PERi-operative Selective Decontamination of the Digestive tract to prevent severe infectious complications after Esophagectomy: a Randomized multicenter clinical trial in patients with primary resectable esophageal carcinoma (cT1-4, N0-3, M0)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud University Medical Center

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Neoplasms [C04]

Trial duration

17 Oct 2024 → ongoing

Decision date (initial)

2024-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMw · KCE

External identifiers

EU CT number

2023-504144-33-01

ClinicalTrials.gov

NCT05865743

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

Secondary objectives 1

1. to evaluate additional benefits, such as reduction of other infectious complications including anastomotic leakage, overall health and wellbeing during the recovery period, and risks of SDD. Furthermore, outcomes will be used for a cost-effectiveness analysis.

Conditions and MedDRA coding

esophageal cancer

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. - 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
2. - Age ≥ 18 years
3. - Able to give written informed consent

Exclusion criteria 9

1. - Patients planned for rescue surgery
2. - Patients planned for colonic interposition
3. - Known or suspected pregnancy
4. - Patients who have undergone upper GI surgery within 30 days before randomization
5. - Unable to understand the study information, study instructions and give informed consent
6. - Patients enrolled in a trial that would interact with the intervention
7. - Patients with a known allergy, sensitivity, or interaction to investigational medicinal product
8. - Patients undergoing CVVH
9. - Patients with the inability to swallow the SDD

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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)

Secondary endpoints 8

1. the cumulative incidence of all postoperative infectious complications within 30 days as registered in DUCA (postoperative pneumonia, Clostridium difficile infection, urinary tract infection, wound infection/abscess requiring wound opening or antibiotic treatment, central line infection requiring line removal or antibiotic treatment, intra-thoracic/intra-abdominal abscess, generalised sepsis as defined by Evans, Rhodes (30), other infections requiring antibiotics
2. the cumulative incidence of anastomotic leakage within 30 days after esophagectomy for which endoscopic, radiologic, or surgical re-intervention is needed. This corresponds to the definition of the ECCG of anastomotic leakage type II and III Low, Alderson (32). Anastomotic leakage is defined by contrast leakage on CT-scan with intravenous and oral contrast (swallow CT-scan) upon clinical suspicion, by endoscopy or by drainage of ingested materials into the chest tube (thoracic anastomoses) or in
3. the all-cause mortality within 90 days after surgery
4. the rate of re-operation within 30 days after surgery
5. the postoperative length of stay on the intensive care unit (ICU), including re-admissions within 6 months after surgery
6. the postoperative length of the total hospital stay, including re-admissions for any reasons within 6 months after surgery
7. the quality of life (QoL) after 30 days, 3 months and 6 months after surgery (using internationally validated EORTC OG25, QLQC30 and EuroQoL-5D-5L questionnaires)
8. Direct and indirect costs. The in-hospital and societal costs up to 6 months after surgery will be estimated with the help of the medical consumption questionnaire and the productivity cost questionnaire, developed by the iMTA

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud University Medical Center

Sponsor organisation

Stichting Radboud University Medical Center

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Dr. B.R. Klarenbeek

Public contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Dr. B.R. Klarenbeek

Locations

2 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications