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

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.

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

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.

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

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.

Novel 1-L polyethylene glycol + ascorbate versus high-volume polyethylene glycol regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study.

BACKGROUND AND AIMS: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens. METHODS: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety. RESULTS: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority = .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority = .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P = .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found. CONCLUSIONS: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.).

Retrospective multicenter study on endoscopic treatment of upper GI postsurgical leaks.

BACKGROUND AND AIMS: Therapeutic endoscopy plays a critical role in the management of upper GI (UGI) postsurgical leaks. Data are scarce regarding clinical success and safety. Our aim was to evaluate the effectiveness of endoscopic therapy for UGI postsurgical leaks and associated adverse events (AEs) and to identify factors associated with successful endoscopic therapy and AE occurrence. METHODS: This was a retrospective, multicenter, international study of all patients who underwent endoscopic therapy for UGI postsurgical leaks between 2014 and 2019. RESULTS: Two hundred six patients were included. Index surgery most often performed was sleeve gastrectomy (39.3%), followed by gastrectomy (23.8%) and esophagectomy (22.8%). The median time between index surgery and commencement of endoscopic therapy was 16 days. Endoscopic closure was achieved in 80.1% of patients after a median follow-up of 52 days (interquartile range, 33-81.3). Seven hundred seventy-five therapeutic endoscopies were performed. Multimodal therapy was needed in 40.8% of patients. The cumulative success of leak resolution reached a plateau between the third and fourth techniques (approximately 70%-80%); this was achieved after 125 days of endoscopic therapy. Smaller leak initial diameters, hospitalization in a general ward, hemodynamic stability, absence of respiratory failure, previous gastrectomy, fewer numbers of therapeutic endoscopies performed, shorter length of stay, and shorter times to leak closure were associated with better outcomes. Overall, 102 endoscopic therapy-related AEs occurred in 81 patients (39.3%), with most managed conservatively or endoscopically. Leak-related mortality rate was 12.4%. CONCLUSIONS: Multimodal therapeutic endoscopy, despite being time-consuming and requiring multiple procedures, allows leak closure in a significant proportion of patients with a low rate of severe AEs.

Saline-immersion peroral endoscopic septotomy: a case report.

Video 1Saline-immersion peroral endoscopic septotomy.

Is there a best choice of equipment for colorectal endoscopic submucosal dissection?

INTRODUCTION: Endoscopic submucosal dissection (ESD) is a widely used technique to remove early neoplastic lesions. It was primarily used in the initial days to treat gastric lesions, but recently, the horizon of this endoscopic procedure has expanded, which has allowed us to manage other technically more complex locations, such as the colorectum. AREAS COVERED: There has been an exponential growth regarding the wide range of devices available in the market for performing colorectal ESD. As a result, the aim of this review is to highlight the indication of this endoscopic technique, which device is best suited for which indication, as well as future trajectories in this field. EXPERT OPINION: Although some devices have proven to be more advantageous than others in this area, very often the choice is still subjective, which is commonly attributed to individual preferences and experience. However, an accurate knowledge of the available tools and their functioning, with their pros and cons, is fundamental for any endoscopist venturing into the field of third space endoscopy. In this way, one can choose which device best suits a particular situation, along with simultaneously having the wealth of knowledge related to therapeutic armamentarium at our disposal in the endoscopy suite.

Cold-snare endoscopic resection of non-ampullary duodenal adenomas: Systematic review and pooled-analysis.

BACKGROUND: Mirroring the experience with colonic resections, cold snare-based techniques have been recently proposed for non-ampullary duodenal lesions to reduce the risk of adverse events (AEs). As the duodenal wall is thinner and more vascularized than in the colon, electrocautery-related AEs are relevant issues in this setting. AIMS: We performed a systematic review with pooled-analysis to evaluate the efficacy and safety of this technique. METHODS: Electronic databases (Medline, Scopus, EMBASE) were searched up to January 2023. Full articles including patients with duodenal lesions resected by cold-snare technique were eligible. The adverse events (i.e., bleeding, perforation, stricture), complete resection, and recurrence rates were pooled using a random model. RESULTS: Eleven studies were eligible, providing data on 3137 lesions removed from 233 patients. The overall AE rate for cold snaring was 0.25% (95% CI, 0.19%-0.69%). Among the three studies comparing cold- and hot-snare approaches, procedure-related bleeding rate was significantly lower with cold approach (OR 1.21, 0.51-2.85; p = 0.66). The complete resection rate was 99.40% (95% CI, 98.60%-100%), with a residual/recurrence rate of 12.95% (95% CI, 4.75%-21.16%). On univariate meta-regression, lesion size significantly affected both the adverse events and recurrence risk. CONCLUSION: Cold-snare resection appears effective and extremely safe for resecting non-ampullary duodenal lesions.

Microbial composition associated with biliary stents in patients undergoing pancreatic resection for cancer.

Malignant bile duct obstruction is typically treated by biliary stenting, which however increases the risk of bacterial infections. Here, we analyzed the microbial content of the biliary stents from 56 patients finding widespread microbial colonization. Seventeen of 36 prevalent stent species are common oral microbiome members, associate with disease conditions when present in the gut, and include dozens of biofilm- and antimicrobial resistance-related genes. This work provides an overview of the microbial communities populating the stents.

Cold resection for colorectal polyps: where we are and where we are going?

