Impact of surgery after endoscopically resected high-risk T1 colorectal cancer: results of an emulated target trial.

BACKGROUND AND AIMS: We aimed to compare the long-term outcomes of patients with high-risk T1 colorectal cancer (CRC) resected endoscopically who received either additional surgery or surveillance. METHODS: We used data from routine care to emulate a target trial aimed at comparing 2 strategies after endoscopic resection of high-risk T1 CRC: surgery with lymph node dissection (treatment group) versus surveillance alone (control group). All patients from 14 tertiary centers who underwent an endoscopic resection for high-risk T1 CRC between March 2012 and August 2019 were included. The primary outcome was a composite outcome of cancer recurrence or death at 48 months. RESULTS: Of 197 patients included in the analysis, 107 were categorized in the treatment group and 90 were categorized in the control group. From baseline to 48 months, 4 of 107 patients (3.7%) died in the treatment group and 6 of 90 patients (6.7%) died in the control group. Four of 107 patients (3.7%) in the treatment group experienced a cancer recurrence and 4 of 90 patients (4.4%) in the control group experienced a cancer recurrence. After balancing the baseline covariates by inverse probability of treatment weighting, we found no significant difference in the rate of death and cancer recurrence between patients in the 2 groups (weighted hazard ratio, .95; 95% confidence interval, .52-1.75). CONCLUSIONS: Our study suggests that patients with high-risk T1 CRC initially treated with endoscopic resection may not benefit from additional surgery.

Endoscopic submucosal dissection of appendicular lesions is feasible and safe: a retrospective multicenter study (with video).

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is challenging for appendicular lesions. We report the outcomes of ESD in this context. METHODS: We collected data of ESD procedures for appendiceal neoplasia in a multicenter prospective registry. Main study endpoints were R0, en-bloc, and curative resection rates and adverse event rate. RESULTS: One hundred twelve patients were included, 47 (42%) with previous appendectomy. Fifty-six (50%) were Toyonaga type 3 lesions (15 [13.4%] postappendectomy). En-bloc and R0 resection rates were 86.6% and 80.4%, respectively, with no significant difference associated with different grades of appendiceal invasion (P = .9 and P = .4, respectively) or previous appendectomy (P = .3 for both). The curative resection rate was 78.6%. Additional surgery was performed in 16 cases (14.3%), including 10 (62.5%) Toyonaga type 3 lesions (P = .04). This included the treatment of 5 cases (4.5%) of delayed perforation and 1 acute appendicitis. CONCLUSIONS: ESD for appendicular lesions is a potentially safer and effective alternative to surgery for a significant proportion of patients.

Impact of Sarcopenia on Survival in Patients Treated with FOLFIRINOX in a First-Line Setting for Metastatic Pancreatic Carcinoma.

Sarcopenia, defined as decreased muscle mass and strength, can be evaluated by a computed tomography (CT) examination and might be associated with reduced survival in patients with carcinoma. The prognosis of patients with metastatic pancreatic carcinoma is poor. The FOLFIRINOX (a combination of 5-fluorouracil, irinotecan, and oxaliplatin) chemotherapy regimen is a validated first-line treatment option. We investigated the impact of sarcopenia on overall survival (OS) and progression-free survival (PFS) in patients with metastatic pancreatic carcinoma. Clinical data and CT examinations of patients treated with FOLFIRINOX were retrospectively reviewed. Sarcopenia was estimated using baseline CT examinations. Seventy-five patients were included. Forty-three (57.3%) were classified as sarcopenic. The median OS of non-sarcopenic and sarcopenic patients were 15.6 and 14.1 months, respectively (p = 0.36). The median PFS was 10.3 in non-sarcopenic patients and 9.3 in sarcopenic patients (p = 0.83). No differences in toxicity of FOLFIRINOX were observed. There was a trend towards a higher probability of short-term death (within 4 months of diagnosis) in sarcopenic patients. In this study, the detection of sarcopenia failed to predict a longer OS or PFS in selected patients deemed eligible by a physician for triplet chemotherapy and receiving the FOLFIRINOX regimen in a first-line setting, confirming the major importance of a comprehensive patient assessment by physicians in selecting the best treatment option.

