A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study.

BACKGROUND: High quality bowel preparation prior to colonoscopy can be difficult to achieve in the inpatient setting. Hospitalized patients are at risk for extended hospital stays and low diagnostic yield due to inadequate bowel preparation. The Pure-Vu System is a novel device intended to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation. The objective of the REDUCE study was to conduct the first inpatient study to evaluate optimization of bowel preparation quality following overnight preparation when using the Pure-Vu System during colonoscopy. METHODS: This multicenter, prospective feasibility study enrolled hospitalized subjects undergoing colonoscopy. Subjects recorded the clarity of their last bowel movement using a 5-point scale prior to colonoscopy. After one night of preparation, all enrolled subjects underwent colonoscopy utilizing the Pure-Vu System. The primary endpoint was improvement of colon cleanliness from baseline to post-cleansing with the Pure-Vu System as assessed by the improvement in Boston Bowel Preparation Scale (BBPS). An exploratory analysis was conducted to assess whether the clarity of the last bowel movement could predict inadequate bowel preparation. RESULTS: Ninety-four subjects were included. BBPS analyses showed significant improvements in bowel preparation quality across all evaluable colon segments after cleansing with Pure-Vu, including left colon (1.74 vs 2.89; p < 0.0001), transverse colon (1.74 vs 2.91; p < 0.0001), and the right colon (1.41 vs 2.88; p < 0.0001). Prior to Pure-Vu, adequate cleansing (BBPS scores of ≥ 2) were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively. Subjects with lower bowel movement clarity scores were more likely to have inadequate bowel preparation prior to cleansing with Pure-Vu. CONCLUSIONS: In this feasibility study, the Pure-Vu System appears to be effective in significantly improving bowel preparation quality in hospitalized subjects undergoing colonoscopy. Clarity of last bowel movement may be useful indicator in predicting poor bowel preparation. Larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings. Trial registration Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT03503162).

Patterns of recurrent and persistent intestinal metaplasia after successful radiofrequency ablation of Barrett's esophagus.

OBJECTIVE: Radiofrequency ablation can eradicate Barrett's esophagus successfully in the majority of cases. We sought to determine (1) how often intestinal metaplasia is detected during follow-up endoscopy after successful ablation and (2) patterns of persistent/recurrent intestinal metaplasia. METHODS: Patients ablated successfully during a phase II clinical trial of radiofrequency ablation for Barrett's esophagus were followed using endoscopic surveillance according to a defined protocol. Systematic biopsies were performed in all patients throughout the neosquamous epithelium as well as at the gastroesophageal junction, and patterns of recurrent or persistent intestinal metaplasia were documented. RESULTS: Fifty-three patients were ablated successfully during this single-institution clinical trial. A total of 151 follow-up endoscopies were performed (range, 1-5 endoscopies per patient) and 2492 biopsies were obtained, of which 604 (24%) were from the gastroesophageal junction. The median follow-up period was 18 months (range, 3-50 months). Recurrent/persistent intestinal metaplasia was detected in 14 patients (26%) in 3 distinct patterns: endoscopically invisible intestinal metaplasia underneath the neosquamous epithelium (buried glands) in 3 patients, visible recurrence in the tubular esophagus in 3 patients, and intestinal metaplasia of the gastroesophageal junction (with a squamous-lined tubular esophagus) in 10 patients. Dysplasia or cancer was not detected in any patient during the follow-up period. CONCLUSIONS: Recurrent/persistent intestinal metaplasia after successful radiofrequency ablation of Barrett's esophagus is relatively common. This finding has implications for the continued surveillance of patients who are ablated successfully.

Effect of hiatal hernia size and columnar segment length on the success of radiofrequency ablation for Barrett's esophagus: a single-center, phase II clinical trial.

OBJECTIVE: Hiatal hernia is common in patients with Barrett's esophagus. We sought to evaluate the effect of hiatal hernia size and initial columnar segment length on the success of radiofrequency ablation of Barrett's esophagus. METHODS: A phase II clinical trial was conducted aimed at evaluating the success of radiofrequency ablation in eradicating Barrett's esophagus. Success was defined as complete replacement of the columnar lining with squamous mucosa and lack of intestinal metaplasia using light microscopy. Hiatal hernia size and columnar segment length were measured endoscopically. RESULTS: Sixty-seven patients were accrued to the protocol. In the 55 patients who completed radiofrequency ablation (43 successes, 12 failures), the mean hiatal hernia size was 3.3 cm (range, 0-10 cm), and the mean columnar segment length was 5.4 cm (range, 1-18 cm). The median length of the columnar segment was 3 cm in the successful cases and 8.5 cm in the failed cases (P = .002). Although the median hiatal hernia size was identical in the successful and failed cases (3 cm, P = .38), the median hiatal hernia size was 7 cm (P = .001) in the 6 patients who experienced nonhealing after the initial ablation. Patients who were successfully ablated but had larger hiatal hernias and longer columnar segment lengths required significantly more radiofrequency ablation sessions than those with smaller hernias and shorter segments (P = .003 and P = .007, respectively). CONCLUSIONS: Patients with larger hiatal hernias and longer columnar segments are more likely to experience failure or nonhealing after radiofrequency ablation. These patients also require more radiofrequency ablation treatments to achieve successful eradication of Barrett's esophagus.

Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial.

BACKGROUND: Endoluminal gastroplication has shown promise for the treatment of GERD in short-term studies. Until now, long-term outcome data have been lacking. METHODS: A prospective, multicenter trial enrolled 85 patients with GERD to be treated with endoluminal gastroplication. Inclusion criteria were 3 or more heartburn or regurgitation episodes per week, >4.2% time in 24 hours with esophageal pH < 4, and dependency on antisecretory medications. Exclusion criteria were the presence of varices, achalasia, aperistalsis, or previous gastric resection. Patients underwent manometry, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patient diaries were used to assess medication use and to estimate annual medication cost. RESULTS: At 1- and 2-year follow-up, patients had significant reductions in median heartburn symptom scores (72 at baseline [interquartile range (IQR) 90-48] vs. 4 at 12 months [IQR 43-0] and 16 at 24 months [IQR 53-3.5]; p < 0.0001 vs. baseline) and median regurgitation symptoms (2 at baseline [IQR 3-1] vs. 0 at 12 months (IQR 1-0) and 1 at 24 months [IQR 1-0]; p < 0.0001 vs. baseline). Of all patients, 59% and 52% showed heartburn symptom resolution at 12 and 24 months, respectively ( p < 0.0001 vs. baseline). Also, 83% and 77% had regurgitation symptom resolution at 12 and 24 months, respectively (p < 0.0001 vs. baseline). Proton pump inhibitor use also was significantly reduced at 12 and 24 months after the procedure. At 2-year follow-up, median annualized medication costs were reduced by 88% (1381 US dollars) (p < 0.0001). Endoluminal gastroplication significantly reduced the duration and the number of episodes of esophageal acid exposure (p < 0.0001 vs. baseline). Only 7 patients experienced adverse events. CONCLUSIONS: Endoscopic gastroplication is safe and effective, and is associated with symptom reductions in patients with GERD for at least 24 months.