Last updated on January 2020

Endoscopic Clips Versus Overstich Suturing System Device for Closure of Mucosotomy After G-POEM

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gastroparesis | Diabetic Gastroparesis | Stomach Discomfort | Gastropathy
  • Age: Between 18 - 90 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Refractory (> 6 months) and severe (based on a validated total Gastroparesis Cardinal Symptom Index) gastroparesis, with confirmed gastric emptying based on a gastric emptying study: standardized protocol of scintigraphy in all patients (performed less than 6 months prior to enrolment). The total GSCI (Gastroparesis Cardinal Symptom Index) score must be >2.0
    • Abnormal gastric emptying is defined as retention of Tc-99 m >60% at 2 h and/or 10% of residual activity at 4 h on a standardized sulphur colloid solid-phase gastric emptying study.
    • Abnormal gastric emptying breath test based on a solid normal range determination for the test used (e.g. T1/2 > 109 min)
  2. Severe refractory disease is defined as GCSI >2.0 and failure or recurrence in patients who received available optimal pharmacological therapies.
  3. Persons 18 years or older at the time of signing the informed consent
  4. Signed informed consent

Exclusion Criteria:

  1. No previous attempt with at least one prokinetic drug
  2. No previous attempt to withdraw anticholinergic agents and glucagon like peptide -1 (GLP-1) and amylin analogues in patients treated with these substances
  3. Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
  4. Previous gastric surgery (Billroth I or Billroth II)
  5. Known eosinophilic gastroenteritis
  6. Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
  7. Sever coagulopathy
  8. Oesophageal or gastric varices and /or portal gastropathy
  9. Advanced liver cirrhosis (Child B or Child C)
  10. Active peptic ulcer disease
  11. Pregnancy or puerperium
  12. Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment
  13. Any other condition, which in the opinion of the investigator would interfere with study requirements
  14. Uncontrolled diabetes mellitus
  15. Diagnosis of rumination syndrome or "eating" disorder (mental anorexia, bulimia nervosa)
  16. Inability to obtain informed consent

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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