POP Surgery for Gastroparesis in Diabetes
Recruiting in Palo Alto (17 mi)
Overseen byMathew Allemang, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Disqualifiers: Under 18, Insulin pumps, CGM, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
13467How 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.
12589Eligibility 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 am 18 years old or older.
+1 more
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.
+3 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Endoscopic Per-Oral Pyloromyotomy (POP)Experimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic FoundationCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
Matthew AllemangLead Sponsor
Society of American Gastrointestinal and Endoscopic SurgeonsCollaborator
References
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.
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.
Gastric per-oral endoscopic myotomy with antropyloromyotomy in the treatment of refractory gastroparesis: clinical experience with follow-up and scintigraphic evaluation (with video). [2017]Gastroparesis is a chronic, debilitating condition. We report an experience conducting gastric per-oral endoscopic pyloromyotomy (G-POEM) with objectives to assess clinical efficacy, gastric emptying evolution, and procedural adverse events.
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.
Outcomes and Future Directions of Per-Oral Endoscopic Pyloromyotomy: A View from France. [2019]Gastroparesis is a challenging functional gastroenterological disorder, the complex pathophysiology of which hampers development of therapeutic modalities. Per-oral pyloromyotomy (POP) is a promising endoscopic therapy with a short-term clinical success rate of greater than 80%. Interest in POP is increasing, particularly in France, a country in which there is considerable expertise in submucosal endoscopy and functional disorders. Long-term follow-up and pyloric function evaluation are needed to assess the efficacy of POP in gastroparetic patients.
Gastric per-oral endoscopic myotomy for refractory gastroparesis: a detailed description of the procedure, our experience, and review of the literature. [2019]Gastric per-oral endoscopic myotomy (G-POEM) was introduced four years ago as an investigational procedure for refractory gastroparesis. The safety and efficacy were currently evaluated. With our recent studies on G-POEM, we share our experience and knowledge through the discussion of a detailed description of the procedure and review of the literature. To our knowledge, this is the first systemic review on this new therapeutic endoscopic procedure.
Gastric per-Oral Endoscopic Myotomy for Refractory Gastroparesis: A Meta-Analysis. [2021]The emerging gastric per-oral endoscopic myotomy (G-POEM) is becoming an alternative treatment method for gastroparesis. This study aimed to evaluate the feasibility and safety of G-POEM for gastroparesis.
Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center. [2019]For patients with gastroparesis, temporary pyloric disruption has been shown to improve symptoms and gastric emptying. Per-oral pyloromyotomy (POP) is an innovative endoscopic procedure to divide the pylorus from within a submucosal tunnel, as a corollary to surgical pyloromyotomy. Here we evaluate subjective and objective outcomes 12-weeks after POP at a high volume center.
Per oral endoscopic pyloromyotomy for refractory gastroparesis: initial results from a single institution. [2018]Gastroparesis is a debilitating disease characterized by delayed gastric emptying in the absence of mechanical obstruction. A new intramural technique, per oral endoscopic pyloromyotomy (POP), has been proposed as an alternative to surgical pyloroplasty for the management of medical refractory gastroparesis. Herein, we detail the short-term results of POP at our institution.