BACKGROUND:Endoscopic suture plications at the cardia decreased gastroesophageal reflux disease (GERD) symptoms in short-term studies. Pull-through of submucosal sutures may lead to loss of efficacy. The application of cautery on mucosal surfaces may promote tissue adherence. This study aimed to compare the efficacy of endoluminal gastroplication (ELGP) using Endocinch with and without adjuvant cautery. METHODS: Vertical plications were created using ELGP. Patients were randomized to either ELGP alone or ELGP with an adjuvant bicap cautery. Patients were blinded to their randomization category and encouraged to take antisecretory medications if needed. Heartburn was scored on a scale of 0 (none), 1 (occasional), 2 (frequent), or 3 (daily). Patients undergoing a second antireflux procedure during the follow-up period were considered study failures and scored 3. RESULTS: Of the 18 patients enrolled in the study, 1 was lost to follow-up evaluation at 12 months and 2 could not be followed up at 24 months. The cautery group included 10 patients (9 men) with a mean age of 53.2 years. The group without cautery consisted of 8 patients (5 men) with a mean age of 50.4 years. The use of ELGP with cautery resulted in a trend toward greater improvement in several parameters (heartburn score, total percentage of time that pH was less than 4, and medication use) at 12 months than ELGP without cautery. These trends were not seen at 24 months, when all but 1 patient had ongoing symptoms, used daily proton pump inhibitor/H2-blocker, or went on to undergo a second antireflux procedure (2 Nissen and 3 Enteryx). CONCLUSIONS: Cautery numerically improved plication persistence, decreased esophageal acid exposure, and improved symptoms at 1 year compared with sutures alone. Little or no long-term efficacy of ELGP with or without cautery was observed after 2 years of follow-up evaluation.
RCT Entities:
BACKGROUND: Endoscopic suture plications at the cardia decreased gastroesophageal reflux disease (GERD) symptoms in short-term studies. Pull-through of submucosal sutures may lead to loss of efficacy. The application of cautery on mucosal surfaces may promote tissue adherence. This study aimed to compare the efficacy of endoluminal gastroplication (ELGP) using Endocinch with and without adjuvant cautery. METHODS: Vertical plications were created using ELGP. Patients were randomized to either ELGP alone or ELGP with an adjuvant bicap cautery. Patients were blinded to their randomization category and encouraged to take antisecretory medications if needed. Heartburn was scored on a scale of 0 (none), 1 (occasional), 2 (frequent), or 3 (daily). Patients undergoing a second antireflux procedure during the follow-up period were considered study failures and scored 3. RESULTS: Of the 18 patients enrolled in the study, 1 was lost to follow-up evaluation at 12 months and 2 could not be followed up at 24 months. The cautery group included 10 patients (9 men) with a mean age of 53.2 years. The group without cautery consisted of 8 patients (5 men) with a mean age of 50.4 years. The use of ELGP with cautery resulted in a trend toward greater improvement in several parameters (heartburn score, total percentage of time that pH was less than 4, and medication use) at 12 months than ELGP without cautery. These trends were not seen at 24 months, when all but 1 patient had ongoing symptoms, used daily proton pump inhibitor/H2-blocker, or went on to undergo a second antireflux procedure (2 Nissen and 3 Enteryx). CONCLUSIONS: Cautery numerically improved plication persistence, decreased esophageal acid exposure, and improved symptoms at 1 year compared with sutures alone. Little or no long-term efficacy of ELGP with or without cautery was observed after 2 years of follow-up evaluation.
Authors: C J Filipi; G A Lehman; R I Rothstein; I Raijman; G V Stiegmann; J P Waring; J G Hunter; C J Gostout; S A Edmundowicz; D P Dunne; P A Watson; D A Cornet Journal: Gastrointest Endosc Date: 2001-04 Impact factor: 9.427
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