):175-177. Epub 2022 Mar 14.

Department of Gastroenterology and Hepatology, Humanitas Research Hospital IRCCS, Rozzano, Italy.

Video 1At preoperative esophagram, a typical bird's beak image is shown at the gastroesophageal junction. A gastro-gastric fistula, opening from cardia to fundus, is also shown. A scope fitted with a distal clear cap is introduced. At the cardia, we see the proximal opening of the fistula. Here, we see the gastric fundus. As we go down, the gastric pouch is regular, and further down we reach the pylorus. In the retroflexed view, we recognize the neo-pylorus and the distal opening of the fistula. After submucosal injection on the anterior wall of the esophagus, a longitudinal mucosal incision is made. Submucosal tunnelling is performed using the endoscopic submucosal dissection technique. The gastroesophageal junction is reached, as confirmed by the finding of typical spindle veins. Here, we show submucosal tunnelling across the cardia, extending 2 cm into the gastric pouch. No obstacles from past surgery are encountered. Correct extension of the tunnel down into the cardia is also confirmed by visualizing a blue cushion. Dissection of a circular layer (of the muscularis) is performed and carried into the cardia. Submucosal tunnel is smoothy performed with no issues related to past surgery. Here, we demonstrate myotomy being carried into the gastric pouch across the cardia. We can see the more complex organization of muscular fibers. Again, no obstacles from past surgery are encountered. Myotomy is then completed along the entire length of the submucosal tunnel. Clip closure of the mucosal incision is eventually performed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vgie.2022.02.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108186PMC
May 2022

Artificial intelligence-assisted optical diagnosis for the resect-and-discard strategy in clinical practice: the Artificial intelligence BLI Characterization (ABC) study.

Endoscopy 2022 05 13. Epub 2022 May 13.

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Background: Optical diagnosis of colonic polyps is poorly reproducible outside of high volume referral centers. The present study aimed to assess whether real-time artificial intelligence (AI)-assisted optical diagnosis is accurate enough to implement the leave-in-situ strategy for diminutive (≤ 5 mm) rectosigmoid polyps (DRSPs).

Methods: Consecutive colonoscopy outpatients with ≥ 1 DRSP were included. DRSPs were categorized as adenomas or nonadenomas by the endoscopists, who had differing expertise in optical diagnosis, with the assistance of a real-time AI system (CAD-EYE). The primary end point was ≥ 90 % negative predictive value (NPV) for adenomatous histology in high confidence AI-assisted optical diagnosis of DRSPs (Preservation and Incorporation of Valuable endoscopic Innovations [PIVI-1] threshold), with histopathology as the reference standard. The agreement between optical- and histology-based post-polypectomy surveillance intervals (≥ 90 %; PIVI-2 threshold) was also calculated according to European Society of Gastrointestinal Endoscopy (ESGE) and United States Multi-Society Task Force (USMSTF) guidelines.

Results: Overall 596 DRSPs were retrieved for histology in 389 patients; an AI-assisted high confidence optical diagnosis was made in 92.3 %. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0 % (95 %CI 87.1 %-93.9 %). The PIVI-2 threshold was met with 97.4 % (95 %CI 95.7 %-98.9 %) and 92.6 % (95 %CI 90.0 %-95.2 %) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3 %, 95 %CI 76.4 %-87.3 %) than for experts (91.9 %, 95 %CI 88.5 %-94.5 %); however, nonexperts quickly approached the performance levels of experts over time.

Conclusion: AI-assisted optical diagnosis matches the required PIVI thresholds. This does not however offset the need for endoscopists' high level confidence and expertise. The AI system seems to be useful, especially for nonexperts.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/a-1852-0330DOI Listing
May 2022

Efficacy of a computer-aided detection system in a fecal immunochemical test-based organized colorectal cancer screening program: a randomized controlled trial (AIFIT study).

Endoscopy 2022 05 11. Epub 2022 May 11.

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Background: Computer-aided detection (CADe) increases adenoma detection in primary screening colonoscopy. The potential benefit of CADe in a fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening program is unknown. This study assessed whether use of CADe increases the adenoma detection rate (ADR) in a FIT-based CRC screening program.

Methods: In a multicenter, randomized trial, FIT-positive individuals aged 50-74 years undergoing colonoscopy, were randomized (1:1) to receive high definition white-light (HDWL) colonoscopy, with or without a real-time deep-learning CADe by endoscopists with baseline ADR > 25 %. The primary outcome was ADR. Secondary outcomes were mean number of adenomas per colonoscopy (APC) and advanced adenoma detection rate (advanced-ADR). Subgroup analysis according to baseline endoscopists' ADR (≤ 40 %, 41 %-45 %, ≥ 46 %) was also performed.

