Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial

Gastroparesis Clinical Trial

— EMPTIES  

Official title:

A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05039424
• Other study ID #: 20-160
• Secondary ID: 5R01DK120830-02
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: July 2026

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: Karim Kheniser
• Phone: 2164449941
• Email: khenisk[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female, aged 18-75

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:

1. Active use of narcotic pain medication

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)

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Matthew Allemang	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (28)

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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. — View Citation

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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. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	36-Item Short Form; Quality of Life Survey	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