Objective. To assess the cost-effectiveness of an Intelligent Endoscopy Module for computer-assisted detection and characterization (CADe/CADx) compared to standard practice, from a Spanish National Health System perspective. Methods. A Markov model was designed to estimate total costs, life years gained (LYG), and quality-adjusted life years (QALYs) over a lifetime horizon with annual cycles. A hypothetical cohort of 1,000 patients eligible for colonoscopy (mean age of 61.32 years) was distributed between Markov states according to polyp size, location, and histology based on national screening programs’ data. CADe/CADx efficacy was determined based on adenoma miss rates, and natural disease evolution was simulated according to annual transition probabilities. Detected polyps’ management involved polypectomy and histopathology in standard practice, while with CADe/CADx leave-in-situ strategy was applied for ≤5mm rectosigmoid non-adenomas and resect-and-discard strategy for the rest of ≤5mm polyps. Unit costs (€,2024) included the diagnostic procedure and polyp and CRC management. A 3% annual discount rate was applied to costs and outcomes. The model’s inputs were validated by an expert panel. Results. CADe/CADx resulted more effective (16.37 LYG and 14.32 QALYs) than standard practice (16.33 LYG and 14.27 QALYs) over a lifetime horizon. Total cost per patient was €2,300.76 with CADe/CADx and €2,508.75 with colonoscopy alone. In a hypothetical cohort of 1,000 patients, CADe/CADx avoided 173 polypectomies, 370 histopathologies, and 7 CRC cases. Sensitivity analyses confirmed the model's robustness. Conclusions. The results of this analysis suggest that CADe/CADx would result in a dominant strategy versus standard practice in patients undergoing colonoscopies in Spain.

INTRODUCTION:Pre-clinical studies suggest that thermal ablation of the main pancreatic duct (TAMPD) is more recommendable than glue for reducing postoperative pancreatic fistula (POPF). Our aims were (1) to analyze the changes in the pancreas of patients after TAMPD and (2) to correlate the clinical findings with those obtained from a study on an animal model. MATERIALS AND METHODS:A retrospective early feasibility study of a marketed device for a novel clinical application was carried out on a small number of subjects (n = 8) in whom TAMPD was conducted to manage the pancreatic stump after a pancreatectoduodenectomy (PD). Morphological changes in the remaining pancreas were assessed by computed tomography for 365 days after TAMPD. RESULTS:All the patients showed either Grade A or B POPF, which generally resolved within the first 30 days. The duct's maximum diameter significantly increased after TAMPD from 1.5 ± 0.8 mm to 8.6 ± 2.9 mm after 7 days (p = .025) and was then reduced to 2.6 ± 0.8 mm after 365 days PO (p < .0001). The animal model suggests that TAMPD induces dilation of the duct lumen by enzymatic digestion of ablated tissue after a few days and complete exocrine atrophy after a few weeks. CONCLUSIONS:TAMPD leads to long-term exocrine pancreatic atrophy by completely occluding the duct. However, the ductal dilatation that occurred soon after TAMPD could even favor POPF, which suggests that TAMPD should be conducted several weeks before PD, ideally by digestive endoscopy.

Background: Pancreatic cancer (PCa) and biliary tract carcinomas (BTCa) have high morbidity and mortality rates. Bile duct obstruction (BDO) develops in approximately 65–75% of PCa at diagnosis, delaying the administration of an optimal treatment. In patients not candidates for surgery, BDO is usually treated through endoscopy-guided placement of self-expanding stents in the bile duct. Methods: In this retrospective study, we sought to describe clinical characteristics and outcomes of a cohort of patients with BDO of malignant origin who underwent biliary stent placement (BSP), with a special focus regarding complications developed after the procedure. Patients with PCa or BTCa who underwent BSP from 2014 to April 2019 at our institution were included in this cohort. Demographic and clinicopathologic characteristics were collected. Statistical analysis stratified according to ECOG performance status. Specific information regarding stent material (metallic vs. plastic), as well as incidence and type of complications derived from BSP was also recorded. Results: One-hundred fifteen patients were included. The median age was 72 years. Sixty-six patients (57%) had PCa. All patients presented hyperbilirrubinemia, which decreased after the procedure in 111 (96%) patients. Complications were observed in 44 (38%) patients, most of which 33 (75%) were infections. Median time to complication was one month. The mean overall survival (OS) in our study was 20.3 weeks. Conclusion: BSP effectively decreased hyperbilirubinemia in patients with BDO, however, the procedure associated a significant rate of infectious complications, which can further compromise an effective anti-cancer therapy as well as optimal palliative strategies.

