POP Surgery for Gastroparesis in Diabetes

Overseen By Deanne Nash, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Under 18, Insulin pumps, CGM, 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: 3

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure called per-oral pyloromyotomy (POP) to determine if it can help people with diabetes better manage their blood sugar levels. It targets individuals with difficult-to-treat gastroparesis, a condition where the stomach empties slowly, causing digestion issues. Those who have had diabetes and gastroparesis for a while and struggle with high blood sugar (HbA1c over 7.5%) might be suitable candidates. The trial will measure changes in symptoms and diabetes management before and after the procedure. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for challenging conditions.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that per-oral pyloromyotomy (POP) is safe for patients with gastroparesis?

Research has shown that per-oral pyloromyotomy (POP) is generally safe for individuals with gastroparesis. Studies have found that patients typically tolerate this procedure well. For instance, a study involving multiple centers found that most patients experienced significant symptom relief without major side effects. While some patients reported mild discomfort, serious complications were rare. Another review highlighted that POP has promising long-term results, although further research is needed to confirm this.

In summary, current evidence suggests that POP is a safe option for those with gastroparesis unresponsive to other treatments. It is important to discuss any concerns with a doctor to ensure it is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for gastroparesis, which often include dietary changes, medications like metoclopramide, or even gastric electrical stimulation, Per-oral Pyloromyotomy (POP) offers a novel approach. This endoscopic technique directly targets the pylorus, the stomach's exit valve, by cutting its muscle to improve gastric emptying. Researchers are excited about POP because it could offer a minimally invasive solution that directly addresses the physical blockage causing symptoms, potentially leading to more effective relief and better diabetes management for patients with medically refractory gastroparesis.

What evidence suggests that per-oral pyloromyotomy (POP) might be an effective treatment for gastroparesis in diabetes?

Studies have shown that per-oral pyloromyotomy (POP) effectively treats gastroparesis, especially when other treatments fail. This trial will evaluate the effectiveness of the POP procedure. Research indicates that POP improves symptoms and accelerates stomach emptying. In one study, about 50% of patients reported feeling better six months after the procedure. Long-term results demonstrate that many patients continue to benefit from POP for at least three years. Overall, POP is considered a promising option for managing gastroparesis in individuals with diabetes. ^{1 2 4 5 6}

Who Is on the Research Team?

Mathew Allemang, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with diabetes and gastroparesis, confirmed by specific stomach emptying tests. They must have struggled to control their blood sugar levels, with an average HbA1c above 7.5% in the past three months, and be willing to follow all study procedures.

Inclusion Criteria

Patients are able to complete all study requirements

My average blood sugar level has been high over the past 3 months.

I have been diagnosed with gastroparesis confirmed by a special stomach emptying test.

Exclusion Criteria

I am under 18 years old.

My average blood sugar level has been below 7.5% over the last 3 months.

I cannot or will not wear a CGM sensor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Monitoring

Participants undergo a 10-day period of continuous glucose monitoring (CGM) one month prior to the procedure

1 month

1 visit (in-person)

Treatment

Participants undergo Endoscopic Per-Oral Pyloromyotomy (POP) for medically refractory gastroparesis

1 day

1 visit (in-person)

Post-Treatment Monitoring

Participants undergo a 10-day period of continuous glucose monitoring (CGM) six months after the procedure

6 months

1 visit (in-person)

Follow-up

Participants are monitored for changes in glycemic control and symptom improvement using GCSI and DSMQ scores

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Per-oral Pyloromyotomy (POP)

Trial Overview The trial is testing whether a procedure called per-oral pyloromyotomy (POP), which involves cutting muscles at the stomach's exit to ease food passage, can improve blood sugar control in patients with difficult-to-treat gastroparesis.

How Is the Trial Designed?

Group I: Endoscopic Per-Oral Pyloromyotomy (POP) Experimental Treatment 1 Intervention

The study cohort will include 40 patients with a HbA1c \>7.5% with medically refractory gastroparesis who are scheduled to undergo POP. Each patient will undergo two 10-day periods of CGM at an interval of approximately seven months, one month prior to the procedure and six months after. Symptoms and diabetes management improvement will be measured by the Gastroparesis Cardinal Symptom Index (GCSI) scores and the Diabetes Self-Management Questionnaire (DSMQ).

Per-oral Pyloromyotomy (POP) is already approved in United States, European Union for the following indications:

Approved in United States as G-POEM for:

• Medically refractory gastroparesis

Approved in European Union as G-POEM for:

• Severe gastroparesis
• Diabetic gastroparesis
• Idiopathic gastroparesis
• Postsurgical gastroparesis

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Matthew Allemang

Lead Sponsor

Trials

2

Recruited

140+

Society of American Gastrointestinal and Endoscopic Surgeons

Collaborator

Trials

10

Recruited

660+

Published Research Related to This Trial

Gastric peroral endoscopic pyloromyotomy (G-POEM) is an effective treatment for refractory gastroparesis, demonstrating feasibility in clinical practice.

