Clinical trial NCT05039424: Endoscopic Myotomy of the Pylorus to Improve Emptying and Symptoms Trial
Official title: A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus to Improve Emptying and Symptoms (EMPTIES)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroparesis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of POP vs. sham endoscopic surveillance in patients with medically refractory gastroparesis. This study will also include a crossover approach, offering POP to patients randomized to the sham arm, if they remain symptomatic at 12 weeks post randomization.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.

Eligibility criteria: Inclusion Criteria:

1. Male or female, aged 18-75
2. Diagnosis of medically refractory gastroparesis by 4 hour non-extrapolated solid phase gastric emptying study completed within 12 months of enrollment. Medical refractoriness is defined by at least 6 months of medical treatment with no significant improvement in baseline symptoms
3. Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
4. Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
5. 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
6. Stated willingness to comply with all study procedures and availability for the duration of the study
7. Willingness and reasonable expectation that the individual will be able to travel to the study site for the intervention and each scheduled in-person assessment, as well as virtual assessments if necessary
8. Be able to speak and read the English language.

Exclusion Criteria:

1. Active use of narcotic pain medication
2. Presence of concomitant gastrointestinal transit disorder such as small bowel dysmotility or uncontrolled colonic dysmotility (As defined by clinical judgement or \< 3 bowel movements per week)
3. Etiology of gastroparesis is post-surgical
4. Pregnancy or lactation
5. History of egg allergy
6. Prior surgical intervention of the stomach or gastric pylorus
7. Current parenteral nutrition
8. Uncontrolled coagulopathy (platelet count \<50,000 and INR\>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)

Primary outcomes:
measure: Gastroparesis Cardinal Symptom Index (GCSI)
timeFrame: Baseline, 12 weeks post-procedure
Secondary outcomes:
measure: Gastric Emptying
timeFrame: Baseline, 12 weeks post-procedure
measure: 36-Item Short Form; Quality of Life Survey
timeFrame: Baseline,12 weeks post-procedure
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Matthew Allemang, MD
role: PRINCIPAL_INVESTIGATOR
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