Endoscopic Full-thickness Plication Research Articles

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Randomized Sham Controlled Trials.

Gastroesophageal reflux disease (GERD) affects approximately 20% of adults in the United States. Proton pump inhibitors are the first-line treatment but are associated with long-term side effects. Endoscopic full-thickness plication (EFTP) is a minimally invasive alternative that improves the valvular mechanism of the gastroesophageal junction. This meta-analysis compared EFTP to a sham procedure for the treatment of refractory GERD. This meta-analysis followed the Cochrane guidelines and PRISMA standards and was registered with PROSPERO (CRD42023485506). We searched MEDLINE, Embase, SCOPUS, and Cochrane Library through December 2023. Inclusion criteria targeted Randomized controlled trials comparing EFTP with sham procedures for GERD were included. Statistical analyses utilized RevMan with a random-effects model, and the results were considered significant at p < 0.05. Of the 2144 screened studies, three RCTs with 272 patients with GERD were included: 136 patients underwent EFTP and 136 underwent sham procedures. Primary outcomes showed a significant reduction in PPI usage (RR 0.51; 95% CI 0.35-0.73; p < 0.01) and more than 50% improvement in GERD-HRQL scores at 3 months (RR 15.81; 95% CI 1.40-178.71; p = 0.03). No significant difference was found in the DeMeester scores (MD: 12.57; 95% CI -35.12 to 9.98; p = 0.27). Secondary outcomes showed no significant difference in time with esophageal pH < 4, but a significant reduction in total reflux episodes. EFTP significantly reduced PPI usage, improved GERD-HRQL scores, and decreased total reflux episodes compared with sham procedures, highlighting its potential as a minimally invasive treatment. Further research is needed to compare EFTP with other minimally invasive techniques to determine the most effective treatment option.

Endoscopic Advances in the Diagnosis and Management of Gastroesophageal Reflux Disease.

Gastroesophageal reflux disease (GERD) is one of the most common diseases that occurs secondary to failure of the antireflux barrier system, resulting in the frequent and abnormal reflux of gastric contents to the esophagus. GERD is diagnosed in routine clinical practice based on the classic symptoms of heartburn and regurgitation. However, a subset of patients with atypical symptoms can pose challenges in diagnosing GERD. An esophagogastroduodenoscopy (EGD) is the most common initial diagnostic test used in the assessment for GERD, although half of these patients will not have any positive endoscopic findings suggestive of GERD. The advanced endoscopic techniques have improved the diagnostic yield of GERD diagnosis and its complications, such as Barrett's esophagus and early esophageal adenocarcinoma. These newer endoscopic tools can better detect subtle irregularities in the mucosa and vascular structures. The management options for GERD include lifestyle modifications, pharmacological therapy, and endoscopic and surgical interventions. The latest addition to the armamentarium is the minimally invasive endoscopic interventions in carefully selected patients, including the electrical stimulation of the LES, Antireflux mucosectomy, Radiofrequency therapy, Transoral Incisionless Fundoplication, Endoscopic Full-Thickness plication (GERDx™), and suturing devices. With the emergence of these advanced endoscopic techniques, it is crucial to understand their selection criteria, advantages, and disadvantages.

Endoscopic full-thickness plication along with argon plasma coagulation for treatment of proton pump inhibitor dependent gastroesophageal reflux disease

