Human-artificial intelligence interaction in gastrointestinal endoscopy.

The number and variety of applications of artificial intelligence (AI) in gastrointestinal (GI) endoscopy is growing rapidly. New technologies based on machine learning (ML) and convolutional neural networks (CNNs) are at various stages of development and deployment to assist patients and endoscopists in preparing for endoscopic procedures, in detection, diagnosis and classification of pathology during endoscopy and in confirmation of key performance indicators. Platforms based on ML and CNNs require regulatory approval as medical devices. Interactions between humans and the technologies we use are complex and are influenced by design, behavioural and psychological elements. Due to the substantial differences between AI and prior technologies, important differences may be expected in how we interact with advice from AI technologies. Human-AI interaction (HAII) may be optimised by developing AI algorithms to minimise false positives and designing platform interfaces to maximise usability. Human factors influencing HAII may include automation bias, alarm fatigue, algorithm aversion, learning effect and deskilling. Each of these areas merits further study in the specific setting of AI applications in GI endoscopy and professional societies should engage to ensure that sufficient emphasis is placed on human-centred design in development of new AI technologies.

Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table.

Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning. There is a need to foster an environment conducive to medical technology development and validation so that Europe can continue to play a major role in device innovation while providing high standards of safety. This paper summarizes viewpoints on the topic of device innovation in cardiovascular medicine at the European Society of Cardiology Cardiovascular Round Table, a strategic forum for high-level dialogue to discuss issues related to the future of cardiovascular health in Europe. Devices are developed and improved through an iterative process throughout their lifecycle. Early feasibility studies demonstrate proof of concept and help to optimize the design of a device. If successful, this should ideally be followed by randomized clinical trials comparing novel devices vs. accepted standards of care when available and the collection of post-market real-world evidence through registries. Unfortunately, standardized procedures for feasibility studies across various device categories have not yet been implemented in Europe. Cardiovascular imaging can be used to diagnose and characterize patients for interventions to improve procedural results and to monitor devices long term after implantation. Randomized clinical trials often use cardiac imaging-based inclusion criteria, while less frequently trials randomize patients to compare the diagnostic or prognostic value of different modalities. Applications using machine learning are increasingly important, but specific regulatory standards and pathways remain in development in both Europe and the USA. Standards are also needed for smart devices and digital technologies that support device-driven biomonitoring. Changes in device regulation introduced by the European Union aim to improve clinical evidence, transparency, and safety, but they may impact the speed of innovation, access, and availability. Device development programmes including dialogue on unmet needs and advice on study designs must be driven by a community of physicians, trialists, patients, regulators, payers, and industry to ensure that patients have access to innovative care.

Surgical Antibiotic Prophylaxis: A Proposal for a Global Evidence-Based Bundle.

In the multimodal strategy context, to implement healthcare-associated infection prevention, bundles are one of the most commonly used methods to adapt guidelines in the local context and transfer best practices into routine clinical care. One of the most important measures to prevent surgical site infections is surgical antibiotic prophylaxis (SAP). This narrative review aims to present a bundle for the correct SAP administration and evaluate the evidence supporting it. Surgical site infection (SSI) prevention guidelines published by the WHO, CDC, NICE, and SHEA/IDSA/APIC/AHA, and the clinical practice guidelines for SAP by ASHP/IDSA/SIS/SHEA, were reviewed. Subsequently, comprehensive searches were also conducted using the PubMed®/MEDLINE and Google Scholar databases, in order to identify further supporting evidence-based documentation. The bundle includes five different measures that may affect proper SAP administration. The measures included may be easily implemented in all hospitals worldwide and are based on minimal drug pharmacokinetics and pharmacodynamics knowledge, which all surgeons should know. Antibiotics for SAP should be prescribed for surgical procedures at high risk for SSIs, such as clean-contaminated and contaminated surgical procedures or for clean surgical procedures where SSIs, even if unlikely, may have devastating consequences, such as in procedures with prosthetic implants. SAP should generally be administered within 60 min before the surgical incision for most antibiotics (including cefazolin). SAP redosing is indicated for surgical procedures exceeding two antibiotic half-lives or for procedures significantly associated with blood loss. In principle, SAP should be discontinued after the surgical procedure. Hospital-based antimicrobial stewardship programmes can optimise the treatment of infections and reduce adverse events associated with antibiotics. In the context of a collaborative and interdisciplinary approach, it is essential to encourage an institutional safety culture in which surgeons are persuaded, rather than compelled, to respect antibiotic prescribing practices. In that context, the proposed bundle contains a set of evidence-based interventions for SAP administration. It is easy to apply, promotes collaboration, and includes measures that can be adequately followed and evaluated in all hospitals worldwide.