Results: 800 individuals (median age 61.0 years [interquartile range 55-67]; 409 men) were included: 405 underwent CADe-assisted colonoscopy and 395 underwent HDWL colonoscopy alone. ADR and APC were significantly higher in the CADe group than in the HDWL arm: ADR 53.6 % (95 %CI 48.6 %-58.5 %) vs. 45.3 % (95 %CI 40.3 %-50.45 %; RR 1.18; 95 %CI 1.03-1.36); APC 1.13 (SD 1.54) vs. 0.90 (SD 1.32;  = 0.03). No significant difference in advanced-ADR was found (18.5 % [95 %CI 14.8 %-22.6 %] vs. 15.9 % [95 %CI 12.5 %-19.9 %], respectively). An increase in ADR was observed in all endoscopist groups regardless of baseline ADR.

Conclusions: Incorporating CADe significantly increased ADR and APC in the framework of a FIT-based CRC screening program. The impact of CADe appeared to be consistent regardless of endoscopist baseline ADR.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/a-1849-6878DOI Listing
May 2022

Advanced imaging and artificial intelligence for Barrett's esophagus: What we should and soon will do.

World J Gastroenterol 2022 Mar;28(11):1113-1122

Department of Endoscopy, Humanitas Research Hospital, IRCCS, Rozzano 20089, Italy.

Barrett's esophagus (BE) is a well-established risk factor for esophageal adenocarcinoma. It is recommended that patients have regular endoscopic surveillance, with the ultimate goal of detecting early-stage neoplastic lesions before they can progress to invasive carcinoma. Detection of both dysplasia or early adenocarcinoma permits curative endoscopic treatments, and with this aim, thorough endoscopic assessment is crucial and improves outcomes. The burden of missed neoplasia in BE is still far from being negligible, likely due to inappropriate endoscopic surveillance. Over the last two decades, advanced imaging techniques, moving from traditional dye-spray chromoendoscopy to more practical virtual chromoendoscopy technologies, have been introduced with the aim to enhance neoplasia detection in BE. As witnessed in other fields, artificial intelligence (AI) has revolutionized the field of diagnostic endoscopy and is set to cover a pivotal role in BE as well. The aim of this commentary is to comprehensively summarize present evidence, recent research advances, and future perspectives regarding advanced imaging technology and AI in BE; the combination of computer-aided diagnosis to a widespread adoption of advanced imaging technologies is eagerly awaited. It will also provide a useful step-by-step approach for performing high-quality endoscopy in BE, in order to increase the diagnostic yield of endoscopy in clinical practice.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3748/wjg.v28.i11.1113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8985480PMC
March 2022

Cost-effectiveness of artificial intelligence for screening colonoscopy: a modelling study.

Lancet Digit Health 2022 06 13;4(6):e436-e444. Epub 2022 Apr 13.

Endoscopy Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.

Background: Artificial intelligence (AI) tools increase detection of precancerous polyps during colonoscopy and might contribute to long-term colorectal cancer prevention. The aim of the study was to investigate the incremental effect of the implementation of AI detection tools in screening colonoscopy on colorectal cancer incidence and mortality, and the cost-effectiveness of such tools.

Methods: We conducted Markov model microsimulation of using colonoscopy with and without AI for colorectal cancer screening for individuals at average risk (no personal or family history of colorectal cancer, adenomas, inflammatory bowel disease, or hereditary colorectal cancer syndrome). We ran the microsimulation in a hypothetical cohort of 100 000 individuals in the USA aged 50-100 years. The primary analysis investigated screening colonoscopy with versus without AI every 10 years starting at age 50 years and finishing at age 80 years, with follow-up until age 100 years, assuming 60% screening population uptake. In secondary analyses, we modelled once-in-life screening colonoscopy at age 65 years in adults aged 50-79 years at average risk for colorectal cancer. Post-polypectomy surveillance followed the simplified current guideline. Costs of AI tools and cost for downstream treatment of screening detected disease were estimated with 3% annual discount rates. The main outcome measures included the incremental effect of AI-assisted colonoscopy versus standard (no-AI) colonoscopy on colorectal cancer incidence and mortality, and cost-effectiveness of screening projected for the average risk screening US population.

Findings: In the primary analyses, compared with no screening, the relative reduction of colorectal cancer incidence with screening colonoscopy without AI tools was 44·2% and with screening colonoscopy with AI tools was 48·9% (4·8% incremental gain). Compared with no screening, the relative reduction in colorectal cancer mortality with screening colonoscopy with no AI was 48·7% and with screening colonoscopy with AI was 52·3% (3·6% incremental gain). AI detection tools decreased the discounted costs per screened individual from $3400 to $3343 (a saving of $57 per individual). Results were similar in the secondary analyses modelling once-in-life colonoscopy. At the US population level, the implementation of AI detection during screening colonoscopy resulted in yearly additional prevention of 7194 colorectal cancer cases and 2089 related deaths, and a yearly saving of US$290 million.

Interpretation: Our findings suggest that implementation of AI detection tools in screening colonoscopy is a cost-saving strategy to further prevent colorectal cancer incidence and mortality.

Funding: European Commission and Japan Society of Promotion of Science.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S2589-7500(22)00042-5DOI Listing
June 2022

Informed Consent for Endoscopic Biliary Drainage: Time for a New Paradigm.

