ENDOSCOPIC FULL-THICKNESS PLICATION FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED, SHAM-CONTROLLED TRIALS

Document Type

Conference Proceeding

Publication Date

6-1-2024

Publication Title

Gastrointest Endosc

Abstract

Introduction: The management of gastroesophageal reflux disease (GERD) has witnessed a surge in interest regarding the utilization of endoscopic anti-reflux techniques as alternatives to surgery. Endoscopic full-thickness plication (EFTP) is a procedure involving transmural sutures at the gastro-esophageal junction to alter the anatomy of the gastric cardia, thereby enhancing the valvular mechanism and leading to a reduction in gastro-esophageal reflux. Previous investigations have demonstrated the effectiveness of EFTP when compared to alternative techniques such as radiofrequency treatment, endoscopic polymer implantation (Enteryx), and laparoscopic fundoplication. Objective: The objective of our study is to elucidate the efficacy of EFTP compared to a sham procedure by synthesizing data from available studies. Notably, no systematic review or meta-analysis of pooled data from existing studies is currently present in the literature. Methods: A systematic review of multiple electronic databases up to November 2023 identified studies comparing EFTP with sham procedures. Primary outcomes included total reflux episodes, percent time of esophageal pH less than 4.0, and DeMeester Score. Clinical success was defined as a significant reduction in total reflux episodes, subjective improvement in the symptoms of GERD (using GERD- HRQL questionnaire) and DeMeester Score. Random effects meta-analytic models were employed to calculate pooled proportions. Results: The final analysis incorporated three studies involving 289 patients with GERD. Of these, 143 patients in the intervention group underwent EFTP, while 146 in the control group underwent a sham procedure. The mean age of patients in the intervention group was 42.98 (SD=11.24), and in the control group, it was 42.60 (SD=11.03). Pooled analysis revealed a significant decrease in total reflux episodes post-EFTP with a mean difference of -43.78 (CI: -83.91, -3.65) (P = 0.03). Furthermore, a pooled analysis from two studies indicated a significant number of subjects reporting more than 50% improvement in GERD-HRQL score with an Odds Ratio of 15.81 (CI: 1.40, 178.71) (P = 0.03) in the EFTP group. However, the analysis confirmed that the mean difference (MD) of DeMeester Score (-12.57, CI: -35.12, 9.98, P=0.27) and that of the percentage of time with esophageal pH less than 4 (MD = -7.49, CI: -20.19, 5.20, P = 0.25) were not statistically significant. Conclusion: In summary, EFTP demonstrates effectiveness in reducing total reflux episodes and improving symptoms related to heartburn, as evidenced by improvements in GERD-HRQL, when compared to sham procedures. However, no significant changes were observed in other parameters, such as DeMeester score and median percentage of time with pH less than 4. Further studies with increased statistical power are warranted to explore the non-significant outcomes of this analysis. [Formula presented] Figure 1. Comparison of the outcomes including Total reflux episodes and % time esophageal pH in EFTP cohort vs Sham procedure Cohort. [Formula presented] Figure 2. Comparison of the outcomes including Mean DeMeester Score and Number of people with >50% improvement on GERD-HRQL in 3 month in EFTP cohort vs Sham procedure Cohort.

Volume

99

Issue

6

First Page

AB154

Last Page

AB155

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