Rectal neuroendocrine tumours and the role of emerging endoscopic techniques.

Rectal neuroendocrine tumours represent a rare colorectal tumour with a 10 fold increased prevalence due to incidental detection in the era of colorectal screening. Patient outcomes with early diagnosis are excellent. However endoscopic recognition of this lesion is variable and misdiagnosis can result in suboptimal endoscopic resection with subsequent uncertainty in relation to optimal long-term management. Endoscopic techniques have shown particular utility in managing this under-recognized neuroendocrine tumour.

Unlocking quality in endoscopic mucosal resection.

A review of the development of the key performance metrics of endoscopic mucosal resection (EMR), learning from the experience of the establishment of widespread colonoscopy quality measurements. Potential future performance markers for both colonoscopy and EMR are also evaluated to ensure continued high quality performance is maintained with a focus service framework and predictors of patient outcome.

Development of a clinical score to estimate pancreatitis-related hospital admissions in patients with a new diagnosis of chronic pancreatitis: the trinity score.

BACKGROUND: The clinical course of chronic pancreatitis is unpredictable and there is no globally accepted score to predict the disease course. We developed a clinical score to estimate pancreatitis-related hospitalisation in patients with newly diagnosed chronic pancreatitis. METHODS: We conducted a retrospective cohort study using two clinical chronic pancreatitis databases held in tertiary referral centres in Dublin, Ireland, and in Tarragona, Spain. Individuals diagnosed with chronic pancreatitis between 2007 and 2014 were eligible for inclusion. Candidate predictors included aetiology, body mass index, exocrine dysfunction, smoking and alcohol history. We used multivariable logistic regression to develop the model. RESULTS: We analysed data from 154 patients with newly diagnosed chronic pancreatitis. Of these, 105 patients (68%) had at least one hospital admission for pancreatitis-related reasons in the 6 years following diagnosis. Aetiology of chronic pancreatitis, body mass index, use of pain medications and gender were found to be predictive of more pancreatic-related hospital admissions. These predictors were used to develop a clinical score which showed acceptable discrimination (area under the ROC curve = 0.70). DISCUSSION: We developed a clinical score based on easily accessible clinical parameters to predict pancreatitis-related hospitalisation in patients with newly diagnosed chronic pancreatitis.

Contemporary management of concomitant gallstones and common bile duct stones: a survey of Spanish surgeons.

BACKGROUND: Concomitant gallstones and common bile duct stones (CBDS) is a relatively frequent presentation. The optimal treatment remains controversial and the debate persists between two strategies. The one-stage approach: laparoscopic cholecystectomy with laparoscopic common bile duct exploration (LCBDE) has been shown to be equally safe and more cost-effective than the more traditional two-stage approach: endoscopic retrograde cholangiography followed by laparoscopic cholecystectomy (ERCP + LC). However, many surgeons worldwide still prefer the two-stage procedure. This survey evaluated contemporary management of CBDS in Spain and assessed the impact of surgeon and hospital factors on provision of LCBDE. METHODS: A 25-item, web-based anonymous survey was sent to general surgeons members of the Spanish Surgeons Association. Descriptive statistics were applied to summarize results. RESULTS: Responses from 305 surgeons across 173 Spanish hospitals were analyzed. ERCP is the initial approach for preoperatively suspected CBDS for 86% of surgeons. LCBDE is the preferred method for only 11% of surgeons and only 11% treat more than 10 cases per year. For CBDS discovered intraoperatively, 59% of respondents attempt extraction while 32% defer to a postoperative ERCP. The main reasons cited for not performing LCBDE were lack of equipment, training and timely availability of an ERCP proceduralist. Despite these barriers, most surgeons (84%) responded that LCBDE should be implemented in their departments. CONCLUSIONS: ERCP was the preferred approach for CBDS for the majority of respondents. There remains limited use of LCBDE despite many surgeons indicating it should be implemented. Focused planning and resourcing of both training and operational demands are required to facilitate adoption of LCBDE as option for patients.

Correction: Identification of Informed Consent in Patient Videos on Social Media: Prospective Study.

[This corrects the article DOI: 10.2196/14081.].

Identification of Informed Consent in Patient Videos on Social Media: Prospective Study.

BACKGROUND: The American Medical Association Code of Medical Ethics states that any clinical image taken for public education forms part of the patient's records. Hence, a patient's informed consent is required to collect, share, and distribute their image. Patients must be informed of the intended use of the clinical image and the intended audience as part of the informed consent. OBJECTIVE: This paper aimed to determine whether a random selection of instructional videos containing footage of central venous catheter insertion on real patients on YouTube (Google LLC) would mention the presence of informed consent to post the video on social media. METHODS: We performed a prospective evaluation by 2 separate researchers of the first 125 videos on YouTube with the search term "central line insertion." After duplicates were deleted and exclusion criteria applied, 41 videos of patients undergoing central line insertion were searched for reference to patient consent. In the case of videos of indeterminate consent status, the posters were contacted privately through YouTube to clarify the status of consent to both film and disseminate the video on social media. A period of 2 months was provided to respond to initial contact. Furthermore, YouTube was contacted to clarify company policy. The primary outcome was to determine if videos on YouTube were amended to include details of consent at 2 months postcontact. The secondary outcome was a response to the initial email at 2 months. RESULTS: The researchers compiled 143 videos. Of 41 videos that contained footage of patient procedures, 41 were of indeterminate consent status and 23 contained identifiable patient footage. From the 41 posters that were contacted, 3 responded to initial contact and none amended the video to document consent status. Response from YouTube is pending. CONCLUSIONS: There are instructional videos for clinicians on social media that contain footage of patients undergoing medical procedures and do not have any verification of informed consent. While this study investigated a small sample of available videos, the problem appears ubiquitous and should be studied more extensively.

Metabolic dysfunction and diabetes mellitus during long-term follow-up of severe acute pancreatitis: A case-matched study.

BACKGROUND/OBJECTIVES: Endocrine insufficiency following severe acute pancreatitis (SAP) leads to diabetes of the exocrine pancreas, (type 3c diabetes mellitus), however it is not known how this metabolic phenotype differs from that of type 2 diabetes, or how the two subtypes can be differentiated. We sought to determine the prevalence of diabetes following SAP, and to analyse the behaviour of glucose and pancreatic hormones across a 2-h oral glucose tolerance test (OGTT). METHODS: Twenty-six patients following SAP (mean (range) duration of first SAP episode to study time of 119.3 (14.8-208.9) months) along with 26 matched controls underwent an OGTT with measurement of glucose, insulin, c-peptide, glucagon and pancreatic polypeptide (PP) at fasting/15/90/120min. Beta-cell area was estimated using the 15min c-peptide/glucose ratio, and insulin resistance (IR) using homeostasis model assessment (HOMA) and oral glucose insulin sensitivity (OGIS) models. RESULTS: The prevalence of diabetes/prediabetes was 54% following SAP (38.5% newly-diagnosed compared to 19.2% newly-diagnosed controls). Estimated beta-cell area and IR did not differ between groups. AUC c-peptide was lower in SAP versus controls. AUC insulin and AUC c-peptide were lower in SAP patients with diabetes versus controls with diabetes; between-group differences were observed at the 90 and 120 min time-points only. Half of new diabetes cases in SAP patients were only identified at the 120min timepoint. CONCLUSIONS: Diabetes and pre-diabetes occur frequently following SAP and are difficult to distinguish from type 2 diabetes in controls but are characterised by reduced insulin and c-peptide at later stages of an OGTT. Consistent with this observation, most new post SAP diabetes cases were diagnosed by 2-h glucose levels only.

Clinical Classification and Severity Scoring Systems in Chronic Pancreatitis: A Systematic Review.

