Endoscopic full-thickness resection vs. endoscopic submucosal dissection of residual/recurrent colonic lesions on scars: a retrospective Italian and Japanese comparative study.

BACKGROUND AND AIMS: Endoscopic treatment of recurrent/residual colonic lesions on scars is a challenging procedure. In this setting, endoscopic submucosal dissection (ESD) is considered the first choice, despite a significant rate of complications. Endoscopic full-thickness resection (eFTR) has been shown to be well-tolerated and effective for these lesions. The aim of this study is to conduct a comparison of outcomes for resection of such lesions between ESD and eFTR in an Italian and a Japanese referral center. METHODS: From January 2018 to July 2020, we retrospectively enrolled patients with residual/recurrent colonic lesions, 20 treated by eFTR in Italy and 43 treated by ESD in Japan. The primary outcome was to compare the two techniques in terms of en-bloc and R0-resection rates, whereas complications, time of procedure, and outcomes at 3-month follow-up were evaluated as secondary outcomes. RESULTS: R0 resection rate was not significantly different between the two groups [18/20 (90%) and 41/43 (95%); P= 0.66]. En-bloc resection was 100% in both groups. No significant difference was found in the procedure time (54 min vs. 61 min; P= 0.9). There was a higher perforation rate in the ESD group [11/43 (26%) vs. 0/20 (0%); P= 0.01]. At the 3-month follow-up, two lesions relapsed in the eFTR cohort and none in the ESD cohort (P= 0.1). CONCLUSION: eFTR is a safer, as effective and equally time-consuming technique compared with ESD for the treatment of residual/recurrent colonic lesions on scars and could become an alternative therapeutic option for such lesions.

Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study.

BACKGROUND AND AIMS: Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated the safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions. METHODS: This single-arm, prospective, multicenter study was conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary end points were technical success (the ability of the device to resect the lesion[s] without use of other resection devices without device-related serious adverse events [AEs]) and safety (the occurrence of AEs through 90 days). Secondary end points included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens. RESULTS: Sixty-five patients were in the intention-to-treat/safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP patients were solely treated by using the EPR device. Technical success was achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathologic diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis. CONCLUSIONS: EPR is safe and effective for benign, persistent, large (>20 mm), scarred colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates that >1 treatment is necessary for effective endoscopic treatment. (Clinical trial registration number: NCT04203667.).

Clinical outcomes of endoscopic submucosal dissection for giant rectal tumors larger than 8 cm: A European referral center experience.

BACKGROUND AND AIMS: To date, western data on colorectal ESD are limited. This study aimed to assess the efficacy and safety of rectal ESD for superficial lesions ≥ 8 cm. METHODS: A total of 138 superficial rectal neoplasms treated by ESD were allocated in two groups: 25 in the "giant" ESD group and 113 in the control group. RESULTS: En bloc resection was achieved in 96% of cases in both groups. En bloc R0 resection rate was similar between the "giant" ESD group and the control group (84% vs 86%; p: 0.5) and curative resection was higher in the control group (81%) than in "giant" ESD group (68%) without reaching statistical significance (p: 0.2). Dissection time was significantly longer in the "giant" ESD group (251 vs 108 min; p <0.001), however, dissection speed was significantly higher (0.35 vs 0.17 cm2/min; p: 0.02).). Post-ESD stenosis was observed in 2 patients from the "giant" ESD group (8% vs 0% of control group, p: 0.03). No significant differences were found in delayed bleeding, perforation, local recurrences, and need for additional surgery. CONCLUSIONS: ESD for superficial rectal tumors ≥ 8 cm is a feasible, safe, and effective therapeutic option.

Increasing the accuracy of colorectal cancer screening.

