Evaluation of Computer-Aided Detection During Colonoscopy in the Community (AI-SEE): A Multicenter Randomized Clinical Trial.

INTRODUCTION: There has been increasing interest in artificial intelligence in gastroenterology. To reduce miss rates during colonoscopy, there has been significant exploration in computer-aided detection (CADe) devices. In this study, we evaluate the use of CADe in colonoscopy in community-based, nonacademic practices. METHODS: Between September 28, 2020, and September 24, 2021, a randomized controlled trial (AI-SEE) was performed evaluating the impact of CADe on polyp detection in 4 community-based endoscopy centers in the United States Patients were block-randomized to undergoing colonoscopy with or without CADe (EndoVigilant). Primary outcomes measured were adenomas per colonoscopy and adenomas per extraction (the percentage of polyps removed that are adenomas). Secondary end points included serrated polyps per colonoscopy; nonadenomatous, nonserrated polyps per colonoscopy; adenoma and serrated polyp detection rates; and procedural time. RESULTS: A total of 769 patients were enrolled (387 with CADe), with similar patient demographics between the 2 groups. There was no significant difference in adenomas per colonoscopy in the CADe and non-CADe groups (0.73 vs 0.67, P = 0.496). Although the use of CADe did not improve identification of serrated polyps per colonoscopy (0.08 vs 0.08, P = 0.965), the use of CADe increased identification of nonadenomatous, nonserrated polyps per colonoscopy (0.90 vs 0.51, P < 0.0001), resulting in detection of fewer adenomas per extraction in the CADe group. The adenoma detection rate (35.9 vs 37.2%, P = 0.774) and serrated polyp detection rate (6.5 vs 6.3%, P = 1.000) were similar in the CADe and non-CADe groups. Mean withdrawal time was longer in the CADe group compared with the non-CADe group (11.7 vs 10.7 minutes, P = 0.003). However, when no polyps were identified, there was similar mean withdrawal time (9.1 vs 8.8 minutes, P = 0.288). There were no adverse events. DISCUSSION: The use of CADe did not result in a statistically significant difference in the number of adenomas detected. Additional studies are needed to better understand why some endoscopists derive substantial benefits from CADe and others do not. ClinicalTrials.gov number: NCT04555135.

Randomized Controlled Trial Investigating Cold Snare and Forceps Polypectomy Among Small POLYPs in Rates of Complete Resection: The TINYPOLYP Trial.

INTRODUCTION: Optimizing complete resection during colonoscopy is important because residual neoplastic tissue may play a role in interval cancers. The US Multi-Society Task Force recommends diminutive (≤5 mm) and small (6-9 mm) polyps be removed by cold snare polypectomy (CSP). However, evidence is less clear whether CSP retains significant advantage over cold forceps polypectomy (CFP) for polyps ≤3 mm. METHODS: This study is a single-center prospective noninferiority randomized clinical trial evaluating CFP and CSP for nonpedunculated polyps ≤3 mm. Patients 18 years and older undergoing colonoscopy for any indication were recruited. During each colonoscopy, polyps underwent block randomization to removal with CFP or CSP. After polypectomy, 2 biopsies were taken from the polypectomy margin. The primary noninferiority outcome was the complete resection rate, defined by absence of residual polyp in the margin biopsies. RESULTS: A total of 179 patients were included. Patients had similar distribution in age, sex, race/ethnicity, as well as indication of procedure. A total of 279 polyps ≤3 mm were identified, with 138 in the CSP group and 141 in the CFP group. Mean polypectomy time was longer for CSP compared with CFP (42.3 vs 23.2 seconds, P < 0.001), although a higher proportion of polyps removed by CFP were removed in more than 1 piece compared with CSP (15.6 vs 3.6%, P < 0.001). There were positive margin biopsies in 2 cases per cohort, with a complete resection rate of 98.3% in both groups. There was no significant difference in cohorts in complete resection rates (difference in complete resection rates was 0.057%, 95% confidence interval: -4.30% to 4.53%), demonstrating noninferiority of CFP compared with CSP. DISCUSSION: Use of CFP was noninferior to CSP in the complete resection of nonpedunculated polyps ≤3 mm. CSP required significantly more time to perform compared with CFP. CFP should be considered an acceptable alternative to CSP for removal of polyps ≤3 mm.

Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4-9 mm polyps.

INTRODUCTION: Currently, cold snare polypectomy (CSP) without submucosal injection is recommended for removing polyps < 10 mm. Use of viscous submucosal agents has not been previously evaluated in CSP. We investigate the potential role of EverLift™ (GI Supply, Pennsylvania) in CSP. METHODS: The study is a single-center prospective randomized non-inferiority clinical trial evaluating CSP of non-pedunculated 4-9 mm polyps, with or without submucosal injection of EverLift™. Patients 18-80 years of age presenting for colonoscopy were recruited. Eligible polyps underwent block randomization to CSP with or without EverLift™. Following CSP, two biopsies were performed at the CSP site margin. The primary non-inferiority outcome was complete resection rate, defined by absence of residual polyp in the margin biopsies (non-inferiority margin -10%). RESULTS: A total of 291 eligible polyps underwent CSP, with 142 removed using EverLift™. There was similar polyp size and distribution of pathology between the two groups. Overall, there was a low rate of positive margins with (1.4%) or without submucosal injection (2.8%), with no significant difference in complete resection (difference 1.28%, 95% CI: -2.66 to 5.42%), demonstrating non-inferiority of EverLift™ injection. Use of EverLift™ significantly increased CSP time (109.8 vs 38.8 s, p < 0.0001) and frequency of use of hemostatic clips (13.4 vs 3.6%, p = 0.002). CONCLUSION: Submucosal injection of EverLift™ was non-inferior to CSP of 4-9 mm polyps without injection and increased time for resection as well as use of hemostatic clips to control acute bleeding. Our results suggest that polypectomy of 4-9 mm polyps can be safely performed without submucosal injection of EverLift™.

Evaluation of ethnic influence in the application of a hepatocellular carcinoma predictive model for chronic hepatitis C.

Currently, there is no well-established algorithm predicting hepatocellular carcinoma (HCC) development in untreated hepatitis C virus (HCV) patients. We aimed to validate an algorithm (risk evaluation of viral load elevation and associated liver disease/HCV [REVEAL-HCV]: age, AST, ALT, HCV RNA, HCV genotype, and cirrhosis) developed in Taiwanese patients. We analyzed 1381 (50.1% White, 14.7% Hispanic, 13.8% Asian of diverse origin, and 7.8% African American) adult treatment-naïve HCV patients (no viral co-infection, no HCC within 6 months) at 4 U.S. and one Hong Kong centers (11/1994-10/2017). Compared to the non-Asian cohort, the Asian cohort had a higher percentage of patients in the low-risk group (46.1% vs. 26.1%) and a lower percentage in the high-risk group (12.0% vs. 20.3%, p < 0.01). Overall, 5-year HCC incidence were 1.75%, 4.71%, and 24.4% for low, medium, and high-risk patients, respectively (p < 0.0001). For the overall cohort, area under receiving operating characteristic curve (AUROC) for HCC prediction were 0.83 (95% confidence interval [CI]: 0.72-0.93), 0.82 (95% CI: 0.75-0.88), and 0.84 (95% CI: 0.77-0.89) for 1-, 3-, and 5-year HCC risk, respectively. There was a slightly lower AUROC for Asians compared to the non-Asian cohort at 3 years (0.75 vs. 0.83) and 5 years (0.78 vs. 0.84), though this was not statistically significant. In multivariable analysis, we found male sex, presence of metabolic syndrome as well as the risk score categories to be independently associated with HCC but not ethnicity. The REVEAL-HCV risk score has good validity for both Asian and non-Asian populations. Further studies should consider additional factors, such as sex, metabolic syndrome, and treatment status.

