Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

Not yet recruiting

• Conditions: Gastroparesis; Gastroparesis With Diabetes Mellitus; Gastroparesis Postoperative

• Registration Number: NCT04349670
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-16
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29
• Study Start: 2020-06-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Clinical efficacy	1, 3, 6, 12, 24 months	Change in symptomatological scores

Secondary Outcome Measures

Name	Time	Method
Correlation of symptoms	3, 12, 24 months	Evaluate the correlation between symptoms and gastric emptying

Trial Locations

Locations (1)

Pier Alberto Testoni; 🇮🇹 Milan, Italy