Implementation of a peroral endoscopic myotomy program.

INTRODUCTION: the aim of our study was to develop a peroral endoscopic myotomy (POEM) program in our Unit following a two-step sequence: training on animal models and supervision by an experienced endoscopist during the first human cases. METHODS: a single endoscopist experienced in advanced endoscopy was trained in POEM. After observing POEM in referral centers, training was implemented on swine models (preclinical phase). Technical aspects and adverse events were prospectively recorded. A first subset of cases (group A) was compared to a second one (group B) to assess our progression. Finally, POEM was implemented in humans under the supervision of an experienced endoscopist (clinical phase). The outcomes and adverse events were prospectively recorded. RESULTS: during the preclinical phase, 15 POEM procedures were performed on live pigs. Severe adverse events (AE) were less frequent in group B than in group A (12 % vs 57 %, p = 0.07). After nine cases, a plateau of adverse events was reached. During the clinical phase, eleven POEM procedures were performed in patients under expert supervision. Technical and clinical (Eckardt score ≤ 3) success were 100 % and 91 %, respectively (follow-up 3-21 months). In two cases, intervention of an experienced endoscopist was required (cases 2 and 3) because of a difficult orientation at the esophagogastric junction. One mild pneumoperitoneum occurred, with no severe adverse events reported. CONCLUSIONS: training in animal models and supervision by an experienced endoscopist during the first cases could provide the necessary skills to perform POEM safely and effectively.

Effect of aspirin and antiplatelet drugs on the outcome of the fecal immunochemical test.

OBJECTIVE: To evaluate the effect of aspirin and nonaspirin antiplatelet agents (NAAAs) on the performance of the fecal immunochemical test (FIT). PARTICIPANTS AND METHODS: We performed a post hoc analysis of results from a clinical trial that involved 28,696 asymptomatic average-risk men and women aged 50 to 69 years invited to participate in a colorectal cancer screening program with FIT between November 1, 2008, and June 31, 2011. RESULTS: The test was returned by 6390 individuals (22.3%), of whom 5821 (91.1%) reported not using antiplatelet drugs (nonusers group) and 569 (8.9%) reported using these drugs at the time of testing (users group). The FIT result was positive in 48 of 569 users (8.4%) and 365 of 5821 nonusers (6.3%) (P=.05). A positive FIT result was found in 7.3% (28/384) of aspirin users, 7.1% (10/140) of NAAA users, and 22.2% (10/45) of those undergoing dual antiplatelet therapy (DAPT) (aspirin plus an NAAA). The DAPT subgroup had a significantly higher positive FIT rate than the nonuser group (odds ratio, 3.5; 95% CI, 1.7-7.3; P<.05). The positive predictive value (PPV) for advanced neoplasia (AN) in nonusers was 50.4% vs 50.0% in users (P = .40). The PPV for AN was 57.0% in aspirin users, 30.0% in NAAA users, and 50.0% in DAPT users, without statistically significant differences between the user and nonuser groups. CONCLUSION: The use of DAPT increased the rate of positive FIT results. Use of aspirin, NAAAs, or both did not modify the PPV for AN in this population-based colorectal screening program.