Antiviral therapy and the development of osteopenia/osteoporosis among Asians with chronic hepatitis B.

BACKGROUND: Recent studies have suggested a potential increase in the incidence of osteoporosis for patients receiving tenofovir disoproxil fumarate (TDF), but this issue remains controversial. METHODS: The retrospective cohort study of 1224 Asian chronic hepatitis B (CHB) patients greater than 18 years without baseline osteopenia/osteoporosis seen at four US centers from 2008 to 2016. Patients were categorized into three groups-treatment-naive patients who initiated therapy with TDF (1) or entecavir (ETV) (2), or untreated patients (3). Patients were followed until the development of osteopenia/osteoporosis or end of the study. RESULTS: Of the 1224 study patients, 276 were treated with TDF, 335 with ETV, and 613 were untreated. The prevalence of cirrhosis was lower for untreated patients (2.6% vs 16.3% for TDF and 17.6% for ETV; P < 0.001). The 8-year cumulative incidence rate of osteopenia/osteoporosis was 13.17% for TDF, 15.09% for ETV, and 10.17% for untreated patients, with no statistically significant difference among the three groups ( P = 0.218). On multivariate Cox regression controlling for demographics, osteoporosis risk factors, albumin, and hepatitis B virus (HBV) DNA levels, neither TDF (adjusted hazard ratio [HR] = 0.74; 95% confidence interval [CI]: 0.34 and 1.59) nor ETV (adjusted HR = 0.98; 95% CI: 0.51 and 1.90) were associated with increased osteopenia/osteoporosis risk compared with untreated patients. CONCLUSIONS: Our retrospective study suggests that there is no significant increase in the incidence of osteopenia/osteoporosis for patients with CHB treated with TDF or ETV during a median follow-up of about 4 to 5 years. However, further study with longer follow-up is needed as an anti-HBV therapy, which is often lifelong or long-term and the development of osteopenia/osteoporosis can be a slow process.

Biomechanical Analysis of Scapholunate Ligament Repair Techniques.

PURPOSE: To evaluate the biomechanical properties of 3 scapholunate repair techniques. METHODS: In 51 cadavers, the scapholunate ligament was exposed through a dorsal approach, incised at its scaphoid insertion, and repaired using 1 of 3 techniques: 2 single-loaded suture anchors, 2 double-loaded suture anchors, or 2 transosseous sutures. Twenty-four repaired specimens underwent load to failure (LTF) testing using tensile distraction on a servo-hydraulic machine. Twenty-seven specimens underwent cyclical testing to measure gap formation at the scapholunate joint. RESULTS: The mode of failure was suture pullout through the substance of the ligament in 22 specimens, failure at the bone suture interface in 1, and anchor pullout in 1. Double-loaded anchor repairs demonstrated a significantly higher mean ultimate LTF compared with single-loaded anchor (91 N vs 35 N) and transosseous (91 N vs 60 N) repairs. Transosseous repairs demonstrated a higher mean ultimate LTF compared with single-loaded suture repairs (60 N vs 35 N). After 300 cycles, the average gap for the transosseous repair group was double that for the single- and double-loaded repairs, although not statistically significant. CONCLUSIONS: Primary scapholunate ligament repairs using double-loaded suture anchors demonstrated significantly higher strength compared with single-loaded anchors and transosseous repairs. On cyclic loading, transosseous repairs demonstrated the greatest gap formation with no measurable difference between single- and double-loaded repairs. CLINICAL RELEVANCE: In a cadaveric model for primary repairs, double-loaded suture anchors demonstrated the highest LTF and offer a similar but unproven performance in vivo.

Strategies to manage the difficult colonoscopy.

During endoscopy, an endoscopist is inevitably faced with the occasional "difficult colonoscopy," in which the endoscopist finds it challenging to advance the endoscope to the cecum. Beyond optimization of technique, with minimized looping, minimal insufflation, sufficient sedation, and abdominal splinting when needed, sometimes additional tools may be needed. In this review, we cover available techniques and technologies to help navigate the difficult colonoscopy, including the ultrathin colonoscope, rigidizing overtube, balloon-assisted colonoscopy and the abdominal compression device.