BACKGROUND Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support it utility. Therefore, this study was carried to evaluate the effectiveness and safety newer endoscopic full-thickness fundoplication (EFTP) device along with Argon Plasma Coagulation to treat individuals with GERD. AIM To evaluate the effectiveness and safety newer EFTP device along with Argon Plasma Coagulation to treat individuals with GERD. METHODS This study was a single-center comparative analysis conducted on patients treated at a Noble Institute of Gastroenterology, Ahmedabad, hospital between 2020 and 2022. The research aimed to retrospectively analyze patient data on GERD symptoms and proton pump inhibitor (PPI) dependence who underwent EFTP using the GERD-X system along with argon plasma coagulation (APC). The primary endpoint was the mean change in the total gastroesophageal reflux disease health-related quality of life (GERD-HRQL) score compared to the baseline measurement at the 3-month follow-up. Secondary endpoints encompassed enhancements in the overall GERD-HRQL score, improvements in GERD symptom scores at the 3 and changes in PPI usage at the 3 and 12-month time points. RESULTS In this study, patients most were in Hill Class II, and over half had ineffective esophageal motility. Following the EFTP procedure, there were significant improvements in heartburn and regurgitation scores, as well as GERD-HRQL scores (P &lt; 0.001). PPI use significantly decreased, with 82.6% not needing PPIs or prokinetics at end of 1 year. No significant adverse events related to the procedures were observed in either group. CONCLUSION The EFTP along with APC procedure shows promise in addressing GERD symptoms and improving patients' quality of life, particularly for suitable candidates. Moreover, the application of a lone clip with APC yielded superior outcomes and exhibited greater cost-effectiveness.

Efficacy of different endoscopic treatments for gastroesophageal reflux disease: a systematic review and network meta-analysis

BackgroundThere are no direct comparisons across different endoscopic therapies for gastroesophageal reflux disease (GERD). This study aimed to evaluate the relative effects of different endoscopic therapies in GERD. MethodsFive databases were searched until August 2023 for randomized controlled trials (RCTs) that compared the efficacy of endoscopic band ligation (EBL), Stretta, endoscopic fundoplication (transoral incisionless fundoplication [TIF], endoscopic full-thickness plication [EFTP], and EndoCinch plication procedure [EndoCinch, CR BARD, Billerica, Mass., USA]), or proton pump inhibitors (PPIs)/sham procedure for GERD. Bayesian network meta-analysis was performed. ResultsA total of 19 trials comprising 1181 patients were included. EBL (mean difference [MD], −7.75; 95% credible interval [CrI], −13.90 to −1.44), Stretta (MD, −9.86; 95% CrI, −19.05 to −0.58), and TIF (MD, −12.58; 95% CrI, −20.23 to −4.91) all significantly improved patients’ health-related quality of life score with equivalent efficacy compared with PPIs. TIF and EBL achieved equivalent efficacy in reducing PPIs utility (risk ratio [RR], 0.66; 95% CrI, 0.40–1.05) and both were significantly superior to other endoscopic interventions (Stretta, EFTP, and EndoCinch). Besides, EBL and TIF also could significantly decrease the esophagitis incidence compared with PPIs (EBL [RR, 0.34; 95% CrI, 0.22–0.48] and TIF [RR, 0.38; 95% CrI, 0.15–0.88]). In terms of lower esophageal sphincter (LES) pressure, only TIF could significantly increase the LES pressure (MD, 6.53; 95% CrI, 3.65–9.40) to PPIs. In contrast, TIF was inferior to PPIs in decreasing esophageal acid exposure (MD, 2.57; 95% CrI, 0.77–4.36). ConclusionCombining the evidence, EBL and TIF may have comparable efficacy and both might be superior to Stretta, EFTP, or EndoCinch in GERD treatment.

Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A systematic review and meta-analysis.

Background and study aims Gastroesophageal reflux disease (GERD) is a widespread chronic gastrointestinal condition with an increasing worldwide prevalence. This research was a systematic review and meta-analysis evaluating the efficacy, safety, and long-term outcomes of endoscopic full-thickness plication (EFTP) for the treatment of GERD. Methods A comprehensive search of databases was conducted for studies published up to April 2023. We included randomized controlled trials (RCTs) and prospective observational studies that examined the use of EFTP in treating GERD among adult patients. We calculated pooled effect estimates using a random-effects model. Results EFTP significantly improved GERD Health-Related Quality of Life (GERD-HRQL) scores at 3-, 6-, and 12-month follow-up intervals. A considerable proportion of patients discontinued proton pump inhibitors, with cessation rates of 59% (95% confidence interval [CI]: 0.47-0.71), 68% (95% CI: 0.58-0.78), and 67% (95% CI: 0.46-0.89,) at 3, 6, and 12 months, respectively. At 3 and 6 months, 61% (95% CI: 0.54-0.68) and 66% (95% CI: 0.56-0.76) of patients experienced ≥50% improvement in GERD-HRQL scores. EFTP demonstrated a favorable safety profile, with a low rate of severe adverse events. We observed a 6.76% reduction (95% CI: -14.53-1.02) in the percentage of time with esophageal pH <4, a decrease in DeMeester scores, and fewer total reflux episodes. The average procedure time was 22.75 minutes (95% CI: 22.03-23.48). Subgroup analyses suggest that both the GERDx system and the NDO Plicator are effective and safe in treating GERD. Conclusions The findings from our study reveal that EFTP is a safe and effective treatment for GERD patients who have not responded adequately to conventional therapies. Given its minimally invasive nature, effectiveness, and limited adverse effects, EFTP emerges as a compelling alternative to conventional surgical procedures.

