Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis

Recruiting

• Conditions: Gastroparesis

• Registration Number: NCT04434781
• Lead Sponsor: Indiana University

Brief Summary

Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.

Detailed Description

Gastroparesis is a disease of the stomach where there is significant delay in gastric emptying of contents to the intestines. This disease results in a multitude of symptoms including nausea, vomiting, weight loss, and malnutrition.

Current treatments for gastroparesis include dietary changes, oral medications (prokinetic agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and vomiting), gastric stimulators and rarely surgery.

G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic procedure, is increasingly being performed to assist in the management of certain groups of patients with gastroparesis.

This data will be used for research purposes only to determine the clinical impact of endoscopic treatments on gastroparesis. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-07
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2020-06-14
• Study First Posted: 2020-06-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-08-15
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 18 years of age
• Referral for endoscopic treatment of Gastroparesis for symptom management

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Exclusion Criteria

• < 18 years of age
• Absence of gastroparesis based on scintigraphy studies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM	60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months	The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is.; Nausea or Vomiting (score 0-5 for each of the following 3 criteria); * Nausea; * Retching; * Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria); * Stomach Fullness; * Not able to finish a normal-sized meal; * Feeling excessively full after meals; * Loss of appetite Bloating (score 0-5 for each of the following 2 criteria); * Bloating; * Stomach visibly larger
Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM	baseline; and assess change at 6, and 24 months	we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours
Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM	60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months	Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)
Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM	baseline and assess change at 1,3,6,12,24,36,48 & 60 months	Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States