Medicina (Kaunas) 2022 Feb 22;58(3). Epub 2022 Feb 22.

Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Clinical and Research Center, IRCCS, 20089 Rozzano, Milan, Italy.

Endoscopic retrograde cholangiopancreatography (ERCP) is considered as the first option in the management of malignant biliary obstruction. In case of ERCP failure, percutaneous transhepatic biliary drainage (PTBD) has been conventionally considered as the preferred rescue strategy. However, the use of endoscopic ultrasound (EUS) for biliary drainage (EUS-BD) has proved similarly high rates of technical success, when compared to PTBD. As a matter of fact, biliary drainage is maybe the most evident paradigm of the increasing interconnection between ERCP and EUS, and obtaining an adequate informed consent (IC) is an emerging issue. The aim of this commentary is to discuss the reciprocal roles of ERCP and EUS for malignant biliary obstruction, in order to provide a guide to help in developing an appropriate informed consent reflecting the new biliopancreatic paradigm.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/medicina58030331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8951173PMC
February 2022

Endoscopic ultrasound-guided ablation of solid pancreatic lesions: A systematic review of early outcomes with pooled analysis.

World J Gastrointest Oncol 2022 Feb;14(2):533-542

Endoscopic Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano 20089, Milan, Italy.

Background: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is emerging as a complementary therapeutic approach for pancreatic solid masses. However, results of published data are difficult to interpret because of a retrospective design and small sample size.

Aim: To systematically review data on EUS-RFA for solid lesions and to pool the results of the different experiences in order to provide more consistent evidence in terms of safety and efficacy.

Methods: A comprehensive systematic literature search on the main databases was performed to identify articles in which patients with pancreatic solid lesions underwent EUS-RFA. The primary outcomes were procedure-related adverse events (AEs) and mortality. Secondary outcomes were the technical success rate and the effects on primary tumor growth. Statistical analyses were performed using Stata version 14.0.

Results: In total, 14 studies were included, with 120 patients undergoing 153 ablations of 129 solid pancreatic lesions. The STARmed technology was used in seven studies, the Habib system in six studies, and the HybridTherm probe in one study. The pooled technical success rate was 99.0% ( : 25.82%). The pooled overall AE rate was 8.0% ( : 11.46%). Excluding mild AEs, the pooled rates of serious AEs was 1.0% ( : 0%). No mortality related to the procedure was reported.

Conclusion: The present pooled analysis confirms the safety and feasibility of EUS-RFA.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4251/wjgo.v14.i2.533DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8918998PMC
February 2022

Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia.

Gastroenterology 2022 Jul 15;163(1):295-304.e5. Epub 2022 Mar 15.

Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy; Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy.

Background & Aims: Artificial intelligence (AI) may detect colorectal polyps that have been missed due to perceptual pitfalls. By reducing such miss rate, AI may increase the detection of colorectal neoplasia leading to a higher degree of colorectal cancer (CRC) prevention.

Methods: Patients undergoing CRC screening or surveillance were enrolled in 8 centers (Italy, UK, US), and randomized (1:1) to undergo 2 same-day, back-to-back colonoscopies with or without AI (deep learning computer aided diagnosis endoscopy) in 2 different arms, namely AI followed by colonoscopy without AI or vice-versa. Adenoma miss rate (AMR) was calculated as the number of histologically verified lesions detected at second colonoscopy divided by the total number of lesions detected at first and second colonoscopy. Mean number of lesions detected in the second colonoscopy and proportion of false negative subjects (no lesion at first colonoscopy and at least 1 at second) were calculated. Odds ratios (ORs) and 95% confidence intervals (CIs) were adjusted by endoscopist, age, sex, and indication for colonoscopy. Adverse events were also measured.

Results: A total of 230 subjects (116 AI first, 114 standard colonoscopy first) were included in the study analysis. AMR was 15.5% (38 of 246) and 32.4% (80 of 247) in the arm with AI and non-AI colonoscopy first, respectively (adjusted OR, 0.38; 95% CI, 0.23-0.62). In detail, AMR was lower for AI first for the ≤5 mm (15.9% vs 35.8%; OR, 0.34; 95% CI, 0.21-0.55) and nonpolypoid lesions (16.8% vs 45.8%; OR, 0.24; 95% CI, 0.13-0.43), and it was lower both in the proximal (18.3% vs 32.5%; OR, 0.46; 95% CI, 0.26-0.78) and distal colon (10.8% vs 32.1%; OR, 0.25; 95% CI, 0.11-0.57). Mean number of adenomas at second colonoscopy was lower in the AI-first group as compared with non-AI colonoscopy first (0.33 ± 0.63 vs 0.70 ± 0.97, P < .001). False negative rates were 6.8% (3 of 44 patients) and 29.6% (13 of 44) in the AI and non-AI first arms, respectively (OR, 0.17; 95% CI, 0.05-0.67). No difference in the rate of adverse events was found between the 2 groups.

Conclusions: AI resulted in an approximately 2-fold reduction in miss rate of colorectal neoplasia, supporting AI-benefit in reducing perceptual errors for small and subtle lesions at standard colonoscopy.

