POP Surgery for Gastroparesis in Diabetes
Palo Alto (17 mi)Overseen byMathew Allemang, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: The Cleveland Clinic
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.
What safety data is available for POP surgery in treating gastroparesis?The safety of POP surgery, also known as G-POEM or gastric per-oral endoscopic myotomy, has been evaluated in several studies. It is considered a feasible and effective procedure for refractory gastroparesis, though technically demanding. Studies have investigated its safety and feasibility, particularly after prior gastric electrical stimulation. A meta-analysis and systematic review have also been conducted to assess its safety and efficacy, indicating it is an emerging alternative treatment with ongoing research to standardize techniques and improve outcomes.13578
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.
Is Per-oral Pyloromyotomy (POP) a promising treatment for gastroparesis in diabetes?Yes, Per-oral Pyloromyotomy (POP) is a promising treatment for gastroparesis in diabetes. It has shown a high success rate in improving symptoms and gastric emptying, with studies reporting over 80% short-term success. POP is an innovative procedure that offers a less invasive alternative to traditional surgery, and it is gaining interest and expertise, especially in places like France.24679
What data supports the idea that POP Surgery for Gastroparesis in Diabetes is an effective treatment?The available research shows that POP Surgery, also known as G-POEM, is a promising treatment for gastroparesis, especially when other treatments like gastric electrical stimulation (GES) have not fully worked. One study mentions that POP has a short-term success rate of over 80%, which means most patients feel better after the procedure. Another study highlights that POP has fewer complications compared to a similar surgery called laparoscopic pyloromyotomy. This suggests that POP is not only effective but also safer for patients.15679
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
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.
I cannot or will not follow the study's requirements.
Treatment Details
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
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.
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.
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.
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.
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.
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.
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.
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.