INTRODUCTION: Endoscopic resection of colonic precancerous lesions has been demonstrated to significantly decrease colorectal cancer (CRC) incidence and mortality. Among resection techniques, cold snare polypectomy (CSP) has been shown as a highly feasible, effective and safe option and is widely used in clinical practice, being regarded as the first-line technique for removal of small and diminutive colorectal polyps. On the other hand, conventional hot snare polypectomy (HSP) and endoscopic mucosal resection (EMR), namely the gold standard treatments for larger polyps, may be occasionally associated to complications due to electrocautery injury. AREAS COVERED: To overcome these shortcomings of electrocautery-based resection techniques, in the last few years CSP has been increasingly assessed as a treatment option for additional indications, with a focus on nonpedunculated colorectal polyps ≥10 mm. EXPERT OPINION: This review aims to present current and widened indications of CSP discussing the latest findings from the most remarkable studies, with an insight into technical issues, novelties and potential advances in the near future.

Feasibility and safety of a new dedicated biliary stent for EUS-guided hepaticogastrostomy: The FIT study (with video).

Background and Objectives: EUS-guided biliary drainage (BD) through hepaticogastrostomy (HGS) is an option in case of ERCP failure. Available data suggest that this procedure may be challenging with possible severe adverse events (AEs) mainly due to stent migration. The aim of our pilot study was to prospectively assess the technical and clinical outcomes of EUS-HGS using a new dedicated partially covered self-expandable metal stent with anti-migratory systems. Methods: This is a single-center prospective study enrolling patients with malignant biliary obstruction undergoing EUS-HGS after failed ERCP, between June 2020 and March 2021. The primary endpoint was the technical success rate. Evaluation of specific stent-related technical features as compared with commonly used self-expandable metal stent, clinical success rate, and procedure-related AEs was also assessed. Results: Twenty-two patients (15%-68.2%, female; mean age, 66.0 ± 10.0) were enrolled in the study analysis. Different causes of ERCP failure were infiltration of papilla by neoplastic tissue (4, 18.2%), unreachable papilla for duodenal stricture (9, 40.9%), surgically altered anatomy with Roux-en-Y reconstruction (4, 18.2%), and incomplete BD after transpapillary stent placement (5, 22.7%). Technical success was achieved in all patients, in a mean procedural time of 43.3 ± 26.8 min. Technical features were graded as high or medium in all cases. The clinical success rate was 91% (20/22, mean follow-up: 10.8 ± 3.1 months). There were no cases of stent misplacement or stent migration. Three (13.6%) cases of a hepatic abscess requiring percutaneous drainage and systemic antibiotics were reported, with no impact on clinical success and following oncologic treatments. No deaths occurred. Conclusion: EUS-HGS with a new dedicated stent with anti-migratory systems is feasible and effective, preventing stent migration, and misplacement. Although the persistent procedural challenges, dedicated devices may contribute to outcomes improvement and procedure diffusion.

Updates on the Management of Ampullary Neoplastic Lesions.

Ampullary neoplastic lesions (ANLs) represent a rare cancer, accounting for about 0.6-0.8% of all gastrointestinal malignancies, and about 6-17% of periampullary tumors. They can be sporadic or occur in the setting of a hereditary predisposition syndrome, mainly familial adenomatous polyposis (FAP). Usually, noninvasive ANLs are asymptomatic and detected accidentally during esophagogastroduodenoscopy (EGD). When symptomatic, ANLs can manifest differently with jaundice, pain, pancreatitis, cholangitis, and melaena. Endoscopy with a side-viewing duodenoscopy, endoscopic ultrasound (EUS), and magnetic resonance cholangiopancreatography (MRCP) play a crucial role in the ANL evaluation, providing an accurate assessment of the size, location, and characteristics of the lesions, including the staging of the depth of tumor invasion into the surrounding tissues and the involvement of local lymph nodes. Endoscopic papillectomy (EP) has been recognized as an effective treatment for ANLs in selected patients, providing an alternative to traditional surgical methods. Originally, EP was recommended for benign lesions and patients unfit for surgery. However, advancements in endoscopic techniques have broadened its indications to comprise early ampullary carcinoma, giant laterally spreading lesions, and ANLs with intraductal extension. In this paper, we review the existing evidence on endoscopic diagnosis and treatment of ampullary neoplastic lesions.

Pilot study on a new endoscopic platform for colorectal endoscopic submucosal dissection.

Background: The endoscopic submucosal dissection (ESD) is a technically demanding and time-consuming procedure, with an increased risk of adverse events compared to standard endoscopic resection techniques. The main difficulties are related to the instability of the operating field and to the loss of traction. We aimed to evaluate in a pilot trial a new endoscopic platform [tissue retractor system (TRS); ORISE, Boston scientific Co., Marlborough, MA, USA], designed to stabilize the intraluminal space, and to provide tissue retraction and counter traction. Method: We prospectively enrolled all consecutive patients who underwent an ESD for sigmoid/rectal lesions. The primary outcome was the rate of technical feasibility. Further technical aspects such as en-bloc and R0 resection rate, number of graspers used, circumferential incision time, TRS assemblage time, submucosal dissection time, and submucosal dissection speed were provided. Clinical outcomes (recurrence rate and adverse events) were recorded as well. Results: In all, 10 patients (M/F 4/6, age: 70.4 ± 11.0 years old) were enrolled. Eight out of 10 lesions were located in the rectum. Average lesion size was 31.2 ± 2.7 mm, and mean lesion area was 1628.88 ± 205.3 mm2. The two sigmoid lesions were removed through standard ESD, because the platform assemblage failed after several attempts. All rectal lesions were removed in an en-bloc fashion. R0 resection was achieved in 7/8 (87.5%) patients in an average procedure time of 60.5 ± 23.3 min. None of the patients developed neither intraprocedural nor postprocedural adverse events. Conclusion: TRS-assisted ESD is a feasible option when used in the rectum, with promising result in terms of efficacy and safety outcomes. Nevertheless, our pilot study underlines few technical limitations of the present platform that need to be overcome before the system could be widely and routinely used.