Clinicaltrials: gov, Number: NCT03954548.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1053/j.gastro.2022.03.007DOI Listing
July 2022

Relief of jaundice in malignant biliary obstruction: When should we consider endoscopic ultrasonography-guided hepaticogastrostomy as an option?

Hepatobiliary Pancreat Dis Int 2022 Jun 6;21(3):234-240. Epub 2022 Mar 6.

Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Milan, Italy.

Background: Since it was first described in 2001, endoscopic ultrasonography-guided biliary drainage (EUS-BD) has emerged as an alternative procedure for achieving an endoscopic internal drainage in case of endoscopic retrograde cholangiopancreatography (ERCP) failure. Biliary drainage can be achieved by either a transduodenal extrahepatic approach through EUS-guided choledochoduodenostomy (EUS-CDS), or a transgastric intrahepatic approach, namely EUS-guided hepaticogastrostomy (EUS-HGS) which already holds a remarkable place in the treatment of patients with malignant biliary obstruction.

Data Sources: For this review we did a comprehensive search of PubMed/MEDLINE from inception to May 31, 2021 for papers with a significant sample size (at least 20 patients enrolled) dealing with EUS-HGS. Data on technical success, clinical success and rate of adverse events were collected.

Results: A total of 22 studies with different design, comprising 874 patients, were included. Technical success was achieved in about 96% of cases (ranging from 65% to 100%). Clinical success was obtained in almost 91% of cases (ranging from 76% to 100%). Overall rate of adverse events was 19% (ranging from 0% to 35%). Abdominal pain, self-limiting pneumoperitoneum, bile leak, cholangitis, bleeding, perforation and intraperitoneal migration of the stent were the most common.

Conclusions: Despite both safety and efficacy profile, at the moment HGS still remains a challenging procedure at every single step and must therefore be conducted by a very experienced endoscopist in interventional EUS and ERCP procedures, who is able to deal with the possible severe adverse events of this procedure. A rapid introduction in clinical practice of dedicated devices is desiderable.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hbpd.2022.03.003DOI Listing
June 2022

Discovering the first US FDA-approved computer-aided polyp detection system.

Future Oncol 2022 Apr 27;18(11):1405-1412. Epub 2022 Jan 27.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.

Colorectal cancer is the third most common cancer worldwide. Because of the slow progression of the precancerous precursors, an efficient endoscopic surveillance strategy may be expected. It seems that around one-fourth of colorectal malignancies are still missed during colonoscopy. Several endoscopic technologies have been introduced, without radical changes. Interest in the development of artificial intelligence applications in the medical field has grown in the past decade. Artificial intelligence can help to highlight a specific region of interest that needs closer examination for the identification of polyps. The aim of this review is to report the first clinical experiences with the first US FDA-approved, real-time, deep-learning, computer-aided detection system (GI Genius™, Medtronic).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2217/fon-2021-1135DOI Listing
April 2022

Clinical outcome of non-curative endoscopic submucosal dissection for early colorectal cancer.

Gut 2022 Jan 20. Epub 2022 Jan 20.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.

Objective: Endoscopic submucosal dissection (ESD) in a curative intent for submucosa-invasive early (T1) colorectal cancers (T1-CRCs) often leads to subsequent surgical resection in case of histologic parameters indicating higher risk of nodal involvement. In some cases, however, the expected benefit may be offset by the surgical risks, suggesting a more conservative approach.

Design: Retrospective analysis of consecutive patients with T1-CRC who underwent ESD at 13 centres ending inclusion in 2019 (n=3373). Cases with high risk of nodal involvement (non-curative ESD: G3, submucosal invasion>1000 µm, lymphovascular involvement, budding or incomplete resection/R1) were analysed if follow-up data (endoscopy/imaging) were available, regardless of the postendoscopic management (follow-up vs surgery) selected by the multidisciplinary teams in these institutions. Comorbidities were classified according to Charlson Comorbidity Index (CCI). Outcomes were disease recurrence, death and disease-related death rates in the two groups. Rate of residual disease (RD) at both the previous resection site and regional lymph nodes was assessed in the surgical cases as well as from follow-up in the follow-up group.

Results: Of 604 patients treated by colorectal ESD for submucosally invasive cancer, 207 non-curative resections (34.3%) were included (138 male; mean age 67.6±10.9 years); in 65.2% of cases, no complete resection was achieved (R1). Of the 207 cases, 60.9% (n=126; median CCI: 3; IQR: 2-4) underwent surgical treatment with RD in 19.8% (25/126), while 39.1% (n=81, median CCI: 5; IQR: 4-6) were followed up by endoscopy in all cases. Patients in the follow-up group had a higher overall mortality (HR=3.95) due to non-CRC causes (n=9, mean survival after ESD 23.7±13.7 months). During this follow-up time, tumour recurrence and disease-specific survival rates were not different between the groups (median follow-up 30 months; range: 6-105).

Conclusion: Following ESD for a lesion at high risk of RD, follow-up only may be a reasonable choice in patients at high risk for surgery. Also, endoscopic resection quality should be improved.

