Endoscopic Clips Versus Overstich Suturing System Device for Closure of Mucosotomy After G-POEM
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      Gastric per-oral endoscopic pyloromyotomy (G-POEM) has been assessed as new modality for
      treatment of refractory gastroparesis. G-POEM is promising method, which is still under
      investigation as its safety and efficacy has not been established yet. The ideal closure
      technique in patients undergoing G-POEM needs to be established. Several techniques may be
      used for endoscopic mucosal closure: endoscopic clips, OTSC (over the scope clips), endo-loop
      based methods (KING closure) or endoscopic suture.

      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. endoscopic
      suturing system (OverStitch).
    

Detailed description: 
      Based 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. G-POEM is a new and promising method,
      which is still under investigation as its safety and efficacy has not been established yet.
      There are several questions, which need to be answered before G-POEM is considered as a
      standard clinical procedure. These questions concern, among others, efficacy, safety,
      technical performance etc. Mucosal incision should be endoscopically closed to prevent
      leakage into the abdominal cavity. Obtaining adequate mucosal closure is one of the most
      important steps of the procedure and is essential in avoiding major morbidity. The ideal
      closure technique in patients undergoing G-POEM needs to be established. Several techniques
      may be used for endoscopic mucosal closure: endoscopic clips, OTSC clips, endo-loop based
      methods (KING closure) or endoscopic suture. At present, simple closure with endoscopic clips
      has been the most frequently described method for mucosal closure in patients undergoing
      G-POEM. 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. Thus, endoscopic clips may not be an ideal
      closure method in the stomach. A platform that replicates a principle of surgical suturing is
      endoscopic suturing system.

      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. endoscopic
      suturing system (OverStitch).

      Investigators plan to randomize 30-40 patients (15-20 in both arms, ratio 1:1).

      The assigned closure method will be decided by an endoscopist prior to starting closure.
    

Intervention name(s): Closure of mucosotomy using endoscopic clips; Closure of mucosotomy using OverStitch™ suturing device
Intervention type(s): Procedure; Procedure
Intervention description(s): Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done using endoscopic clips. These are used in endoscopy to mechanically close two mucosal surfaces without the need for surgery and suturing. In this study, the following endoclips may be used: Resolution 360™ Clip (Boston Scientific), QuickClip Pro™(Olympus) or Instinct™ Endoscopic Hemoclip (Cook Medical).; Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done by OverStitch™ (Apollo Endosurgery Inc., Austin, Texas, USA), which is a suturing device that enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures through a flexible endoscope.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will be allocated to the corresponding group according to a peri-procedural finding, availability of a respective closure method and endoscopist´s decision.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Gastric Per-oral Endoscopic Pyloromyotomy