Gastric Mapping for Gastroparesis

Overseen By Marita Salame, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Pregnant, Breast-feeding, Spinal injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Body Surface Gastric Mapping can identify which patients with gastroparesis—a condition that slows or stops food movement from the stomach—would benefit from G-POEM (Gastric Peroral Endoscopic Myotomy). The trial will explore how this mapping can improve treatment for those with gastroparesis symptoms. Suitable candidates for this trial are those already considered for the G-POEM procedure and who do not have severe skin allergies or spinal cord-related gastroparesis. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for gastroparesis.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that Body Surface Gastric Mapping is safe for patients with gastroparesis?

Research has shown that G-POEM, a procedure for treating gastroparesis, is generally safe. Studies indicate it effectively reduces symptoms over the long term. In a follow-up lasting four years, about 77.5% of patients reported positive results. Although about 13% of patients experience a return of symptoms each year, the procedure is usually well-tolerated. A wide range of studies supports its safety and effectiveness, regardless of the cause of gastroparesis. Many people benefit from G-POEM, though larger studies are needed to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Gastric Mapping for Gastroparesis because it offers a new way to understand and treat this challenging condition. Unlike current treatments like dietary changes, medications, and surgical options that often focus on symptom management, this technique uses Body Surface Gastric Mapping to provide detailed insights into gastric muscle activity. This approach could lead to more targeted and effective treatments by pinpointing the precise areas of the stomach that are malfunctioning. By mapping gastric activity, doctors hope to better tailor treatments, potentially improving outcomes for people with gastroparesis.

What evidence suggests that Body Surface Gastric Mapping is effective for gastroparesis?

Research shows that G-POEM, a procedure involving small cuts in the stomach muscle, effectively treats gastroparesis, a condition that slows stomach emptying. Studies found that about 98.6% of patients experienced successful results, even when other treatments failed. After four years, 77.5% of patients continued to do well, though some experienced a return of symptoms each year. G-POEM effectively addresses various causes of gastroparesis, including diabetes, past surgeries, or unknown reasons. Overall, G-POEM has proven to be a safe and long-lasting option for people with this challenging condition.

In this trial, participants will undergo Body Surface Gastric Mapping, an experimental approach, to further understand and evaluate the effectiveness of treatments like G-POEM for gastroparesis. ^{1 2 4 6 7}

Who Is on the Research Team?

Mohammad Al-Haddad, MD

Principal Investigator

Indiana Unversity/Indiana University Health

Are You a Good Fit for This Trial?

This trial is for individuals with gastroparesis, a condition where the stomach empties too slowly. Participants should be candidates for or have had a G-POEM procedure. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am considered a candidate for the G-Poem procedure at this hospital.

Exclusion Criteria

Pregnant or breast-feeding

I have a drain or tube placed in my abdomen.

I have gastroparesis because of a spinal cord injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo Body Surface Gastric Mapping (BSGM) and other baseline assessments prior to G-POEM procedure

1 week

1 visit (in-person)

Treatment

Participants undergo the G-POEM procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in BSGM measures, symptoms, and quality of life at 3 and 6 months post-G-POEM

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• G-POEM

Trial Overview The study is testing if Body Surface Gastric Mapping, a non-invasive test, can predict who will benefit from G-POEM (a procedure to help food leave the stomach faster) and monitor its success in patients with gastroparesis.

How Is the Trial Designed?

Group I: Body Surface Gastric Mapping Experimental Treatment 1 Intervention

G-POEM is already approved in United States, European Union for the following indications:

Approved in United States as G-POEM for:

• Gastroparesis

Approved in European Union as G-POEM for:

• Gastroparesis

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Gastric peroral endoscopic pyloromyotomy (G-POEM) is a promising treatment for gastroparesis, showing a significant reduction in symptoms and gastric emptying times in a study of 36 patients over 15 months.

The study found that the procedure time decreased significantly with experience, reaching an average of 60.5 minutes by the 18th case, indicating a learning curve that improves efficiency for endoscopists performing G-POEM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve. Reja, M., Mishra, A., Tyberg, A., et al.[2023]

Gastric peroral endoscopic myotomy (G-POEM) shows a clinical success rate of 75.8% for treating refractory gastroparesis, which is comparable to the 77.3% success rate of surgical pyloroplasty, based on the Gastroparesis Cardinal Symptom Index (GCSI) score.

The study found that factors like idiopathic gastroparesis and previous treatments with botulinum toxin or gastric stimulators may positively predict the success of G-POEM, indicating its potential effectiveness in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. Mohan, BP., Chandan, S., Jha, LK., et al.[2021]

In a randomized trial involving 41 patients with severe gastroparesis, G-POEM (endoscopic pyloromyotomy) demonstrated a treatment success rate of 71%, significantly higher than the 22% success rate in the sham group, indicating its efficacy in symptom relief.