INTRODUCTION: Colorectal cancer (CRC) is a major health issue, being responsible for nearly 10% of all cancer-related deaths. Since CRC is often an asymptomatic or paucisymptomatic disease until it reaches advanced stages, screening is crucial for the diagnosis of preneoplastic lesions or early CRC. AREAS COVERED: The aim of this review is to summarize the literature evidence on currently available CRC screening tools, with their pros and cons, focusing on the level of accuracy reached by each test over time. We also provide an overview of novel technologies and scientific advances that are currently being investigated and that in the future may represent real game-changers in the field of CRC screening. EXPERT OPINION: We suggest that best screening modalities are annual or biennial FIT and colonoscopy every 10 years. We believe that the introduction of artificial intelligence (AI)-tools in the CRC screening field could lead to a significant improvement of the screening efficacy in reducing CRC incidence and mortality in the future. More resources should be put into implementing CRC programs and support research project to further increase the accuracy of CRC screening tests and strategies.

Accuracy of narrow-band imaging in predicting the histology of anal intraepithelial lesions.

BACKGROUND AND AIM: Anal intraepithelial neoplasia (AIN) is the precursor of anal squamous carcinoma, frequently underappreciated by most gastroenterologists. Purpose of the study is to assess the diagnostic accuracy of narrow-band imaging (NBI) in predicting the histology of anal lesions, considering a new NBI classification. METHODS: This is a retrospective analysis of consecutive patients with suspected anal squamous intraepithelial lesions (SILs) and superficially invasive squamous cell carcinoma (SISCCA) who underwent anorectal-sigmoidoscopy. Three expert endoscopists reviewed all the images collected during colonoscopies in white light and NBI in order to generate a practical classification of three main different NBI patterns. RESULTS: After the modified Delphi process, the final NBI classification, mainly based on intrapapillary capillary loops (IPCL) changes included three different NBI pattern. NBI pattern I: elongation of IPCL toward epithelial surface; NBI pattern 2: thickened and tortuous IPCL; NBI pattern 3: mosaic-like disposition of IPCL. We found that NBI pattern positively correlated to the histologic type of the lesions and tumor grade (Spearman's rho = 0.9671, P = 0.0000). Among 58 anal lesions included, 41/41 (100%) LSILs have been classified as NBI pattern I, 10/11 (90.91%) HSILs as NBI pattern II, 1/11 HSIL as NBI pattern I, 4/4 SISCCA as NBI pattern III and 2/2 invasive cancer as NBI pattern III. Diagnostic accuracy of NBI pattern II or III in predicting histology differentiating HSIL or SISCCA/IC versus LSIL showed a sensitivity of 100%, (95% CI: 92.3-100%) and a specificity of 94.1% (95% CI: 83.8-98.3%). CONCLUSION: The accuracy of this new NBI score system in predicting the histology of anal lesions showed encouraging data in term of sensitivity and specificity in differentiating HSIL or SISCCA/IC versus LSIL, but the clinical usefulness and application of these findings should be evaluated in a prospective larger study.

Endoscopists performance in optical diagnosis of colorectal polyps in artificial intelligence studies.

Widespread adoption of optical diagnosis of colorectal neoplasia is prevented by suboptimal endoscopist performance and lack of standardized training and competence evaluation. We aimed to assess diagnostic accuracy of endoscopists in optical diagnosis of colorectal neoplasia in the framework of artificial intelligence (AI) validation studies. Literature searches of databases (PubMed/MEDLINE, EMBASE, Scopus) up to April 2022 were performed to identify articles evaluating accuracy of individual endoscopists in performing optical diagnosis of colorectal neoplasia within studies validating AI against a histologically verified ground-truth. The main outcomes were endoscopists' pooled sensitivity, specificity, positive and negative predictive value (PPV/NPV), positive and negative likelihood ratio (LR) and area under the curve (AUC for sROC) for predicting adenomas versus non-adenomas. Six studies with 67 endoscopists and 2085 (IQR: 115-243,5) patients were evaluated. Pooled sensitivity and specificity for adenomatous histology was respectively 84.5% (95% CI 80.3%-88%) and 83% (95% CI 79.6%-85.9%), corresponding to a PPV, NPV, LR+, LR- of 89.5% (95% CI 87.1%-91.5%), 75.7% (95% CI 70.1%-80.7%), 5 (95% CI 3.9%-6.2%) and 0.19 (95% CI 0.14%-0.25%). The AUC was 0.82 (CI 0.76-0.90). Expert endoscopists showed a higher sensitivity than non-experts (90.5%, [95% CI 87.6%-92.7%] vs. 75.5%, [95% CI 66.5%-82.7%], p < 0.001), and Eastern endoscopists showed a higher sensitivity than Western (85%, [95% CI 80.5%-88.6%] vs. 75.8%, [95% CI 70.2%-80.6%]). Quality was graded high for 3 studies and low for 3 studies. We show that human accuracy for diagnosis of colorectal neoplasia in the setting of AI studies is suboptimal. Educational interventions could benefit by AI validation settings which seem a feasible framework for competence assessment.

