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The assigned closure method will be decided by an endoscopist prior to starting closure. Investigators plan to randomize 30-40 patients (15-20 in both arms, ratio 1:1).
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The aim of this prospective, open-label study is to compare efficacy and safety of two methods for incision closure in patients who undergo G-POEM: endoscopic clips vs. A platform that replicates a principle of surgical suturing is endoscopic suturing system. Thus, endoscopic clips may not be an ideal closure method in the stomach. However, as gastric mucosa is thicker compared to the esophagus, where clips are used for POEM without any major problems, several authors have described problems during gastric incision closure - it takes a rather longer time, some clips cannot be placed and in some patients, other closure method had to be used. At present, simple closure with endoscopic clips has been the most frequently described method for mucosal closure in patients undergoing G-POEM. Several techniques may be used for endoscopic mucosal closure: endoscopic clips, OTSC clips, endo-loop based methods (KING closure) or endoscopic suture. The ideal closure technique in patients undergoing G-POEM needs to be established. Obtaining adequate mucosal closure is one of the most important steps of the procedure and is essential in avoiding major morbidity. Mucosal incision should be endoscopically closed to prevent leakage into the abdominal cavity. These questions concern, among others, efficacy, safety, technical performance etc. There are several questions, which need to be answered before G-POEM is considered as a standard clinical procedure. G-POEM is a new and promising method, which is still under investigation as its safety and efficacy has not been established yet.
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Why Should I Register and Submit Results?īased on principles of NOTES (natural orifice transluminal endoscopic surgery), a mini-invasive therapeutic procedure such as per-oral endoscopic myotomy (POEM) or gastric per-oral endoscopic pyloromyotomy (G-POEM) have been assessed as new modalities for treatment of oesophageal achalasia or refractory gastroparesis.