Airborne transmission of SARS-Cov2: What consequences for digestive endoscopy?

The SARS-Cov-2 disease disrupted essential hospital procedures, such as gastrointestinal (GI) endoscopy, due to concerns about air transmission and the risk of exposing health care workers. With the spread of the pandemic, air transmission was considered as the main source of SARS-Cov2 transmission. This raised the problem of transmission by aerosolization of viral particles in operating rooms as well as endoscopy units. This is in line with the known airborne transmission of many other respiratory viruses. The risk of SARS-Cov-2 transmission during GI endoscopy was initially reduced by controlled measures, involving personal protections (mask…), restricted access to endoscopy rooms, and detection of infected patients. Gastrointestinal endoscopy generates aerosols, which may carry viruses. In addition, the endoscopy system may facilitate the diffusion of virus particles or fomites considering the forced-air cooling system used to maintain a stable temperature inside the box (25°C). The volume of air that goes through the light source box is high (240-300 m3 for a 1-h period). Moreover, the light system contains an air pump to inflate air inside the gut lumen. In order to isolate people from hazard, different levels of protection and solutions to avoid airborne transmission of microorganisms should be proposed, such as the reinforcement of personal protective equipment, the change in the way people work and engineering control of the risk.

Predictive factors of radiofrequency ablation failure in the treatment of dysplastic Barrett's esophagus.

INTRODUCTION: Radiofrequency ablation (RFA) has become the recommended endoscopic treatment for flat dysplastic Barrett's esophagus. However, the outcomes of this treatment are variable across European countries. Our aim was to report the results of a French high-volume center, and to investigate factors associated with treatment failure. METHODS: We conducted a single-center retrospective study from a prospectively collected database from 2011 to 2020, including all consecutive patients treated with RFA for flat dysplastic Barrett's esophagus. The primary endpoint was the failure rate of esophageal radiofrequency treatment, defined as either persistence of intestinal metaplasia at the end of treatment, or neoplastic progression during RFA. RESULTS: 96 patients treated with a median of four RFA sessions for a mean C5M6 Barrett's esophagus were included in the analysis. Complete eradication of intestinal metaplasia and dysplasia were achieved in 59% and 79% of patients, respectively, resulting in a treatment failure rate of 41%. Ten patients experienced neoplastic progression during treatment. We recorded 14% of post-RFA esophageal strictures, all successfully treated by endoscopic dilatation. Univariate analysis identified the length of Barrett's esophagus and the absence of hiatal hernia as predictive factors for treatment failure, however not confirmed in multivariate analysis. CONCLUSION: In our experience, RFA of flat dysplastic Barrett's esophagus had a 41% treatment failure rate. The length of the Barrett's segment might be associated with treatment failure. Although our results confirm a role for RFA in the management of dysplastic Barrett's esophagus, the treatment failure rate was higher than expected. This suggest that endoscopists, even in high-volume centers, should receive specific training in RFA.

A new system to prevent SARS-CoV-2 and microorganism air transmission through the air circulation system of endoscopes.

Background and study aims Evidence for the modes of transmission of SARS-CoV-2 remains controversial. Recently, the potential for airborne spread of SARS-CoV-2 has been stressed. Air circulation in gastrointestinal light source boxes and endoscopes could be implicated in airborne transmission of microorganisms. Methods The ENDOBOX SC is a 600 × 600 mm cube designed to contain any type of machine used during gastrointestinal endoscopy. It allows for a 100-mm space between a machine and the walls of the ENDOBOX SC. To use the ENDOBOX SC, it is connected to the medical air system and it provides positive flow from the box to the endoscopy room. The ENDOBOX SC uses medical air to inflate the digestive tract and to decrease the temperature induced by the microprocessors or by the lamp. ENDOBOX SC has been investigated in different environments. Results An endoscopic procedure performed without ventilation was interrupted after 40 minutes to prevent computer damage. During the first 30 minutes, the temperature increased from 18 °C to 31 °C with a LED system. The procedure with fans identified variations in temperature inside the ENDOBOX SC from 21 to 26 °C (±â€Š5 °C) 1 hour after the start of the procedure. The temperature was stable for the next 3 hours. Conclusions ENDOBOX SC prevents the increase in temperature induced by lamps and processors, allows access to all necessary connections into the endoscopic columns, and creates a sterile and positive pressure volume, which prevents potential contamination from microorganisms.

