Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years.

BACKGROUND: Transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE. METHODS: Forty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12 months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3 years are reported in this study (PP- and ITT-analysis). RESULTS: TIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year. CONCLUSION: TIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases. CLINICALTRIALS: GOV: ID: NCT03669874.

Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis.

Background and study aims Few reports exist about long-term outcomes of transoral incisionless fundoplication (TIF) for treating refractory gastro-esophageal reflux disease (GERD). Methods A literature search of four major scientific databases was performed up to May 2020 for studies reporting on more than 3-year outcomes of TIF. Data on atient satisfaction, proton pump inhibitor (PPI) daily consumption, PPI use reduction, GERD health-related quality-of-life (GERD-HRQL) score, and normalization of heartburn and regurgitation scores were pooled and summarized with forest plots. Publication bias and heterogeneity were explored. Results Overall, eight studies (418 patients, 232 men; 55.5 %) with a mean follow-up of 5.3 years (range: 3-10 years) were included. The pooled proportion of patient-reported satisfaction before and after TIF was 12.3 % (95 % CI:12.3-35.1 %, I 2  = 87.4 %) and 70.6 % (95 % CI:51.2-84.6, I 2  = 80 %), respectively, corresponding to an odds ratio of 21.4 (95 % CI:3.27-140.5). Pooled rates of patients completely off PPIs and on occasional PPIs were 53.8 % (95 %CI: 42.0 %-65.1 %) and 75.8 % (95 %CI: 67.6-82.6), respectively. The pooled estimated mean GERD-HRQL scores off PPI before and after TIF werey 26.1 (95 %CI: 21.5-30.7; range: 20.0-35.5) and 5.9, respectively (95 %CI:0.35.1-11.4; range: 5.3-9.8; P  < 0.001). The overall pooled rates of heartburn and regurgitation scores normalization were 73.0 % (95 %CI: 0.62-0.82) and 86 %, respectively (95 %CI: 75.0-91.0 %). Conclusion Our study shows that TIF appears to offer a long-term safe therapeutic option for selected patients with GERD who refuse life-long medical therapy or surgery, are intolerant to PPIs, or are at increased surgical risk.

Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes.

BACKGROUND: Transoral incisionless fundoplication (TIF) with the Medigus ultrasonic surgical endostapler (MUSE) is a new intervention for the treatment of the gastroesophageal reflux disease (GERD). The aim of this study was to assess the 12-month clinical, functional, and endoscopic effects of TIF by MUSE. METHODS: Patients undergoing MUSE completed the GERD-Health Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires, and underwent endoscopy, esophageal 24-hour pH-impedance recording, and high resolution manometry (HRM) before the TIF procedure and 12 months later, or after 6 months for HRM. RESULTS: Among the 37 patients treated, esophageal intubation was not possible in one and esophageal perforation occurred in another. Clinical and endoscopic follow-up at 12 months was completed in 20 patients, with significant improvements in GERD-HRQL, RSI, heartburn, regurgitation scores, and proton pump inhibitor (PPI) consumption observed. One patient required surgery for persisting symptoms. Functional follow-up was possible in 13 patients and showed no significant improvements in the analyzed parameters. CONCLUSIONS: TIF with MUSE significantly improved symptoms at 1-year follow-up, allowing the consumption of PPIs to be stopped or halved in 90 % of patients.

Transoral incisionless fundoplication with EsophyX for gastroesophageal reflux disease: clinical efficacy is maintained up to 10 years.

Background Transoral incisionless fundoplication with EsophyX is reported to be effective in patients with gastroesophageal reflux disease in short-medium term follow-up. Aim To examine clinical outcomes up to 10 years. Methods In total, 51 procedures were performed in 50 patients. All entered a yearly clinical follow-up schedule including gastroesophageal reflux disease health-related quality-of-life questionnaires, heartburn and regurgitation scores, and daily proton pump inhibitor consumption. Results The procedure was successfully performed in 49/50 patients. Severe complications occurred in 2/51 procedures. The remaining 49 patients were re-evaluated at 2 and 3 years, 41 after 5 years, 30 after 7 years, and 14 after 10 years. Eight patients were lost to follow-up between 3 and 5 years. Seven patients who were unresponsive to endoscopic fundoplication underwent surgical fundoplication. The mean scores at 2 years were significantly lower than before the procedure and did not change substantially during the follow-up. The rates of patients who had stopped or halved antisecretive therapy 2, 3, 5, 7, and 10 years after the procedure were 86.7 %, 84.4 %, 73.5 %, 83.3 %, and 91.7 %, respectively. Conclusions Transoral incisionless fundoplication with EsophyX is an effective therapeutic option for symptomatic gastroesophageal reflux disease patients, with Hill grades I - II or hiatal hernia < 2 cm, who refuse life-long medical therapy or surgery.

