A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis

NCT04869670 | Terminated Results

• 2 other identifiers: 21-001928R01DK125680
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.

Conditions

Gastroparesis

Keywords

Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

Outcome Measures

Primary Outcomes (1)

• GCSI-DD Change

  The effect of GPOEM on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. ANMS GCSI-DD evaluates five core symptoms: nausea, bloating, upper abdominal pain, stomach fullness and inability to finish a meal. Each symptom is rated 0-4 with 0= none, 1= mild, 2= moderate, 3= severe, and 4= very severe. The five responses are summed and divided by the number of responses completed to compute a total mean score range from 0-4, with higher scores indicating worse symptoms.

  Baseline to 48 weeks post treatment

Secondary Outcomes (1)

• Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale

  Baseline to 48 weeks post treatment

Study Arms (2)

G-POEM

EXPERIMENTAL

Procedure: Gastric peroral endoscopic myotomy.

Sham procedure

SHAM COMPARATOR

Procedure: Sham Gastric peroral endoscopic myotomy.

Interventions

Gastric peroral endoscopic myotomy. PROCEDURE

Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.

G-POEM

Sham Gastric peroral endoscopic myotomy. PROCEDURE

Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.

Sham procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
• Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
• Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
• Moderate to severe delay in gastric emptying, defined as \> 25% solid retained at 4 hours or \> 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
• No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.

You may not qualify if:

• Another active disorder which could explain symptoms in the opinion of the investigator.
• Gastric retention of solids at 4 hours \< 25% or \< 75% at 2 hours.
• Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
• Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
• Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
• New medications for gastroparesis-related symptoms started within 1 month prior to registration.
• Pregnancy or nursing.
• Failure to give informed consent.
• Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
• Botox injection into the pylorus within 3 months prior to registration.
• Allergy to eggs or Egg Beaters and Ensure.

Sponsors & Collaborators

• Mayo Clinic: lead
• Johns Hopkins University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated early due to an inability to recruit patients for the sham component of the study.

Results Point of Contact

• Title: Dr. Jay Pasricha
• Organization: Mayo Clinic

Pasricha.Jay@mayo.edu

4803014679

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 3, 2021
• Study Start: July 12, 2023
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)