Gastroparesis Due to Diabetes Mellitus, Gastroparesis Postoperative, Idiopathic Gastric Stasis
Conditions
Keywords
G-POEM, Safety, Efficacy
Brief 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.
Interventions
PROCEDUREG-POEM
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.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with refractory gastroparesis based on delayed gastric emptying symptoms: Nausea, retching, vomiting, abdominal pain, early satiety, post-prandial fullness, bloating. * Refractoriness defines as the presence of symptoms with failure or recurrence after other type of treatment. * Any etiology: diabetes, post-surgical, idiopathic
Exclusion criteria
* Pregnancy * Portal hypertension * Gastric malignant condition * Active prepyloric ulcer * Mechanical pyloric stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of G-POEM in gastroparesis in percentage of scintigraphic improvement at 4hrs | 1, 6 and 12 months | The investigators will compare the percentage of improvement in scintigraphy before and after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| security of G-POEM in gastroparesis | up to 30 days after procedure | measured as the presence of complications during or after procedure |
Countries
Mexico
Outcome results
None listed