Endoscopic suturing for gastroesophageal reflux disease: clinical outcome with the Bard EndoCinch

Transcription

1 Gastrointest Endoscopy Clin N Am 13 (2003) Endoscopic suturing for gastroesophageal reflux disease: clinical outcome with the Bard EndoCinch Richard I. Rothstein, MD a, *, Charles J. Filipi, MD b a Section of Gastroenterology Dartmouth Hitchcock Medical Center, One Medical Drive, Lebanon, NH 03756, USA b Department of Surgery, Creighton University Medical Center, Omaha, NE, USA Gastroesophageal reflux disease (GERD) is a chronic illness that affects over seven percent of individuals on a daily basis in the United States and accounts for the highest burden of gastrointestinal disease expenditure in direct and indirect annual costs ($10 billion) [1]. The primary objective of anti-reflux therapy is relief of symptoms, with secondary goals to heal esophagitis, prevent reflux-related complications, and maintain remission. Treatment options have traditionally included long-term use of acid suppressing medications or surgical intervention with fundoplication, and both are successful in meeting these goals [2 4]. New innovative endoscopic therapies for GERD have provided an alternative to medical or surgical treatments. These interventions may be considered a bridge therapy because patients who undergo the endoscopic treatments can still elect to be treated with chronic medications or fundoplication if the endoscopic therapy does not provide symptom relief or if symptoms later recur. These treatments do not interfere with subsequent surgical intervention if undertaken. These endoscopic or endoscopy-assisted treatments include sewing/plication techniques, radiofrequency thermal therapies, and injection/implantable biopolymer therapies. These alternative therapies are undergoing rapid development, and most initial reports address symptom relief in short-term follow-up studies of mild GERD patients. Their usefulness as successful GERD treatments will be determined from long-term follow-up, sham-controlled studies, and from the careful scientific study of the effect of the endoscopic treatments on GERD pathophysiologic parameters. Cost-effective analyses and post-marketing docu- * Corresponding author. address: richard.rothstein@dartmouth.edu (R.I. Rothstein) /03/$ see front matter D 2003, Elsevier Science (USA). All rights reserved. doi: /s (02)

2 90 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) mentation of complications will better define the role of these new endoscopic therapies in the management of GERD patients. In this article, the authors review the clinical technique and clinical outcomes from the initial experiences with the Bard EndoCinch (Bard Endoscopic Technologies, Billerica, MA) endoscopic sewing device. The review includes data from the published multi-center US trial, and includes information from abstracts presented at recent scientific sessions awaiting peer-review and publication. Bard EndoCinch clinical technique The components of the Bard EndoCinch endoluminal plicating system are described in previous reviews and in another chapter in this issue, as is its evolution to the form in current clinical use [5 10]. The clinical application of this instrument for use in the treatment of gastroesophageal reflux disease is detailed in the following section. Informed consent is obtained for the EndoCinch procedure that includes an initial routine upper endoscopy, placement of an esophageal overtube, and subsequent interchange of two videoendoscopes that will be used to create the gastric plications. The risks are standard as for routine gastroscopy and include bleeding, perforation, aspiration, and the possibility of a medication reaction, among others. The endoscopic session is generally longer in duration and requires higher doses of sedation than routine diagnostic endoscopy, on a par with therapeutic ERCP. After spraying the pharynx with a topical anesthetic and placing the patient in the left lateral position, conscious sedation is administered. A routine upper endoscopy is performed using a standard videogastroscope and landmarks reviewed, with attention to the different rotatory and flexion maneuvers needed to traverse the distal esophagus and gastroesophageal junction. The distance from the incisors to the gastroesophageal junction is measured. A guidewire is then advanced through the gastroscope into the distal stomach, and the gastroscope removed while keeping the guidewire in an antral location. An oro-esophageal overtube is loaded onto a 42 or 45 French Savary-type esophageal dilator and advanced into position over the guidewire. The dilator and wire are subsequently removed from the patient, and the overtube remains as a conduit for subsequent instrument passage and exchanges. As an alternative, after performing the initial surveillance gastroscopy and extraction of that endoscope, a 46F Hurst Maloney dilator can be inserted into the overtube and the dilator gently advanced into the distal esophagus and stomach. The overtube is then pushed over the dilator with a rotating movement through the upper esophageal sphincter and into position. Following insertion, the proximal end of the overtube is secured into the bite block. After lubricating the overtube lumen with commercial PAM 1 (International Home Foods, Parsippany, NJ), the gastroscope with its attached sewing capsule is then placed into the overtube and advanced down the esophagus to the level of the z-line demarcating the squamocolumnar junction.