G-POEM also led to a notable reduction in gastric retention from 22% to 12% at 4 hours, showcasing its effectiveness in improving gastric emptying compared to no change in the sham group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial. Martinek, J., Hustak, R., Mares, J., et al.[2022]

Gastric per-oral endoscopic myotomy (G-POEM) demonstrated a 100% technical success rate in treating refractory gastroparesis among 235 patients, significantly improving symptoms as measured by the Gastroparesis Cardinal Symptom Index (GCSI) and gastric emptying times.

The procedure had a relatively low complication rate of 5.1% during the procedure and 6.8% post-procedure, with complications being manageable, indicating that G-POEM is a safe option for patients with refractory gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric per-oral endoscopic myotomy (G-POEM) is a promising treatment for refractory gastroparesis: a systematic review and meta-analysis. Yan, J., Tan, Y., Zhou, B., et al.[2021]

Gastric peroral endoscopic pyloromyotomy (G-POEM) demonstrated a mid-term clinical success rate of 69% at 6 months for treating refractory gastroparesis, with significant improvements in symptoms as measured by the Gastroparesis Cardinal Symptoms Index (GCSI).

The procedure was technically successful in all 29 patients, with a low complication rate (only two minor complications), indicating that G-POEM is a safe and reproducible treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. Gonzalez, JM., Benezech, A., Vitton, V., et al.[2018]

Gastric peroral endoscopic myotomy (G-POEM) is a safe procedure for treating refractory gastroparesis, with 14% of patients experiencing adverse events (AEs), mostly mild and manageable.

The likelihood of experiencing AEs is significantly lower for endoscopists who have performed more than 20 G-POEM procedures, highlighting the importance of experience in reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study. Ichkhanian, Y., Vosoughi, K., Aghaie Meybodi, M., et al.[2021]

Gastric per-oral endoscopic myotomy (G-POEM) is a safe and effective procedure for treating refractory gastroparesis, with 70-80% of patients experiencing significant symptom improvement and enhanced quality of life within six months after the procedure.

This systematic review highlights that G-POEM shows promising results based on early data, but further well-designed studies are needed to fully evaluate its long-term efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric per-oral endoscopic myotomy for refractory gastroparesis: a detailed description of the procedure, our experience, and review of the literature. Li, L., Spandorfer, R., Qu, C., et al.[2019]

A 31-year-old female patient with severe refractory gastroparesis underwent a second gastric peroral endoscopic myotomy (G-POEM) after the first procedure failed to improve her condition, demonstrating the feasibility of repeated G-POEM in such cases.

The second G-POEM led to significant clinical improvement and better gastric emptying, suggesting that repeated procedures may be beneficial for patients with persistent pylorospasm, although the reasons for the initial failure remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful repeated gastric peroral endoscopic myotomy (re-G-POEM) in the treatment of postsurgical gastroparesis. Dražilová, D., Vacková, Z., Husťak, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10052481/

Gastric peroral endoscopic pyloromyotomy (G-POEM) in ... Three studies showed that at the 4-year follow-up, the response to G-POEM was durable, but there was a yearly recurrence rate of 13% or more.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949708623000821

Long-term outcomes (≥3 years) after gastric peroral ... We found that G-POEM is an effective long-term treatment option for patients with refractory gastroparesis, with technical and clinical success rates of 98.6% ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(23)00212-3/fulltext

AGA Clinical Practice Update on Gastric Peroral ... One hundred and two patients completed 48 months of follow-up and the clinical success rate at 4 years was 77.5%. Patients with diabetic ...

4. giejournal.org giejournal.org/article/S0016-5107(24)03461-8/abstract

Efficacy and safety of gastric peroral endoscopic myotomy ... Based on this meta-analysis, G-POEM is effective and safe for treating refractory gastroparesis irrespective of the etiology, with significant ...

5. gastro.org gastro.org/clinical-guidance/update-on-gastric-peroral-endoscopic-myotomy-g-poem-for-gastroparesis/

Update on gastric peroral endoscopic myotomy (G-POEM ... G-POEM has been found to be efficacious in treating patients with gastroparesis from diabetes, prior surgery and idiopathic causes.

6. igiejournal.org igiejournal.org/article/S2949-7086(23)00082-1/fulltext

Long-term outcomes (≥3 years) after gastric peroral ... The primary outcome was clinical success 3 years after G-POEM. Secondary outcomes included changes in Gastroparesis Cardinal Symptom Index score ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000296102500025X

Long term outcomes of gastric per oral endoscopic ... G-POEM is a safe procedure that shows promising long-term outcomes for gastroparesis symptom relief. Larger studies with more complete follow-up are needed.