Factors Associated with Polyp Detection Rate in European Colonoscopy Practice: Findings of The European Colonoscopy Quality Investigation (ECQI) Group.

Background: The European Colonoscopy Quality Investigation (ECQI) Group aims to raise awareness for improvement in colonoscopy standards across Europe. We analysed data collected on a sample of procedures conducted across Europe to evaluate the achievement of the polyp detection rate (PDR) target. We also investigated factors associated with PDR, in the hope of establishing areas that could lead to a quality improvement. Methods: 6445 form completions from 12 countries between 2 June 2016 and 30 April 2018 were considered for this analysis. We performed an exploratory analysis looking at PDR according to European Society of Gastrointestinal Endoscopy (ESGE) definition. Stepwise multivariable logistic regression analysis was conducted to determine the most influential associated factors after adjusting for the other pre-specified variables. Results: In our sample there were 3365 screening and diagnostic procedures performed in those over 50 years. The PDR was 40.5%, which is comparable with the ESGE minimum standard of 40%. The variables found to be associated with PDR were in descending order: use of high-definition equipment, body mass index (BMI), patient gender, age group, and the reason for the procedure. Use of HD equipment was associated with a significant increase in the reporting of flat lesions (14.3% vs. 5.7%, p < 0.0001) and protruded lesions (34.7% vs. 25.4%, p < 0.0001). Conclusions: On average, the sample of European practice captured by the ECQI survey meets the minimum PDR standard set by the ESGE. Our findings support the ESGE recommendation for routine use of HD colonoscopy.

BRIDGE -1 TRIAL: BReak Interval Delayed surgery for Gastrointestinal Extraperitoneal rectal cancer, a multicentric phase III randomized trial.

Design: Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC).Several studies have shown a correlation between a longer interval between the end of nCRT and surgery (surgical interval - SI) and an increased pathological complete response (pCR) rate, with a maximum obtained between 10 and 13 weeks.The primary endpoint of this multicenter, 2-arm randomised trial is to investigate SI lengthening, evaluating the difference in terms of complete response (CR) and Tumor Regression Grade (TRG)1 rate in the two arms. Secondly, the impact of SI lengthening on survival outcomes and quality of life (QoL) will be investigated. Methods: Intermediate-risk LARC patients undergoing nCRT will be prospectively included in the study. nCRT will be administered with a total dose of 55 Gy in 25 fractions on Gross Tumor Volume (GTV) plus the corresponding mesorectum of 45 Gy in 25 fractions on the whole pelvis. Chemotherapy with oral capecitabine will be administered continuously.The patients achieving a clinical major or complete response assessed at clinical-instrumental re-evaluation at 7-8 weeks after treatment completion, will be randomized into two groups, to undergo surgery or local excision at 9-11 weeks (control arm) or at 13-16 weeks (experimental arm). Pathological response will be assessed on the surgical specimen using the AJCC TNM v.7 and the TRG according to Mandard. Patients will be followed up to evaluate toxicity and QoL.The promoter center of the trial will conduct the randomization process through an automated procedure to prevent any possible bias.For sample size calculation, using CR difference of 20% as endpoint, 74 patients per arm will be enrolled. Conclusions: The results of this study may prospectively provide a new time frame for the clinical re-evaluation for complete/major responders patients in order to increase the CR rate to nCRT.Trial registration:ClinicalTrials.gov Identifier: NCT03581344.