Trial Registration Number: NCT03987828.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/gutjnl-2020-323897DOI Listing
January 2022

Endoscopic submucosal dissection for colorectal neoplasia: outcomes and predictors of recurrence.

Endosc Int Open 2022 Jan 14;10(1):E127-E134. Epub 2022 Jan 14.

Humanitas University, Department of Biomedical Science, Pieve Emanuele (Milan), Italy.

The role of endoscopic submucosal dissection (ESD) for colorectal lesions in Western communities is unclear and its adoption is still limited. The aim of this study is to assess the long-term outcomes of a large cohort of patients treated with colorectal ESD in a tertiary Western center. A retrospective analysis was conducted on patients treated by ESD for superficial colorectal lesions between February 2011 and November 2019. The primary outcome was the recurrence rate. Secondary outcomes were en-bloc and R0 resection rates, procedural time, adverse events (AEs), and need for surgery. The curative resection rate was assessed for submucosal invasive lesions. A total of 327 consecutive patients, median age 69 years (IQR 60-76); 201 men (61.5 %) were included in the analysis. Of the lesions, 90.8 % were resected in an en-bloc fashion. The rate of R0 resection was 83.1 % (217/261) and 44.0 % (29/66) for standard and hybrid ESD techniques, respectively. Submucosal invasion and piecemeal resection independently predicted R1 resections. A total of 18(5.5 %) intra-procedural AEs (perforation:11, bleeding:7) and 12(3.7 %) post-procedural AEs occurred (perforation:2, bleeding: 10). Eighteen adenoma recurrences per 1,000 person-years (15cases, 5.6 %) were detected after a median follow-up time of 36 months. All recurrences were detected within 12 months. No carcinoma recurrences were observed. R1 resection status and intra-procedural AEs independently predicted recurrences with seven vs 150 recurrences per 1,000 person-years in the R0 vs R1 group, respectively. Colorectal ESD is a safe and effective option for managing superficial colorectal neoplasia in a Western setting, with short and long-terms outcomes comparable to Eastern studies. En-bloc R0 resection and absence of intra-procedural AEs are associated with reduced risk of recurrence.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/a-1551-3058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8759944PMC
January 2022

Comparing the number and relevance of false activations between 2 artificial intelligence computer-aided detection systems: the NOISE study.

Gastrointest Endosc 2022 05 4;95(5):975-981.e1. Epub 2022 Jan 4.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Endoscopy Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy.

Background And Aims: Artificial intelligence has been shown to be effective in polyp detection, and multiple computer-aided detection (CADe) systems have been developed. False-positive (FP) activation emerged as a possible way to benchmark CADe performance in clinical practice. The aim of this study was to validate a previously developed classification of FPs comparing the performances of different brands of approved CADe systems.

Methods: We compared 2 different consecutive video libraries (40 video per arm) collected at Humanitas Research Hospital with 2 different CADe system brands (CADe A and CADe B). For each video, the number of CADe false activations, cause, and time spent by the endoscopist to examine the area erroneously highlighted were reported. The FP activations were classified according to the previously developed classification of FPs (the NOISE classification) according to their cause and relevance.

Results: In CADe A 1021 FP activations were registered across the 40 videos (25.5 ± 12.2 FPs per colonoscopy), whereas in CADe B 1028 were identified (25.7 ± 13.2 FPs per colonoscopy; P = .53). Among them, 22.9 ± 9.9 (89.8% in CADe A) and 22.1 ± 10.0 (86.0% in CADe B) were because of artifacts from the bowel wall. Conversely, 2.6 ± 1.9 (10.2% in CADe A) and 3.5 ± 2.1 (14% in CADe B) were caused by bowel content (P = .45). Within CADe A each false activation required .2 ± .9 seconds, with 1.6 ± 1.0 FPs (6.3%) requiring additional time for endoscopic assessment. Comparable results were reported within CADe B with .2 ± .8 seconds spent per false activation and 1.8 ± 1.2 FPs per colonoscopy requiring additional inspection.

Conclusions: The use of a standardized nomenclature provided comparable results with either of the 2 recently approved CADe systems. (Clinical trial registration number: NCT04399590.).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.gie.2021.12.031DOI Listing
May 2022

Sporadic non-ampullary duodenal adenomas: efficacy and outcomes of endoscopic resection.

Surg Endosc 2022 Jul 7;36(7):5224-5231. Epub 2022 Jan 7.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center, Rozzano, MI, Italy.

Background And Aims: Sporadic non-ampullary duodenal adenomas (SNDAs) are often referred to tertiary centers because of the challenges in endoscopic resection. There is a paucity of data on both technical and clinical outcomes. The aim of our study was to evaluate the efficacy and safety of endoscopic resection for the treatment of SNDA in two western centers.

Methods: This is a retrospective study reporting data of a cohort of patients referred for resection of SNDA between 2013 and 2017. Patients with familial adenomatous polyposis or ampullary lesions were excluded from present analysis. Outcomes considered for this study were technical success, adverse events, recurrence and need for surgery.

