Outcomes of Endoluminal Gastric Plication for the Treatment of Gastroesophageal Reflux Disease (2003)

Gastroesophageal reflux disease (GERD) is very common in the USA. Although proton-pump inhibitors are effective in alleviating GERD symptoms, many patients do not find relief with medication alone or become dependent on these medications for life. The lifelong cost of such medications can be burdensome. For these reasons, many patients with GERD have undergone invasive procedures including Nissen fundoplication and more recent endoscopic techniques to alter their anatomy enough to prevent the reflux of acid into the esophagus. Newer procedures including endoluminal gastric plication (ELGP) look promising, but long-term follow-up is needed to more thoroughly assess outcomes. We have studied the outcomes of 43 patients who underwent ELGP and analyzed the efficacy of this particular technique in alleviating symptoms and eliminating the need for proton-pump inhibitors. METHODS Patients The study examined patients who underwent ELGP between October 2000 and April 2001. Some who underwent the procedure were referred by their physicians, and others self-referred after hearing about the procedure through the media. To be a candidate for the procedure, the patient had to have reflux symptoms that were relieved or partially relieved by H2 blockers or proton-pump inhibitors. Classic symptoms of GERD were defined as regurgitation of sour material in the mouth or heartburn. The patients also underwent initial diagnostic tests including manometry, 24-hour pH testing, and endoscopy. Patients with Barrett’s esophagus, motility disorders, or large hiatal hernias, as determined by endoscopy, were excluded as candidates. Patients who had documented reflux by pH probe testing with no contra indications to the procedure were candidates. During this time period, 43 patients met the criteria and underwent ELGP. Procedure After consents were obtained, patients were placed in the left lateral decubitus position, and a trained anesthesiologist administered general anesthesia or deep conscious sedation using propofol. An overtube was placed in the patient’s esophagus. The endoscope was then passed through the overtube to the level of the squamocolumnar junction. The suturing device located at the tip of the endoscope was then placed in apposition to the luminal wall, and suction was applied to draw and hold tissue in the suture chamber. Once an adequate amount of tissue was in the chamber, a suture was placed. A second suture was then placed adjacent to the first, and the 2 were tied together to create a plication. This technique was repeated, and all patients received 1 to 3 plications depending on their anatomy and the endoscopic appearance after placement of each suture. Endpoints The goal of this study was to determine the long-term effectiveness of ELGP for the treatment of GERD. To achieve this with a retrospective review of medical records alone, we confined our endpoints to 1 objective outcome: whether patients were taking proton-pump inhibitors or H2 blockers 1 year after the procedure. Follow-up The patients in the study were monitored up to 2 years after their procedure. Initially, each patient had a 3-day and a 3-month follow-up visit with a trained gastroenterologist. The physician’s office also contacted patients by telephone 1 year after the pro cedure. At that time, the patients were asked 2 questions to determine the effectiveness of the procedure. The first question was whether they were on or off their medicines for the treatment of reflux symptoms. If they were still taking medicines, they were asked if the amount of medicine was the same as before the procedure or less. Their answers were recorded, and the information in the charts was reviewed retrospectively. RESULTS All 43 patients were successfully contacted by telephone, and the results were recorded in the charts. When the patients were asked if they were still on medicines, 19 patients (44%) responded yes. Of these patients, 11 responded that they were on less medicine, and 8 replied that they were on the same doses. Twenty-four patients (56%) reported no reflux and no medicines for GERD 1 year after ELGP. There were no major complications in any of the procedures. Minor complications included sore throat and chest pain immediately after the procedure. These symptoms generally resolved within 72 hours.