INTRODUCTION: Chronic pancreatitis (CP) is characterised by pain, functional deficits, nutritional and mechanical complications. Frequently managed in out-patient settings, the clinical course is unpredictable and requires multi-disciplinary care. There remains substantial variation in management. In contrast to acute pancreatitis, there are no globally accepted classification or severity scores to predict the disease course or compare interventions. We conducted a systematic review to determine the scope and clinical use of existing scoring systems. METHODS: A systematic search was developed with a medical librarian using the Embase, Medline and Cochrane databases. Original articles and conference abstracts describing an original or modified classification or scoring system in CP that stratified patients into clinical and/or severity categories were included. To assess clinical application/validation, studies using all or part of a score as a stratification tool to measure another parameter or outcome were selected. Studies reporting on diagnosis or aetiology only were excluded. Four authors performed the search in independent pairs and conflicts were resolved by a fifth author using CovidenceTM systematic review software. RESULTS: Following screening 6,652 titles and 235 full-text reviews, 48 papers were analysed. Eleven described original scores and 6 described modifications of published scores. Many were comprehensive but limited in capturing the full spectrum of disease. In 31 studies, a score was used to categorise patients to compare or correlate various outcome measures. Exocrine and endocrine dysfunction and pain were included in 6, 5, and 4 scoring systems, respectively. No score included other nutrition parameters, such as bone health, malnutrition, or nutrient deficiency. Only one score has been objectively validated prospectively and independently for monitoring clinical progression and prognosis, but this had been applied to an in-patient population. CONCLUSION: Available systems and scores do not reflect recent advances and guidelines in CP and are not commonly used. A practical clinical classification and scoring system, validated prospectively for prognostication would be useful for the meaningful analysis in observational and interventional studies in CP.

Single-stage approach for the management of choledocolithiasis with concomitant cholelithiasis. Implementation of a protocol in a secondary hospital.

BACKGROUND: Current evidence shows that single-stage treatment of concomitant choledocholithiasis and cholelithiasis is as effective and safe as two-stage treatment. However, several studies suggest that single-stage approach requires shorter hospitalization time and is more cost-effective than the two-stage approach, even though it requires considerable training. This study aimed to evaluate the implementation of a protocol for managing concomitant choledocholithiasis and cholelithiasis using single-stage treatment. METHODS: A prospective cohort study of patients diagnosed with cholelithiasis and choledocholithiasis who were treated with the single-stage treatment - transcystic instrumentation, choledocotomy or intraoperative endoscopic retrograde cholangiopancreatography (ERCP) - between September 2010 and June 2017 was assessed. The primary outcomes were complications, hospital stay, operative time and recurrence rate. RESULTS: 164 patients were enrolled. 141 (86%) were operated laparoscopically. Preoperatively diagnosed stones were not found by intraoperative imaging or disappeared after "flushing" in 38 patients (23.2%). Surgical approach was transcystic in 45 patients (27.41%), choledochotomy in 74 (45.1%), intraoperative ERCP in 4 (2.4%), and bilioenteric derivation in 3 (1.8%). Mean hospitalization stay was 4.4 days. Mean operative time was 166 min 27 patients (16.5%) had complications and 1 patient was exitus (0.6%). Recurrence rate was 1.2%. CONCLUSIONS: Single-stage approach is a safe and effective management option for concomitant cholelithiasis and choledocolithiasis. Furthermore, a significant number of common bile duct stones pass spontaneously to duodenum or can benefit from a transcystic approach, with presumable low morbidity and cost-efficiency.

The Role of Staging Laparoscopy in Resectable and Borderline Resectable Pancreatic Cancer: A Systematic Review and Meta-Analysis.

AIM: The study aimed to determine the additional value of staging laparoscopy in patients with pancreatic cancer deemed potentially resectable based on computed tomography imaging. METHODS: A systematic literature search was performed using MEDLINE and the Cochrane Register of Controlled Trials (January 1995 to June 2017). Primary outcome measures were the overall yield and sensitivity to detect non-resectable disease. Quality of studies was assessed with the Newcastle-Ottawa Scale. RESULTS: From 156 records, 15 studies including 2,776 patients met the inclusion criteria. In 12 studies, reporting outcomes on 1,756 patients with resectable disease after standard imaging, 350 (20%, range 14-38%) cases of non-resectable cancer were detected with staging laparoscopy. In 3 studies on 242 patients with locally advanced disease after standard imaging, staging laparoscopy detected metastases in 86 patients (36%). The failure rate of staging laparoscopy to detect non-resectable disease was 5% (64 of 1,406). CONCLUSION: Staging laparoscopy reduces the non-therapeutic laparotomy rate, and in locally advanced or borderline resectable disease, staging laparoscopy could more accurately select patients for neoadjuvant protocols.

The potential role of gut microbiota in pancreatic disease: A systematic review.