Results: 120 patients (mean age 66 ± 11.9 years, 64male) were enrolled in the study. Mean size of the lesions was 23.3 mm (range 5-80). Fifty-six en-bloc endoscopic mucosal resection (EMR) (46.6%), 41 piecemeal EMR (pEMR) and 23 endoscopic submucosal dissection were performed. Intra-procedural perforation was observed in 4 patients (3.3%). Fourteen post-procedural (11.6%) adverse events were recorded. All post-procedural perforations occurred in lesions > 30 mm. Recurrence was observed in 11 patients (9.5%) during a mean follow-up of 29 months. All recurrences were successfully managed endoscopically. 119 patients were still alive at last follow-up.

Conclusion: Endoscopic resection can be successfully carried out in majority of patients. Size > 30 mm seems to be the predictor of high adverse events risk.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00464-021-08900-5DOI Listing
July 2022

Submucosal tunnelling techniques for Zenker's diverticulum: a systematic review of early outcomes with pooled analysis.

Eur J Gastroenterol Hepatol 2021 12;33(1S Suppl 1):e78-e83

Gastroenterology Department, Endoscopy Unit, Humanitas Clinical and Research Center -IRCCS.

In the last decade, flexible endoscopic septotomy has been reported as a well-tolerated and effective treatment for Zenker's diverticulum. More recently, novel endoscopic submucosal tunneling techniques, namely Zenker-PerOral Endoscopic Myotomy (Z-POEM) and PerOral Endoscopic Septotomy (POES) have been proposed to obtain complete muscular septum exposure and deeper myotomy. The aim of this study is to provide a systematic review with a meta-analysis of the first experiences of third space approaches for Zenker's diverticulum. Electronic databases (Medline, Scopus, EMBASE) were searched up to October 2020. Studies including patients with symptomatic Zenker's diverticulum who underwent endoscopic treatment by submucosal tunneling technique were eligible. Procedural, clinical and safety outcomes were assessed by pooling data with a random-effect model to obtain a proportion with a 95% confidence interval. Nine retrospective studies were eligible for inclusion (196 patients). Five studies were performed in the USA, two in Europe and two in Asia. Endoscopic treatment was feasible in 96.9% (I2 = 0%) of patients. The mean procedure duration was 36.4 ± 14.3 minutes. Clinical success was achieved after 93.4% (I2 = 0%) of procedures. The overall adverse events rate was 4.9% (I2 = 0%). No differences between the two approaches (Z-POEM vs POES) have been shown in terms of both efficacy and safety. Submucosal tunneling techniques appear to be feasible for symptomatic Zenker's diverticulum, with promising results in terms of efficacy and safety outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/MEG.0000000000002318DOI Listing
December 2021

Fluid cushion protects against thermal damage during argon plasma coagulation.

Ann Gastroenterol 2021 Nov-Dec;34(6):845-851. Epub 2021 Sep 14.

Department of Biomedical Sciences, Humanitas University, Milan, Italy (Roberta Maselli, Marco Spadaccini, Alessandro Repici).

Background: Thermal damage to the muscle layer during mucosal application of argon plasma coagulation (APC) may be avoided by creating a fluid cushion within the submucosal layer, but the minimum injection volume needed or the ideal injection fluid are yet to be established. We conducted a systematic study with this aim.

Methods: All experiments were performed in an porcine gastrointestinal tract model. Five different fluids (saline, Glyceol, Gelafundin, Voluven, and Eleview) of different volumes were injected into the submucosa of different parts of the gastrointestinal tract. APC was applied to the mucosa at different power settings. Immediately after APC treatment, the temperature was measured through a thermocouple placed inside the fluid cushion, just on top of the muscle layer. The minimum volume of fluid needed to protect the muscle layer from thermal damage was determined.

Results: There was no difference in the temperature measured among the different injection fluids at the surface of the muscle, in all the locations, at equal injection volumes and power settings. The minimum amounts of fluid needed to protect the muscle layer were 2 and 3 mL for power settings of 30-90 W and 90-120 W, respectively.

Conclusions: Normal saline and 4 commercially available submucosal injection fluids possess similar thermal protective effects. To reduce the likelihood of thermal damage to deeper layers when APC is applied, a minimum injection volume of 3 mL is recommended if less than 90 W power will be utilized over 3 sec.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.20524/aog.2021.0667DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8596213PMC
September 2021

EUS-guided hepaticogastrostomy and antegrade direct peroral cholangioscopy: An effective alternative to overcome the distance (with video).

Endosc Ultrasound 2021 Nov 8. Epub 2021 Nov 8.

Department of Gastroenterology, Digestive Endoscopy Unit, Humanitas Research Hospital - IRCCS, Rozzano, Milano, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4103/EUS-D-21-00087DOI Listing
November 2021

EUS and ERCP partnership.

Endosc Ultrasound 2021 Nov 8. Epub 2021 Nov 8.