Oropharyngeal acid reflux and motility abnormalities of the proximal esophagus.

AIM: To investigate the relationship between pathological oropharyngeal (OP) acid exposure and esophageal motility in patients with extra-esophageal syndromes. METHODS: In this prospective study we enrolled consecutive outpatients with extra-esophageal symptoms suspected to be related to gastroesophageal reflux disease (GERD). We enrolled only patients with a reflux symptom index (RSI) score-higher than 13 and with previous lung, allergy and ear, nose and throat evaluations excluding other specific diagnoses. All patients underwent 24-h OP pH-metry with the Dx probe and esophageal high-resolution manometry (HRM). Patients were divided into two groups on the basis of a normal or pathological pH-metric finding (Ryan Score) and all manometric characteristics of the two groups were compared. RESULTS: We examined 135 patients with chronic extra-esophageal syndromes. Fifty-one were considered eligible for the study. Of these, 42 decided to participate in the protocol. Patients were divided into two groups on the basis of normal or pathological OP acid exposure. All the HRM parameters were compared for the two groups. Significant differences were found in the median upper esophageal sphincter resting pressure (median 71 mmHg vs 126 mmHg, P = 0.004) and the median proximal contractile integral (median 215.5 cm•mmHg•s vs 313.5 cm•mmHg•s, P = 0.039), both being lower in the group with pathological OP acid exposure, and the number of contractions with small or large breaks, which were more frequent in the same group. This group also had a larger number of peristaltic contractions with breaks in the 20 mmHg isobaric contour (38.7% vs 15.38%, P < 0.0001). CONCLUSION: In patients with suspected GERD-related extra-esophageal syndromes pathological OP acid exposure was associated with weaker proximal esophageal motility.

Transoral incisionless fundoplication for gastro-esophageal reflux disease: Techniques and outcomes.

Gastro-esophageal reflux disease (GERD) is a very common disorder that results primarily from the loss of an effective antireflux barrier, which forms a mechanical obstacle to the retrograde movement of gastric content. GERD can be currently treated by medical therapy, surgical or endoscopic transoral intervention. Medical therapy is the most common approach, though concerns have been increasingly raised in recent years about the potential side effects of continuous long-term medication, drug intolerance or unresponsiveness, and the need for high dosages for long periods to treat symptoms or prevent recurrences. Surgery too may in some cases have consequences such as long-lasting dysphagia, flatulence, inability to belch or vomit, diarrhea, or functional dyspepsia related to delayed gastric emptying. In the last few years, transoral incisionless fundoplication (TIF) has proved an effective and promising therapeutic option as an alternative to medical and surgical therapy. This review describes the steps of the TIF technique, using the EsophyX(®) device and the MUSE(TM) system. Complications and their management are described in detail, and the recent literature regarding the outcomes is reviewed. TIF reconfigures the tissue to obtain a full-thickness gastro-esophageal valve from inside the stomach, by serosa-to-serosa plications which include the muscle layers. To date the procedure has achieved lasting improvement of GERD symptoms (up to six years), cessation or reduction of proton pump inhibitor medication in about 75% of patients, and improvement of functional findings, measured by either pH or impedance monitoring.

2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation.

BACKGROUND: Chronic constipation is a risk factor of inadequate bowel preparation for colonoscopy; however, no large clinical trials have been performed in this subgroup of patients. AIMS: To compare bowel cleansing efficacy, tolerability and acceptability of 2-L polyethylene-glycol-citrate-simethicone (PEG-CS) plus 2-day bisacodyl (reinforced regimen) vs. 4-L PEG in patients with chronic constipation undergoing colonoscopy. METHODS: Randomized, observer-blind, parallel group study. Adult outpatients undergoing colonoscopy were randomly allocated to 2-L PEG-CS/bisacodyl or 4-L PEG, taken as split regimens before colonoscopy. Quality of bowel preparation was assessed by the Ottawa Bowel Cleansing Scale (OBCS). The amount of foam/bubble interfering with colonic visualization was also measured. RESULTS: 400 patients were enrolled. There was no significant difference in successful cleansing (OBCS score ≤6): 80.2% in the 2-L PEG-CS/bisacodyl vs. 81.4% in the 4-L PEG group. Significantly more patients taking 2L PEG-CS/bisacodyl showed no or minimal foam/bubbles in all colonic segments (80% vs. 63%; p<0.001). 2-L PEG-CS/bisacodyl was significantly more acceptable for ease of administration (p<0.001), willingness to repeat (p<0.001) and showed better compliance (p=0.002). CONCLUSION: Split 2-L PEG-CS plus bisacodyl was not superior to split 4-L PEG for colonoscopy bowel cleansing in patients with chronic constipation; however, it performed better than the standard regimen in terms of colonic mucosa visualization, patient acceptance and compliance.

Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study.

BACKGROUND: Transoral incisionless fundoplication (TIF) with the EsophyX™ device creates an antireflux valve with good functional results in patients with gastro-esophageal reflux disease (GERD). The aim of this study was to assess the long-term effect of TIF 2.0 on pathological reflux and symptoms in GERD patients with daily dependence on proton pump inhibitors (PPI). METHODS: Fifty patients underwent TIF. All underwent GERD-HRQL and GERD-QUAL questionnaires, upper GI endoscopy, esophageal manometry, and 24-h pH-impedance before and 6, 12, and 24 months after TIF, and subsequent yearly clinical re-evaluation. RESULTS: Patients were followed for up to six years (mean 52.7 ± 19.7 months). In all, 83.7, 79.6, 87.8, and 84.4% of patients stopped or halved the PPI therapy 6, 12, 24, and 36 months after TIF. Three-year figure remained stable up to 6 years. Symptom scores off PPI were significantly lower at 6, 12, 24, and 36 months. At 6 months, Hill's grade I of the newly created valve persisted in all pre-procedure Hill's grade I patients, in 66.7% of grade II and 58.3% of grade III. This figure remained substantially unchanged at 12 and 24 months, too. Impedance monitoring indicated significantly fewer total and acid refluxes after treatment (p = 0.01). Factors predicting good outcomes were pre-procedure Hill's grade I-II, no hiatal hernia or hernia ≤2 cm (p = 0.03), absence of ineffective esophageal motility (p < 0.0001), and number of fasteners deployed (p = 0.01). CONCLUSIONS: TIF by the EsophyX achieved lasting elimination of daily dependence on PPI in 75-80% of patients for up to 6 years. TIF seems an effective therapy for selected symptomatic GERD patients.

A single-centre prospective, cohort study of the natural history of acute pancreatitis.

BACKGROUND: The natural history of acute pancreatitis is based on clinical studies that aim to elucidate the course of disease on the basis of predicted risk factors. AIMS: To evaluate the long-term occurrence of recurrent acute pancreatitis and chronic pancreatitis in a cohort of patients following an initial episode of acute pancreatitis. METHODS: 196 patients were enrolled consecutively and studied prospectively. Clinical characteristics, exogenously/endogenously-associated factors, and evolution to recurrent acute pancreatitis and chronic pancreatitis were analyzed. RESULTS: 40 patients developed recurrent acute pancreatitis 13 of whom developed chronic pancreatitis. In a univariate analysis, recurrent acute pancreatitis was associated with an idiopathic aetiology (p<0.001), pancreas divisum (p=0.001), and higher usage of cigarettes and alcohol (p<0.001; p=0.023). Chronic pancreatitis was associated with a severe first episode of acute pancreatitis (p=0.048), PD (p=0.03), and cigarette smoking (p=0.038). By multivariate analysis, pancreas divisum was an independent risk factor for recurrent acute pancreatitis (OR 11.5, 95% CI 1.6-83.3). A severe first-episode of acute pancreatitis increased the risk of progressing to chronic pancreatitis by nine-fold. CONCLUSIONS: Special attention should be given to patients who experience a severe first attack of acute pancreatitis as there appears to be an increased risk of developing chronic pancreatitis over the long term.

pH-Impedance Findings and proton pump inhibitors-responsiveness in patients with typical gastroesophageal reflux disease symptoms in a large single-center Italian series.