3 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) The target area is identified for apposition of the capsule to the gastric surface in the proximal stomach. This is typically within 1 cm distal to the z-line for circumferential plication placement, or within 3 cm for linear or helical pattern location. Suction is applied to the capsule by way of the externally attached accessory tubing, thereby drawing the adjacent tissue into the capsule cavity. After waiting 10 seconds, the handle is depressed, forcing the t-tag and needle through the suctioned tissue; withdrawing the handle leaves the tag captured into the tip of the sewing capsule. Release of suction and forward advancement of the endoscope a few centimeters releases the stitched tissue from the capsule lumen, and the endoscope is then withdrawn through the overtube. The same tilt-tag is reloaded into the hollow-core needle to place a second stitch at a location within 1 to 1.5 cm of the initial stitch. As the reloaded device is advanced into position for the placement of the second stitch, an assistant carefully pulls back on the free suture end, taking up the slack in the monofilament to prevent crossing or tangling in the second stitch site. The second stitch is placed as for the first one, and the endoscope removed. The suture ends are now extra-corporeal and can be adjusted gently to remove any redundant loop. The other gastroscope is now needed to finish the plication. In the original technique, half-hitches were hand tied and pushed to the surface of the stomach with the knot-pusher. Each subsequent half-hitch (five to six total) was performed with entry and removal of the endoscope by way of the overtube, and the final step involved removal of the pushing catheter and insertion of the guillotine catheter into the biopsy channel of the gastroscope. Backthreading the suture ends through this cutting catheter and using the suture as a guide to the gastric surface, a quick back-tug on the catheter would cut the ends of the knot at the stomach surface. The total time to create one plication with this original method was about 15 minutes. The new cinching/cutting catheter reduces the time to create a plication to about five minutes. The repetitive hand-tying steps and exchange of pushing and cutting catheters is replaced by the passage of one cinching catheter backloaded onto the suture material and guided to the gastric surface where the cinching tag is placed and sutures are cut in one action. (Fig. 1A D) Stitches to form plications can be placed in several patterns: linear, circumferential, or helical. The usual target for placement of plications is 1 cm below the z- line at three, six, and nine o clock for the circumferential pattern and at two o clock 3, 2 and 1 cm below the z-line for the linear configuration. In the helical configuration, which can also be applied to small hiatal hernias, a total of 4 to 6 plications are placed for a length of 3 to 4 cm below and up to the squamocolumnar juction [11]. For example, with 4 plications to be located in a normal cardia, the first plication is placed at two to four o clock 2.5 to 2 cm distal to the squamocolumnar junction (SQJ). The second plication is at four to seven o clock 1.5 to 1 cm below the SQJ followed by plications at 7 to 11 o clock 1 to 0.5 cm below the z-line and finally12 to 2 o clock at the SQJ. Larger hiatal hernias have been treated and may require additional plications with this method. At the completion of the procedure, photographic documentation with direct and retroflexed views documents the baseline post-procedural appearance

4 92 Fig. 1. Bard EndoCinch (Far Left) Suction of tissue just beneath the z-line. (Middle Left) Needle with pre-loaded suture advanced. (Middle Right) Cinching/cutting catheter advanced to tissue. (Far Right) Final appearance of plication in cardia. R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003)