Factors Associated with Withdrawal Time in European Colonoscopy Practice: Findings of the European Colonoscopy Quality Investigation (ECQI) Group.

The European Colonoscopy Quality Investigation (ECQI) Group aims to raise awareness for improvement in colonoscopy standards across Europe. We analyzed data collected on a sample of procedures conducted across Europe to evaluate the achievement of the European Society of Gastrointestinal Endoscopy (ESGE) mean withdrawal time (WT) target. We also investigated factors associated with WT, in the hope of establishing areas that could lead to a quality improvement. METHODS: 6445 form completions from 12 countries between 2 June 2016 and 30 April 2018 were considered for this analysis. We performed an exploratory analysis looking at WT according to the ESGE definition. Stepwise multivariable logistic regression analysis was conducted to determine the most influential associated factors after adjusting for the other pre-specified variables. RESULTS: In 1150 qualifying colonoscopies, the mean WT was 7.8 min. Stepwise analysis, including 587 procedures where all inputs were known, found that the variables most associated with mean WT were a previous total colonoscopy in the last five years (p = 0.0011) and the time of day the colonoscopy was performed (p = 0.0192). The main factor associated with a WT < 6 min was the time of day that a colonoscopy was performed. Use of sedation was the main factor associated with a higher proportion of WT > 10 min, along with a previous colonoscopy. CONCLUSIONS: On average, the sample of European practice captured by the ECQI survey met the minimum standard set by the ESGE. However, there was variation and potential for improvement.

THUNDER 2: THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI guided radiotherapy.

BACKGROUND: Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality in locally advanced rectal cancer (LARC). Since response to radiotherapy (RT) is dose dependent in rectal cancer, dose escalation may lead to higher complete response rates. The possibility to predict patients who will achieve complete response (CR) is fundamental. Recently, an early tumour regression index (ERI) was introduced to predict pathological CR (pCR) after nCRT in LARC patients. The primary endpoints will be the increase of CR rate and the evaluation of feasibility of delta radiomics-based predictive MRI guided Radiotherapy (MRgRT) model. METHODS: Patients affected by LARC cT2-3, N0-2 or cT4 for anal sphincter involvement N0-2a, M0 without high risk features will be enrolled in the trial. Neoadjuvant CRT will be administered using MRgRT. The initial RT treatment will consist in delivering 55 Gy in 25 fractions on Gross Tumor Volume (GTV) plus the corresponding mesorectum and 45 Gy in 25 fractions on the drainage nodes. Chemotherapy with 5-fluoracil (5-FU) or oral capecitabine will be administered continuously. A 0.35 Tesla MRI will be acquired at simulation and every day during MRgRT. At fraction 10, ERI will be calculated: if ERI will be inferior than 13.1, the patient will continue the original treatment; if ERI will be higher than 13.1 the treatment plan will be reoptimized, intensifying the dose to the residual tumor at the 11th fraction to reach 60.1 Gy. At the end of nCRT instrumental examinations are to be performed in order to restage patients. In case of stable disease or progression, the patient will undergo surgery. In case of major or complete clinical response, conservative approaches may be chosen. Patients will be followed up to evaluate toxicity and quality of life. The number of cases to be enrolled will be 63: all the patients will be treated at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. DISCUSSION: This clinical trial investigates the impact of RT dose escalation in poor responder LARC patients identified using ERI, with the aim of increasing the probability of CR and consequently an organ preservation benefit in this group of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04815694 (25/03/2021).

Efficacy and safety of endoscopic resection techniques of large colorectal lesions: experience of a referral center in Italy.