Division of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Rozzano, Digestive Endoscopy Unit, Milano, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4103/EUS-D-21-00083DOI Listing
November 2021

Right atrial mass diagnosed during endoscopic ultrasound in a patient with intraductal papillary mucinous neoplasm of the pancreas and dyspnea.

Endoscopy 2021 Oct 8. Epub 2021 Oct 8.

IRCCS Humanitas Research Hospital, Endoscopic Unit, Department of Gastroenterology, Milan, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/a-1638-9369DOI Listing
October 2021

A prospective study on quality in endoscopic retrograde cholangiopancreatography (ERCP): trend in Italy from the REQUEST study.

Endosc Int Open 2021 Oct 16;9(10):E1563-E1571. Epub 2021 Sep 16.

Department of Gastroenterology, Nuovo Regina Margherita Hospital, Roma, Italy.

Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure with a relatively high rate of adverse events. Data on training of operators and fulfillment of quality indicators in Italy are scarce. The goal of this study was to assess the overall quality of ERCP in Italy compared to international standards. This was a prospective, observational study from different Italian centers performing ERCP. Operators answered a questionnaire, then recorded data on ERCPs over a 1-to 3-month period. Nineteen Italian centers participated in the study. The most common concern of operators about training was the lack of structured programs. Seven/19 centers routinely used conscious sedation for ERCP. Forty-one experienced operators and 21 trainees performed 766 ERCPs: a successful deep biliary cannulation in native-papilla patients was achieved in 95.1 % of cases; the post-ERCP pancreatitis (PEP) rate was 5.4 % in native-papilla patients; cholangitis rate was 1.0 %; bleeding and perforation occurred in 2.7 % and 0.4 % of the patients, respectively. This study revealed that, overall, ERCP is performed in the participating Italian centers meeting good quality standards, but structured training and sedation practice are still subpar. The bleeding and perforation rate slightly exceeded the American Society of Gastrointestinal Endoscopy indicator targets but they are comparable to the reported rates from other international surveys.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/a-1531-4691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8445684PMC
October 2021

Computer-aided detection versus advanced imaging for detection of colorectal neoplasia: a systematic review and network meta-analysis.

Lancet Gastroenterol Hepatol 2021 10 5;6(10):793-802. Epub 2021 Aug 5.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Rozzano, Milan, Italy.

Background: Computer-aided detection (CADe) techniques based on artificial intelligence algorithms can assist endoscopists in detecting colorectal neoplasia. CADe has been associated with an increased adenoma detection rate, a key quality indicator, but the utility of CADe compared with existing advanced imaging techniques and distal attachment devices is unclear.

Methods: For this systematic review and network meta-analysis, we did a comprehensive search of PubMed/Medline, Embase, and Scopus databases from inception to Nov 30, 2020, for randomised controlled trials investigating the effectiveness of the following endoscopic techniques in detecting colorectal neoplasia: CADe, high definition (HD) white-light endoscopy, chromoendoscopy, or add-on devices (ie, systems that increase mucosal visualisation, such as full spectrum endoscopy [FUSE] or G-EYE balloon endoscopy). We collected data on adenoma detection rates, sessile serrated lesion detection rates, the proportion of large adenomas detected per colonoscopy, and withdrawal times. A frequentist framework, random-effects network meta-analysis was done to compare artificial intelligence with chromoendoscopy, increased mucosal visualisation systems, and HD white-light endoscopy (the control group). We estimated odds ratios (ORs) for the adenoma detection rate, sessile serrated lesion detection rate, and proportion of large adenomas detected per colonoscopy, and calculated mean differences for withdrawal time, with 95% CIs. Risk of bias and certainty of evidence were assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Findings: 50 randomised controlled trials, comprising 34 445 participants, were included in our main analysis (six trials of CADe, 18 of chromoendoscopy, and 26 of increased mucosal visualisation systems). HD white-light endoscopy was the control technique in all 50 studies. Compared with the control technique, the adenoma detection rate was 7·4% higher with CADe (OR 1·78 [95% CI 1·44-2·18]), 4·4% higher with chromoendoscopy (1·22 [1·08-1·39]), and 4·1% higher with increased mucosal visualisation systems (1·16 [1·04-1·28]). CADe ranked as the superior technique for adenoma detection (with moderate confidence in hierarchical ranking); cross-comparisons of CADe with other imaging techniques showed a significant increase in the adenoma detection rate with CADe versus increased mucosal visualisation systems (OR 1·54 [95% CI 1·22-1·94]; low certainty of evidence) and with CADe versus chromoendoscopy (1·45 [1·14-1·85]; moderate certainty of evidence). When focusing on large adenomas (≥10 mm) there was a significant increase in the detection of large adenomas only with CADe (OR 1·69 [95% CI 1·10-2·60], moderate certainty of evidence) when compared to HD white-light endoscopy; CADe ranked as the superior strategy for detection of large adenomas. CADe also seemed to be the superior strategy for detection of sessile serrated lesions (with moderate confidence in hierarchical ranking), although no significant increase in the sessile serrated lesion detection rate was shown (OR 1·37 [95% CI 0·65-2·88]). No significant difference in withdrawal time was reported for CADe compared with the other techniques.

