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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK120830-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.
A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic per-oral pyloromyotomy (POP) | Active Comparator | Participants will undergo Endoscopic per-oral pyloromyotomy (POP). |
|
| Sham / Control Arm | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic per-oral pyloromyotomy (POP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroparesis Cardinal Symptom Index (GCSI) | Change in Gastroparesis Cardinal Symptom Index (GCSI) at Baseline to 12 weeks post-procedure. Possible scores range from 0 (None) to 5 (Very Severe). | Baseline, 12 weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Emptying | Change in gastric emptying as measured by a standardized 4-hour solid scintigraphic gastric emptying study at Baseline to 12 weeks post-procedure | Baseline, 12 weeks post-procedure |
| 36-Item Short Form; Quality of Life Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Allemang, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17950441 | Background | 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. | |
| 18047541 | Background | 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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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D000074882 | Pyloromyotomy |
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D005743 | Gastrectomy |
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A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of POP vs. sham endoscopic surveillance in patients with medically refractory gastroparesis. This study will also include a crossover approach, offering POP to patients randomized to the sham arm, if they remain symptomatic at 12 weeks post randomization.
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| Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption | Procedure | 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. |
|
Change in 36-Item Short Form Survey (SF-36) score from Baseline to 12 weeks post-procedure. The weighted sums of responses to questions in the survey produce eight separate scales which are scored from 0-100, with zero indication maximum disability and one hundred indicating no disability in that domain.
| Baseline,12 weeks post-procedure |
| 28402773 | Background | Mayer-Davis EJ, Lawrence JM, Dabelea D, Divers J, Isom S, Dolan L, Imperatore G, Linder B, Marcovina S, Pettitt DJ, Pihoker C, Saydah S, Wagenknecht L; SEARCH for Diabetes in Youth Study. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Apr 13;376(15):1419-1429. doi: 10.1056/NEJMoa1610187. |
| 15129893 | Background | 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. |
| 12848636 | Background | 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. |
| 16553582 | Background | 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. |
| 28110376 | Background | Yu D, Ramsey FV, Norton WF, Norton N, Schneck S, Gaetano T, Parkman HP. The Burdens, Concerns, and Quality of Life of Patients with Gastroparesis. Dig Dis Sci. 2017 Apr;62(4):879-893. doi: 10.1007/s10620-017-4456-7. Epub 2017 Jan 21. |
| 27775961 | Background | Lacy BE, Crowell MD, Mathis C, Bauer D, Heinberg LJ. Gastroparesis: Quality of Life and Health Care Utilization. J Clin Gastroenterol. 2018 Jan;52(1):20-24. doi: 10.1097/MCG.0000000000000728. |
| 14572555 | Background | Jones MP, Maganti K. A systematic review of surgical therapy for gastroparesis. Am J Gastroenterol. 2003 Oct;98(10):2122-9. doi: 10.1111/j.1572-0241.2003.07721.x. |
| 26246804 | Background | Lal N, Livemore S, Dunne D, Khan I. Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterol Res Pract. 2015;2015:762972. doi: 10.1155/2015/762972. Epub 2015 Jul 12. |
| 15836452 | Background | Ramkumar D, Schulze KS. The pylorus. Neurogastroenterol Motil. 2005 Jun;17 Suppl 1:22-30. doi: 10.1111/j.1365-2982.2005.00664.x. |
| 3699409 | Background | Mearin F, Camilleri M, Malagelada JR. Pyloric dysfunction in diabetics with recurrent nausea and vomiting. Gastroenterology. 1986 Jun;90(6):1919-25. doi: 10.1016/0016-5085(86)90262-3. |
| 25667022 | Background | Koch KL, Calles-Escandon J. Diabetic gastroparesis. Gastroenterol Clin North Am. 2015 Mar;44(1):39-57. doi: 10.1016/j.gtc.2014.11.005. |
| 24529808 | Background | 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. |
| 21720926 | Background | Hibbard ML, Dunst CM, Swanstrom LL. Laparoscopic and endoscopic pyloroplasty for gastroparesis results in sustained symptom improvement. J Gastrointest Surg. 2011 Sep;15(9):1513-9. doi: 10.1007/s11605-011-1607-6. Epub 2011 Jul 1. |
| 27036896 | Background | 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. |
| 28752406 | Background | 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. |
| 28567693 | Background | 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. |
| 30004920 | Background | Rodriguez J, Strong AT, Haskins IN, Landreneau JP, Allemang MT, El-Hayek K, Villamere J, Tu C, Cline MS, Kroh M, Ponsky JL. Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center. Ann Surg. 2018 Sep;268(3):421-430. doi: 10.1097/SLA.0000000000002927. |
| 28275310 | Background | Woodhouse S, Hebbard G, Knowles SR. Psychological controversies in gastroparesis: A systematic review. World J Gastroenterol. 2017 Feb 21;23(7):1298-1309. doi: 10.3748/wjg.v23.i7.1298. |
| 9824125 | Background | Soykan I, Sivri B, Sarosiek I, Kiernan B, McCallum RW. Demography, clinical characteristics, psychological and abuse profiles, treatment, and long-term follow-up of patients with gastroparesis. Dig Dis Sci. 1998 Nov;43(11):2398-404. doi: 10.1023/a:1026665728213. |
| 17944739 | Background | Arts J, Holvoet L, Caenepeel P, Bisschops R, Sifrim D, Verbeke K, Janssens J, Tack J. Clinical trial: a randomized-controlled crossover study of intrapyloric injection of botulinum toxin in gastroparesis. Aliment Pharmacol Ther. 2007 Nov 1;26(9):1251-8. doi: 10.1111/j.1365-2036.2007.03467.x. |
| 20538073 | Background | 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. |
| 23895180 | Background | 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. |
| 28504312 | Background | Gonzalez JM, Benezech A, Vitton V, Barthet M. G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. Aliment Pharmacol Ther. 2017 Aug;46(3):364-370. doi: 10.1111/apt.14132. Epub 2017 May 15. |
| 26140897 | Background | Mancini SA, Angelo JL, Peckler Z, Philp FH, Farah KF. Pyloroplasty for Refractory Gastroparesis. Am Surg. 2015 Jul;81(7):738-46. |
| 27354102 | Background | Khashab MA, Ngamruengphong S, Carr-Locke D, Bapaye A, Benias PC, Serouya S, Dorwat S, Chaves DM, Artifon E, de Moura EG, Kumbhari V, Chavez YH, Bukhari M, Hajiyeva G, Ismail A, Chen YI, Chung H. Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2017 Jan;85(1):123-128. doi: 10.1016/j.gie.2016.06.048. Epub 2016 Jun 25. |
| 20304396 | Background | Gersin KS, Rothstein RI, Rosenthal RJ, Stefanidis D, Deal SE, Kuwada TS, Laycock W, Adrales G, Vassiliou M, Szomstein S, Heller S, Joyce AM, Heiss F, Nepomnayshy D. Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates. Gastrointest Endosc. 2010 May;71(6):976-82. doi: 10.1016/j.gie.2009.11.051. Epub 2010 Mar 20. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074433 | Myotomy |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |