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

Primary Purpose

Gastroparesis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric peroral endoscopic myotomy.
Sham Gastric peroral endoscopic myotomy.
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 with mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 2.3
  • Refractory gastroparesis, defined using our previously published data, as a failure to improve by at least 1 point on the GCSI scale over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants ((5-hydroxytryptamine receptor antagonists (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. Gastric emptying scintigraphy will be performed within 6 months of registration.
  • No evidence of mechanical obstruction based on upper GI endoscopy or barium series within 2 years of registration

Exclusion Criteria:

  • Another active disorder which could explain symptoms in the opinion of the investigator
  • Gastric retention of solids at 4 hours < 25%
  • Ongoing use of prokinetic agents (e.g. metoclopramide, erythromycin, prucalopride) or drugs that slow down gastric emptying (tricyclic antidepressants, anti-cholinergic agents and narcotics)
  • Significant systemic illness such as chronic renal failure or liver disease as defined by Child-Pugh score of 10 or greater
  • Poorly controlled diabetes with hemoglobin A1c (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

Sites / Locations

  • Mayo Clinic ArizonaRecruiting
  • Johns Hopkins Bayview Medical Center
  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

G-POEM

Sham procedure

Arm Description

Outcomes

Primary Outcome Measures

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. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours.

Secondary Outcome Measures

Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
The effect of GPOEM on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QOL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL).

Full Information

First Posted
April 22, 2021
Last Updated
August 3, 2023
Sponsor
Mayo Clinic
Collaborators
Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04869670
Brief Title
A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis
Official Title
A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-POEM
Arm Type
Experimental
Arm Title
Sham procedure
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Gastric peroral endoscopic myotomy.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Gastric peroral endoscopic myotomy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
GCSI-DD change
Description
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. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours.
Time Frame
Baseline to 48 weeks post treatment
Secondary Outcome Measure Information:
Title
Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
Description
The effect of GPOEM on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QOL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL).
Time Frame
Baseline to 48 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Busciglio
Phone
507-266-6615
Email
Busciglio.irene@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Barahona
Phone
480-301-4238
Email
Barahona.Guillermo@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Camilleri, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Barahona
Phone
480-301-4238
Email
Barahona.Guillermo@mayo.edu
First Name & Middle Initial & Last Name & Degree
Pankaj J Pasricha, MBBS, MD
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Eckert, RN
Phone
507-538-5860
Email
Eckert.Deborah@mayo.edu
First Name & Middle Initial & Last Name & Degree
Michael Camilleri, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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