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

Trial Summary

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 data supports the effectiveness of the treatment Per-oral Pyloromyotomy (POP) for gastroparesis in diabetes?

Research shows that Per-oral Pyloromyotomy (POP) is a promising treatment for gastroparesis, with studies reporting a short-term clinical success rate of over 80%. It is considered safe and feasible, especially for patients who have not responded to other treatments. ^{1 2 3 4 5}

Is POP surgery safe for humans?

Research shows that POP surgery, also known as G-POEM, is generally considered safe for treating gastroparesis, with studies focusing on its safety and feasibility. However, as with any medical procedure, there may be risks, and more studies are needed to standardize techniques and improve outcomes. ^{1 3 4 6 7}

How is the treatment Per-oral Pyloromyotomy (POP) different from other treatments for gastroparesis?

Per-oral Pyloromyotomy (POP) is a unique treatment for gastroparesis because it involves an endoscopic procedure where the pyloric muscle is cut from within using a tunneling technique, unlike traditional surgical methods. This minimally invasive approach offers a promising alternative for patients who do not respond to other treatments, with a high short-term success rate. ^{1 2 5 8 9}

What is the purpose of this trial?

This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.

Research Team

Mathew Allemang, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

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

Safety and Feasibility of Per-Oral Pyloromyotomy as Augmentative Therapy after Prior Gastric Electrical Stimulation for Gastroparesis. [2020]

2. United States 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. [2021]

3. United States 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). [2017]

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

Technical Aspects of Peroral Endoscopic Pyloromyotomy. [2019]

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

Outcomes and Future Directions of Per-Oral Endoscopic Pyloromyotomy: A View from France. [2019]

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

Gastric per-Oral Endoscopic Myotomy for Refractory Gastroparesis: A Meta-Analysis. [2021]

8. United States 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. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Per oral endoscopic pyloromyotomy for refractory gastroparesis: initial results from a single institution. [2018]