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Schuitenmaker JM, van Hoeij FB, Schijven MP, et al. Pneumatic dilation for persistent dysphagia after antireflux surgery, a multicentre single-blind randomised sham-controlled clinical trial. Gut. 2021;71(1):10-15doi: 10.1136/gutjnl-2020-322355.
Schuitenmaker, J. M., van Hoeij, F. B., Schijven, M. P., Tack, J., Conchillo, J. M., Hazebroek, E. J., Smout, A. J. P. M., & Bredenoord, A. J. (2022). Pneumatic dilation for persistent dysphagia after antireflux surgery, a multicentre single-blind randomised sham-controlled clinical trial. Gut, 71(1), 10-15. https://doi.org/10.1136/gutjnl-2020-322355
Schuitenmaker, Jeroen M, et al. "Pneumatic dilation for persistent dysphagia after antireflux surgery, a multicentre single-blind randomised sham-controlled clinical trial." Gut vol. 71,1 (2022): 10-15. doi: https://doi.org/10.1136/gutjnl-2020-322355
Schuitenmaker JM, van Hoeij FB, Schijven MP, Tack J, Conchillo JM, Hazebroek EJ, Smout AJPM, Bredenoord AJ. Pneumatic dilation for persistent dysphagia after antireflux surgery, a multicentre single-blind randomised sham-controlled clinical trial. Gut. 2022 Jan;71(1):10-15. doi: 10.1136/gutjnl-2020-322355. Epub 2021 Jan 15. PMID: 33452179.
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Gut. 2022 Jan;71(1):10-15. doi: 10.1136/gutjnl-2020-322355. Epub 2021 Jan 15.

Pneumatic dilation for persistent dysphagia after antireflux surgery, a multicentre single-blind randomised sham-controlled clinical trial.

Gut

Jeroen M Schuitenmaker, Froukje B van Hoeij, Marlies P Schijven, Jan Tack, José M Conchillo, Eric J Hazebroek, André J P M Smout, Albert J Bredenoord

Affiliations

  1. Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC Location AMC, Amsterdam, The Netherlands [email protected].
  2. Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC Location AMC, Amsterdam, The Netherlands.
  3. Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC Location AMC, Amsterdam, The Netherlands.
  4. Department of Gastroenterology and Hepatology, KU Leuven University Hospitals, Leuven, Belgium.
  5. Department of Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, The Netherlands.
  6. Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.

PMID: 33452179 DOI: 10.1136/gutjnl-2020-322355

Abstract

OBJECTIVE: There is no evidence-based treatment for persistent dysphagia after laparoscopic fundoplication. The aim of this study was to evaluate the effect of pneumatic dilation on persistent dysphagia after laparoscopic fundoplication.

DESIGN: We performed a multicentre, single-blind, randomised sham-controlled trial of patients with persistent dysphagia (>3 months) after laparoscopic fundoplication. Patients with an Eckardt symptom score ≥4 were randomly assigned to pneumatic dilation (PD) using a 35 mm balloon or sham dilation. Primary outcome was treatment success, defined as an Eckardt score <4 and a minimal reduction of 2 points in the Eckardt score after 30 days. Secondary outcomes included change in stasis on timed barium oesophagogram, change in high-resolution manometry parameters and questionnaires on quality of life, reflux and dysphagia symptoms.

RESULTS: Forty-two patients were randomised. In the intention-to-treat analysis, the success rates of PD (7/21 patients (33%)) and sham dilation (8/21 patients (38%)) were similar after 30 days (risk difference -4.7% (95% CI (-33.7% to 24.2%) p=0.747). There was no significant difference in change of stasis on the timed barium oesophagogram after 2 min (PD vs sham: median 0.0 cm, p25-p75 range 0.0-4.3 cm vs median 0.0 cm, p25-p75 range 0.0-0.0; p=0.122) or change in lower oesophageal sphincter relaxation pressure (PD vs sham: 10.54±6.25 vs 14.60±6.17 mm Hg; p=0.052). Quality of life, reflux and dysphagia symptoms were not significantly different between the two groups.

CONCLUSION: Pneumatic dilation with a 35 mm balloon is not superior to sham dilation for the treatment of persistent dysphagia after fundoplication.

© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: anti-reflux surgery; dysphagia; gastro-esophageal reflux disease; lower oesophageal sphincter

Conflict of interest statement

Competing interests: JT received grant support from Sofar, received consulting fees from Ironwood and received speaker fees from Truvion. AJB received grant support from Bayer, Norgine, Nutricia, SST,

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