What side effects are associated with this type of intervention?

Common treatments for gastroparesis, such as peroral endoscopic pyloromyotomy (G-POEM), gastric electrical stimulation, and botulinum toxin injections, have various side effects. G-POEM can lead to complications like mucosal perforation, bleeding, and infection. Gastric electrical stimulation may cause lead dislodgement, infection, and pain at the implantation site. Botulinum toxin injections can result in temporary muscle weakness and, in some cases, may not provide lasting symptom relief. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for gastroparesis, though not all are directly similar to G-POEM. Gastric electrical stimulation (GES) with the Enterra Therapy system is one such FDA-approved treatment, which involves implanting a device to stimulate stomach muscles and improve gastric emptying. While not involving cutting the pyloric muscle, it is an interventional approach aimed at improving gastric motility. There are no specific FDA approvals for procedures exactly like G-POEM, but the concept of modifying the pyloric muscle to enhance gastric emptying is being explored in clinical trials.

What other types of research exist?

A promising novel alternative to Peroral Endoscopic Pyloromyotomy (G-POEM) for gastroparesis patients is gastric electrical stimulation. This treatment has shown benefits in reducing symptoms, decreasing the need for medications, and lowering hospitalization rates.

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Procedure

G-POEM for Gastroparesis

N/A

Recruiting

Led By Pankaj Pasricha, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration with mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 2.3

Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.

Must not have

Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.

Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 48 weeks post treatment

Summary

This trial is testing a new procedure called G-POEM in patients whose gastroparesis doesn't get better with medication. The goal is to see if G-POEM helps these patients by making it easier for food to leave the stomach. G-POEM is a novel endoscopic technique developed to treat refractory gastroparesis, especially in patients who have not responded to other treatments like gastric electrical stimulators.

Who is the study for?

This trial is for adults with gastroparesis, a condition causing chronic nausea or vomiting, who haven't improved after trying standard treatments for at least six months. Participants must have confirmed delayed gastric emptying and a specific symptom severity score. Excluded are those with other conditions that could explain symptoms, severe systemic illnesses, uncontrolled diabetes, recent changes in medications for gastroparesis, pregnancy, or certain allergies.

What is being tested?

The study compares the effectiveness of G-POEM (a surgical procedure to cut stomach muscles) against sham surgery (a fake operation) over 12 months in patients whose gastroparesis doesn't respond to medication. The goal is to see which treatment helps more and identify factors predicting better outcomes.

What are the potential side effects?

While not explicitly listed here, potential side effects may include pain at the incision site from the endoscopic procedure, infection risk due to surgery, gastrointestinal symptoms like bloating or diarrhea post-procedure and possible anesthesia-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had symptoms like chronic nausea or vomiting for at least a year.

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I have had symptoms like chronic nausea or vomiting for at least a year.

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My severe stomach emptying issue hasn't improved despite trying many treatments.

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My upper GI tests show no blockages.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe kidney or liver disease.

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My diabetes is not well-managed, with an HbA1c over 10%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 48 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 48 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 48 weeks post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GCSI-DD change

Secondary study objectives

Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: G-POEMExperimental Treatment1 Intervention

Group II: Sham procedurePlacebo Group1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Gastroparesis treatments aim to improve gastric emptying and alleviate symptoms. Common treatments include dietary modifications, medications like prokinetics (e.g., metoclopramide) that stimulate stomach muscle contractions, and antiemetics to control nausea. More advanced treatments, such as Peroral Endoscopic Pyloromyotomy (G-POEM), involve cutting the pyloric muscle to enhance gastric emptying by reducing pyloric resistance. This is crucial for gastroparesis patients as it directly addresses the impaired motility and pyloric dysfunction, potentially providing significant symptom relief and improving quality of life.