Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis
Condition: Gastroparesis Postoperative; Gastroparesis Due to Diabetes Mellitus; Idiopathic Gastric Stasis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a
      mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral
      endoscopic myotomy (G-POEM) is a new treatment that has demonstrated initial promising
      results in these patients. The investigators aims are to evaluate security and efficacy of
      this endoscopic treatment in participants with refractory gastroparesis.
    

Detailed description: 
      Gastroparesis is a chronic, condition characterized by a delayed gastric emptying without a
      mechanical obstruction. This disease is associated with high morbidity and mortality with a
      prevalence up to 4% of population. Patients with this disease have a reduced quality of life.
      The principal etiologies include: post-surgical, diabetes, medications and idiopathic.
      Symptoms include nausea, vomiting, early satiety, bloating and abdominal pain. Diagnosis is
      based on the combination of symptoms and studies as gastroscopy that shows retained food in
      the stomach without a gastric outlet obstruction and confirmed with a gastric emptying
      scintigraphy. Treatments have limited effect in these patients, including medications,
      botulinum toxin injection, surgical gastric electrical stimulation, laparoscopic pyloroplasty
      and stent placement. G-POEM is a new technique based on per-oral endoscopic myotomy treatment
      in achalasia patients, which has been recently proposed for treatment of patients with
      refractory gastroparesis with good initial results. The investigators aim is to evaluate the
      safety and efficacy of this new technique in a group of mexican participants with this
      disease.
    

Intervention name(s): G-POEM
Intervention type(s): Procedure
Intervention description(s): After confirmation of refractory gastroparesis, participants will undergo to gastric POEM. Participants will be admitted to hospital 24hrs before procedure and IV antibiotics will be given and then the procedure will be done. Technique consist of 4 steps: First: a submucosa injection of saline solution with methylene blue at 3-4cms from pylorus. Second: a submucosa incision and tunnel creation up to pyloric area. Third: Myotomy of the circular and longitudinal muscular layers of the pylorus and the antrum. Fourth: closure of the mucosal incision with hemoclips. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic and scintigraphic studies up to 1 year after procedure.
Other intervention name(s): Gastric per-oral endoscopic myotomy
Intervention model: Single Group Assignment
Intervention model description: This a prospective study that evaluates G-POEM in a group of participants with diagnosis of refractory gastroparesis. Participants are sequentially recruited as diagnosed.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: G-POEM; Safety; Efficacy