What side effects are associated with this type of intervention?

Common treatments for gastroparesis, including prokinetic agents like metoclopramide and erythromycin, gastric electrical stimulation, and endoscopic procedures like G-POEM, have various side effects. Metoclopramide can cause tardive dyskinesia, while erythromycin may lead to gastrointestinal disturbances and antibiotic resistance. Gastric electrical stimulation can result in infection, lead migration, and pain at the implantation site. Endoscopic procedures like G-POEM can cause perforation, bleeding, and infection. Transpyloric stenting with LAMS, which keeps the pylorus open to facilitate gastric emptying, may have risks such as stent migration, occlusion, and local irritation or ulceration.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for gastroparesis, including metoclopramide, which is commonly used to increase gastric emptying. Other drugs like domperidone and erythromycin are also used, although they may not have specific FDA approval for gastroparesis. Cisapride was previously used but is now limited due to safety concerns. Procedural interventions such as gastric per-oral endoscopic pyloromyotomy (GPOEM) and transpyloric stenting with lumen apposing metal stent (LAMS) are being studied to facilitate gastric emptying by keeping the pylorus open, offering potential alternatives for patients with refractory symptoms.

What other types of research exist?

Promising novel alternatives to Transpyloric Stenting with LAMS for gastroparesis patients include Gastric Per-Oral Endoscopic Pyloromyotomy (G-POEM), which involves endoscopic cutting of the pyloric muscle to improve gastric emptying, and the use of prokinetic agents like prucalopride and relamorelin, which enhance gastrointestinal motility. Additionally, advancements in gastric electrical stimulation (GES) devices, which deliver electrical pulses to stimulate gastric contractions, are also being explored as potential treatments.

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Transpyloric Stenting for Gastroparesis

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Patients with diabetic, idiopathic or post-surgical gastroparesis

Patients with confirmed diagnosis of gastroparesis via gastric emptying study (abnormal gastric emptying will be defined as ≥10 % residual activity at 4 h on a standardized nuclear medicine TC-99 m sulfur colloid solid-phase gastric emptying study)

Must not have

Patients with cirrhosis

Patients with prior history of gastroenteric anastomosis or any GI surgeries with pyloric involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 years

Summary

This trial tests if placing a special device in the stomach can help patients with severe stomach issues who don't respond to usual treatments. The device keeps the stomach opening clear to improve symptoms. If successful, it may indicate that a more permanent procedure could also work.

Who is the study for?

This trial is for adults over 18 with gastroparesis that hasn't improved with standard treatments or those who can't take them due to allergies. It's open to patients with diabetic, idiopathic, or post-surgical forms of the condition confirmed by a gastric emptying study. People can't join if they've had certain GI surgeries, cancer in the stomach area, are unstable for endoscopy procedures, have liver cirrhosis, are pregnant/breastfeeding, or have significant blood clotting issues.

What is being tested?

The study is testing whether placing a transpyloric stent (a type of tube) across the pylorus (the stomach's exit) predicts success for a later procedure called G-POEM in treating severe gastroparesis. Participants will be randomly assigned to receive either the actual stenting procedure or a sham (fake) procedure as part of this forward-looking research.

What are the potential side effects?

Potential side effects from transpyloric stenting may include discomfort at the stent site, risk of infection, bleeding during placement and possible migration or blockage caused by the stent. The severity and occurrence can vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I have gastroparesis due to diabetes, surgery, or an unknown cause.

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I have been diagnosed with gastroparesis through a gastric emptying study.

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I am over 18 with gastroparesis not improved by standard treatments or cannot use them due to allergies.

Exclusion Criteria

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

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I have cirrhosis.

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I have had stomach or intestine surgery that involved the pylorus.

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I have cancer in my stomach or esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical response will be assessed by the gastroparesis cardinal symptom index (GCSI) scores

Secondary study objectives

Adverse events

Age

BMI

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Transpyloric stentActive Control1 Intervention

In this group, patient's will be randomized to receive a transpyloric stent for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

Group II: ShamPlacebo Group1 Intervention

In this group, patient's will be randomized to sham for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

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

Common treatments for gastroparesis include pharmacologic agents like metoclopramide, which enhances gastric motility by stimulating muscle contractions in the stomach, and erythromycin, which mimics the action of motilin to promote gastric emptying. Endoscopic and surgical interventions, such as gastric per-oral endoscopic pyloromyotomy (G-POEM) and transpyloric stenting with lumen apposing metal stent (LAMS), aim to improve gastric emptying by addressing pyloric dysfunction. These procedures keep the pylorus open, allowing for better passage of stomach contents into the small intestine. This is crucial for gastroparesis patients as it helps alleviate symptoms like nausea, vomiting, and abdominal pain, thereby improving their quality of life.

A Systematic Review of the Therapeutic Role of Gastric Pacemakers in Adults With Gastroparesis.