5 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) for future comparison. The overtube is then removed over the endoscope and careful inspection of the proximal esophagus conducted as the endoscope is finally withdrawn. Patients are observed following the procedure and instructed to eat a soft diet on the day of the procedure, with no further restriction on diet or activities on subsequent days. Different recommendations have been made for discontinuing antisecretory medications following the procedure. Our custom has been to stop the medications on the day of the procedure, expecting that symptoms will be controlled if the procedure was successful. A clinical research nurse conducts follow-up assessments of outcome measures. Additional modifications in the technique continue to be studied. One group has addressed the hypothesis that endoscopically-placed sutures can lose efficacy over time when sutures become disrupted by pulling through the gastric mucosa. They presented preliminary information suggesting that the application of cautery to the lesser curvature before placement of linear sutures may reduce the chance of suture pull-through and improve plication adhesion, persistence and clinical outcome [12]. Their prospective, randomized trial evaluating the role of supplemental cautery is ongoing and the authors await the final results. Clinical experience A review of the literature was conducted to obtain an overview of the clinical results of endoluminal gastroplasty to date. Unfortunately, most data is available only from abstracts, and the authors await their submission for peer review for full details. Nonetheless, it seems reasonable to include this information in a preliminary assessment of the available initial clinical experience. The American multi-center trial that provided data to the Food and Drug Administration for approval of the device involved 64 patients from 8 sites [13]. It suggested that endoluminal gastric plication is a safe outpatient treatment for GERD, with the expectation that about two-thirds of patients will be successfully treated at six months follow-up. Inclusion criteria were three or more episodes per week of heartburn when off anti-secretory medications (with or without erosive esophagitis), benefit from and dependency on continued use of anti-secretory drugs for symptom control, and documented acid reflux as determined by ph monitoring (ph < 4 greater than 4% of the time). Exclusion criteria included dysphagia, more than grade II (Savary-Miller) esophagitis while on medications, body mass index (BMI) greater than 40 kg/m2, GERD refractory to antisecretory therapy, and a hiatal hernia over 2 cm in length. Treatment success was defined as a decrease in the heartburn severity score of 50% in addition to a reduction in the use of anti-reflux medications to under four doses per month. Subjects underwent endoscopy, esophageal manometry, ambulatory ph monitoring, symptom severity scoring, and quality of life assessments before and following endoscopic therapy. Patients were randomized to either linear or circumferential suture plication configurations. The linear configuration consisted of plications stacked on the lesser curvature one centimeter apart with

6 94 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) the most proximal plication at or just below the squamocolumnar junction. For the circumferential group plications were placed just below the squamocolumnar juction approximately 120 degrees apart. Sixty-four patients with GERD were enrolled and had the endoluminal gastric plication procedure (ELGP). Fifty two percent were randomized to the linear configuration and 48% to the circumferential plication pattern. Of the initial 64 patients 11 underwent a second procedure for a variety of reasons including technical failure, hypoxemia and initial treatment failure. All investigators performed their first procedure in humans on study patients. The initial mean heartburn symptom score was 62.7, falling significantly to a mean of 16.7 and 17 at three and six monthes post-procedure, respectively. Initial regurgitation scores significantly improved in this short-term follow-up. No significant difference was found in lower esophageal sphincter resting pressure or length. There was no significant effect on mucosal healing, with 25 percent of patients having grade 2 esophagitis at baseline and 19 percent having it at the six-month follow-up. The percent total time the ph was < 4, total number of reflux episodes, and percent upright time ph was < 4 were all significantly improved at six months follow-up but none returned to the normal range. There were 11 patients whose total DeMeester score did return to normal post-procedure. Improvement in symptoms did not always correlate with improvement of esophagitis or ph profiles. Plication configuration, plication number and operator experience did not correlate with ph results. Quality of life scores at six months post-procedure were significantly improved for social functioning and bodily pain. There was no difference in any outcomes related to linear versus circumferential placement of the stitches. Most importantly, at six months follow-up, 62 percent of patients were taking less than four doses of medications per month and were considered treatment successes. Adverse events in this trial included pharyngitis (31 percent), vomiting (14 percent), abdominal or chest pain (14 to 16 percent), and two episodes of minor mucosal tear believed to have been related to the use of the oro-esophageal overtube. Oxygen desaturation determined by pulse oximetry occurred in 4 patients during the procedure. A combination of overtube use and difficult airway access was considered to be the cause of hypoxemia in two of these patients. In this initial cohort, there was one subject who experienced a suture microperforation that was treated conservatively with intravenous antibiotics and a brief hospitalization. The investigators concluded that the procedure was safe and best suited for patients with uncomplicated GERD as an alternative to drug therapy. The procedure is complex and the results are dependent on the operator and a team receiving specialized training. Control of symptoms short term The results from other investigators have shown similar benefits and risks during short-term follow-up [14 22]. Statistically significant effects on symptom

7 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) Table 1 Significant effect on symptoms short-term outcomes n = # enrolled (# at f/u) Mean F/U (mos) HSS RFS Filipi (2001) 64(47) 6 yes yes Park (2001) yes yes Patel (2001) yes yes Mahmood (2001) 20(11) 3 yes yes Maple (2001) 23(21) 6.7 yes yes Abdu-Rebyeh (2002) 16(14) < 3 yes Liu (2002) 19(17) < 6 yes yes Caca (2002) 44(26) 6 yes Chen (2002) 183(42) 12 yes yes Arts (2002) 20 3 yes improvement for heartburn symptom score (HSS) and regurgitation frequency score (RFS) were seen in these preliminary reports at follow-up intervals of 3 to 12 months. The results from these investigations are presented in Table 1. Effect on medication use short-term The reduction in medication use following endoscopic treatment has been reported in almost all of these preliminary series, and as can be seen in Table 2, 20% to 76% of treated individuals were completely off PPI therapy at follow-ups ranging from 3 to 12 months. Effect on 24-hour ph exposure Where studied, there was reported a significant improvement in acid exposure, usually reflected in improvement of 24-hour total acid exposure, reduction of acid reflux events, or improvement in DeMeester score [13,14,18 24]. Normalization Table 2 Medication use short-term outcomes n = # enrolled (# evaluated at f/u) Mean F/U (mos) % Off PPI Filipi (2001) 64(51) 6 62 Park (2001) n/a Patel (2001) Mahmood (2001) 20(11) 3 67 Maple (2001) 23(21) Abdu-Rebyeh (2002) 16(14) < 3 50 Liu (2002) 19(17) < 6 59 Caca (2002) 44(26) 6 65 Chen (2002) 183(42) Arts (2002)

8 96 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) Table 3 Significant effect on 24-hour ph exposure n = # enrolled Mean f/u (mos) Y/N % Normalized Filipi (2001) 64 6 yes Swain (1997) 28 3 yes Raijman (2002) 5 1 yes Abou-Rebyeh (2002) 14 < 3 yes 30 Liu (2002) 19 < 6 no Caca (2002) 18 6 yes Mahmood (2002) 11 3 yes 45 Chen (2002) yes 32 Park (2001) yes Arts (2002) 20 3 yes 35 was only reported in 30% to 45% of treated individuals who underwent follow-up testing. See Table 3. Change of lower esophageal sphincter pressure or length In brief reports of small numbers of studied subjects, listed in Table 4, a significant effect of endoluminal gastroplication to augment lower esophageal sphincter pressure or length was not consistently demonstrated [13,14,16,19,20, 23,25,26]. Other outcomes One report of a small series of investigated subjects showed a significant effect of endoluminal gastroplication to decrease transient lower esophageal sphincter relaxations (tlesrs) [26]. As reported in the initial multi-centered prospective study, no significant effect was demonstrated in healing of esophagitis, with 25% having erosive disease at baseline and 19% of the cohort having esophagitis at 6 months follow-up [13]. Table 4 Significant effect on lower esophageal sphincter pressure or length n = # enrolled Mean f/u (mos) Y/N Filipi (2001) 64 6 no Swain (1997) 28 3 yes Park (2001) yes Raijman (2001) 5 1 yes Tam (2002) 10 6 yes Liu (2002) 19 < 6 no Caca (2002) 18 6 no Mahmood (2001) 18 3 no