BACKGROUND: Endoscopic mucosal resection and submucosal dissection (ESD) are treatments of choice for superficial neoplastic colorectal lesions. Only a few studies have compared these techniques. AIM: To compare the efficacy and safety of endoscopic piecemeal mucosal resection (EPMR), ESD and hybrid-endoscopic submucosal dissection (H-ESD) of large colorectal lesions in a Western endoscopic center. METHODS: This is a retrospective analysis on a prospective medical database of consecutive colorectal superficial lesions larger than 20 mm, resected by EPMR, ESD or H-ESD collected from 2015 to 2019. RESULTS: Two hundred twenty-nine colorectal lesions were included. All lesions were completely endoscopically resected, 65.9% by EPMR, 19.7% by ESD and 14.4% by H-ESD. Endoscopic control after the index procedure was available for 86.5% patients. Among these patients, 80% had a second follow-up colonoscopy. The overall recurrence rate was 13.2, 0 and 6.1% for EPMR, ESD and H-ESD respectively, with a significant difference between EPMR and ESD. All recurrences were endoscopically treated during follow-up procedures. Risk of complications was not significantly different between the three groups. CONCLUSIONS: EPMR, ESD and H-ESD are effective and safe procedures. Recurrence rate in EPMR was higher but can be managed endoscopically with high success rates. EPMR is faster and technically simpler so should be considered a potential first-line therapy for colorectal superficial neoplastic lesions.

Colonoscopy quality across Europe: a report of the European Colonoscopy Quality Investigation (ECQI) Group.

Background and study aims The European Colonoscopy Quality Investigation (ECQI) Group comprises expert colonoscopists and investigators with the aim of raising colonoscopy standards. We assessed the levels of monitoring and achievement of European Society of Gastrointestinal Endoscopy (ESGE) performance measures (PMs) across Europe using responses to the ECQI questionnaires. Methods The questionnaire comprises three forms: institution and practitioner questionnaires are completed once; a procedure questionnaire is completed on multiple occasions for individual total colonoscopies. ESGE PMs were approximated as closely as possible from the data collected via the procedure questionnaire. Procedure data could provide rate of adequate bowel preparation, cecal intubation rate (CIR), withdrawal time, polyp detection rate (PDR), and tattooing resection sites. Results We evaluated ECQI questionnaire data collected between June 2016 and April 2018, comprising 91 practitioner and 52 institution questionnaires. A total of 6445 completed procedure forms were received. Institution and practitioner responses indicate that routine recording of PMs is not widespread: adenoma detection rate (ADR) is routinely recorded in 29 % of institutions and by 34 % of practitioners; PDR by 42 % and 47 %, CIR by 62 % and 64 %, bowel preparation quality by 56 % and 76 %, respectively. Procedure data showed a rate of adequate bowel preparation of 84.2 %, CIR 73.4 %, PDR 40.5 %, mean withdrawal time 7.8 minutes and 12.2 % of procedures with possible removal of a non-pedunculated lesion ≥ 20 mm reporting tattooing. Conclusions Our findings clearly show areas in need of quality improvement and the importance of promoting quality monitoring throughout the colonoscopy procedure.

Outpatient ESD for challenging colorectal lesions: Is it feasible and safe for western countries?

Background and study aims The need for hospital beds during the COVID-19 pandemic almost overwhelmed the health care systems all over the world. Therefore, elective non-life-saving procedures were postponed. We decided to perform all colorectal endoscopic mucosal dissections (ESDs) for challenging lesions as outpatient procedures, organizing an ad hoc path to management of any delayed post-procedural complications. The aim of the present study was to retrospectively evaluate the feasibility and safety of outpatient ESD for colorectal tumors. Patients and methods From March 2020 to May 2020, outpatient colorectal ESDs were performed for 15 challenging lesions. We retrospectively investigated feasibility and safety of the procedures, rates of en bloc resection, and complications rates. Results The mean age of the patients was 66.5 years and 40 % of the them were on antiplatelet/anticoagulation therapy. Median size of removed lesions was 45 mm (range 32-77) and 38 mm (range 24 to 55) Five patients (33 %) had rectal tumors extending to the dentate line and four (26.6 %) were recurrences on a scar of previous endoscopic or surgical local resections. All complications, such as bleeding or visible microperforation, were managed endoscopically and no delayed perforations occurred. One patient had fever (37.5 °C), while three patients complained of anal pain after ESD for a rectal tumor that extended to the dentate line (RTDL); all patients were managed conservatively. Conclusion Outpatient colorectal ESD is feasible and safe for challenging lesions. It reduces costs of hospitalization but direct access to the endoscopy service to manage potential post-ESD complications should always be guaranteed.