Background Early diagnosis is crucial for patients with pancreatic ductal adenocarcinoma (PDAC). The AXL receptor tyrosine kinase is proteolytically processed releasing a soluble form (sAXL) into the blood stream. Here we explore the use of sAXL as a biomarker for PDAC. Methods AXL was analysed by immunohistochemistry in human pancreatic tissue samples. RNA expression analysis was performed using TCGA/GTEx databases. The plasma concentrations of sAXL, its ligand GAS6, and CA19-9 were studied in two independent cohorts, the HMar cohort (n = 59) and the HClinic cohort (n = 142), including healthy controls, chronic pancreatitis (CP) or PDAC patients, and in a familial PDAC cohort (n = 68). AXL expression and sAXL release were studied in PDAC cell lines and murine models. Findings AXL is increased in PDAC and precursor lesions as compared to CP or controls. sAXL determined in plasma from two independent cohorts was significantly increased in the PDAC group as compared to healthy controls or CP patients. Patients with high levels of AXL have a lower overall survival. ROC analysis of the plasma levels of sAXL, GAS6, or CA19-9 in our cohorts revealed that sAXL outperformed CA19-9 for discriminating between CP and PDAC. Using both sAXL and CA19-9 increased the diagnostic value. These results were validated in murine models, showing increased sAXL specifically in animals developing PDAC but not those with precursor lesions or acinar tumours. Interpretation sAXL appears as a biomarker for early detection of PDAC and PDAC-CP discrimination that could accelerate treatment and improve its dismal prognosis. Copyright (C) 2021 The Author(s). Published by Elsevier B.V.

Abstract Background It is unknown whether narrow-band imaging (NBI) could be more effective than high-definition white-light endoscopy (HD-WLE) in detecting serrated lesions in patients with prior serrated lesions > 5 mm not completely fulfilling serrated polyposis syndrome (SPS) criteria. Methods We conducted a randomized, cross-over trial in consecutive patients with prior detection of at least one serrated polyp ≥10 mm or ≥ 3 serrated polyps larger than 5 mm, both proximal to the sigmoid colon. Five experienced endoscopists performed same-day tandem colonoscopies, with the order being randomized 1:1 to NBI—HD-WLE or HD-WLE—NBI. All tandem colonoscopies were performed by the same endoscopist. Results We included 41 patients. Baseline characteristics were similar in the two cohorts: NBI—HD-WLE (n = 21) and HD-WLE—NBI (n = 20). No differences were observed in the serrated lesion detection rate of NBI versus HD-WLE: 47.4% versus 51.9% (OR 0.84, 95% CI: 0.37–1.91) for the first and second withdrawal, respectively. Equally, no differences were found in the polyp miss rate of NBI versus HD-WLE: 21.3% versus 26.1% (OR 0.77, 95% CI: 0.43–1.38). Follow-up colonoscopy in nine patients (22%) allowed them to be reclassified as having SPS. Conclusions In patients with previous serrated lesions, the serrated lesion detection rate was similar with NBI and HD-WLE. A shorter surveillance colonoscopy interval increases the detection of missed serrated polyps and could change the diagnosis of SPS in approximately one in every five patients. Trial registration ClinicalTrials.gov NCT02406547 , registered on April 2, 2015.

BACKGROUND AND OBJECTIVES the impact of surgical primary tumor resection on survival of obstructive metastatic colorectal cancer remains controversial. The primary goal of this study was to analyze survival in patients with obstructive metastatic colorectal cancer after treatment with either resection surgery or a colonic stent. MATERIAL AND METHODS a prospective study was performed of all patients with stage-IV colorectal cancer and obstructive manifestations, diagnosed from 2005 to 2012 and managed with either resection surgery or a colonic stent. Cases with a perforation, abscess, right colon or distal rectal malignancy, multiple colorectal cancer or derivative surgery were excluded. RESULTS a total of 95 patients were included, 49 were managed with resection surgery and 46 with a colonic stent. The colonic stent group had a higher Charlson index (9.5 ± 2.1 vs 8.6 ± 1.5, p = 0.01), a shorter time to oral intake (0.9 ± 1.1 vs 16.4 ± 53.5 days, p = 0.05), a shorter hospital stay (4 ± 4.8 vs 16.7 ± 15.5 days, p = 0.0001), less need for stomata (11.1 % vs 32.7 %, p = 0.01), fewer early complications (4.3 % vs 46.9 %, p = 0.0001) and more late complications (33.3 % vs 6.4 %, p = 0.001). Undergoing chemotherapy (p = 0.008) was the only independent factor related to increased survival. In the subgroup of patients managed with chemotherapy, surgical primary tumor resection was an independent factor associated with increased survival. CONCLUSION both treatments are effective for resolving obstructive manifestations in patients diagnosed with stage-IV obstructive colorectal cancer. Resection surgery has no positive impact on survival and thus cannot be recommended as a therapy of choice.