S602 Outcomes of Endoscopic Full-Thickness Plication Devices for Patients With GERD: A Retrospective Study

S602 Outcomes of Endoscopic Full-Thickness Plication Devices for Patients With GERD: A Retrospective Study

A simple endoscopic full-thickness plication procedure for the treatment of gastroesophageal reflux disease.

Endoscopic full-thickness plication (EFTP) of the cardia or fundus has been shown to have efficacy in treating patients with gastroesophageal reflux disease (GERD) [1] [2]. However, EFTP requires proprietary equipment that may not be available in many countries. Herein, we describe a novel method of EFTP using an endoloop and metal clips, which we termed endoclip and loop cardioplication (ECLC).

235 5-YEAR FOLLOW-UP OF A PROSPECTIVE CLINICAL TRIAL OF AN ENDOSCOPIC FULL-THICKNESS PLICATION DEVICE (GERDX™) FOR THE TREATMENT OF GERD

Abstract The gold-standard in the operative treatment of gastroesophageal reflux disease (GERD) is the laparoscopic fundoplication. Alternatively, endoscopic devices to rebuild the gastroesophageal valve were invented. The aim of our study is to assess the improvement of GERD symptoms and quality of life in patients five years after the endoscopic full-thickness plication with the GERDx™ device. Methods Between 2013 and 2016 a prospective trial was implemented with forty patients and an endoscopic plication due to reflux symptoms with a pathologic workup for GERD. Limitation for the use of GERDx™ was a 2 cm hiatal hernia. Follow-up workup was done with high resolution manometry (HRM), 24 h-pH-impedance-catheter gastroscopy and questionaires for quality of life (GIQLI) and reflux-symptoms (SCL). Results Median follow-up time was 57 months (36–74 months). There was a significant improvement of the DeMeester score, GIQLI and SCL between pre- and postoperative values in short-term as well as long-term follow-up. At least 55% of patients were assessed as failure of the plication device due to redo operations with laparoscopic fundoplication in 25% and/or necessary PPI use for GERD symptoms (40%). There is no pre- and postoperative significant difference in quality of life or reflux scores between successful and failed endoplications, but patients with laparoscopic redo operations showed significant higher DeMeester scores before and after endoscopic treatment. Conclusion There is a higher failure rate to the endoscopic full-thickness plication than to the laparoscopic fundoplication. A small group of well selected patients is eligible for the endoscopic GERDx™ device. In case of therapeutic failure a classic laparoscopic redo fundoplication is possible under more challenging operative conditions.

Feasibility of resection and plication "RAP" technique for management of medically refractory GERD in patients with altered gastric anatomy.

