Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

Gastroparesis Clinical Trial

Official title:

Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024709
• Other study ID #: 87RI18_0033
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a large multicenter retrospective French cohort conducted in seven French centers that had performed at least five G-POEM procedures at the end of 2017. All patients treated by G-POEM for refractory gastroparesis since April 30, 2014 (first case of GPOEM in France) in these seven centers were included in this study and followed until April 2019. The data were collected retrospectively regarding medical and technical data, and then prospectively for the following data, which were included in a database for each center and combined for analysis.

Gastric Cardinal Symptoms Index (GCSI) was used to evaluate symptoms and their severity. It applies a Likert scale ranging from 0 to 5 (5 being the highest score) for three subscales: satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of two items). The total GCSI score was the mean of the three subscales. A GCSI score ≥ 2.6 is considered moderate gastroparesis and ≥ 3 is considered severe.

Gastric emptying scintigraphy (GES) was used to confirm delayed gastric emptying, since it is considered the gold standard according to the American Society of Neurogastroenterology. Patients consume a radiolabeled meal, receive imaging at specific time-points to determine gastric retention. The exam is pathological when retention is > 90% after 1 hour, > 60% after 2 hours (H2), > 30% after 3 hours (H3), and > 10% after 4 hours (H4). All but one center performed the GES according to the US guidelines: that center performed a 3-hour GES with a local validation of a threshold of 30% retention at H3 to define delayed gastric emptying. A %H4 retention > 30% was defined as severe delayed gastric emptying.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• treatment by G-POEM during the study period,

• at least a 1-year follow-up, and

• GCSI evaluation before and 1 year after G-POEM.

Exclusion Criteria:

• missing GCSI before and/or 12 months after G-POEM,

• non-pathological GES before G-POEM: delayed gastric emptying was defined as t ½ > 113 min and %H4 retention > 10%, and

• loss to follow-up or death before 12 months

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Procedure:
• Gastric Peroral Endoscopic Myotomy
Creation by submucosal dissection of a tunnel in the gastric wall at the level of the antrum, then of a pyloric and antral myotomy, before closing the mucosal access by clips.

Locations

Country	Name	City	State
France	University Hospital	Lille
France	University Hospital	Limoges
France	Hospices Civiles Lyon	Lyon
France	University Hospital	Marseille
France	University Hospital	Nice
France	Cochin Hospital	Paris
France	University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (6)

Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20. — View Citation

Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13. — View Citation

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

Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotté P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12. — View Citation

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. — View Citation

Revicki DA, Camilleri M, Kuo B, Szarka LA, McCormack J, Parkman HP. Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD). Neurogastroenterol Motil. 2012 May;24(5):456-63, e215-6. doi: 10.1111/j.1365-2982.2012.01879.x. Epub 2012 Jan 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success of G-POEM	evaluate the clinical success at the 1-year follow-up, defined by a decrease in the GCSI score by at least 1 point compared to baseline.	1 year
Secondary	Incidence of adverse events of pylorotomy	analysis of adverse events during the two years following the pylorotomy (including perforation per-gesture, bleeding post-gesture). ASGE lexicon will be used to grade these adverse events	2 years
Secondary	Clinical success of G-POEM	evaluate the clinical success at the 1-year follow-up, defined by a decrease in the Gastroparesis Cardinal Symptoms Index score by at least 1 point compared to baseline. GCSI is a Likert scale ranging from 0 to 5 (5 being the worst score) for three subscales: satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of two items). The total GCSI score was the mean of the three subscales. A GCSI score = 2.6 is considered moderate gastroparesis and = 3 is considered severe.	2 years
Secondary	Delayed gastric emptying after the procedure	Gastric emptying scintigraphy (GES) was used to confirm delayed gastric emptying, since it is considered the gold standard according to the American Society of Neurogastroenterology. Patients consume a radiolabeled meal, receive imaging at specific time-points to determine gastric retention. The exam is pathological when retention is > 90% after 1 hour, > 60% after 2 hours (H2), > 30% after 3 hours (H3), and > 10% after 4 hours (H4). Percent retention at 2hours and 4hours will be compared before and after the procedure.	2 years