BACKGROUND: Several studies have suggested a link between microbiota imbalance and some gastrointestinal, inflammatory and neoplastic diseases. However, the role in pancreatic diseases remain unclear. To evaluate the available evidence for pancreatic diseases, we undertook a systematic review. METHODS: OVID Medline (1946-2017), EMBASE (1980-2017) and the Cochrane Central Register of Controlled Trials (CENTRAL Issue 3, 2017) were searched for studies on microbiota in pancreatic disease. We also searched the reference lists of retrieved papers, and conference proceedings. We excluded animal studies, reviews, and case reports. RESULTS: A total of 2833 articles were retrieved. After screening and applying the exclusion criteria, 10 studies were included. Three studies showed lower levels of Bifidobacterium or Lactobacillus and higher levels of Enterobacteriaceae in chronic pancreatitis. Two of these studies were uncontrolled, and the third (controlled) study which compared patients with endocrine and exocrine insufficiency, reported that Bacteroidetes levels were lower in those patients without diabetes, while Bifidobacteria levels were higher in those without exocrine insufficiency. Only one study investigated acute pancreatitis, showing higher levels of Enterococcus and lower levels of Bifidobacterium versus healthy participants. There was an overall association between pancreatic cancer and lower levels of Neisseria elongate, Streptococcus mitis and higher levels of Porphyromonas gingivalis and Granulicatella adiacens. CONCLUSIONS: Current evidence suggests a possible link between microbiota imbalance and pancreatic cancer. Regarding acute and chronic pancreatitis, data are scarce, dysbiosis appears to be present in both conditions. However, further investigation is required to confirm these findings and to explore therapeutic possibilities.

Distant melanoma causing small bowel obstruction.

Small bowel obstructions (SBOs) are common. Adhesions make up the majority of cases at 84.9%, followed by abdominal herniae and malignancies. A 71-year-old female presented with total constipation, abdominal distension, on a background of resected cutaneous melanoma nine years prior. A CT-scan showed small bowel intussusception and disseminated mucosal-enhancing lesions consistent with metastases. She was brought to the operating theatre where six areas of intussusception were identified and manually reduced. Biopsies confirmed the diagnosis of melanoma. Melanoma of the gastrointestinal tract (GIT) is rare, with most cases occurring as metastasis from cutaneous lesions. Melanomas of the GIT are usually asymptomatic in their early stages, and are often diagnosed when complications, such as obstruction or perforation occur. Management of such cases consists mainly of surgical intervention to resolve the complication. In people who present with SBO without previous surgeries or herniae, a malignant cause must be considered.

A tenebrous tale: malignant melanoma of the oesophagus.

A 57-year-old man presented with a 4-month history of worsening symptoms of oesophageal obstruction. The physical examination was unremarkable. An oesophagogastroduodenoscopy revealed an exophytic tumour in the distal oesophagus. A biopsy demonstrated malignant melanoma. Staging of the melanoma showed disseminated lymph node and bony-spine metastases. He had no prior history of cutaneous or ocular melanoma. Following full multidisciplinary team input, he was palliated with a metal mesh stent and immunotherapy. He died 3 months later following community management.

Liver transplantation for hepatocellular carcinoma in Ireland: Pre-operative alpha-fetoprotein predicts tumour recurrence in a 14-year single-centre national experience.

AIM: To examine the results of orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC) in Ireland over a 14-year period. METHODS: Cases of HCC receiving OLT between January 1995 and September 2009 in the Irish Liver Transplant Unit were reviewed from a prospectively maintained database. Outcome measures included overall and recurrence free survival, alpha-fetoprotein (AFP) and tumour pathological features. RESULTS: On explant pathology, 57 patients had HCC. The median follow-up time was 42.7 mo. The overall 1, 3 and 5 years survival was 87.7%, 72.1% and 72.4%. There was no difference in survival when compared to patients undergoing OLT without malignancy. The tumour recurrence rate was 14%. The Milan criteria were exceeded in 32% of cases but this did not predict overall survival or recurrence. On multivariate analysis pre-operative AFP > 100 ng/mL was an independent risk factor for recurrence (RR = 5.2, CI: 1.1-24.3, P = 0.036). CONCLUSION: Patients undergoing OLT for HCC had excellent survival even when conventional listing criteria were exceeded. Pre-operative AFP predicts recurrence independent of tumour size and its role in selection criteria should be investigated in larger studies.