Background and study aims Gastroesophageal reflux disease (GERD) is common, especially in patients after gastric surgery. Medical management of GERD is ineffective in up to 30 % patients and revisional gastric surgery for management of GERD is associated with higher morbidity. We aimed to assess the safety, feasibility, and efficacy of a novel endoscopic resection and plication (RAP) anti-reflux procedure for management of medically refractory GERD in patients with altered gastric anatomy. Patients and methods The RAP procedure involves endoscopic mucosal resection and full-thickness plication over the right posterior-medial axis extending 15 mm above and 20 to 30 mm below the squamocolumnar junction. Adverse events, technical feasibility, GERD health-related quality-of-life (GERD-HRQL) scores, and medication use were prospectively recorded. Results Twenty consecutive patients with previous gastric surgery underwent RAP between September 2018 and August 2020 with a median follow-up of 5.7 months. The median procedure duration was 66 minutes (IQR 53.8–89.5). RAP was technically successful in 19 patients. One patient developed gastric hemorrhage from suture dehiscence, which was managed endoscopically, and four patients developed esophageal stricture requiring endoscopic dilation. Following the RAP procedure, significant improvement in GERD-HRQL score was observed (mean 26.9, 95 %CI 23.36–30.55, P < 0.01). Fourteen of 19 patients reported > 50 % improvement in GERD-HRQL scores. Sixteen of 18 patients reported reduction in requirement for or cessation of antacid therapy. Conclusions Patients with refractory GERD after gastric surgery have limited therapeutic options. We have demonstrated that the RAP procedure is feasible, safe, and clinically effective at short-term follow-up. It provides a potential alternative to revisional surgery in patients with altered gastric anatomy.

Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial

BackgroundThe majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of...

Clinical feasibility of a new full-thickness endoscopic plication device (GERDx\u2122) for patients with GERD: results of a prospective trial

BackgroundPrevious studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL).MethodsProspective one-arm trial evaluating the outcome of forty patients with GERD subjected to endoscopic plication with the GERDx™ device. We included patients with at least one typical reflux symptom despite treatment with a PPI for > 6 months, pathologic esophageal acid exposure, hiatal hernia of size < 2 cm, and endoscopic Hill grade II–III. Evaluation of Gastrointestinal Quality of Life Index (GIQLI), symptom scores, esophageal manometry, and impedance-pH-monitoring were performed at baseline and at 3 months after surgery. (Trial Registration: ClinicalTrials.gov NCT 01798212.)ResultsThere were no intraoperative complications. Four out of forty patients experienced postoperative complications requiring intervention. Seven of forty patients were subjected to laparoscopic fundoplication 3 months after endoscopic plication due to persistent symptoms and were lost to further follow-up. Thirty out of forty patients were available at 3-month follow-up. There was an improvement of the GIQLI score, from a mean of 92.45 ± 18.47 to 112.03 ± 13.11 (p < 0.001). The general reflux-specific score increased from a mean of 49.84 ± 24.83 to 23.93 ± 15.63 (p < 0.001), and the DeMeester score from a mean of 46.48 ± 30.83 to 20.03 ± 23.62 (p < 0.001). There was no significant change in manometric data after intervention. Three of thirty patients continued daily antireflux medication.ConclusionsEndoscopic plication with the GERDx™ device reduced distal acid exposure of the esophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GERD.

Full-thickness Gastroplication for the Treatment of Gastroesophageal Reflux Disease

This was a prospective study that evaluates subjective and objective patient parameters 3 months after full-thickness gastroplication. Forty-one patients with documented gastroesophageal reflux disease and persistent symptoms despite medical treatment, without radiologic visible hiatal hernia, were enrolled in the study and underwent endoscopic full-thickness gastroplication with one or more plicator implants. Evaluation of Gastrointestinal Quality of Life Index, symptoms typically related to reflux, gas bloat, and bowel dysfunction and esophageal manometry, and impedance-pH monitoring were performed at baseline and 3 months after the procedure. The mean Gastrointestinal Quality of Life Index score, and general and reflux-specific scores improved significantly (P<0.01), and gas bloat-specific symptom scores and bowel dysfunction-specific symptom scores were reduced (P<0.05) on follow-up. The numbers of total, acid, proximal, upright, and recumbent reflux episodes were all reduced (P<0.01). Manometric data remained almost unchanged. DeMeester score reduced nonsignificantly (P<0.098). 21.6% of the patients were on proton-pump inhibitor medication on a daily basis after the procedure. There was only 1 postprocedure incident (bleeding) that required intervention. In conclusion, endoscopic full-thickness plication is a safe and well-tolerated procedure that significantly improves quality of life and eliminates gastroesophageal reflux disease symptoms in the majority of patients, without side effects seen after laparoscopic fundoplication.

Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants

Subjective and especially objective data after endoluminal full-thickness gastroplication are scarce. To evaluate symptoms and reflux activity 12 months after gastroplication by using multichannel intraluminal impedance monitoring. Open-label, prospective, single-center study. Tertiary referral hospital in Zell am See, Austria. Subjects without hiatal hernias with documented GERD and persistent or recurrent symptoms despite treatment with a proton pump inhibitor. A total of 36 patients underwent endoscopic full-thickness gastroplication with 1 or more Plicator implants. Mean Gastrointestinal Quality of Life Index and reflux-specific symptom scores significantly improved on follow-up (P < .01). Atypical reflux, gas/bloating, and bowel dysfunction-specific symptom scores as well as belching and dysphagia scores improved. Twenty-two patients returned for esophageal manometry and multichannel intraluminal impedance testing 1 year after surgery. DeMeester scores decreased from 20 to 10 (P < .029). The median numbers of total, acid, proximal, upright, and recumbent reflux episodes were all significantly reduced (P < .05). Manometric data were virtually unchanged. The percentage of patients taking proton pump inhibitors on daily basis after the procedure was 11.5%. There was only 1 postprocedure incident (bleeding) that required intervention. Three of 36 patients (8.3%) were considered treatment failures because of persistent symptoms and were assigned to undergo laparoscopic fundoplication. No randomized comparison with a sham procedure or laparoscopic fundoplication; follow-up interval. Endoscopic plication is safe and improves objective and subjective parameters at 1-year follow-up, without side effects seen after laparoscopic fundoplication. Further studies on the clinical merit of this procedure in specific patient populations are warranted.

Endoscopic full-thickness plication versus laparoscopic fundoplication: a prospective study on quality of life and symptom control

Endoscopic antireflux techniques have emerged as alternative therapies for gastroesophageal reflux disease (GERD). Endoscopic plication receives continuing interest as an effective and safe procedure. This treatment option has not been the subject of comparison with well-established operative therapies to date. The present study aimed at comparatively evaluating the effectiveness of endoscopic plication and laparoscopic fundoplication in terms of quality of life and symptom control. Between October 2006 and April 2010, 60 patients with documented GERD were randomly assigned to undergo either endoscopic plication or laparoscopic fundoplication. Quality-of-life scores and symptom grading were recorded before treatment and at 3- and 12-month follow-up. Outcomes were compared with the statistical significance set at a p value of 0.05. Twenty-nine patients from the endoscopic group and 27 patients from the operative group were available at follow-up. Quality-of-life scores showed a substantial and similar increase for both groups after treatment. Symptoms of heartburn (p < 0.02), regurgitation (p < 0.004), and asthma (p = 0.03) were significantly improved in the endoscopic group, whereas laparoscopic fundoplication was more effective in controlling symptoms of heartburn (p < 0.01) and regurgitation (p < 0.05) compared to the endoscopic procedure. Endoscopic plication and laparoscopic fundoplication resulted in significant symptom improvement with similar quality-of-life scores in a selected patient population with GERD, whereas operative treatment was more effective in the relief of heartburn and regurgitation at the expense of higher short-term dysphagia rates.

Comparing the effectiveness of endoscopic full-thickness plication and endoscopic radiofrequency treatments for patients with GERD

Keywords:: antirefluxBarrett’s esophagusendoluminalfull-thickness plicationfundoplication gastroesophageal junctiongastroesophageal refluxlower esophageal sphincterradiofrequency

Evaluating outcomes of endoscopic full-thickness plication for gastroesophageal reflux disease (GERD) with impedance monitoring

