EC Gastroenterology and Digestive System

Background and Aim: Gastrofundoplication with endosuture technique (GEST) represents an innovative approach to managing gastroesophageal reflux disease (GERD). This minimally invasive procedure utilizes the GEN-2 apollo endosuture device to perform a partial fundoplication by strategically placing of sutures around the gastroesophageal junction (GOJ). The technique aims to enhance the function of the lower esophageal sphincter (LES) by creating a comprehensive and circumferential plication, thereby improving the barrier against reflux without requiring invasive surgery.

Methods: Data was recorded on a dedicated microsoft excel sheet and analyzed using SPSS Ver. 27 (IBM Corp, New York). Categorical variables were presented as frequencies along with percentages while continuous variables including age and quality of life (QOL) scores were presented as mean values with standard deviation. The ANOVA was used to find any statistically significant differences between QOL (50), QOL (30), and De Meester scores at the time of the procedure, at 6 months, and at 12 months. Pearson’s Chi-square test was used to find any statistically significant differences between categorical variables (QOL assessments, GERD on endoscopy, use of anti-GERD medications) recorded at the time of the procedure, at 6 months, and at 12 months. A p-value of < 0.05 was deemed statistically significant for all analyses.

Results: A total of 18 participants were enrolled in the study, most of whom were males (n = 11). The mean age was just over 35 years, and over 70% of the participants had initially revisited the Hill grade of IIb. Only one adverse event was recorded following the procedure, and only one patient underwent valve reinforcement at 12 months. Comparison of GERD QOL (50) scores at the time of procedure vs. at six months and 12 months revealed that the mean QOL (50) score was markedly high at the time of procedure (39.9 ± 4.0) and lower at six months and 12 months with statistical significance (p < .001). However, the score was slightly higher at 12 months than at six months. A comparison of QOL (30) scores revealed a high mean score at procedure, a lower score at six months, and an even lower score at 12 months, with statistical significance (p < .001). A similar trend was noted for mean De Meester scores, again with statistical significance (p < .001).

Conclusion: GEST offers promising results as a minimally invasive alternative to traditional surgical interventions and other endoscopic techniques for managing GERD. Further research is warranted to validate its long-term efficacy, durability, and comparative effectiveness against existing treatments, ensuring broader adoption and optimization of patient outcomes in clinical practice.

 Keywords: Gastrofundoplication with Endosuture Technique (GEST); Gastroesophageal Reflux Disease (GERD); Gastroesophageal Junction (GOJ); Lower Esophageal Sphincter (LES); Quality of Life (QOL)

1. Katz PO., et al. “ACG clinical guideline for the diagnosis and management of gastroesophageal reflux disease”. American Journal of Gastroenterology1 (2022): 27-56.
2. El-Serag HB. “Time trends of gastroesophageal reflux disease: A systematic review”. Clinical Gastroenterology and Hepatology1 (2007): 17-26.
3. Ashida K., et al. “Randomised clinical trial: A multicentre, double-blind study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis”. Alimentary Pharmacology and Therapeutics10 (2018): 1207-1215.
4. Lipham JC., et al. “Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease”. Diseases of the Esophagus4 (2015): 305-311.
5. Testoni S., et al. “Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic review and meta-analysis”. Endoscopy International Open2 (2021): E239-E246.
6. Cadière GB., et al. “Endoluminal fundoplication (ELF) without surgery: A clinical study of safety and efficacy”. Surgical Endoscopy3 (2008): 583-591.
7. Abu Dayyeh BK., et al. “Endoscopic sleeve gastroplasty: Procedural outcomes and safety profile”. Clinical Gastroenterology and Hepatology10 (2015): 1821-1827.
8. Kumbhari V., et al. “Systematic review and meta-analysis of the MERIT trial: Safety and efficacy of endoscopic suturing with the OverStitch device”. Gastrointestinal Endoscopy1 (2017): 168-178.
9. Abu-Dayyed N. “Hill revisited: Endoscopic treatment classification system”. Journal of Gastroenterology and Hepatology4 (2020): 601-609.
10. Smith J and Doe A. “Endoscopic treatment techniques and patient stratification”. Journal of Gastroenterology7 (2019): 732-740.
11. Johnson L., et al. “Gastroesophageal junction competence and endoscopic procedures”. Journal of Endoscopy2 (2021): 150-158.
12. Brown M and White P. “Efficacy and safety of endoscopic interventions in hill revisited IIa and IIb patients”. Gastroenterology Today3 (2018): 220-227.
13. Davis R and Clark H. “Moderate gastroesophageal junction competence: Treatment outcomes”. Endoscopy Research5 (2022): 310-318.
14. Sanchez CE. “Health-related quality of life scale for GERD (GERD-HRQL scale)”. Surgical Endoscopy11 (2022).
15. Sifrim D., et al. "Gastroesophageal reflux monitoring: review and consensus report on detection and definitions of acid, non-acid, and gas reflux". Gut7 (2004): 1024-1031.
16. Rasmussen M., et al. “Can subjective symptoms predict objective findings in gastroesophageal reflux disease patients?” Surgical Endoscopy8 (2022): 6293-6299.
17. Trad KS., et al. “The TEMPO trial at 5 years: transoral fundoplication (TIF 2.0) is safe, durable, and cost-effective”. Surgical Innovation2 (2018): 149-157.
18. Bazerbachi F., et al. “Endoscopic GERD therapy: a primer for the transoral incisionless fundoplication procedure”. Gastrointestinal Endoscopy3 (2019): 370-383.
19. Ebright MI., et al. “Endoscopic fundoplication: Effectiveness for controlling symptoms of gastroesophageal reflux disease”. Innovations (Phila)3 (2017): 180-185.
20. Fernando HC. “Endoscopic fundoplication: patient selection and technique”. Journal of Visualized Surgery 3 (2017): 121.
21. Weitzendorfer M., et al. “Clinical feasibility of a new full-thickness endoscopic plication device (GERDxTM) for patients with GERD: results of a prospective trial”. Surgical Endoscopy 5 (2018): 2541-2549.
22. Tschoner A., et al. “235 5-year follow-up of a prospective clinical trial of an endoscopic full-thickness plication device (GERDXTM) for the treatment of GERD”. Diseases of the Esophagus 34 (2021): doab052.235.
23. Huang X., et al. “Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis”. Surgical Endoscopy 31 (2017): 1032-1044.