Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial
NCT ID: NCT05039424
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2022-02-23
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Endoscopic per-oral pyloromyotomy (POP)
Participants will undergo Endoscopic per-oral pyloromyotomy (POP).
Endoscopic per-oral pyloromyotomy (POP)
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.
Sham / Control Arm
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.
Endoscopic per-oral pyloromyotomy (POP)
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.
Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption
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 The gastroscope is withdrawn and the patient is extubated.
Interventions
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Endoscopic per-oral pyloromyotomy (POP)
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.
Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
4. Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
5. 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
6. Stated willingness to comply with all study procedures and availability for the duration of the study
7. 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
8. Be able to speak and read the English language.
Exclusion Criteria
2. 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)
3. Etiology of gastroparesis is post-surgical
4. Pregnancy or lactation
5. History of egg allergy
6. Prior surgical intervention of the stomach or gastric pylorus
7. Current parenteral nutrition
8. Uncontrolled coagulopathy (platelet count \<50,000 and INR\>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Matthew Allemang
OTHER
Responsible Party
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Matthew Allemang
Principal Investigator
Principal Investigators
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Matthew Allemang, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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References
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McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010 Nov;8(11):947-54; quiz e116. doi: 10.1016/j.cgh.2010.05.020. Epub 2010 Jun 9.
Hasler WL. Gastroparesis: symptoms, evaluation, and treatment. Gastroenterol Clin North Am. 2007 Sep;36(3):619-47, ix. doi: 10.1016/j.gtc.2007.07.004.
Wang YR, Fisher RS, Parkman HP. Gastroparesis-related hospitalizations in the United States: trends, characteristics, and outcomes, 1995-2004. Am J Gastroenterol. 2008 Feb;103(2):313-22. doi: 10.1111/j.1572-0241.2007.01658.x. Epub 2007 Nov 28.
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Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Gastroparesis Cardinal Symptom Index (GCSI): development and validation of a patient reported assessment of severity of gastroparesis symptoms. Qual Life Res. 2004 May;13(4):833-44. doi: 10.1023/B:QURE.0000021689.86296.e4.
Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x.
Abell TL, Bernstein RK, Cutts T, Farrugia G, Forster J, Hasler WL, McCallum RW, Olden KW, Parkman HP, Parrish CR, Pasricha PJ, Prather CM, Soffer EE, Twillman R, Vinik AI. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006 Apr;18(4):263-83. doi: 10.1111/j.1365-2982.2006.00760.x.
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Toro JP, Lytle NW, Patel AD, Davis SS Jr, Christie JA, Waring JP, Sweeney JF, Lin E. Efficacy of laparoscopic pyloroplasty for the treatment of gastroparesis. J Am Coll Surg. 2014 Apr;218(4):652-60. doi: 10.1016/j.jamcollsurg.2013.12.024. Epub 2013 Dec 24.
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Lebares C, Swanstrom LL. Per-Oral Pyloromyotomy (POP): An Emerging Application of Submucosal Tunneling for the Treatment of Refractory Gastroparesis. Gastrointest Endosc Clin N Am. 2016 Apr;26(2):257-270. doi: 10.1016/j.giec.2015.12.012.
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.
Rodriguez JH, Haskins IN, Strong AT, Plescia RL, Allemang MT, Butler RS, Cline MS, El-Hayek K, Ponsky JL, Kroh MD. Per oral endoscopic pyloromyotomy for refractory gastroparesis: initial results from a single institution. Surg Endosc. 2017 Dec;31(12):5381-5388. doi: 10.1007/s00464-017-5619-5. Epub 2017 May 31.
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McCallum RW, Sarosiek I, Parkman HP, Snape W, Brody F, Wo J, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil. 2013 Oct;25(10):815-e636. doi: 10.1111/nmo.12185. Epub 2013 Jul 29.
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Other Identifiers
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20-160
Identifier Type: -
Identifier Source: org_study_id
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