Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

Recruiting

• Conditions: Gastroparesis

• Registration Number: NCT06381349
• Lead Sponsor: Chris Varghese

Brief Summary

Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \<1 month prior to GPOEM. All subjects will then be followed up for 12 months.

Detailed Description

This protocol proposes no change to the clinical management of patients which is left to the discretion of the patients' primary clinical team.

Patients as part of this study will undergo a baseline assessment via Gastric Alimetry, and concurrent symptom, quality of life, and health psychology questions.

GPOEM will be performed as per standard site protocol, with data captured in RDCap.

Patients will be followed up at 1-month, 3-month, 6-months, and 12-months using the myCap (REDCap) app.

Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure.

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-24
• Status Verified: 2024-05
• Study Start: 2024-07-07
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-05-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Aged 18 years or older
• Indicated for GPOEM

Exclusion Criteria

• Pregnant or breast-feeding
• Inability to perform Gastric Alimetry test: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastroparesis Cardinal Symptom Index (GCSI)	6 months	≥ 1 decrease in total GCSI score \[higher score = worse symptoms\]

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)	1, 3, 6, and 12 months	0 - 5; higher score = better quality of life
Patient Health Questionnaire - 8 (PHQ-8)	6, and 12 months	0 - 12; higher score being increased depression severity
Work Productivity and Activity Impairment (WPAI)	12 months	0-100%; higher scores indicating increased loss of work productivity and activity impairment
EQ-5D scores	1, 3, 6, and 12 months	0 - 1; higher score being better quality of life
Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM)	1, 3, 6, and 12 months	0 - 1; higher score being increased symptom burden
Generalized Anxiety Disorder 7-item (GAD-7)	6, and 12 months	0 - 21; higher score indicates increased anxiety
Perceived Stress Scale 4 (PSS-4)	6, and 12 months	0 - 16; higher scores indicate higher stress
Brief Illness Perception Questionnaire-Revised	6, and 12 months	0 - 80; higher scores indicate worse illness perception
Alimetry® Gut-Brain Wellbeing (AGBW)	1, 3, 6, and 12 months	0 - 40; higher scores indicate higher mental health burden

Trial Locations

Locations (1)

University of Auckland; 🇳🇿 Auckland, New Zealand