Endoscopic Pyloromyotomy for Gastroparesis

(EMPTIES Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Matthew Allemang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Matthew Allemang

Must not be taking: Narcotics, Anticoagulants

Disqualifiers: Pregnancy, Egg allergy, Post-surgical gastroparesis, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively using narcotic pain medication or anticoagulant medications (except antiplatelet therapy).

What data supports the effectiveness of the treatment Endoscopic Pyloromyotomy for Gastroparesis?

Research shows that Gastric Peroral Endoscopic Myotomy (G-POEM), a type of endoscopic pyloromyotomy, is a promising and effective procedure for treating gastroparesis, especially when other treatments have failed. Studies indicate that it can improve symptoms in patients with gastroparesis, although more research is needed to standardize techniques and improve outcomes.

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Is endoscopic pyloromyotomy generally safe for humans?

Endoscopic pyloromyotomy, also known as G-POEM or POP, is considered a promising and feasible procedure for treating gastroparesis, with studies focusing on its safety and feasibility. While more research is needed to standardize techniques and improve outcomes, it is emerging as a safe option, especially for those who have not responded to other treatments.

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How is the treatment Endoscopic Per-oral Pyloromyotomy (POP) unique for gastroparesis?

Endoscopic Per-oral Pyloromyotomy (POP) is a novel treatment for gastroparesis that involves cutting the pyloric muscle using an endoscopic technique, which is less invasive than traditional surgical methods. This approach is unique because it allows for a minimally invasive procedure that can be performed endoscopically, potentially reducing recovery time and complications compared to laparoscopic surgery.

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Eligibility Criteria

This trial is for adults aged 18-75 with severe gastroparesis not improved by at least 6 months of medical treatment. Participants must be able to travel for assessments, take oral meds, follow dietary/medication regimens post-procedure, and use effective contraception if applicable. Excluded are those with post-surgical gastroparesis, pregnant or breastfeeding individuals, uncontrolled blood clotting issues, egg allergies, prior stomach surgeries or on parenteral nutrition.

Inclusion Criteria

I have completed evaluations by specialists for my gastroparesis.

Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen

For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Exclusion Criteria

I am receiving nutrition through an IV.

You are currently taking strong pain medication.

You have had an allergic reaction to eggs in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endoscopic per-oral pyloromyotomy (POP) or a sham diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption

12 weeks

1 visit (in-person) for procedure

Follow-up

Participants are monitored for changes in symptoms and gastric emptying

12 weeks

Regular follow-up visits (frequency not specified)

Open-label extension (optional)

Participants in the sham group may opt into endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic

Participant Groups

The study compares an endoscopic procedure called per-oral pyloromyotomy (POP), which cuts the muscle at the stomach exit to improve emptying against a sham intervention without this cut in patients with tough-to-treat gastroparesis.

Group I: Endoscopic per-oral pyloromyotomy (POP) Active Control 1 Intervention

Participants will undergo Endoscopic per-oral pyloromyotomy (POP).

Group II: Sham / Control Arm Placebo Group 2 Interventions

Participants will undergo a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. Following the 12-week blinded trial period, these participants will be unblinded and offered Endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic.

Endoscopic per-oral pyloromyotomy (POP) is already approved in United States, European Union, Japan for the following indications:

🇺🇸 Approved in United States as G-POEM/POP for:

• Medically refractory gastroparesis

🇪🇺 Approved in European Union as G-POEM/POP for:

• Medically refractory gastroparesis

🇯🇵 Approved in Japan as G-POEM/POP for:

• Medically refractory gastroparesis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic Foundation Cleveland, OH

Who Is Running the Clinical Trial?

Matthew Allemang Lead Sponsor

The Cleveland Clinic Lead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Collaborator

References

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

Technical Aspects of Peroral Endoscopic Pyloromyotomy. [2019] Gastric peroral endoscopic pyloromyotomy (G-POEM or POP) is a feasible and effective procedure for the treatment of refractory gastroparesis. G-POEM is a technically demanding endoscopic procedure. As of yet, there is no consensus on the technique. A variety of techniques have been reported in published studies. The essential technical steps of the procedure are (1) establishment of submucosal tunnel in gastric antrum, (2) identification of the pyloric muscular ring, (3) selective circular myotomy, and (4) a 2.5-cm to 3.0-cm length of myotomy. There are still some technical questions unanswered, and more studies are needed to establish standardized techniques and possible improvement of outcomes.

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

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve. [2023] Gastric peroral endoscopic pyloromyotomy (G-POEM) is a novel option for patients with gastroparesis. It involves submucosal tunneling across the pylorus, followed by pyloromyotomy, and subsequent closure of the endoscopic tunnel. The aim of this study was to determine the learning curve for G-POEM.

3. 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] For medically refractory diabetic or idiopathic gastroparesis, gastric electrical stimulation (GES) is an excellent option for symptom control; however, a small subset of patients may develop recurrent or persistent symptoms. Per-oral pyloromyotomy (POP, also described by some authors as gastric per-oral endoscopic myotomy or G-POEM) is an emerging therapy for medically refractory gastroparesis. This study investigated the safety and feasibility of POP after previous GES for recurrent or persistent gastroparesis.

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

Outcomes of per oral endoscopic pyloromyotomy in gastroparesis worldwide. [2020] Per oral endoscopic pyloromyotomy (POP), also known as gastric per-oral endoscopic myotomy (GPOEM), is a novel procedure with promising potential for the treatment of gastroparesis. As more data emerge and the procedure is becoming more recognized in clinical practice, its safety and efficacy need to be carefully evaluated. Appropriate patient selection for favorable clinical success prediction after GPOEM also needs additional research. This review aims to systemically summarize the existing data on clinical outcomes of POP. Symptomatologic responses to the procedure, its adverse effects, procedural techniques, and predictive factors of clinical success are also discussed.

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

Gastric Per Oral Endoscopic Myotomy (G-POEM) for the Treatment of Refractory Gastroparesis: Early Experience. [2018] Gastric per oral endoscopic myotomy (G-POEM) of the pylorus is a technique that is recently being used to treat gastroparesis. Our aim was to report our experience in performing G-POEM for refractory gastroparesis of different etiologies and determine symptom improvement.

6. 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] Per-oral endoscopic pyloromyotomy (POP) is a promising new therapy in the treatment of gastroparesis, where the pyloric muscle is cut using an endoscopic tunneling technique. This study was designed to report outcomes from our initial experience and compare the rate of complications to the laparoscopic equivalent using the American College of Surgeons (ACS) risk calculator.