Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial

NCT05039424 | Active Not Recruiting DMC

• 2 other identifiers: 20-1605R01DK120830-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Gastroparesis Cardinal Symptom Index (GCSI)

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

  Baseline, 12 weeks post-procedure

Secondary Outcomes (2)

• Gastric Emptying

  Baseline, 12 weeks post-procedure

• 36-Item Short Form; Quality of Life Survey

  Baseline,12 weeks post-procedure

Study Arms (2)

Endoscopic per-oral pyloromyotomy (POP)

ACTIVE COMPARATOR

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

Procedure: Endoscopic per-oral pyloromyotomy (POP)

Sham / Control Arm

SHAM COMPARATOR

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.

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

Interventions

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.

Endoscopic per-oral pyloromyotomy (POP); Sham / Control Arm

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 The gastroscope is withdrawn and the patient is extubated.

Sham / Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Matthew Allemang: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (28)

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• Allemang MT, Strong AT, Haskins IN, Rodriguez J, Ponsky JL, Kroh M. How I Do It: Per-Oral Pyloromyotomy (POP). J Gastrointest Surg. 2017 Nov;21(11):1963-1968. doi: 10.1007/s11605-017-3510-2. Epub 2017 Jul 27.

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MeSH Terms

Conditions

Gastroparesis

Interventions

Pyloromyotomy; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures

Study Officials

• Matthew Allemang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 9, 2021
• Study Start: February 23, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)