Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

IRCCS San Raffaele40 enrolled

Overview

The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gastroparesis Gastroparesis Postoperative Gastroparesis With Diabetes Mellitus

Interventions

GPOEM - gastric per-oral endoscopic myotomyPROCEDURE

Endoscopic section of the pyloric muscle with submucosal tunnel technique.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Pier Alberto Testoni

Milan, Italy

Outcomes

Primary Outcomes

Clinical efficacy

Change in symptomatological scores

Time frame: 1, 3, 6, 12, 24 months

Functional efficacy

Change of scintigraphy evaluated gastric emptying time

Time frame: 3, 12, 24 months

Complications

Evaluation of the operative adverse events

Time frame: peri-operative time (48 hours)

Secondary Outcomes

Correlation of symptoms

Evaluate the correlation between symptoms and gastric emptying

Time frame: 3, 12, 24 months

Data from ClinicalTrials.gov

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