Multicenter evaluation of recurrence in endoscopic submucosal dissection and endoscopic mucosal resection in the colon: A Western perspective.

BACKGROUND: While colon endoscopic mucosal resection (EMR) is an effective technique, removal of larger polyps often requires piecemeal resection, which can increase recurrence rates. Endoscopic submucosal dissection (ESD) in the colon offers the ability for en bloc resection and is well-described in Asia, but there are limited studies comparing ESD vs EMR in the West. AIM: To evaluate different techniques in endoscopic resection of large polyps in the colon and to identify factors for recurrence. METHODS: The study is a retrospective comparison of ESD, EMR and knife-assisted endoscopic resection performed at Stanford University Medical Center and Veterans Affairs Palo Alto Health Care System between 2016 and 2020. Knife-assisted endoscopic resection was defined as use of electrosurgical knife to facilitate snare resection, such as for circumferential incision. Patients ≥ 18 years of age undergoing colonoscopy with removal of polyp(s) ≥ 20 mm were included. The primary outcome was recurrence on follow-up. RESULTS: A total of 376 patients and 428 polyps were included. Mean polyp size was greatest in the ESD group (35.8 mm), followed by knife-assisted endoscopic resection (33.3 mm) and EMR (30.5 mm) (P < 0.001). ESD achieved highest en bloc resection (90.4%) followed by knife-assisted endoscopic resection (31.1%) and EMR (20.2%) (P < 0.001). A total of 287 polyps had follow-up (67.1%). On follow-up analysis, recurrence rate was lowest in knife-assisted endoscopic resection (0.0%) and ESD (1.3%) and highest in EMR (12.9%) (P = 0.0017). En bloc polyp resection had significantly lower rate of recurrence (1.9%) compared to non-en bloc (12.0%, P = 0.003). On multivariate analysis, ESD (in comparison to EMR) adjusted for polyp size was found to significantly reduce risk of recurrence [adjusted hazard ratio 0.06 (95%CI: 0.01-0.57, P = 0.014)]. CONCLUSION: In our study, EMR had significantly higher recurrence compared to ESD and knife-assisted endoscopic resection. We found factors including resection by ESD, en bloc removal, and use of circumferential incision were associated with significantly decreased recurrence. While further studies are needed, we have demonstrated the efficacy of ESD in a Western population.

Immunoglobulin G4-Seronegative Autoimmune Cholangiopathy With Pancreatic and Hepatic Involvement Mimicking as Primary Sclerosing Cholangitis.

Immunoglobulin G4-seronegative autoimmune cholangiopathy is a rare cause of biliary strictures. We describe a 27-year-old man presenting with elevated liver enzymes, recurrent cholangitis/bacteremia, biliary strictures, and normal immunoglobulin G4 levels, who was initially diagnosed with primary sclerosing cholangitis, and later listed for transplantation for recurrent bacteremia. Subsequent surveillance imaging demonstrated morphologic changes consistent with biliary strictures and autoimmune pancreatitis. Initiating corticosteroids resulted in liver enzyme normalization and stricture improvement. Diagnosing seronegative autoimmune cholangiopathy remains challenging given similar presentation to primary sclerosing cholangitis. This case highlights importance of a wide differential for biliary strictures, with increased suspicion in those developing pancreatic changes in this setting.

Subcutaneous Sweet Syndrome Successfully Treated With Ustekinumab in a Patient With Ulcerative Colitis.

