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CC BY 4.0 · Endoscopy 2023; 55(08): 689-698
DOI: 10.1055/a-2040-4042
Original article

Endoscopic full-thickness plication for the treatment of gastroesophageal reflux after peroral endoscopic myotomy: a randomized sham-controlled study

Amit Maydeo 
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
,
Gaurav Patil
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
,
Nagesh Kamat 
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
,
Ankit Dalal 
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
,
Amol Vadgaonkar
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
,
Sanil Parekh
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
,
Rajen Daftary
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
,
Sehajad Vora
1   Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
› Author AffiliationsTrial Registration: Clinical Trials Registry India Registration number (trial ID): CTRI/2019/06/019819 Type of study: Prospective, Randomized Sham Controlled study
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Referred to by:

Author commentary on Amit Maydeo et al.Endoscopy 2023; 55(08): v21-v21
DOI: 10.1055/a-2046-3043

Referred to by:

Stapling peroral endoscopic myotomy over Heller?Endoscopy 2023; 55(08): 699-700
DOI: 10.1055/a-2073-3702

Abstract

Background Endoscopic full-thickness plication (EFTP) has shown promising results in gastroesophageal reflux disease (GERD), but its efficacy in GERD after peroral endoscopic myotomy (POEM) is unclear.

Methods In a prospective, randomized trial of post-POEM patients dependent on proton pump inhibitors (PPIs) for documented GERD, patients underwent EFTP (plication to remodel the gastroesophageal flap valve) or an endoscopic sham procedure (positioning of the EFTP device, but no stapling). The primary end point was improvement in acid exposure time (AET) < 6 % (3 months). Secondary end points included improvement in esophagitis (3 months), GERD Questionnaire (GERDQ) score (3 and 6 months), and PPI usage (6 months).

Results 60 patients were randomized (30 in each group). At 3 months, a significantly higher proportion of patients achieved improvement in AET < 6 % in the EFTP group compared with the sham group (69.0 % [95 %CI 52.1–85.8] vs. 10.3 % [95 %CI 0–21.4], respectively). EFTP was statistically superior to sham (within-group analysis) in improving esophageal AET, DeMeester Score, and all reflux episodes (P < 0.001). A nonsignificant improvement in esophagitis was noted in the EFTP group (P = 0.14). Median GERDQ scores (3 months) were significantly better (P < 0.001) in the EFTP group, and the same trend continued at 6 months. A higher proportion of patients in the sham group continued to use PPIs (72.4 % [95 %CI 56.1–88.7] vs. 27.6 % [95 %CI 11.3–43.8]). There were no major adverse events in either group.

Conclusion EFTP improved post-POEM GERD symptoms, 24-hour pH impedance findings with normalization in one-third, and reduced PPI usage at 6 months.

Tables 1 s–6 s, Figs. 1 s–3 s, Appendix 1 s



Publication History

Received: 05 September 2022

Accepted after revision: 01 February 2023

Article published online:
21 March 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
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