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Per-Oral Pyloromyotomy (POP) in the treatment of medical refractory gastroparesis : A randomized, sham-controlled trial

Award Number: R01DK120830
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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PROJECT SUMMARY/ABSTRACT: Gastroparesis is a chronic, debilitating functional disorder of the stomach characterized by a delay in gastric emptying without evidence of mechanical obstruction. Classic etiologies of gastroparesis include idiopathic, post-surgical/iatrogenic, and diabetic. The incidence of gastroparesis is rapidly increasing coinciding with the diabetes epidemic in developed countries. Initial management of gastroparesis includes dietary modifications and prokinetic and/or antiemetic medications; however, these tend to lose efficacy over time and are often associated with intolerable side effects. Surgical therapy for gastroparesis is typically pursued once maximal medical therapy is no longer efficacious and may include gastric electrical stimulation, gastric bypass or subtotal gastrectomy in most cases. Disruption of the gastric pyloric sphincter (pyloroplasty, pyloromyotomy) has recently shown promise as a stomach-preserving option that does not involve the significant anatomical rearrangement required of gastrectomy. Per-oral pyloromyotomy (POP) is a novel endoscopic surgery that has shown promising utility for the management of medically refractory gastroparesis in several small single center studies. This intervention involves the division of the gastric pylorus via an endoscopic approach, accomplishing the same functional outcome of laparoscopic or open pyloromyotomy, without the invasiveness of open or laparoscopic surgery. Prior non-comparative retrospective studies have demonstrated both improvement of gastroparesis symptoms and improved gastric emptying. To date, there have been no prospective studies evaluating the efficacy of this procedure or comparisons to a control procedure. We aim to explore the utility of POP in producing symptomatic relief of gastroparesis-related symptoms as evaluated by validated scoring systems (Objective 1) and objective gastric emptying as measured by solid-phase scintigraphic gastric emptying studies (Objective 2). The proposed research is innovative in that it would additionally control for the placebo effect by blinding patients to receiving POP versus a sham intervention. This contribution would be significant as traditional gastroparesis therapies do not adequately address the clinical need, and supports the mission of the NIDDK to assess new therapeutic options in clinical trials. POP represents a potential intervention with far greater safety profile and less morbidity compared to other surgical modalities.


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 = $253,575 )
2024	2024	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE OF CASE WESTERN RESERVE UNIVERSITY	9500 EUCLID AVE.	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/26/2024	NON-COMPETING CONTINUATION	$253,575
														Subtotal = $253,575

Issue Date FY: 2023 ( Subtotal = $271,533 )
2023	2023	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE OF CASE WESTERN RESERVE UNIVERSITY	9500 EUCLID AVE.	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	4/10/2023	NON-COMPETING CONTINUATION	$271,533
														Subtotal = $271,533

Issue Date FY: 2022 ( Subtotal = $251,098 )
2022	2022	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	4/4/2022	NON-COMPETING CONTINUATION	$25,110
2022	2022	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	3/2/2022	NON-COMPETING CONTINUATION	$225,988
														Subtotal = $251,098

Issue Date FY: 2021 ( Subtotal = $251,098 )
2021	2021	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	4/9/2021	NON-COMPETING CONTINUATION	$251,098
2021	2020	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/22/2020	NEW	$0
														Subtotal = $251,098

Issue Date FY: 2020 ( Subtotal = $251,098 )
2020	2020	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/14/2020	NEW	$251,098
														Subtotal = $251,098

Grand Total All Awards = $1,278,402

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Per-Oral Pyloromyotomy (POP) in the treatment of medical refractory gastroparesis : A randomized, sham-controlled trial

Award Number: R01DK120830

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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