Perioperative SDD to Prevent Infectious Complications After Esophagectomy

NCT05865743 | Recruiting Phase 3 DMC

• 1 other identifier: 2023-504144-33-00
• Study Type: interventional
• Target: 854
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• the cumulative incidence of postoperative pneumonia within 30 days after surgery

  The primary outcome parameter is the cumulative incidence of postoperative pneumonia within 30 days after surgery. Pneumonia will be defined by the following criteria: * Positive sputum culture OR * Presence of a new progressive radiographic infiltrate plus at least 2 of the following clinical features: * Fever \> 38.5°C * Leukocytosis (\>11.0) or leukopenia (\<4.0) * Purulent secretions

  Within 30 days after surgery

Secondary Outcomes (10)

• the cumulative incidence of all postoperative infectious complications within 30 days after surgery

  Within 30 days after surgery

• the cumulative incidence of anastomotic leakage within 30 days after esophagectomy for which endoscopic, radiologic, or surgical re-intervention is needed

  Within 30 days after surgery

• the mortality rate within 90 days after surgery

  Within 90 days after surgery

• the rate of re-operation within 30 days after surgery

  Within 30 days after surgery

• the postoperative length of stay on the intensive care unit (ICU) within 6 months after surgery defined in days

  Within 6 months after surgery

Study Arms (2)

SDD treatment

EXPERIMENTAL

Standard of care + SDD treatment

Drug: SDD

Standard of care

NO INTERVENTION

Standard of care

Interventions

SDD DRUG

The intervention group receives SDD treatment additional to standard care, comprising two distinct liquids for oral administration: first the 5 ml amphotericin B suspension (100 mg/ml) and subsequently the 5 ml "SDD base for suspension", containing both colistin sulphate (20 mg/ml) and tobramycin sulphate (16 mg/ml). Patients take the 5 ml amphotericin B, followed by the 5 ml "SDD base for suspension", four times daily for one week, starting three days prior to the surgery. On the day of surgery, intake is limited to an early morning and a late evening dose.

Also known as: Standard of care

SDD treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic esophagectomy with curative intent or for esophageal reconstruction with a gastric or jejunal interposition
• Age ≥ 18 years,
• Able to give written informed consent.

You may not qualify if:

• Patients planned for rescue surgery,
• Patients planned for colonic interposition,
• Known or suspected pregnancy,
• Patients who have undergone upper GI surgery within 30 days before randomization,
• Unable to understand the study information, study instructions and give informed consent.
• Patients enrolled in a trial that would interact with the intervention
• Patients with a known allergy, sensitivity, or interaction to investigational medicinal product.
• Patients with known/documented colonization of Enterobacteriaceae and or Pseudomonas Aeruginosa that are resistant to both tobramycin/gentamicin and to carbapenem antibiotics
• Patients undergoing CVVH.
• Patients with documented chronic renal failure (GFR \< 15 mls/min) or who are on chronic intermittent hemo- or peritoneal dialysis,
• Women of childbearing potential at risk of pregnancy, not using adequate contraception,
• Patients with the inability to swallow the SDD
• Patients with pre-existing degenerative neuromuscular diseases like, but not limited to, myasthenia gravis or Parkinson disease).

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (2)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Radboudumc

Nijmegen, 6525GA, Netherlands

RECRUITING

Related Publications (3)

• Low DE, Alderson D, Cecconello I, Chang AC, Darling GE, D'Journo XB, Griffin SM, Holscher AH, Hofstetter WL, Jobe BA, Kitagawa Y, Kucharczuk JC, Law SY, Lerut TE, Maynard N, Pera M, Peters JH, Pramesh CS, Reynolds JV, Smithers BM, van Lanschot JJ. International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy: Esophagectomy Complications Consensus Group (ECCG). Ann Surg. 2015 Aug;262(2):286-94. doi: 10.1097/SLA.0000000000001098.

  PMID: 25607756 BACKGROUND

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

• Grootenhuis JGA, Seurs W, Garms LM, de Vries M, Ubels S, van Werkhoven HC, Rosman C, Schouten JA, Klarenbeek BR, Van Veer H. 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. Trials. 2025 Dec 4;27(1):16. doi: 10.1186/s13063-025-09311-w.

  PMID: 41345690 DERIVED

Related Links

• DUCA Data

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Camiel Rosman, Prof

  RadoudUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Grootenhuis, MD

CONTACT

+31655740313; justin.grootenhuis@radboudumc.nl

Research Coordinator

CONTACT

+31655740313; persuader.heel@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 19, 2023
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: six months after database lock
• Access Criteria: Upon request to the Principal investigator, with a sufficiently substantiated study protocol.

Locations

NL (1); BE (1)