Interpretation: Based on the published literature, detection rates of colorectal neoplasia are higher with CADe than with other techniques such as chromoendoscopy or tools that increase mucosal visualisation, supporting wider incorporation of CADe strategies into community endoscopy services.

Funding: None.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S2468-1253(21)00215-6DOI Listing
October 2021

Safety and efficacy of multiband mucosectomy for Barrett's esophagus: a systematic review with pooled analysis.

Ann Gastroenterol 2021 Jul-Aug;34(4):487-492. Epub 2021 Apr 2.

Endoscopy Unit "Humanitas Research Hospital", MI, Italy (Marco Spadaccini, Roberta Maselli, Piera Alessia Galtieri, Alessandro Fugazza, Andrea Anderloni, Silvia Carrara, Gaia Pellegatta, Alessandro Repici).

Background: According to guidelines, all visible lesions in Barrett's esophagus (BE) should be endoscopically resected. Available methods of endoscopic resection include the cap-assisted technique and, more recently, multiband mucosectomy (MBM). Data on the efficacy and safety of MBM have yet to be systematically reviewed. We performed the first systematic review with pooled analysis to evaluate the outcomes of MBM in patients with BE.

Methods: Electronic databases (Medline, Scopus, EMBASE) were searched up to August 2019. Studies including patients with BE who underwent MBM were eligible. The primary outcome was the adverse events rate. Secondary outcomes were the proportions of complete resections and R0 resections. Outcomes were assessed by pooling data using a random or fixed-effect model, according to the degree of heterogeneity, to obtain a proportion with a 95% confidence interval.

Results: Fourteen studies were eligible (1334 procedures, 986 patients). The adverse event rate was 5.3%. Immediate and post-procedural bleeding, perforations and strictures occurred in 0.2%, 0.7%, 0.3% and 3.9% of procedures, respectively. Focal lesions were resected at a complete rate of 97.6% with an R0 resection rate of 94.1%.

Conclusion: MBM is a safe and effective technique for treating visible lesions in BE.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.20524/aog.2021.0620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276358PMC
April 2021

Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes.

Am J Gastroenterol 2021 09;116(9):1853-1858

Endoscopy Unit, Humanitas Clinical and Research Center, RCCS, Milano, Italy.

Introduction: 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.

Methods: 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.

Results: 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.

Discussion: 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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.14309/ajg.0000000000001356DOI Listing
September 2021

Artificial intelligence and colonoscopy experience: lessons from two randomised trials.

Gut 2022 04 29;71(4):757-765. Epub 2021 Jun 29.

Gastroenterology and Digestive Endoscopy Unit, Ospedale Nuovo Regina Margherita, Roma, Italy.

Background And Aims: Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1).

Methods: In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40-80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting.

Results: In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis.

Conclusions: In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR.

Trial Registration Number: NCT:04260321.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/gutjnl-2021-324471DOI Listing
April 2022

Systematic review with meta-analysis: the long-term efficacy of Barrett's endoscopic therapy-stringent selection criteria and a proposal for definitions.

Aliment Pharmacol Ther 2021 08 24;54(3):222-233. Epub 2021 Jun 24.

Department of Gastroenterology, Kansas City VA Medical Center, Kansas City, MO, USA.

Background: Barrett's endoscopic therapy (BET) is well established for neoplasia in Barrett's oesophagus using a concept of complete eradication of all Barrett's. However, long-term efficacy is not known.

Aims: To perform a systematic review and meta-analysis to examine long-term efficacy of BET for Barrett's neoplasia.

Methods: Electronic databases were searched for studies meeting stringent criteria: (a) subjects with high-grade dysplasia and/or superficial adenocarcinoma who underwent BET (ablation ± endoscopic mucosal resection); (b) BET completion by confirmation of complete eradication of neoplasia (CE-N) and intestinal metaplasia (CE-IM) with systematic sampling and (c) clearly defined follow-up (endoscopy and biopsy) protocol of ≥2 years thereafter for detection of recurrence. Pooled estimates of CE-N and CE-IM after BET completion and follow-up were analysed.

Results: Eight studies met the stringent criteria (n = 794, males 89%, age 64.6 years). Despite high efficacy of BET at therapy completion (CE-N: 95.9 [91.7-98.7]%; CE-IM: 90.9 [83-96.6]%), this declined (CE-N: 89 [73.4-98.2]%; CE-IM: 77.8 [65.6-88]%) over 3.4 years of follow-up. There was considerable heterogeneity. Only two studies reported a post-BET follow-up of >5 years (CE-IM 50 [41.5%-58.5]%). Higher person years of follow-up seem to correlate with decrease in BET efficacy.

Conclusion: Using stringent criteria for appropriate study selection with sufficient follow-up, a lack of high-quality controlled intervention trials becomes evident for assessment of long-term durable remission rates of BET despite initial high success rates. We plea for a uniform documentation of study details which could be used in future trials.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/apt.16473DOI Listing
August 2021
-->