The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective.

BACKGROUND: Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0. METHODS: A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated. RESULTS: Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001). CONCLUSION: In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm.

BACKGROUND: Four randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX® device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure. METHODS: The TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (<2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group (n = 40) or to PPI group (n = 23). Following evaluation at 6 months, all remaining PPI patients (n = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis. RESULTS: At 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p < 0.0001. The mean total % time pH <4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups. CONCLUSION: This study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial.

BACKGROUND: Incomplete control of troublesome regurgitation and extraesophageal manifestations of chronic gastroesophageal reflux disease (GERD) is a known limitation of proton pump inhibitor (PPI) therapy. This multicenter randomized study compared the efficacy of transoral incisionless fundoplication (TIF) against PPIs in controlling these symptoms in patients with small hiatal hernias. METHODS: Between June and August 2012, 63 patients were randomized at 7 US community hospitals. Patients in the PPI group were placed on maximum standard dose (MSD). Patients in the TIF group underwent esophagogastric fundoplication using the EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation or extraesophageal symptoms. Secondary outcomes were normalization of esophageal acid exposure (EAE), PPI usage and healing of esophagitis. RESULTS: Of 63 randomized patients (40 TIF and 23 PPI), 3 were lost to follow-up leaving 39 TIF and 21 PPI patients for analysis. At 6-month follow-up, troublesome regurgitation was eliminated in 97% of TIF patients versus 50% of PPI patients, relative risk (RR) = 1.9, 95% confidence interval (CI) = 1.2-3.11 (P = .006). Globally, 62% of TIF patients experienced elimination of regurgitation and extraesophageal symptoms versus 5% of PPI patients, RR = 12.9, 95% CI = 1.9-88.9 (P = .009). EAE was normalized in 54% of TIF patients (off PPIs) versus 52% of PPI patients (on MSD), RR = 1.0, 95% CI = 0.6-1.7 (P = .914). Ninety percent of TIF patients were off PPIs. CONCLUSION: At 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD.

Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study.

BACKGROUND: The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF. METHODS: In seven United States centers, patients with hiatal hernia ≤ 2 cm and abnormal esophageal acid exposure (EAE) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. McNemar's test or Fisher exact test was used to compare proportions. RESULTS: Of 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE. CONCLUSIONS: The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up.

Usefulness and impact on management of positive and negative capsule endoscopy.

OBJECTIVE: To determine the usefulness of positive and negative capsule endoscopies (CEs), and the impact of each on short- and long-term patient management. METHODS: Medical records were reviewed for 70 consecutive CE patients. Based on outcomes from referring physicians, it was determined whether CE was useful, partially useful or not useful at all in the overall patient management, and whether CE assisted in providing a diagnosis, and impacted on short-term long-term management. RESULTS: CE indications included overt bleeding (37%), occult bleeding (20%), iron deficiency (17%), abdominal pain and weight loss (13%), assessing the extent of or confirming a diagnosis of Crohn's disease (9%) and screening for familial adenomatous polyposis (4%). Positive studies were seen in 58% of overt bleeds, 50% of occult bleeds, 33% of iron deficiencies and 33% of Crohn's diseases. Overall, 28 studies (40%) were positive studies and 42 (60%) were negative studies. CE aided in diagnosis in 11 of 28 (39%) positive and 12 of 42 (29%) negative studies (P=0.35). Positive and negative CEs had an impact on short-term management in 12 of 28 (43%) versus 18 of 42 (43%) cases, respectively (P=1.0), and on long-term management in 14 of 28 (50%) versus 15 of 42 (36%) cases, respectively (P=0.23). For positive and negative studies, respectively, CE was considered useful in 12 of 28 (43%) versus 15 of 42 (36%) cases (39% overall), partially useful in 10 of 28 (36%) versus 10 of 42 (24%) cases (28% overall), and not useful at all in six of 28 (21%) versus 17 of 42 (40%) cases (33% overall). CONCLUSIONS: Although a negative CE may aid in making a definitive diagnosis in only 29% of patients, its effect on management and overall usefulness is similar to that of a positive CE. A physician's decision on whether to order CE should not be based solely on the pretest probability of a positive examination but also on the clinical utility of a negative study.

Canadian physicians' choices for their own colon cancer screening.

INTRODUCTION: Compliance with colorectal cancer (CRC) screening in Canada is low. The aim of the present survey was to determine whether Canadian physicians older than 50 years were pursuing colon cancer screening. Specifically, physicians were asked to identify their modality of choice and identify their barriers to screening. METHODS: Surveys were mailed to members, older than 50 years, of the Canadian Association of Gastroenterology, the Society of Obstetricians and Gynaecologists of Canada, the Canadian Society of Internal Medicine, the Canadian Psychiatric Association and the Canadian Association of Radiologists. RESULTS: Of 2,807 surveys, 46% were returned. Screening for CRC was reported by 53% of respondents. The Canadian Association of Radiologists members (61%) and the Canadian Association of Gastroenterology members (61%) were more likely to be screened than other specialties (P<0.01 and P<0.05, respectively). Members of the Society of Obstetricians and Gynaecologists of Canada (44%) were least likely to be screened (P<0.001). Men (P<0.001) and Ontario physicians (P<0.01) were more likely to be screened than women and Canadian physicians from other provinces, respectively. Colonoscopy (56%) was the most common screening modality used, followed by fecal occult blood testing (27%). Respondents who had not been screened cited a lack of personal time (47%) and insufficient data to warrant screening (14%). DISCUSSION: More than one-half of all respondents were screened for CRC. Colonoscopy is the most common screening modality used. Lack of time is the most common reason cited for not participating in CRC screening.

Relationship of aging and tobacco use with the development of aberrant crypt foci in a predominantly African-American population.

BACKGROUND AND AIMS: In clinical studies, diminished folate availability appears to increase the risk for colorectal neoplasms. Additionally, alcohol and tobacco use are associated with an increased risk for colon cancer, but the early pathologic events by which these agents promote neoplastic transformation are not well understood. Aberrant crypt foci (ACF) are potential precursors of adenoma and cancer, and can be visualized by magnification endoscopy. We hypothesized that folate depletion is linked to ACF formation and therefore studied the association between tissue folate, dietary habits, and ACF number in patients undergoing screening colonoscopy. METHODS: Eighty-three patients, undergoing screening colonoscopy at an urban Veterans Affairs and university hospital, completed a questionnaire concerning alcohol, nonsteroidal anti-inflammatory drug (NSAID), and tobacco use. Folate intake was calculated from food frequency questionnaires. Rectal ACFs were scored using magnification chromoendoscopy (magnification, 35 x) by methylene blue staining. Folate concentrations in rectal biopsy specimens were determined by microtiter bioassay. RESULTS: ACF number increased with age and with increasing tobacco intake. Decreased colonic folate level was associated with increased homocysteine levels and lower dietary folate intake but did not correlate with ACF number. CONCLUSIONS: Increasing age and tobacco use were linked independently to the presence of colonic ACF in this predominantly African-American population. Folate, alcohol, and acetylsalicylic acid (ASA) use did not influence the prevalence of these lesions.