9 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) Some individual patients healed their esophagitis whereas others developed new erosive disease demonstrable at the follow-up examination. Only a few investigators have reported on the selection of anesthetic agents for the performance of the endoscopic gastroplication. The majority used conscious sedation; a small minority used monitored sedation and about one fifth used general anesthesia. It is not clear whether the rate of general anesthesia related to initial operator preferences on the learning curve or to procedural risk factors such as obesity and other co-morbidities. Most patients tolerate the procedure under routine conscious sedation well. Longer-term follow-up A preliminary report of 33 patients from the initial United States multi-center investigator group followed for up to 2 years demonstrated persistent improvement in heartburn severity and frequency [27]. However, regurgitation was no longer significantly improved. Twenty-five percent of the patients were completely off anti-secretory medications, whereas 28 percent were on minimal medications to control symptoms. The remaining patients were on their original doses of anti-secretory medications (41 percent) or had undergone surgical fundoplication (two patients). Similar findings were described in another preliminary report of 23 patients of whom 22 percent continued to be off anti-secretory medications at two-year follow-up [28]. An additional 30 percent required less than 50 percent of the original dose. The remaining 11 patients had either a need for antisecretory medications greater than 50 percent of the time or had undergone anti-reflux surgery (see Tables 5 and 6). It is important to highlight that these outcomes were from cohorts of patients whose procedure was performed during the investigators learning curve, and that additional experience with the plication procedure (including optimizing the correct number and location of plications) should improve the long-term outcomes. EndoCinch in other clinical evaluations The efficacy of the Endocinch device compared with laparoscopic fundoplication was evaluated in a preliminary report that included 18 patients treated endoscopically who were compared with 16 age-matched patients who underwent laparoscopic Nissen fundoplication [16]. The mean duration of the Table 5 Significant effect on symptoms - long-term outcomes n = # enrolled (# at f/u) Mean f/u (mos) HSS RFS Haber (2001) 25(23) 24 yes Rothstein (2001) 39(33) 25 yes no

10 98 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) Table 6 Medication use long-term outcomes n = # enrolled (# evaluated at f/u) Mean f/u (mos) % Off PPI Haber (2001) 25 (23) Rothstein (2001) 39 (32) procedure (52 versus 116 minutes) and hospital stay (0.05 versus 3.3 days) were shorter in those undergoing the endoscopic procedure. Symptom scores, need for proton pump inhibitors, and quality of life were significantly improved in both groups. However, those undergoing laparoscopic Nissen fundoplication showed greater control of esophageal acid exposure. A preliminary report suggested that the EndoCinch device might be effective in patients with hiatal hernias larger than 2 cm [24]. Such patients, however, required more plications than those with smaller hiatal hernias. An initial report on 32 GERD patients with pulmonary symptoms (wheezing 47%, cough 81%) and daily heartburn (75%) or daily regurgitation (50%) demonstrated significant clinical improvement at a mean follow-up of 6 months [29]. In this patient cohort, wheezing was reduced to 6.3% and cough reduced to 19%, with significant improvements in heartburn symptom score and regurgitation. Only four patients had laryngeal symptoms associated with their GERD, and they did not improve after the endoscopic intervention during the short-term follow-up period. The authors await further clinical experience and longer term follow-up to better understand the role of this therapy in extraesophageal GERD. Comparison of plication pattern helical versus standard Data from the initial multicenter trial showed no difference in outcomes for patients treated with either linear or circumferential plication pattern [13]. In the absence of evidence for enhanced success of a particular technique, individual endoscopists have selected their preference of these standard locations for current EndoCinch procedures. Recently, a brief report compared 24 patients treated with standard endoluminal gastroplication (2 plications) and 18 patients with helical pattern gastroplication (4 to 6 plications) followed for at least 6 months [11]. The investigator did not include in the analysis any patients of his first 30 procedures to eliminate an influence of the learning curve. The groups were comparable in pre-procedural symptom scoring and medication use to control reflux symptoms whereas the helically treated group had greater symptom control and used fewer proton pump inhibitors for symptom control than the group treated with the standard procedure. The authors demonstrated some improvement in esophageal function and mucosal healing in a handful of patients who returned for follow-up testing after being treated with the helical pattern, and had included patients with a hiatal hernia up to 4 cm. The authors do not speculate on the possible role of the

11 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) increased number of plications (4 versus 2) rather than the pattern of plications in the observed outcomes. In another report of a configuration comparison between two circumferential plications (n = 9) and four helical plications (n = 11), no statistically significant differences were found for the clinical outcomes of symptom control, medication use, or effect on esophageal function or improvement in ph control [30]. The authors await further investigation to clarify a potential advantage of the helical technique over the standard procedure. Future studies A single institution, randomized, prospective, sham-controlled trial is underway and the results are eagerly awaited. Sham-treated patients receive the real plications at three months follow-up and all patients have pre- and post-procedural evaluations of symptoms, medication use, quality of life assessments, and ph and motility testing, and endoscopic mucosal observation. Further study of the role of supplemental cautery is anticipated, as is more definitive information on the benefits, if any, of the helical configuration versus standard plication locations. Modification of technique or instrumentation should strive to improve control of esophageal acid exposure. Additional study of the role of endoscopic plication treatment in patients with extraesophageal GERD is needed. Comparisons of the EndoCinch to other types of plicating instruments, and head-to-head comparisons with radiofrequency treatment, implantation or injection therapies, or laparoscopic surgical intervention for GERD are important areas for future investigation. Summary From a review of the single peer reviewed published report and the brief preliminary studies presented in abstract form, the BARD EndoCinch procedure seems safe and demonstrates an acceptable efficacy for symptom control during short-term follow-up. Most patients (about 2 out of 3) do well with improvement of GERD symptoms during the first post-procedural year. This benefit may wane over time. Objective benefit is lacking with the minority of treated individuals achieving normalization of 24-hour total acid exposure, and no significant effect has been seen in healing of esophagitis. This may focus the treatment towards that group of GERD patients with mild or non-erosive disease. The authors have no information that the endoscopic therapy could prevent reflux-related complications, and long-term data is awaited from accumulated clinical experience to establish the maintenance profile of this novel treatment. The outcomes from the sham trial, and long-term follow-up data will help to define the role of this antireflux therapy. The authors need additional studies to define the effect of endoluminal plication on the function of the lower esophageal sphincter to optimize its benefit for patients.

12 100 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) References [1] Sandler RS, Everhart JE, Donowitz M, et al. The burden of selected digestive diseases in the United States. Gastroenterology 2002;122: [2] Klinkenberg Knol EC, Nelis F, Dent J, et al. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: Efficacy, safety, and influence on gastric mucosa. Gastroenterology 2000;118: [3] Spechler SJ, Lee E, Ahnen D, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: Follow-up of a randomized controlled trial. JAMA 2001; 285: [4] Lundell L, Miettinen P, Myrvold HE, et al. Continued (5-year) follow-up of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease. J Am Coll Surg 2001;192: [5] Swain CP, Mills TN. An endoscopic sewing machine. Gastrointest Endosc 1986;32:36 8. [6] Swain CP, Brown GJ, Mills TN. An endoscopic stapling device: The development of a new flexible endoscopically controlled device for placing multiple transmural staples in gastrointestinal tissue. Gastrointest Endosc 1989;35: [7] Swain CP, Kadirkamanathan SS, Gong F, et al. Knot tying at flexible endoscopy. Gastrointest Endosc 1994;40: [8] Kadirkamanathan SS, Evans DF, Gong F, et al. Antireflux operations at flexible endoscopy using endoluminal stitching techniques: An experimental study. Gastrointest Endosc 1996; 44: [9] Kadirkamanathan SS, Yazaki E, Evans DF, et al. An ambulant porcine model of acid reflux used to evaluate endoscopic gastroplasty. Gut 1999;44: [10] Swain CP, Park P. BARD EndoCinch: the device, the technique and pre-clinical studies. In: Rothstein RI, editor. Endoscopic therapy for gastroesophageal reflux disease, Gastrointestinal Clinics of North America. New York: W B Saunders Co; [11] Raijman I, Walters R, Garza C, et al. Helical endoluminal gastroplication (ELGP) compared with standard ELGP in patients with gastroesophageal reflux disease (GERD) [abstract]. Gastrointest Endosc 2002;55:AB260. [12] Lehman GA, Dunne DP, Hieston K, et al. Suturing plication of cardia with Endocinch device: Effect of supplemental cautery. A human prospective randomized trial [abstract]. Gastrointest Endosc 2002;55:AB260. [13] Filipi C, Lehman G, Rothstein RI, et al. Transoral endoscopic suturing for gastroesophageal reflux disease: A multicenter trial. Gastrointest Endosc 2001;53: [14] Swain CP, Park PO, Kjellin T, et al. Endoscopic gastroplasty for gastro-oesophageal reflux disease [abstract]. Gastrointest Endosc 2001;51:144. [15] Patel VM. Clinical utility of endoluminal gastroplication for gastroesophageal reflux disease in private practice a prospective study of 55 patients in the Southwest [abstract]. Am J Gastroenterol 2001;96S:89. [16] Mahmood Z, Byrne PJ, McCullough J, et al. A comparison of BARD EndoCinch transoesophageal endoscopic plication (BETEP) with laparoscopic fundoplication (LNF) for the treatment of gastroesophageal reflux disease (GORD) [abstract]. Gastrointest Endosc 2002;55:AB90. [17] Maple JT, Alexander JA, Gostout CJ, et al. Endoscopic gastroplasty for GERD: Not as good as billed? A single-center 6 month report [abstract]. Am J Gastroenterol 2001;96S:65. [18] Abdu Rebyeh H, Hoepffner N, Osmanoglou E, et al. Endoscopic suturing is able to reduce pathologica; acid reflux in gastroesophageal reflux disease [abstract]. Gastrointest Endosc 2002; 55:AB [19] Liu JJ, Knapp R, Carr-Lock DL. Treatment of medication refractory gastroesophageal reflux disease with endoluminal gastroplication [abstract]. Gastrointest Endosc 2002;55:AB257. [20] Caca K, Schiefke I, Soder H, et al. Endoluminal gastroplication (EndoCinch) in GERD patients refractory to PPI therapy [abstract]. Gastrointest Endosc 2002;55:AB110. [21] Chen YK, Raijman I, Ben Menachem T, et al. One-year follow up of endoluminal gastro-