Propensity score-matched comparison of short- and long-term outcomes between surgery and endoscopic submucosal dissection (ESD) for intestinal type early gastric cancer (EGC) of the middle and lower third of the stomach: a European tertiary referral center experience.

BACKGROUND: Despite the comparable results between ESD and gastrectomy reported in multiple Asiatic studies, limited data are currently present on the long-term efficacy of ESD for EGC in Western countries. The aim of this study was to compare the short- and long-term outcomes of the endoscopic submucosal dissection and surgery for non-diffuse early gastric cancer treatment in a Western cohort of patients. METHODS: All patients with a diagnosis of intestinal type EGC located in the middle and lower third of the stomach from 2005 to 2015 were enrolled in the study. All patients completed a 5-year follow-up. Patients were divided according to the procedure performed (ESD/subtotal gastrectomy). The two groups were matched for age, gender, ASA score, tumor dimension, and grade of infiltration (mucosa/submucosa). RESULTS: After matching, 84 patients (42 per group) were included in the analysis. Peri-procedural morbidity rate was 7.1% and no difference was observed between the two groups (4.8% vs 9.5% for ESD and STG groups, respectively; p = 0.3). Similar results in terms of 5-year OS and DFS were observed for ESD and STG (77.7% vs 71.8% ; p = 0.78 and 74.9% vs 72% ; p = 0.7, respectively). At the multivariate analysis, ASA3 score was recognized as the only negative predictor factor for the 5-year OS (OR 6.2; 95% CI 2.2-16.8; p < 0.001). Regarding the DFS, both ASA3 score (OR 4.4; 95% CI 1.7-10.9; p < 0.001) and submucosal infiltration(OR 5.1; 95% CI 1.2-22.4 ; p = 0.02) were identified as independent risk factors for a worse outcome. CONCLUSIONS: Our results confirm the safety and feasibility ESD for EGC treatment in a Western setting. In addition, this is one of the few reports showing comparable results both in terms of short- and long-term outcomes between ESD and surgery for intestinal type ECG treatment in Western countries.

Endoscopic submucosal dissection: Italian national survey on current practices, training and outcomes.

BACKGROUND AND AIMS: Most of the evidence supporting endoscopic submucosal dissection (ESD) comes from Asia. European data are primarily reported by specialized referral centers and thus may not be representative of common European ESD practice. The aim of this study is to understand the current state of ESD practice across Italian endoscopy centers. METHODS: All Italian endoscopists who were known to perform ESD were invited to complete a structured questionnaire including: operator features and competencies, ESD training details and clinical outcomes over a 2-year period. RESULTS: Twenty-nine operators from 23 centers (69% response rate) completed the questionnaire: 18 (62%) were <50 years old; 7 (24%) were female; 16 (70%) were located in Northern Italy. Overall ESD volume was <40 cases in 9 (31%) operators, 40-80 in 8 (27.5%), 80-150 in 4 (13.8%) and >150 in 8 (27.5%). Colorectal ESD was predominant for operators with an experience >80 cases. En-bloc resection rates ranged from 77.2 to 97.2% depending on the anatomic location with an R0 resection rate range of 75.3-93.6%. ESD perforation rates in the colon and rectum were significantly lower when experience was >150 compared to 80-150 cases (p < 0.0001 and p = 0.006 for colon and rectum, respectively). CONCLUSION: ESD in Italy is performed by a significant number of operators. Overall, Italian endoscopists performing ESD have achieved a good competence level. However, there is much variability in training protocols, initial supervision of procedures, practice settings, case mix and procedural volume/year that are likely responsible for some of the suboptimal resectional outcomes and increased perforation risk, mainly in the colon. Standardized training programs, practice parameters and auditing of outcomes are required.

