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

Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository

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

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Mohammad Al-Haddad, MD; Phone Number: 317-944-0980; Email: moalhadd@iu.edu
• Study Contact Backup: Name: Jacque Peterman; Phone Number: 317-944-0980; Email: petermaj@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Hospital
      • Contact: Mohammad Al-Haddad, MD; Phone Number: 317-944-0980; Email: moalhadd@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

As long as patients fall under the inclusion criteria and do not fall under exclusions, every patient can be considered. Patient must be declared safe to undergo procedure on individual basis from an evaluation from head doctor on study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM	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	60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months
Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM	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)	60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months
Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM	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	baseline and assess change at 1,3,6,12,24,36,48 & 60 months
Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM	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	baseline; and assess change at 6, and 24 months

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Mohammad Al-Haddad, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: June 14, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Gastroparesis; GPOEM; Myotomy; Gastric Per-Oral Endoscopic Myotomy; g-poem
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 1708840627

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No