Endoscopic full-thickness plication allows transmural suturing at the gastroesophageal junction to recreate the antireflux barrier. Multichannel intraluminal impedance monitoring (MII) can be used to detect nonacid or weakly acidic reflux, acidic swallows, and esophageal clearance time. This study used MII to evaluate the outcome of endoscopic full-thickness plication. In this study, 12 subsequent patients requiring maintenance proton pump inhibitor therapy underwent endoscopic full-thickness plication for treatment of gastroesophageal reflux disease. With patients off medication, MII was performed before and 6-months after endoscopic full-thickness plication. The total median number of reflux episodes was significantly reduced from 105 to 64 (p = 0.016). The median number of acid reflux episodes decreased from 73 to 43 (p = 0.016). Nonacid reflux episodes decreased from 23 to 21 (p = 0.306). The median bolus clearance time was 12 s before treatment and 11 s at 6 months (p = 0.798). The median acid exposure time was reduced from 6.8% to 3.4% (p = 0.008), and the DeMeester scores were reduced from 19 to 12 (p = 0.008). Endoscopic full-thickness plication significantly reduced total reflux episodes, acid reflux episodes, and total reflux exposure time. The DeMeester scores and total acid exposure time for the distal esophagus were significantly improved. No significant changes in nonacid reflux episodes and median bolus clearance time were encountered.

Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease using multiple Plicator implants: 12-month multicenter study results

The full-thickness Plicator (Ethicon Endosurgery, Sommerville, NJ, USA) was developed for endoscopic treatment of gastroesophageal reflux disease (GERD). The goal is to restructure the antireflux barrier by delivering transmural pledgeted sutures through the gastric cardia. To date, studies using this device have involved the placement of a single suture to create the plication. The purpose of this study was to evaluate the 12-month safety and efficacy of this procedure using multiple implants to restructure the gastroesophageal (GE) junction. A multicenter, prospective, open-label trial was conducted at four tertiary centers. Eligibility criteria included symptomatic GERD [GERD Health-Related Quality-of-Life (GERD-HRQL) questionnaire, off of medication], and pathologic reflux (abnormal 24-h pH) requiring daily proton pump inhibitor therapy. Patients with Barrett's epithelium, esophageal dysmotility, hiatal hernia > 3 cm, and esophagitis (grade III or greater) were excluded. All patients underwent endoscopic full-thickness plication with linear placement of at least two transmural pledgeted sutures in the anterior gastric cardia. Forty-one patients were treated. Twelve months post treatment, 74% of patients demonstrated improvement in GERD-HRQL scores by > or = 50%, with mean decrease of 17.6 points compared with baseline (7.8 vs. 25.4, p < 0.001). Using an intention-to-treat model, 63% of patients had symptomatic improvements of > or = 50%, with mean GERD-HRQL decrease of 15.0 (11.0 vs. 26.0, p < 0.001). The need for daily proton pump inhibitor (PPI) therapy was eliminated in 69% of patients at 12 months on a per-protocol basis, and 59% on an intention-to-treat basis. Adverse events included postprocedure abdominal pain (44%), shoulder pain (24%), and chest pain (17%). No long-term adverse events occurred. Endoscopic full-thickness plication using multiple Plicator implants can be used safely and effectively to improve GERD symptoms and reduce medication use.

Endoluminal Full-Thickness Plication and Radiofrequency Treatments for GERD

Endoluminal therapies have emerged as adjuncts for the treatment of gastroesophageal reflux disease (GERD) in select patients. To compare the effectiveness of endoscopic full-thickness plication and endoscopic radiofrequency treatments for patients with GERD. A total of 126 patients who underwent either endoscopic full-thickness plication (FTP) of the gastric cardia or endoscopic radiofrequency (RF) treatment of the esophagogastric junction during a 4-year period were included (68 underwent RF and 58 underwent FTP). Follow-up data was obtained for 51% of patients (mean follow-up, 6 months). Comparison of medication use, symptom scores, and pH values at baseline and follow-up. In the RF group, patients with moderate to severe heartburn decreased from 55% to 22% (P < .01), and proton pump inhibitor (PPI) use decreased from 84% to 50% (P = .01). Decreases were also seen for dysphagia, voice symptoms, and cough. Percentage of time the pH was less than 4 was unchanged. In the FTP group, patients with moderate to severe heartburn decreased from 53% to 43% (P = .3), and PPI use decreased from 95% to 43% (P = .01). Percentage of time the pH was less than 4 decreased from 10.0% to 6.1% (P = .05). Decreases were also seen for regurgitation, voice symptoms, and dysphagia. There was no change in scores for chest pain or asthma in either group. For patients with GERD, RF and FTP both resulted in a decrease in both PPI use and in scores for voice symptoms and dysphagia. In addition, RF resulted in decreased heartburn and cough, while FTP resulted in the most dramatic reduction in regurgitation. Our experience indicates that both procedures are effective, providing symptomatic relief and reduction in PPI use. For patients whose chief complaint is regurgitation, FTP may be the preferred procedure.

