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NCT Number: NCT05039424

Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms 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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 18-75
  • 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
  • Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
  • 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
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • 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
  • Be able to speak and read the English language.

Exclusion criteria

  • Active use of narcotic pain medication
  • 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)
  • Etiology of gastroparesis is post-surgical
  • Pregnancy or lactation
  • History of egg allergy
  • Prior surgical intervention of the stomach or gastric pylorus
  • Current parenteral nutrition
  • Uncontrolled coagulopathy (platelet count <50,000 and INR>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)

Treatment and study plan

Endoscopic per-oral pyloromyotomy (POP)

Procedure

Per-oral pyloromyotomy (POP), alternatively knows as gastric per-oral endoscopic myotomy (G-POEM), accomplishes longitudinal division of the pylorus using an endoscope. This procedure involves utilizing endoscopic electrosurgical knife to make an incision in the gastric mucosa and develop a submucosal tunnel to visualize the pyloric ring. The pyloric ring is divided longitudinally, and the mucosotomy incision is sealed with endoscopic clips.

Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption

Procedure

While under general anesthesia, a standard gastroscope is introduced and a diagnostic upper endoscopy is performed. The operator talks through the procedure steps as if completing POP. The gastroscope is withdrawn and the patient is extubated.

Primary outcomes

  1. Gastroparesis Cardinal Symptom Index (GCSI)

    Time frame: Baseline, 12 weeks post-procedure

    Change in Gastroparesis Cardinal Symptom Index (GCSI) at Baseline to 12 weeks post-procedure. Possible scores range from 0 (None) to 5 (Very Severe).

Secondary outcomes

  1. Gastric Emptying

    Time frame: Baseline, 12 weeks post-procedure

    Change in gastric emptying as measured by a standardized 4-hour solid scintigraphic gastric emptying study at Baseline to 12 weeks post-procedure

  2. 36-Item Short Form; Quality of Life Survey

    Time frame: Baseline,12 weeks post-procedure

    Change in 36-Item Short Form Survey (SF-36) score from Baseline to 12 weeks post-procedure. The weighted sums of responses to questions in the survey produce eight separate scales which are scored from 0-100, with zero indication maximum disability and one hundred indicating no disability in that domain.

Sponsors and collaborators

Lead sponsor

Matthew Allemang

Other

Collaborators

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

Registry information

Official study title

A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)

Acronym: EMPTIES

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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