BACKGROUND Colonoscopy attendance is a key quality parameter in colorectal cancer population screening programmes. Within these programmes, educative interventions with bidirectional contact carried out by trained personnel have been proved to be an important tool for colonoscopy attendance improvement, and because of its huge clinical and economic impact, they have been widely implemented. However, outside of this population programmes, educative measures to improve colonoscopy attendance have been poorly studied and no navigation interventions are usually performed. AIM To investigate the clinical and economic impacts of an educational telephone intervention on colonoscopy attendance outside colorectal cancer screening programmes. METHODS This randomized controlled trial included consecutive patients referred to colonoscopy from primary care centres from November 2017 to May 2018. The intervention group (IG) received a telephone intervention, while the control group (CG) did not. Patients assigned to the IG received an educational telephone call 7 d before the colonoscopy appointment. The intervention was carried out by two nurses with deep endoscopic knowledge who were previously trained for a telephone educational intervention for colonoscopy. The impact on patient compliance with preparedness protocols related to bowel cleansing, anti-thrombotic management, and sedation scheduling was also evaluated. A second call was conducted to assess patient satisfaction. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed. RESULTS A total of 738 and 746 patients were finally included in the IG and CG respectively. Six hundred thirteen (83%) patients were contacted in the IG. The non-attendance rate was lower in the IG, both in the ITT analysis (IG 8.4% vs CG 14.3%, P < 0.001) and in the PP analysis (4.4% vs 14.3%, P < 0.001). In a multivariable analysis, belonging to the control group increased the risk of non-attendance in both, the ITT analysis (OR 1.81, 95%CI: 1.27 to 2.58, P = 0.001) and the PP analysis (OR 3.56, 95%CI: 2.25 to 5.64, P < 0.001). There was also a significant difference in compliance with preparedness protocols [bowel cleansing: IG 61.7% vs CG 52.6% (P = 0.001), antithrombotic management: IG 92.5% vs CG 62.8% (P = 0.001), and sedation scheduling: IG 78.8% vs CG 0% (P ≤ 0.001)]. We observed a net benefit of €55600/year after the intervention. The information given before the procedure was rated as excellent by 26% (CG) and 51% (IG) of patients, P ≤ 0.001. CONCLUSION Educational telephone nurse intervention improves attendance, protocol compliance and patient satisfaction in the non-screening colonoscopy setting and has a large economic impact, which supports its imple-mentation and maintenance over time.

Background. Individuals with a family history of colorectal cancer (CRC) have an increased risk of CRC. We evaluated the diagnostic yield of CCE in the detection of lesions and also two different colon preparations. Methods. A prospective multicenter study was designed to assess CCE diagnostic yield in a cohort of asymptomatic individuals with a family history of CRC. CCE and colonoscopy were performed on the same day by 2 endoscopists who were blinded to the results of the other procedure. Results. Fifty-three participants were enrolled. The sensitivity, specificity, PPV, and NPV of CCE for detecting advanced adenomas were 100%, 98%, 67%, and 100%. Sensitivity, specificity, PPV, and NPV of CCE for the diagnosis of individuals with polyps were 87%, 97%, 93%, and 88%, respectively. CCE identify 100% of individuals with significant or advanced lesions. Overall cleanliness was adequate by 60.7% of them. The PEG-ascorbic boost seems to improve colon cleanliness, with similar colonic transit time. Conclusion. CCE is a promising tool, but it has to be considered as an alternative technique in this population in order to reduce the number of colonoscopies performed. More studies are needed to understand appropriate screening follow-up intervals and optimize the bowel preparation regimen.

Background: Over the last years, our knowledge on pathogenesis of gastric MALT lymphoma has greatly improved, but its morphological diagnosis is still hampered by overlapping histological features with advanced chronic gastritis. MicroRNAs are deregulated in lymphomas, but their role and usefulness in gastric MALT lymphoma has not been extensively investigated. Materials and Methods: We analyzed the expression of 384 miRNAs using TaqMan microRNA assay in a training series of 10 gastric MALT lymphomas, 3 chronic gastritis and 2 reactive lymph nodes. Then, significantly deregulated miRNAs were individually assessed by real-time PCR in a validation series of 16 gastric MALT lymphomas and 12 chronic gastritis. Results: Gastric MALT lymphoma is characterized by a specific miRNA expression profile. Among the differentially expressed miRNAs, a significant overexpression of miR-142-3p and miR-155 and down-regulation of miR-203 was observed in gastric MALT lymphoma when compared to chronic gastritis. Conclusion: miR-142-3p, miR-155 and miR-203 expression levels might be helpful biomarkers for the differential diagnosis between gastric MALT lymphomas and chronic gastritis.