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Research Article|Articles in Press

Real-World Evidence of Safety and Effectiveness of Barrett’s Endoscopic Therapy

Published:March 11, 2023DOI:https://doi.org/10.1016/j.gie.2023.03.009
Real-World Evidence of Safety and Effectiveness of Barrett’s Endoscopic Therapy
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      Abstract

      Background and Aims

      Real-world data on the adverse events and the survival benefit of Barrett’s endoscopic therapy (BET) is limited. We aim to examine the safety and effectiveness (survival benefit) of BET in patients with neoplastic Barrett’s esophagus (BE).

      Methods

      An electronic health record-based database (TriNetX) was utilized to select patients with BE with dysplasia and esophageal adenocarcinoma (EAC) from 2016 to 2020. Primary outcome was 3-year mortality among patients with high-grade dysplasia (HGD) or EAC who underwent BET versus two comparison cohorts: patients with HGD or EAC who had not undergone BET and patients with gastroesophageal reflux disease (GERD) but no BE/EAC. Secondary outcome was adverse events (esophageal perforation, upper gastrointestinal bleeding, chest pain, and esophageal stricture) following BET. 1:1 propensity score matching was performed to control for confounding variables.

      Results

      We identified 27,556 patients with BE and dysplasia, of which 5,295 underwent BET. Following propensity matching, patients with HGD and EAC who underwent BET had significantly lower 3-year mortality (HGD: RR=0.59, 95% CI 0.49-0.71; EAC: RR=0.53, 95% CI 0.44-0.65) compared with corresponding cohorts who did not undergo BET (p<0.001). There was no difference in median 3-year mortality between controls (GERD without BE/EAC) compared to patients with HGD (RR 1.04, 95% CI 0.84-1.27) who underwent BET. Finally, there was no difference in median 3-year mortality between patients who underwent BET compared to patients who underwent esophagectomy among both HGD (RR 0.67 [95% CI 0.39-1.14], p=.14) and EAC (RR 0.73 [95% CI 0.47-1.13], p=.14). Esophageal stricture was the most common adverse event (6.5%) following BET.

      Conclusions

      Real-world, population-based evidence from this large database shows that endoscopic therapy is safe and effective for BE patients. Endoscopic therapy is associated with a significantly lower 3-year mortality; however, it leads to esophageal strictures in 6.5% of treated patients.

      Keywords

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      Article info

      Publication history

      Accepted: March 8, 2023
      Received in revised form: March 7, 2023
      Received: October 9, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Author contributions:

      Ritu R. Singh: Planning the study, data collection, data analysis and interpretation, and drafting the manuscript.

      Madhav Desai: Concept, design, drafting the manuscript, critical review, approval.

      Michael Bourke: Manuscript, Critical review, approval

      Gary Falk: Critical review, approval

      Vani Konda: Critical review, approval

      Uzma Siddiqui: Critical review, approval

      Alessandro Repici: Critical review, approval

      Cesare Hassan: Critical review, approval

      Prateek Sharma: Concept, design, drafting the manuscript, critical review, approval.

      Financial Support: None

      Potential Competing Interests:

      Ritu R. Singh: None

      Madhav Desai: Grant Support – Intercept Pharma

      Michael Bourke: None

      Gary Falk: Research Funding – Lucid and Castle Biosciences; Consulting – CDx, Exact, Castle Biosciences, Lucid and Phathom

      Vani Konda

      Uzma Siddiqui: Consultant, speaker – Boston Scientific, Olympus, Medtronic, ConMed, Cook; Speaker – Ovesco, Pinnacle Biologics

      Alessandro Repici: None

      Cesare Hassan: None

      Prateek Sharma: Consultant for Boston Scientific, Olympus Inc; Grant support: US Endoscopy, Medtronics, Fujifilms, Ironwood, Cosmo pharmaceuticals, Erbe

      Identification

      DOI: https://doi.org/10.1016/j.gie.2023.03.009

      Copyright

      © 2023 by the American Society for Gastrointestinal Endoscopy

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