Ustekinumab, an inhibitor of the interleukin-12/23 pathway, received Food and Drug Administration (FDA) approval in 2019 for induction and maintenance therapy in patients with moderate-to-severe ulcerative colitis (UC). Data regarding the efficacy of ustekinumab in the treatment of extraintestinal manifestations of UC are unclear. Sweet syndrome, an acute febrile neutrophilic dermatosis, is a cutaneous manifestation of inflammatory bowel disease that parallels disease activity. In this study, we present the first case of subcutaneous Sweet syndrome with sterile osteomyelitis in a patient with UC successfully treated with ustekinumab.

De Novo Diagnosis of Lymphocytic Colitis After SARS-CoV-2 Vaccination.

SARS-CoV-2 mRNA vaccines are safe and effective for most patients. Gastrointestinal complications reported after vaccination have included gastroparesis and inflammatory bowel disease flares. In this study, we present a unique case of lymphocytic colitis that occurred in a healthy middle-aged man after Moderna SARS-CoV-2 mRNA vaccination. This reveals an unexpected complication of a mRNA vaccine that presented as worsening diarrhea after vaccination in a dose-dependent pattern. Caregivers should be aware of lymphocytic colitis as a possible complication of the Moderna vaccine and monitor those patients closely for symptom resolution.

Clinical evaluation of a real-time artificial intelligence-based polyp detection system: a US multi-center pilot study.

Artificial intelligence (AI) has increasingly been employed in multiple fields, and there has been significant interest in its use within gastrointestinal endoscopy. Computer-aided detection (CAD) can potentially improve polyp detection rates and decrease miss rates in colonoscopy. However, few clinical studies have evaluated real-time CAD during colonoscopy. In this study, we analyze the efficacy of a novel real-time CAD system during colonoscopy. This was a single-arm prospective study of patients undergoing colonoscopy with a real-time CAD system. This AI-based system had previously been trained using manually labeled colonoscopy videos to help detect neoplastic polyps (adenomas and serrated polyps). In this pilot study, 300 patients at two centers underwent elective colonoscopy with the CAD system. These results were compared to 300 historical controls consisting of consecutive colonoscopies performed by the participating endoscopists within 12 months prior to onset of the study without the aid of CAD. The primary outcome was the mean number of adenomas per colonoscopy. Use of real-time CAD trended towards increased adenoma detection (1.35 vs 1.07, p = 0.099) per colonoscopy though this did not achieve statistical significance. Compared to historical controls, use of CAD demonstrated a trend towards increased identification of serrated polyps (0.15 vs 0.07) and all neoplastic (adenomatous and serrated) polyps (1.50 vs 1.14) per procedure. There were significantly more non-neoplastic polyps detected with CAD (1.08 vs 0.57, p < 0.0001). There was no difference in ≥ 10 mm polyps identified between the two groups. A real-time CAD system can increase detection of adenomas and serrated polyps during colonoscopy in comparison to historical controls without CAD, though this was not statistically significant. As this pilot study is underpowered, given the findings we recommend pursuing a larger randomized controlled trial to further evaluate the benefits of CAD.

Early Esophageal Cancer: What the Gastroenterologist Needs to Know.

Endoscopic findings in early esophageal cancer are often subtle and require careful inspection and meticulous endoscopic examination. When dysplasia is suspected, we recommend performing 1 or 2 targeted biopsies of the abnormal area and review with a pathologist specialized in evaluating gastrointestinal diseases. In the case of adenocarcinoma, after resection of any visible cancer, residual Barrett's can be treated by ablation. Endoscopic resection can offer the opportunity for patients to avoid surgery. Further studies are needed to evaluate the optimal management of circumferential and near-circumferential lesions as well as tools and techniques to facilitate the performance of endoscopic submucosal dissection and endoscopic mucosal resection.

Over-the-Scope Clip in the Treatment of Gastrointestinal Leaks and Perforations.

