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A randomized control trial of G-POEM for gastroparesis to assess feasibility, safety, efficacy and physiological mechanisms

Award Number: R01DK125680
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT Gastroparesis is defined as a gastrointestinal motility disorder with objectively delayed gastric emptying of solids in the absence of mechanical obstruction, associated with upper gastrointestinal symptoms including early satiety, postprandial fullness, nausea, vomiting, bloating, and upper abdominal pain. The pathophysiology of gastroparesis includes postprandial antral hypomotility and pylorospasm, which may reflect extrinsic (vagal) denervation, enteric (intrinsic) neuropathy involving excitatory or inhibitory neurons or electrical syncytium (such as interstitial cells of Cajal) which may result from imbalance of CD206-positive macrophages that protect these intrinsic mechanisms. The introduction of G-POEM involving endoscopic pyloromyotomy has focused attention on pyloric dysfunction as a potentially important factor in the pathogenesis of this syndrome. However, many unknowns remain. First, the reported trials are uncontrolled with results that are short-term and inconsistent so the true efficacy of this procedure is not clear. Second, given that it is unlikely that G-POEM is a panacea for all patients, it is important to determine which of several possible factors influence outcome e.g. etiology (specifically diabetic versus idiopathic gastroparesis); demographic factors (age, BMI, psychological factors, duration of illness), baseline severity of gastric retention; gastric dysrhythmia, pyloric distensibility or scarring (as measured by EndoFLIP), postprandial antral motility and “isolated” pylorospasm (tonic elevation of baseline pressure independent of antral contractions). Our general hypothesis is that G-POEM is efficacious in relieving some or all symptoms of gastroparesis and that efficacy differs according to diagnosis, baseline retardation of gastric emptying, antropyloroduodenal motility and pyloric sphincter diameter and compliance. We will examine this hypothesis in a controlled short- term study that will inform future, more definitive trials on G-POEM on the optimal patient selection and outcome criteria. The aims of this pilot and feasibility, hypothesis-generating study are: Aim 1: To evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with drug-refractory gastroparesis, as measured by validated questionnaires and to perform a pilot analysis of factors predictive of the outcome including demographics, etiology, vagal dysfunction, in vivo gastric physiology, (emptying of solids, postprandial antral motility, gastric dysrhythmia and pyloric motor functions). Aim 2. To compare the long-term (1 year or more) outcomes in patients randomized to G-POEM with matched patients prospectively followed in the national Gastroparesis registry run by the Gastroparesis Clinical Research Consortium (GpCRC). .


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $518,756 )
2024	2024	MAYO CLINIC ARIZONA	13400 E SHEA BLVD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	004	4	6/10/2024	NON-COMPETING CONTINUATION	$518,756
2024	2023	MAYO CLINIC ARIZONA	13400 E SHEA BLVD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	3	2/20/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$596,104
2024	2023	MAYO CLINIC ARIZONA	13400 E SHEA BLVD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	10/19/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2022	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	2/20/2024	NON-COMPETING CONTINUATION	-$593,950
2024	2021	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	2/20/2024	NEW	-$2,154
														Subtotal = $518,756

Issue Date FY: 2023 ( Subtotal = $510,733 )
2023	2023	MAYO CLINIC ARIZONA	13400 E SHEA BLVD	SCOTTSDALE	AZ	85259	MARICOPA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	8/24/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$510,733
2023	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/24/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $510,733

Issue Date FY: 2022 ( Subtotal = $593,950 )
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	5/25/2022	NON-COMPETING CONTINUATION	$593,950
2022	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/4/2022	NEW	$0
														Subtotal = $593,950

Issue Date FY: 2021 ( Subtotal = $606,350 )
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/2/2021	NEW	$606,350
														Subtotal = $606,350

Grand Total All Awards = $2,229,789

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A randomized control trial of G-POEM for gastroparesis to assess feasibility, safety, efficacy and physiological mechanisms

Award Number: R01DK125680

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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