INTRODUCTION: A multicenter study with a limited sample size found that absence of esophagitis, presence of functional digestive disorders, and overweight were associated with proton pump inhibitors (PPI) failure. AIM: To assess clinical and reflux patterns associated with PPI-responsiveness. MATERIALS AND METHODS: Patients with typical gastroesophageal reflux disease (GORD) symptoms had 24 hours pH-impedance monitoring off therapy. Responders had <2 days of symptoms per week while on standard-dose/double-dose PPI. Clinical and reflux parameters were considered for analysis. RESULTS: A total of 514 patients were included (267 women), 185 patients were considered PPI responders, and 329 were considered nonresponders. In the whole population, the only significant factor in the prediction of responsiveness to PPI at the multivariate analysis was the presence of esophagitis (P=0.028). The factors identified as significant in patients with a pathologic acid exposure (142 patients) in the prediction of responsiveness to PPI were overweight (body mass index >25 kg/m(2)) and the presence of esophagitis (P=0.019 and 0.043, respectively). CONCLUSIONS: We confirm that no reflux pattern demonstrated by 24 hours pH-impedance monitoring is associated to PPI response in GORD patients. Presence of esophagitis in the whole population and overweight in patients with pathologic GORD, but not dyspepsia, are strongly associated with PPI-responsiveness.

High-definition with i-Scan gives comparable accuracy for detecting colonic lesions by non-expert and expert endoscopists.

BACKGROUND: Lesion detection rate during colonoscopy may be influenced by the endoscopist's experience. EPK-i system colonoscopy (i-Scan) can improve mucosal and vascular visualization for detecting lesions. AIM: To compare mucosal lesions detection rate and the withdrawal time of the instrument among non-expert and expert endoscopists. METHODS: Colonoscopy records of all consecutive patients undergoing first HD+ with i-Scan- or SWL-equipped colonoscopy for colorectal cancer screening over a twelve-month period were evaluated, in a "post hoc" analysis. RESULTS: 542 colonoscopies (389 HD+ with i-Scan; 153 SWL): expert and non-expert endoscopists did respectively 272 and 117 HD+ with i-Scan and 83 and 70 SWL colonoscopies. Expert endoscopists did more i-Scan colonoscopies than non-experts (p=0.006). In the SWL procedures, the experts detected mucosal lesions in more colonoscopies than non-experts (61/22 vs. 23/47, p=0.0001) and found a significantly higher mean number of lesions (1.34 vs. 0.47; p=0.0001). Experts detected more or less the same mean number of lesions with both imaging techniques, while among non-experts detection with HD+ with i-Scan was significantly better than with SWL imaging (1.39 vs. 0.47; p=0.0001). CONCLUSIONS: HD+ with i-Scan imaging enables less skilled endoscopists to achieve results comparable to those of experienced ones in detecting mucosal lesions.

Oropharyngeal pH monitoring for laryngopharyngeal reflux: is it a reliable test before therapy?

OBJECTIVE: Current methods of measuring pharyngeal pH are problematic. The aim of the study was to assess the ability of the oropharyngeal pH monitoring (Restech) in predicting the response to proton pump inhibitor (PPI) therapy in patients with gastroesophageal reflux disease-related laryngopharyngeal symptoms. STUDY DESIGN: The study design is prospective and uncontrolled. METHODS: Twenty-two consecutive naive patients with chronic laryngeal symptoms were enrolled. Reflux symptom index, fibrolaryngoscopy, and 24-hour oropharyngeal pH monitoring were performed. Both patients and laryngoscopist were blinded by the results of Restech. All the patients were given a 3-month therapy with pantoprazole of 40mg twice a day and then repeated both the reflux symptom index and fibrolaryngoscopic evaluation. Patients were considered as responders if a five-point decrease in symptom score was recorded. RESULTS: Thirteen of the 22 patients (59.1%) responded to therapy. Laryngoscopic findings did not correlate with the clinical improvement after the 3 months of PPI. Nine patients (40.9%) had a pathologic Restech study, and all resulted responsive to PPI; nine patients (40.9%) with a negative Restech were nonresponsive to PPI, and four patients (18.2%) despite a negative Restech resulted responsive to therapy. Responsive patients showed both a higher oropharyngeal acid exposure in orthostatic position and a higher Ryan score, compared with nonresponders (49.74±58.11 vs 2.12±0.0, P=0.002). Considering responsiveness to medical therapy as the gold standard of laryngopharyngeal reflux (LPR) for the diagnosis of LPR, Restech showed a sensitivity of 69% and a specificity of 100%. CONCLUSIONS: The high specificity and reasonable sensitivity of this technique make the Restech an interesting tool before therapy of patients with pharyngoesophageal reflux.