The Safety of Long-Term Proton Pump Inhibitor Use on Cardiovascular Health: A Meta-Analysis.

Introduction: Proton pump inhibitors (PPIs) are one of the most prescribed classes of drugs worldwide as a first-line treatment of acid-related disorders. Although adverse effects are rare and rapidly reversible after a short exposure, concerns have been recently raised about a greater toxicity on cardiovascular health after a longer exposure, especially when combined with clopidogrel. We aimed to evaluate the safety of long-term PPI use on cardiovascular health in patients with known atheromatous cardiovascular disease. Methods: A literature search was conducted in the PubMed, Embase, and Cochrane Library databases and grey literature in April 2022. Articles published between 2014 and 2022 were considered relevant if they were designed as randomized controlled trials (RCTs) that included post hoc analyses or prospective observational studies and if they investigated clinical cardiovascular outcomes associated with PPI use for 6 months or more in patients suffering from cardiovascular disease requiring antiplatelet agent therapy and/or coronary angioplasty. Statistical analyses were performed using RevMan 5.4 software (Computer program, the Cochrane Collaboration, 2020, London, UK). The risk of bias was assessed using the Cochrane risk-of-bias tool for the RCTs and the Newcastle−Ottawa scale for the observational studies. Results: A total of 10 full-text articles involving 53,302 patients were included. Substantial heterogeneity was found among the 10 included studies. The primary analysis showed no significant differences between the PPI group and the control group for the risks of major adverse cardiovascular events (MACEs), all-cause death (ACD), or target vessel revascularization (TVR) using a random-effects model (OR 1.15, 95% CI 0.98−1.35, p = 0.08, I2 = 73%; OR 1.24, 95% CI 0.94−1.65, p = 0.13, I2 = 63%; and OR 1.19, 95% CI 0.76−1.87, p = 0.45, I2 = 61%, respectively). The primary analysis yielded similar results for the risks of myocardial infarction (MI), stroke, and cardiovascular death (CVD) using a fixed-effects model (OR 0.98, 95% CI 0.88−1.09, p = 0.66, I2 = 0%; OR 1.02, 95% CI 0.90−1.17, p = 0.73, I2 = 0%; and OR 1.04, 95% CI 0.94−1.16, p = 0.44, I2 = 35%, respectively). Likewise, a subgroup analysis based on eight randomized controlled trials failed to identify any association between PPI use and the risks of MACEs, MI, stroke, TVR, ACD, or CVD using a fixed-effects model (overall pooled OR 1.01, 95% CI 0.96−1.06; p = 0.66; I2 = 0%). The pulled data from the two included observational studies (OS) demonstrated a significantly increased risk of MACEs in the PPI group (OR 1.42, 95% CI [1.29−1.57], p <0.001; I2 = 0%). In another subgroup analysis, no evidence of an increased risk of adverse cardiovascular events in the co-therapy PPI/clopidogrel versus clopidogrel alone groups was found with the exception of the risk of ACD (OR 1.50, 95% CI 1.23−1.82, p = 0.001, I2 = 0%). Nevertheless, after performing a sensitivity analysis reaching heterogeneity I2 = 0%, the co-prescription of PPIs and clopidogrel was at increased risk of MACEs (p < 0.001), CVD (p = 0.008), and TVR (p < 0.001) but remained statistically non-significant for the risk of MI (p = 0.11). Conclusions: The overall results of this meta-analysis showed that long-term PPI use was not associated with an increased risk of adverse cardiovascular events. However, inconsistent results were found for combined PPI/clopidogrel therapy. These results should be considered with caution in light of the significant heterogeneity, the limited number of included studies, and the lack of adjustment for potential confounders.

Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19.