Eosinophilic oesophagitis (in nickel-allergic patient) regressed after nickel oral desensitization: A case report.

The eosinophilic oesophagitis (EoE) is a chronic immune/antigen disorder of the oesophagus clinically characterized by dysphagia and pathologically by mucosa eosinophilic infiltration. Th2-type allergic reactions are considered having important roles in the aetiopathogenesis of EoE. Avoidance of food allergens, administration of steroidal anti-inflammatory medications and dilation of the oesophagus are the most important treatments. 'Systemic nickel allergy syndrome' (SNAS) interests about 20% of patients with nickel contact allergy which could present systemic cutaneous manifestations (urticaria, oedema, etc.) and also respiratory and digestive symptoms (meteorism, abdominal pain, diarrhoea, etc.). In the literature, it is demonstrated that nickel oral immunotherapy is effective in reducing symptoms of SNAS and in modulating inflammatory parameters. We describe the case of a 48-year-old woman suffering from EoE not responsive to the topical steroid administration and diagnosis of SNAS. The patient started nickel oral desensitization according to the literature protocol continuing nickel-free diet. After 1 year from the beginning of the treatment, during the maintenance dose (500 ng three times a week), she decreased gradually the dosage of immunotherapy and reintroduced all the culprit foods. After the immunotherapy interruption, during the free diet, she repeated the oesophagogastroscopy with a complete macroscopic and histological resolution. We showed the first case of an EoE in a patient affected by SNAS responsive to the nickel-free diet and the oral immunotherapy.

Endoscopic submucosal dissection of gastric superficial neoplastic lesions: a single Western center experience.

BACKGROUND: Endoscopic submucosal dissection (ESD) allows "en bloc" resection of superficial gastric lesions. OBJECTIVE: The aim of this study is to report "en bloc" resection rate, procedure results, post resection features, analysis of complications, and relapses at mid-long term follow-up on an Italian center case series of patients with superficial gastric neoplastic lesions treated with ESD. METHODS: This is a retrospective evaluation of a prospectively collected series of patients diagnosed with gastric superficial lesions who underwent ESD between November 2007 and May 2015. The analysis included demographic, clinical, endoscopic, and histological data. In detail, the following features were analyzed: (1) "en bloc" resection rate; (2) R0, R1, and RX rate; (3) complication rate; and (4) neoplastic recurrence during follow-up. A comparison was performed between lesions treated according to standard and to extended criteria. RESULTS: In the analysis, therefore, 70 superficial lesions and 70 endoscopic procedures were considered.Overall, 53 (76%) procedures were performed according to the extended-ESD criteria. The remaining 17 (24%) cases were performed according to standard criteria. In 68/70 (97%) procedures "en bloc" resection was successful. Forty-four (65.6%) patients had a R0 resection, while 15 (22%) patients had a R1 and the remaining 8 (12.4%) patients were RX. Two patients (2.8%) experienced a major complication. Overall, 7 patients (10.4%) required surgery: in two cases because of local recurrence, in one case for an intraprocedural complication not amenable to endoscopic treatment, in three patients with R1 vertical margins, and in the last patient because of an aggressive pathology (i.e. signet ring cell adenocarcinoma). The mean follow-up of patients with neoplastic lesions was 36.6 ± 13.1 months. CONCLUSION: ESD for early gastric cancer is a safe and effective technique when performed by experienced Endoscopists also in Western setting. When comparing the outcomes of the ESD in patients with standard and extended indication there is no significant difference in terms of complete resection, complications and local recurrence rates. Larger Western studies are needed to clearly define the role and the outcomes of ESD in regions at low incidence for gastric neoplasia.