13 R.I. Rothstein, C.J. Filipi / Gastrointest Endoscopy Clin N Am 13 (2003) plication (ELGP): clinical and economic outcomes of the U. S. multicenter trial [abstract]. Gastrointest Endosc 2002;55:AB [22] Arts J, Slootmaekers S, Sifrim D, et al. Endoluminal gastroplication (Endocinch) in GERD patients refractory to PPI therapy [abstract]. Gastroenterology 2002;122:AB [23] Swain CP, Kadirkamanadan SS, Gong F, et al. Endoscopic gastroplasty for gastroesophageal reflux disease [abstract]. Gastrointest Endosc 1997;47:AB85. [24] Raijman I, Ben Menachem T, Starpoli AA, et al. Endoluminal gastroplication (ELGP) improves GERD symptoms in patients with large hiatal hernias [abstract]. Gastrointest Endosc 2002; 55:AB255. [25] Raijman I, Ben Menachem T, Reddy G, Chen Y. Symptomatic response to endoluminal gastroplication (ELGP) in patients with gastroesophageal reflux disease: A multi-center study [abstract]. Gastrointest Endosc 2001;53:74. [26] Tam W, Holloway R, Dent J, et al. Impact of endoscopic suturing of the gastroesophageal junction on lower esophageal sphincter function and gastroesophageal reflux in patients with reflux disease [abstract]. Gastroenterol 2002;122:AB390. [27] Rothstein RI, Pohl H, Grove M, et al. Endoscopic gastric plication for the treatment of GERD: Two year follow-up results [abstract]. Am J Gastroenterol 2001;96S:107. [28] Haber GB, Marcon NE, Kortan P, et al. A 2-year follow-up of 25 patients undergoing endoluminal gastric plication (ELGP) for gastroesophageal reflux disease (GERD) [abstract]. Gastrointest Endosc 2001;53:116. [29] Shahrier M, Raijman I, Starpoli A, et al. Endoluminal gastroplication (ELGP) improves acidrelated pulmonary symptoms in GERD patients [abstract]. Gastroenterology 2002;122:263. [30] Filipi CJ, Gerhardt JD. Comparison of endoluminal gastroplication configuration techniques [abstract]. Am J Gastroenterol 2002;97:AB89.