While perforations, postoperative fistulas, and leaks have traditionally led to surgical or interventional radiology consultation for management, the introduction of the over-the-scope clip has allowed increased therapeutic possibilities for endoscopists. While primarily limited to case reports and series, the over-the-scope clip successfully manages gastrointestinal bleeding, perforations, as well as postoperative leaks and fistulas. Retrospective studies have demonstrated a relatively high success rate and a low complication rate. Given the similarity to variceal banding equipment, the learning curve with the over-the-scope clip is rapid. However, given the higher risk of procedures involving the use of the over-the-scope clip, it is essential to obtain the scope in a stable position and grasp sufficient tissue with the cap using a grasping tool and/or suction. From our experience, while closure may be successful in lesions sized up to 3 cm, successful outcomes are obtained for lesions sized <1 cm. Ultimately, given the limited available data, prospective randomized trials are needed to better evaluate the utility of the over-the-scope clip in various clinical scenarios, including fistula and perforation management.

Artificial intelligence applications in inflammatory bowel disease: Emerging technologies and future directions.

Inflammatory bowel disease (IBD) is a complex and multifaceted disorder of the gastrointestinal tract that is increasing in incidence worldwide and associated with significant morbidity. The rapid accumulation of large datasets from electronic health records, high-definition multi-omics (including genomics, proteomics, transcriptomics, and metagenomics), and imaging modalities (endoscopy and endomicroscopy) have provided powerful tools to unravel novel mechanistic insights and help address unmet clinical needs in IBD. Although the application of artificial intelligence (AI) methods has facilitated the analysis, integration, and interpretation of large datasets in IBD, significant heterogeneity in AI methods, datasets, and clinical outcomes and the need for unbiased prospective validations studies are current barriers to incorporation of AI into clinical practice. The purpose of this review is to summarize the most recent advances in the application of AI and machine learning technologies in the diagnosis and risk prediction, assessment of disease severity, and prediction of clinical outcomes in patients with IBD.

Hepatitis B Virus Reactivation Potentiated by Biologics.

Hepatitis B virus (HBV) reactivation can be a serious complication for patients with chronic or resolved HBV infection when treated with biologics. For HBsAg-positive patients receiving biologics, the risk of HBV reactivation is moderate to high. HBsAg-negative/anti-HBc positive patients are at lower risk of HBV reactivation than HBsAg-positive patients. However, patients taking anti-CD20 agents, such as rituximab, have high risk of HBV reactivation (>10%), so antiviral prophylactic therapies are required. This review provides the different classes of biologics associated with HBV reactivation, stratifies the various reactivation risk levels by HBV status and biologic agent, and discusses management strategies.

Cadaveric Testing of a Novel Scapholunate Ligament Reconstruction.

Background Existing scapholunate interosseous ligament (SLIL) reconstruction techniques include fixation spanning the radiocarpal joint, which do not reduce the volar aspect of the scapholunate interval and may limit wrist motion. Questions/Purpose This study tested the ability of an SLIL reconstruction technique that approximates both the volar and dorsal scapholunate intervals, without spanning the radiocarpal joint, to restore static scapholunate relationships. Materials and Methods Scapholunate interval, scapholunate angle, and radiolunate angle were measured in nine human cadaveric specimens with the SLIL intact, sectioned, and reconstructed. Fluoroscopic images were obtained in six wrist positions. The reconstruction was performed by passing tendon graft through bone tunnels from the dorsal surface toward the volar corner of the interosseous surface. After reduction of the scapholunate articulation, the graft was tensioned within the lunate bone tunnel, secured with an interference screw in the scaphoid, and sutured to the dorsal SLIL remnant. Differences among testing states were evaluated using repeated measures ANOVA. Results There was a significant increase in the scapholunate interval in all wrist positions after complete SLIL disruption. Compared with the disrupted state, there was a significant decrease in scapholunate interval in all wrist positions after reconstruction using a tendon graft and interference screw. Conclusion Our SLIL reconstruction technique reconstructs the volar and dorsal ligaments of the scapholunate joint and adequately restores static measures of scapholunate stability. This technique does not tether the radiocarpal joint and aims to optimize volar reduction. Clinical Relevance Our technique offers an alternative option for SLIL reconstruction that successfully restores static scapholunate relationships.