Karim S. Trad

Efficacy of Transoral Fundoplication vs Omeprazole for Treatment of Regurgitation in a Randomized Controlled Trial

BACKGROUND & AIMS Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

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.

A Prospective Multicenter Registry of Patients with Chronic Gastroesophageal Reflux Disease Receiving Transoral Incisionless Fundoplication

BACKGROUND This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings. STUDY DESIGN Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures at 10 centers were enrolled in this prospective, open-label, multicenter, single-arm study. Symptom improvement and objective outcomes of TIF were analyzed at 6-month follow-up. RESULTS One hundred TIF procedures were performed. No complications were reported. Median GERD symptom duration was 9 years (range 1 to 35 years) and median duration of proton pump inhibitor (PPI) use was 7 years (1 to 20 years). Maximal medical therapy resulted in incomplete symptom control for 92% of patients; GERD Health-Related Quality of Life (GERD-HRQL) total score was normalized in 73%. Median heartburn and regurgitation scores improved significantly, from 18 (range 0 to 30) and 15 (range 0 to 30) on PPIs before TIF to 3 (range 0 to 25) and 0 (range 0 to 25), respectively; p < 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p < 0.001. Eighty percent of patients were completely off PPIs after TIF vs 92% of patients on PPIs before TIF. Preoperative factors associated with clinical outcomes were less severe heartburn (total GERD-HRQL ≤ 30, p = 0.02) and the presence of esophagitis (p < 0.02). CONCLUSIONS Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GERD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow-up.

Endoscopic axillary exploration and sentinel lymphadenectomy

AbstractBackground: Minimally invasive approaches have changed the practice of surgery in several specialties. The purpose of this study was to develop a reproducible endoscopic technique for the evaluation of the axilla in breast cancer patients. Methods: A total of 23 patients with biopsy-proven breast carcinoma were enrolled. Patients were positioned in the supine position with the ipsilateral arm abducted at 90°. A 1-cm skin incision was made at the superior aspect of the axilla. Dissection was carried bluntly to the lateral border of the pectoralis major. A balloon distention device was inserted into the tract and distended under endoscopic vision to create a working space. Insufflation was initiated up to a pressure of 8 mmHg. A 30° laparoscope was introduced for visualization of axillary contents. One or two additional 5-mm cannulas were placed as needed under direct visualization. Manipulation of axillary contents was performed, and in 19 patients a sentinel node identification technique was applied. Results: In all patients, using insufflation and minimal instrument dissection, the axillary vein, long thoracic, and thoracodorsal nerves were found in their usual anatomical locations. Utilizing blunt and sharp dissection, the axilla was thoroughly inspected, and individual lymph nodes were easily identified and extracted. In 11 of 19 patients, a sentinel node or blue dye was identified using isosulfan blue. There was a procedure concordance of 84%, and there were no complications. Conclusions: We describe a novel endoscopic technique for the evaluation of the axilla in breast cancer patients. This technique allows (a) creation of a minimally invasive working space within the axilla, (b) recognition of key axillary anatomic landmarks, and (c) instrument manipulation within the axilla to identify and extract lymph nodes, and apply the sentinel node technique. This is the first report of a minimally invasive approach to axillary exploration to employ sentinel lymph node mapping.

The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience

Purpose:This study aimed to assess the impact of transoral incisionless fundoplication (TIF) on patients with chronic gastroesophageal reflux disease (GERD) at 12-month follow-up. Methods:Clinical outcomes of 100 consecutive patients with chronic GERD who underwent TIF between January 2010 and February 2011 were analyzed. Results:There were no major complications reported. Esophageal acid exposure was normalized in 14/27 (52%) of patients who underwent 12-month pH testing. Seventy-four percent of all patients were off proton pump inhibitors versus 92% on daily proton pump inhibitors before TIF, P<0.001. Daily bothersome heartburn and regurgitation symptoms were eliminated in 66/85 (78%) and 48/58 (83%) of patients. Median reflux symptom index score was reduced from 20 (0 to 41) to 5 (0 to 44), P<0.001. Two patients reported de novo dysphagia and 1 patient reported bloating (scores 0 to 3). Six patients underwent revision; 5 laparoscopic Nissen fundoplication and 1 TIF. Conclusions:TIF provided a safe and effective therapeutic option for carefully selected patients with chronic GERD.

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.

Comparison of acid reduction in antiulcer operations

AbstractBackground: Three acid-reducing operations have recently been described for the laparoscopic treatment of peptic ulcer disease. These consist of a posterior truncal vagotomy combined with either (1) an anterior seromyotomy (SERO), (2) an anterior highly selective vagotomy (AHSV), or (3) a linear stapled lesser curvature excision (STAP). The purpose of this study was to investigate the physiologic effects of these procedures in terms of basal and maximal acid outputs. Methods: Fifty New Zealand rabbits were prospectively randomized into five open laparotomy groups (n= 10): a control group without vagal manipulation (CON), a bilateral truncal vagotomy with pyloromyotomy group (VP), a SERO group, an AHSV group, and a STAP group. All animals underwent placement of a gastrostomy tube for subsequent gastric secretory analysis. On postoperative day 6, basal acid outputs (BAO) and maximal acid outputs (MAO) following IV pentagastrin stimulation (30 μg/kg/h) were measured. Results were compared statistically using the ANOVA method. Results: Pentagastrin stimulation was associated with a significant increase in MAO in the CON group (p < 0.05 vs BAO); however, this response was effectively blunted in all the experimental groups. There were no differences in BAO or MAO between any of the vagotomized groups (SERO, HSV, STAP, VP). Conclusions: We conclude that the three acid-reducing procedures modified for laparoscopy are equally efficacious in reducing gastric acid secretion and that they compare favorably with VP. To our knowledge, this is the first report comparing basal and stimulated gastric acid secretion between these new acid-reducing techniques.