The Plicator procedure for the treatment of gastroesophageal reflux disease: a registry study

Endoscopic full-thickness plication of the gastric cardia using the Plicator is shown to be effective for the treatment of symptomatic gastroesophageal reflux disease (GERD) in both prospective and randomized controlled trials. This registry study aimed to evaluate Plicator procedure safety and efficacy among GERD patients treated in routine clinical practice at multiple academic and nonacademic centers. An open-label, prospective multicenter trial was conducted at seven centers under institutional review board approval. Patients with symptomatic GERD completed a series of questionnaires at baseline to assess GERD symptoms, heartburn/regurgitation scores, antisecretory medication use, and treatment satisfaction. All the patients then underwent the Plicator procedure with placement of a single transmural pledgeted suture in the anterior gastric cardia. The patients were reevaluated at 12 months after plication. The 12-month follow-up assessment was completed by 81 patients. At 12 months, the mean GERD Health-Related Quality-of-Life score had improved significantly compared with the baseline score (12.0 vs 26.6; p < 0.001), with 66% of the subjects showing an GERD-HRQL score improved 50% or more. Statistically significant improvements also were observed in median heartburn and regurgitation symptom scores. At 12 months, the need for daily proton pump inhibitor (PPI) therapy was eliminated for 58% of the patients. At baseline, 18% of the subjects had been satisfied with their GERD symptom control while on antisecretory therapy. At 12 months, 75% of the patients were satisfied with their GERD symptom control after undergoing the Plicator procedure, and 86% would recommend the procedure to family or friends. There were no serious adverse events and no late onset of any adverse events. In this multicenter study, the Plicator procedure effectively improved GERD quality-of-life scores, reduced GERD symptoms and medication use, and yielded higher treatment satisfaction than with the use of chronic antisecretory therapy. These effects all were seen 12 months after plication, and no major adverse effects were observed.

The Endoscopic Plicator Procedure for GERD Using Two Full-Thickness Plications

Purpose: The Plicator® (NDO Surgical, Mansfield MA) endoscopically delivers full-thickness pledgeted sutures to restructure the gastroesophageal junction and the anti-reflux barrier. To date, all Plicator studies have involved the placement of a single, full-thickness suture at the gastro-esophageal junction. The purpose of this pilot study was to evaluate the safety and effectiveness of placing two pledgeted sutures in the anterior gastric cardia. Methods: Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered in an open-label, prospective, single-center pilot study. Patients with hiatal hernias > 3 cm, grade III and IV esophagitis, and Barrett's esophagus were excluded. All patients received two full-thickness Plicator sutures in the anterior gastric cardia, serially placed within 1 cm of the GEJ. The following were assessed at baseline and 18-months post-treatment: GERD-HRQL, VAS and medication use. The primary study endpoint was ≥50% improvement in GERD-HRQL score. Results: Thirty-seven patients underwent endoscopic full-thickness plication using two sutures. At 18-months post-treatment, the proportion of patients achieving ≥50% improvement in GERD-HRQL score was 57%. Median GERD-HRQL scores improved 61% compared to baseline off-meds scores (12.5 vs. 25.9, P < 0.001) and were superior when compared to patients' baseline on-meds GERD-HRQL scores (12.5 vs.15.6, P= 0.023). Heartburn symptoms measured by VAS showed a median improvement of 77% versus off-med baseline (P < 0.001). Complete PPI cessation was achieved in 35% of patients, with an additional 39% of patients able to reduce their PPI dose by at least half. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse events were observed during extended follow-up. Conclusion: Endoscopic full-thickness plication using two sutures showed in 57% of patients an improvement in GERD-HRQL ≥50% at 18 months. Median GERD-HRQL scores improved 61% and heartburn symptoms showed a median improvement of 77%. Complete PPI cessation was achieved in 35% of patients. No new adverse events were observed during the 18 month follow-up.