Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial (EMPTIES)

Matthew Allemang

Status: Active, not recruiting

Conditions: Gastroparesis

Treatments: Procedure: Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption; Procedure: Endoscopic per-oral pyloromyotomy (POP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05039424

20-160

5R01DK120830-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Endoscopic per-oral pyloromyotomy (POP)

Active Comparator group

Description:

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

Treatment:

Procedure: Endoscopic per-oral pyloromyotomy (POP)

Sham / Control Arm

Sham Comparator group

Description:

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.

Treatment:

Procedure: Endoscopic per-oral pyloromyotomy (POP)

Procedure: Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption