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

Trial Summary

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 data supports the idea that Gastric Mapping for Gastroparesis is an effective treatment?

The available research shows that Gastric Mapping for Gastroparesis, also known as G-POEM, is considered a promising treatment for people with severe and hard-to-treat gastroparesis. Several studies highlight its potential benefits. For instance, a systematic review and meta-analysis found it to be effective and safe for treating this condition. Additionally, a pilot trial described it as a minimally invasive option with positive results. Although still experimental, these studies suggest that G-POEM could be a valuable alternative for those who do not respond well to other treatments. ^{1 2 3 4 5}

What safety data is available for G-POEM treatment?

Several studies have evaluated the safety of Gastric Peroral Endoscopic Myotomy (G-POEM) for treating refractory gastroparesis. An international multicenter study comprehensively analyzed adverse events associated with G-POEM, identifying predictive factors for these events. Additionally, a systematic review and meta-analysis assessed the safety and efficacy of G-POEM, comparing it to surgical pyloroplasty. These studies indicate that G-POEM is a promising and minimally invasive treatment option, though data on safety and efficacy are still being gathered. ^{1 2 6 7 8}

Is G-POEM a promising treatment for gastroparesis?

Yes, G-POEM is a promising treatment for gastroparesis. It is a new, minimally invasive technique that has shown potential in helping patients with this condition. Studies suggest it could be an effective option for those who haven't responded well to other treatments. ^{1 4 5 6 8}

What is the purpose of this trial?

The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms. the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis and/or G-POEM procedure.

Research Team

Mohammad Al-Haddad, MD

Principal Investigator

Indiana Unversity/Indiana University Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve. [2023]

2. Spain 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. [2018]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Successful repeated gastric peroral endoscopic myotomy (re-G-POEM) in the treatment of postsurgical gastroparesis. [2022]

6. Germany 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. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study. [2021]

8. Germany 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. [2021]