The procedure involves several key technical steps, but there is currently no standardized technique, indicating a need for further research to optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Aspects of Peroral Endoscopic Pyloromyotomy. Tao, J., Patel, V., Mekaroonkamol, P., et al.[2019]

Gastric per-oral endoscopic pyloromyotomy (G-POEM) was successfully performed on 12 patients with refractory gastroparesis, achieving a 100% technical success rate and significant improvements in symptoms as measured by the Gastroparesis Cardinal Symptoms Index (GCSI).

The procedure demonstrated promising efficacy, with 85% of patients showing clinical improvement and 75% achieving normalized gastric emptying, while no adverse events were reported, indicating G-POEM is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric per-oral endoscopic myotomy with antropyloromyotomy in the treatment of refractory gastroparesis: clinical experience with follow-up and scintigraphic evaluation (with video). Gonzalez, JM., Lestelle, V., Benezech, A., et al.[2017]

Per-oral pyloromyotomy (POP) is an emerging endoscopic treatment for gastroparesis, showing a short-term clinical success rate of over 80%, indicating its potential effectiveness.

There is a growing interest in POP, especially in France, but further long-term studies and evaluations of pyloric function are necessary to fully understand its efficacy in treating gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Future Directions of Per-Oral Endoscopic Pyloromyotomy: A View from France. Jacques, J., Legros, R., Monteil, J., et al.[2019]

In a study of 11 patients undergoing per-oral endoscopic pyloromyotomy (POP) for gastroparesis, 86% showed normal gastric emptying three months post-surgery, indicating effective treatment.

POP demonstrated significantly lower complication rates and shorter hospital stays compared to the laparoscopic equivalent, with no complications observed in the POP group versus a predicted 10.05% for laparoscopic pyloromyotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Per-oral Pyloromyotomy for Gastroparesis: Initial Experience and Postoperative Comparison to Predicted Complications Following Laparoscopic Pyloromyotomy as Calculated by the ACS Risk Calculator. Ward, MA., Hasan, SS., Whitfield, EP., et al.[2021]

In a study of 47 patients with medically refractory gastroparesis, the per oral endoscopic pyloromyotomy (POP) procedure significantly reduced gastric retention from an average of 37% to 20% after 3 months, indicating improved gastric emptying.

Patients also reported a significant decrease in symptoms, with the Gastroparesis Cardinal Symptom Index (GCSI) score improving from an average of 4.6 to 3.3 post-procedure, demonstrating POP's efficacy in symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Per oral endoscopic pyloromyotomy for refractory gastroparesis: initial results from a single institution. Rodriguez, JH., Haskins, IN., Strong, AT., et al.[2018]

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 per-oral endoscopic myotomy (G-POEM) has been found to be a feasible and safe treatment for gastroparesis, with a clinical response rate of 84% based on an analysis of 272 patients from 8 studies.

The procedure showed significant improvements in gastric emptying scores, with a pooled adverse event rate of only 12%, suggesting it could be considered a first-line therapy for certain patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric per-Oral Endoscopic Myotomy for Refractory Gastroparesis: A Meta-Analysis. Li, P., Ma, B., Gong, S., et al.[2021]

Per-oral pyloromyotomy (POP) is a safe and feasible treatment for patients experiencing recurrent symptoms of gastroparesis after gastric electrical stimulation (GES), with no complications reported in the study of 22 patients.

Patients showed significant improvement in symptoms, as measured by the Gastroparesis Cardinal Symptom Index, with an average reduction of 1.63 points, and 7 out of 11 patients had normal gastric motility or emptying studies post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Per-Oral Pyloromyotomy as Augmentative Therapy after Prior Gastric Electrical Stimulation for Gastroparesis. Strong, AT., Rodriguez, J., Kroh, M., et al.[2020]

In a study of 100 patients with gastroparesis, the innovative procedure called per-oral pyloromyotomy (POP) led to significant improvements in symptoms and gastric emptying, with a notable reduction in the Gastroparesis Cardinal Symptom Index (GCSI) score from 3.82 to 2.54 (P < 0.001).

78% of patients showed better gastric emptying after the procedure, with 57% achieving normal gastric emptying, indicating that POP is an effective organ-sparing treatment option for those with medically refractory gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center. Rodriguez, J., Strong, AT., Haskins, IN., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7297609/

Peroral endoscopic pyloromyotomy for gastroparesis Conclusion This meta-analysis demonstrates that G-POEM is effective and shows promising outcomes in the clinical response and gastric emptying scintigraphy for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S221074012400202X

Efficacy of gastric per-oral endoscopic myotomy remains ... G-POEM is safe and remains effective after GES or previous pyloric treatment failure, with 50% efficacy at 6 months.

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

AGA Clinical Practice Update on Gastric Peroral ... G-POEM, also called peroral endoscopic pyloromyotomy, should be considered for patients with medically refractory gastroparesis. G-POEM has been ...

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

Long-term outcomes (≥3 years) after gastric peroral ... G-POEM has a durable long-term clinical success rate. Further studies are needed to identify patient selection factors that will enhance its clinical success.

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

Efficacy and safety of gastric peroral endoscopic myotomy ... Our primary outcome was clinical success based on etiology, with an additional subgroup analysis on Gastroparesis Cardinal Symptom Index (GCSI) ...

6. 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.