Endoscopic mucosal resection of non-ampullary sporadic duodenal adenomas: a retrospective analysis with long-term follow-up.

OBJECTIVE: We investigate the efficiency of endoscopic mucosal resection (EMR) of non-ampullary sporadic duodenal adenomas (NASDA) in a retrospective analysis with long-term follow-up. METHODS: Consecutive patients undergoing EMR of NASDA between May 2002 and December 2016 were retrospectively identified from an electronic database. Endoscopic follow-up was scheduled after 3, 6 and 12 months for the first year, then yearly for up to five years. RESULTS: EMR of 75 NASDA was performed in 68 patients (56% en-bloc, 44% piecemeal). Retroperitoneal perforations occurred in 3/68 (4.4%) patients, were treated by surgical (n = 2) or percutaneous (n = 1) drainage; delayed bleeding was reported in 13/75 (17.3%) resections and was successfully managed by endoscopy (n = 12) or radiologic embolization (n = 1). There was no procedure-related mortality. Follow-up was available in 61/68 patients (89.7%) after a median time of 59 months from resection. Residual and recurrent adenoma were diagnosed in 9 (14.5%) and 6 (10.9%) cases, respectively; all but one were successfully retreated endoscopically. CONCLUSIONS: EMR for NASDA is effective with a favorable long-term outcome. Local recurrences can be retreated endoscopically. A recall system, patient's compliance to endoscopic follow-up are mandatory to detect recurrences and their prompt treatment.

Impact of 2 generational improvements in colonoscopes on adenoma miss rates: results of a prospective randomized multicenter tandem study.

BACKGROUND AND AIMS: Numerous randomized studies have shown that changing certain features of colonoscopes, usually incorporated when switching from one endoscope generation to the next, mostly do not increase adenoma yield. There is, however, indirect evidence that it may be necessary to skip one instrument generation (ie, changing from one generation to the next but one) to achieve this effect. METHODS: We compared the latest-generation colonoscopes from one company (Olympus Exera III, 190-C) with the next to last one (Olympus 160/5-C) in a prospective multicenter study randomized for the order of colonoscopes in a tandem fashion, involving 2 different examiners. Patients with increased risk for colorectal neoplasia undergoing colonoscopy (positive fecal occult blood test, personal/familial history of colorectal cancer/adenoma, rectal bleeding, recent change in bowel movements) were included. The primary outcome was the adenoma miss rate with the 190 (190-C) colonoscope in comparison with the 160/5 colonoscope (160/5-C). RESULTS: A total of 856 patients (48.8% male; mean age, 58.3 years) with a personal (41%) or family (38%) history of colorectal neoplasia, rectal bleeding (19%), and other indications were included. Of the 429 patients in the 190-C first group, 16.6% (95% confidence interval [CI], 13.0%-20.1%) had at least one adenoma missed during the first procedure, compared with 30.2% (95% CI, 25.9%-34.6%) in the group with 160/5-C first (P < .001). Similarly, the adenoma detection rate during the first colonoscopy was 43.8% versus 36.5% (P = .030) for 190-C versus 160/5-C, respectively. CONCLUSIONS: This randomized tandem trial showed lower adenoma miss rates and higher adenoma detection rates for the newer 190 colonoscopes compared with the 160/5 series. These results suggest that it takes multiple improvements, such as those implemented over 2 instrument generations, before an effect on adenoma (miss) rate can be observed. (Study registration number: ISRCTN 2010-A01256-33.).

Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG.

BACKGROUND: Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4L (PEG 4L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability. AIM: To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4L. METHODS: In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2L or PEG 4L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good. RESULTS: 422 patients received Clensia (n=213) or PEG 4L (n=209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4L group respectively. Clensia was demonstrated to be equivalent to PEG 4L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4L 63%, P=0.0314) and willingness-to-repeat (93.9% vs 82.2%, P=0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4L, P=0.9388). CONCLUSIONS: The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4L, with better gastrointestinal tolerability and acceptability.