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Randomized controlled trial of intravenous sedation vs general anesthesia for esophageal dilation with percutaneous endoscopic gastrostomy in esophageal cancer patients

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Abstract

Background

Esophageal squamous cell cancer (ESCC) is mostly diagnosed in its later stages, when patients present with dysphagia and weight loss. Esophageal dilation with percutaneous endoscopic gastrostomy (PEG) is a common surgical procedure in patients with locally advanced ESCC because of tumor obstruction and enteral nutrition support during neoadjuvant or definitive concurrent chemoradiotherapy (CCRT). Esophageal dilation with PEG is widely performed under general anesthesia (GA) with endotracheal intubation.

Aim of the study

To determine the overall success rate of completing this procedure using intravenous (IV) sedation with dexmedetomidine (DEX) relative to GA and to compare its perioperative conditions, including procedure times, pain scores (visual analog scale), adverse events, and costs.

Settings

Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Thailand.

Patients and methods

Prospective randomized controlled trial (RCT) of locally advanced ESCC patients who had dysphagia and needed esophageal dilation with PEG between January 2020 and December 2021. Esophageal dilation (using a Savary-Gilliard dilator) and PEG were performed using the pull technique.

Results

Seventy patients were randomly assigned to either the DEX group (n = 34) or the GA group (n = 36). All patients in both groups underwent successful surgery. The DEX group had a significantly shorter procedure time, lower procedure cost, and lower total hospital cost than the GA group. However, there were no significant between-group differences in pain scores or length of hospital stay. There were no serious adverse events in either group; however, the GA group had some incidences of sore throat, transient hoarseness, and atelectasis.

Conclusion

This study found that IV sedation with DEX during esophageal dilation with PEG was as effective and safe as using GA.

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Acknowledgements

We would like to thank Dr. Alan Geater and Ms. Walaluk Jitpiboon, Department of Epidemiology, for the statistical analysis. Mr. David Patterson, International Affairs Unit, Faculty of Medicine, Prince of Songkla University, reviewed the manuscript.

Funding

This project was funded by the Faculty of Medicine, Prince of Songkla University, Thailand, PSU 61–368-10–1 grant to S.S.

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Authors

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Correspondence to Somkiat Sunpaweravong.

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Disclosures

The authors: Dr. SS, Dr. PB, Dr. OK, Dr. KY, Dr. SR, Dr. SL, and Ms. OC: declare no conflicts of interest or financial ties to disclose.

Ethical approval

This study was performed in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all patients. IRB approval was obtained from the Faculty of Medicine, Prince of Songkla University Review Board (REC.61–368-10–1). The trial was registered with the University Hospital Medical Information Network UMIN Clinical Trials Registry (UMIN000038996). The study was conducted according to the CONSORT 2010 guidelines and checklists.

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Sunpaweravong, S., Benjhawaleemas, P., Karnjanawanichkul, O. et al. Randomized controlled trial of intravenous sedation vs general anesthesia for esophageal dilation with percutaneous endoscopic gastrostomy in esophageal cancer patients. Surg Endosc 37, 5109–5113 (2023). https://doi.org/10.1007/s00464-023-09984-x

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  • DOI: https://doi.org/10.1007/s00464-023-09984-x

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