Comparison of Outcomes for Single vs Double Pyloromyotomy for Gastroparesis Randomized Controlled Trial

NCT06173336 | Withdrawn

• 1 other identifier: 275425
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis. This will be a randomized controlled trial of all the patients who are referred to the University of Arkansas Medical Sciences (UAMS) for gastric peroral endoscopic pyloromyotomy (G-POEM) for treatment of refractory and severe gastroparesis. During G-POEM procedure, either single or double pyloromyotomy will be performed with randomization. The aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.

Conditions

Gastroparesis

Keywords

Gastric Per-Oral Endoscopic Myotomy (G-POEM)

Outcome Measures

Primary Outcomes (3)

• Clinical success at 3 months, 6 months and 12 months follow up

  Measuring clinical success

  3, 6 and 12 months

• Gastroparesis Cardinal Symptom Index (GCSI) score before and after GPOEM at 3, 6 months and 12 months follow up

  Measuring GCSI scores

  3, 6 and 12 months

• Technical success rate

  Measuring technical success

  At time of procedure

Secondary Outcomes (3)

• Total procedure time for each method

  At time of procedure

• Adverse events like pneumoperitoneum, gi bleeding, perforation, infection and abdominal pain

  0 and1 month

• Recurrence of symptoms

  3, 6 and 12 months

Study Arms (2)

Single pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM)

ACTIVE COMPARATOR

Single cut pyloromyotomy technique during gastric per-oral endoscopic myotomy (G-POEM) procedure

Procedure: gastric per-oral endoscopic myotomy (G-POEM)

Double pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM)

ACTIVE COMPARATOR

Double cut pyloromyotomy technique during gastric per-oral endoscopic myotomy (G-POEM) procedure

Procedure: gastric per-oral endoscopic myotomy (G-POEM)

Interventions

gastric per-oral endoscopic myotomy (G-POEM) PROCEDURE

Comparing single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.

Double pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM); Single pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with refractory (persistent symptoms for \>6 months refractory to medical therapy) and severe gastroparesis based on GCSI \> 2, with confirmed im-paired gastric emptying based on gastric emptying.
• Persons 18 years or older at the time of signing the informed consent

You may not qualify if:

• No previous attempt with at least one prokinetic drug.
• Previous gastric surgery.
• Esophageal or gastric varices and /or portal gastropathy.
• Pregnant patients.
• Malignant or pre-malignant gastric diseases.

Sponsors & Collaborators

• University of Arkansas: lead

Related Publications (11)

• Jung HK, Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Szarka LA, Mullan B, Talley NJ. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009 Apr;136(4):1225-33. doi: 10.1053/j.gastro.2008.12.047. Epub 2008 Dec 24.

  PMID: 19249393 RESULT

• Verga MC, Mazza S, Azzolini F, Cereatti F, Conti CB, Drago A, Soro S, Elvo B, Grassia R. Gastric per-oral endoscopic myotomy: Indications, technique, results and comparison with surgical approach. World J Gastrointest Surg. 2022 Jan 27;14(1):12-23. doi: 10.4240/wjgs.v14.i1.12.

  PMID: 35126859 RESULT

• Camilleri M, Chedid V, Ford AC, Haruma K, Horowitz M, Jones KL, Low PA, Park SY, Parkman HP, Stanghellini V. Gastroparesis. Nat Rev Dis Primers. 2018 Nov 1;4(1):41. doi: 10.1038/s41572-018-0038-z.

  PMID: 30385743 RESULT

• 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.

  PMID: 15129893 RESULT

• Lacy BE, Parkman HP, Camilleri M. Chronic nausea and vomiting: evaluation and treatment. Am J Gastroenterol. 2018 May;113(5):647-659. doi: 10.1038/s41395-018-0039-2. Epub 2018 Mar 15.

  PMID: 29545633 RESULT

• Hirsch W, Nee J, Ballou S, Petersen T, Friedlander D, Lee HN, Cheng V, Lembo A. Emergency Department Burden of Gastroparesis in the United States, 2006 to 2013. J Clin Gastroenterol. 2019 Feb;53(2):109-113. doi: 10.1097/MCG.0000000000000972.

  PMID: 29256990 RESULT

• Rao AS, Camilleri M. Review article: metoclopramide and tardive dyskinesia. Aliment Pharmacol Ther. 2010 Jan;31(1):11-9. doi: 10.1111/j.1365-2036.2009.04189.x.

  PMID: 19886950 RESULT

• Ahuja NK, Clarke JO. Pyloric Therapies for Gastroparesis. Curr Treat Options Gastroenterol. 2017 Mar;15(1):230-240. doi: 10.1007/s11938-017-0124-4.

  PMID: 28124202 RESULT

• Aghaie Meybodi M, Qumseya BJ, Shakoor D, Lobner K, Vosoughi K, Ichkhanian Y, Khashab MA. Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis. Endosc Int Open. 2019 Mar;7(3):E322-E329. doi: 10.1055/a-0812-1458. Epub 2019 Feb 28.

  PMID: 30842971 RESULT

• Khashab MA, Stein E, Clarke JO, Saxena P, Kumbhari V, Chander Roland B, Kalloo AN, Stavropoulos S, Pasricha P, Inoue H. Gastric peroral endoscopic myotomy for refractory gastroparesis: first human endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2013 Nov;78(5):764-8. doi: 10.1016/j.gie.2013.07.019. No abstract available.

  PMID: 24120337 RESULT

• Abdelfatah MM, Li B, Kapil N, Noll A, Li L, Luo H, Chen H, Xia L, Chen X, Patel V, Mekaroonkamol P, Massaad J, Keilin S, Cai Q. Short-term outcomes of double versus single pyloromyotomy at peroral endoscopic pyloromyotomy in the treatment of gastroparesis (with video). Gastrointest Endosc. 2020 Sep;92(3):603-609. doi: 10.1016/j.gie.2020.01.016. Epub 2020 Jan 17.

  PMID: 31958460 RESULT

MeSH Terms

Conditions

Gastroparesis

Interventions

Pyloromyotomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy

Study Officials

• Sumant Inamdar, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: June 17, 2025
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share