OBJECTIVE: To assess post-discharge persistent symptoms and health-related quality of life (HRQoL) of patients hospitalized in a COVID-19 ward unit more than 100 days after their admission. METHODS: All eligible patients were contacted by phone by trained physicians and were asked to answer to a dedicated questionnaire. Patients managed in hospital ward without needing intensive care were compared with those who were transferred in intensive care units (ICU). RESULTS: We included 120 patients after a mean (±SD) of 110.9 (±11.1) days following admission. The most frequently reported persistent symptoms were fatigue (55%), dyspnoea (42%), loss of memory (34%), concentration and sleep disorders (28% and 30.8%, respectively). Comparisons between ward- and ICU patients led to no statistically significant differences regarding those symptoms. In both group, EQ-5D (mobility, self-care, pain, anxiety or depression, usual activity) was altered with a slight difference in pain in the ICU group. CONCLUSION: Most patients requiring hospitalization for COVID-19 still have persistent symptoms. While there were few differences between HRQoL between ward and ICU patients, our findings must be confirmed in larger cohorts, including more severe patients.

A nomogram to predict the risk of unfavourable outcome in COVID-19: a retrospective cohort of 279 hospitalized patients in Paris area.

OBJECTIVE: To identify predictive factors of unfavourable outcome among patients hospitalized for COVID-19. METHODS: We conducted a monocentric retrospective cohort study of COVID-19 patients hospitalized in Paris area. An unfavourable outcome was defined as the need for artificial ventilation and/or death. Characteristics at admission were analysed to identify factors predictive of unfavourable outcome using multivariable Cox proportional hazard models. Based on the results, a nomogram to predict 14-day probability of poor outcome was proposed. RESULTS: Between March 15th and April 14th, 2020, 279 COVID-19 patients were hospitalized after a median of 7 days after the first symptoms. Among them, 88 (31.5%) patients had an unfavourable outcome: 48 were admitted to the ICU for artificial ventilation, and 40 patients died without being admitted to ICU. Multivariable analyses retained age, overweight, polypnoea, fever, high C-reactive protein, elevated us troponin-I, and lymphopenia as risk factors of an unfavourable outcome. A nomogram was established with sufficient discriminatory power (C-index 0.75), and proper consistence between the prediction and the observation. CONCLUSION: We identified seven easily available prognostic factors and proposed a simple nomogram for early detection of patients at risk of aggravation, in order to optimize clinical care and initiate specific therapies. KEY MESSAGES Since novel coronavirus disease 2019 pandemic, a minority of patients develops severe respiratory distress syndrome, leading to death despite intensive care. Tools to identify patients at risk in European populations are lacking. In our series, age, respiratory rate, overweight, temperature, C-reactive protein, troponin and lymphocyte counts were risk factors of an unfavourable outcome in hospitalized adult patients. We propose an easy-to-use nomogram to predict unfavourable outcome for hospitalized adult patients to optimize clinical care and initiate specific therapies.

Applicability of the CURB-65 pneumonia severity score for outpatient treatment of COVID-19.

OBJECTIVES: The CURB-65 is a severity score to predict mortality secondary to community acquired pneumonia and is widely used to identify patients who can be managed as outpatients. However, whether CURB-65 can be applicable to COVID-19 patients for the decision of outpatient treatment is still unknown. METHODS: We conducted a retrospective single-centre study assessing the performance of the CURB-65 to predict the risk of poor outcome, defined as the need for mechanical ventilation and/or death, among patients hospitalized for COVID-19. The association between the CURB-65 and the outcome was assessed by a univariable Cox proportional hazard regression model. RESULTS: A total of 279 patients were hospitalized between March 15th and April 14th, 2020. According to the CURB-65, 171 (61.3%) patients were considered at low risk (CURB-65 01), 66 (23.7%) at intermediate risk (CURB-65=2), and 42 (15.1%) had high risk of 30-day mortality (CURB-65 35). During the study period, 88 (31.5%) patients had a poor outcome. The CURB-65 was strongly associated with a poor outcome (Pfor linear trend <0.001). However, among patients with a CURB-65 of 01, thus considered at low risk, 36/171 (21.1%) had a poor outcome. CONCLUSIONS: Our study suggests that the applicability of CURB-65 to guide the decision of inpatient or outpatient care is scarce, as it does not safely identify patients who could be managed as outpatients.