Gastroparesis, Gastroparesis Postoperative, Gastroparesis With Diabetes Mellitus
Conditions
Keywords
GPOEM, gastroparesis, pyloromyotomy
Brief summary
The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.
Detailed description
After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol. Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications. Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.
Interventions
PROCEDUREGPOEM - gastric per-oral endoscopic myotomy
Endoscopic section of the pyloric muscle with submucosal tunnel technique.
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Gastroparesis (GCSI \> 2 OR Gastric emptying half-time \> 180 min OR gastric retention at 120 min \> 60% OR good response to botulinum if former criteria not met)
Exclusion criteria
* Age \< 18 years * Inability to understand protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy | 1, 3, 6, 12, 24 months | Change in symptomatological scores |
| Functional efficacy | 3, 12, 24 months | Change of scintigraphy evaluated gastric emptying time |
| Complications | peri-operative time (48 hours) | Evaluation of the operative adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of symptoms | 3, 12, 24 months | Evaluate the correlation between symptoms and gastric emptying |
Countries
Italy
Outcome results
None listed