PERi-operative Selective Decontamination of the digestive tract to prevent severe infectious complications after Esophageal Resection - study protocol of the PERSuaDER-trial - 854 patients - evaluating perioperative SDD

Sep 30, 2026

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Perioperative selective decontamination of the digestive tract (SDD) is evaluated as a prophylactic antibiotic strategy to reduce severe postoperative infectious complications after esophageal resection. The protocol targets the presumed source of postoperative pneumonia: (micro-)aspiration of bacteria from the oropharyngeal and gastrointestinal tract, while preserving anaerobic protective microbiota. A multicenter randomized controlled pragmatic superiority trial enrolls 854 patients with primary resectable esophageal carcinoma. The intervention uses SDD oral liquids (amphotericin B plus colistin sulfate and tobramycin) starting 3 days preoperatively, with follow-up 30 days post-surgery.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages12

Reading Time30 min

AccessFree to download

Study protocol

Background

Methods

Intervention

Discussion

Trial registration

Keywords

Administrative information

Grootenhuis et al. Trials (2026) 27:16 [https://doi.org/10.1186/s13063-025-09311-w](https://doi.org/10.1186/s13063-025-09311-w) Trials STUDY PROTOCOL Open Access PERi-operative Selective Decontamination of the digestive tract to prevent severe infectious complications after Esophageal Resection: study protocol of the PERSuaDER-trial, a multicenter randomized controlled trial in patients with primary resectable esophageal carcinoma Justin G. A. Grootenhuis 1*† , Ward Seurs2,3†, Linda M. Garms 1, Marjan de Vries 1, Sander Ubels1,4, Henri C. van Werkhoven5, Camiel Rosman 1, Jeroen A. Schouten6,7,8, Bastiaan R. Klarenbeek 1 and Hans Van Veer2,3 Abstract Background Esophagectomy is a highly complex surgical procedure, and it is associated with significant morbidity and mortality. The postoperative complication rate is high, with pneumonia being the most common. These are thought to arise from (micro-)aspiration of bacteria residing in the oropharyngeal and gastrointestinal (GI) tract. Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic strategy aimed at preventing these infections. SDD decolonizes the oropharyngeal and GI tract from pathogenic aerobic gram-negative rods, fungi and yeasts, while anaerobic, protective microbiota are preserved. The PERSuaDER trial aims to evaluate whether perioperative SDD can reduce postoperative pneumonia after esophagectomy. Methods The PERSuaDER-trial is a randomized, controlled, open-label, superiority, multicenter, pragmatic, groupsequential trial aiming to include 854 patients with primary resectable esophageal carcinoma ((y)cT1-4a N0-3 M0) scheduled for transthoracic esophagectomy. The intervention group will receive SDD prophylaxis in addi tion to the standard care regimen. The SDD treatment comprises two oral liquids: an oral suspension containing amphotericin B and an oral solution containing both colistin sulfate and tobramycin. Participants are required to swallow the SDD suspension four times a day for 1 week, starting 3 days prior to the surgical procedure, with two doses on the day of surgery. All other aspects of care are identical to those provided to the control group (standard care without SDD) . Participants will be asked to keep a diary and fill out quality of life, medical consumption, †Justin G. A. Grootenhuis and Ward Seurs contributed equally to this work and are shared first authors. *Correspondence: Justin G. A. Grootenhuis [justin.grootenhuis@radboudumc.nl](justin.grootenhuis@radboudumc.nl) Full list of author information is available at the end of the article © The Author(s) 2026. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/.)[.](http://creativecommons.org/licenses/by/4.0/.) Grootenhuis etal. Trials (2026) 27:16 Page 2 of 12 and productivity cost questionnaires. Interim analyses will take place after 30% and 60% of the participants have completed follow-up of 30 days after surgery, and after completion or termination of the trial. Discussion It is hypothesized that the addition of SDD to the standard peri-operative care in esophageal cancer surgery will result in a

FAQs

What postoperative problem does the PERSuaDER trial aim to prevent?

The trial aims to reduce postoperative pneumonia and other postoperative infectious complications after esophagectomy for primary resectable esophageal carcinoma.

How does the SDD intervention work in the trial?

Participants receive two oral liquids: amphotericin B suspension and an oral solution containing colistin sulfate and tobramycin. The suspension is swallowed four times daily for one week, starting 3 days before surgery.

Who is eligible and what is the study design?

The trial is a randomized, controlled, open-label, superiority, multicenter pragmatic group-sequential study aiming to include 854 patients with primary resectable esophageal carcinoma scheduled for transthoracic esophagectomy.

Sep 30, 2026

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