Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Cédric CIRENEI, MD,PhD

The perioperative management of esophageal cancer has evolved considerably in recent years.

Over the last 30 years, postoperative mortality has been steadily decreasing. However, respiratory morbidity remains high (30-40%). This is due to the procedure itself requiring a thoracic approach and intraoperative unipulmonary ventilation. The postoperative pulmonary complications (PPCs) are multiple: bronchial congestion, atelectasis, pneumopathy, acute respiratory distress syndrome (ARDS), liquid pleural effusion, pneumothorax.

In general, prevention and early treatment are aimed at limiting the evolution towards acute respiratory failure requiring ventilatory assistance.

Chest radiography is essential for the presumptive diagnosis of pneumopathy in particular, but the interpretation of the images may be difficult.

Thoracic computed tomography (CT) is the gold standard because it is sensitive and can discriminate among differential diagnoses. This is difficult to perform: it requires intra-hospital transport of patient, who is often in acute respiratory failure, and the availability of an examination area.

Lung ultrasound is used at the bedside for diagnosis of lung infection in intensive care unit. This has a sensitivity close to thoracic CT and has the advantage of being feasible at any time, does not require transport of the patient and is not irradiating.

Lung ultrasound allows early detection of the need for ventilatory support in postoperative major abdominal surgery . In addition, the sensitivity of lung ultrasound is close to that of CT, allowing this examination to be relied upon.

The main objective of the study is to determine the role of lung ultrasound in the prediction of postoperative pulmonary complications within one hour after extubation.

Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy

Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy: A Prospective Observational Study

University Hospital, Lille

Infections

Symptoms and General Pathology

Shock, Septic

Shock

Sepsis

Toxemia

Communicable Diseases

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

beta-Lactams

Antibiotics, Antitubercular

Fluoroquinolones

Methicillin

* According to the results of the antibiogram of the suspected causative bacteria, the ''pivotal'' antibiotic (antipseudomonal betalactam) used for empirical treatment is switched to an antibiotic with a spectrum as narrow as possible according to the targeted pathogens,
* Stop the companion antibiotic (aminoglycoside, fluoroquinolone, macrolide) between day 2 and day 3 of antibiotic treatment as much as possible,
* Stop the empirical antibiotic directed against methicillin-resistant staphylococcus aureus (MRSA) or an enterococcus in the absence of these bacteria in the culture.

* The companion antibiotic is stopped between day 3 and day 5 of antibiotic treatment as much as possible and according to the local prescription,
* Empirical antibiotics directed against MRSA or enterococcus were used according to local prescription and/or international guidelines,
* The pivotal antibiotic of the empirical treatment is continued for the entire duration of the treatment, independently of microbiological results. For prolonged treatment, the physician has the choice of de-escalating after 8-15 days of treatment.

All the therapeutic protocols made the object of a consensus between the different partners of the study.

Antibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation.

Antibiotic de-escalation

Antibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation.

Standard treatment

GENRE Dominique, MD

COURNIER Sandra

Mokart Djamel, MD, PhD

MOKART Djamel, MD

De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens.

Observational studies suggested that this strategy seems to be safe. However, there is no adequate, direct evidence showing de-escalation of antimicrobial agents to be effective and safe for onco-hematology patients with sepsis or septic shock. Thus, randomized clinical trials are needed for testing the safety and efficiency of de-escalation of antimicrobial therapy.

The investigator's hypothesis is that de-escalation of empirical antimicrobial therapy in onco-hematology patients with sepsis or septic shock is noninferior to the continuation of empirical antimicrobial therapy.

The first aim of the study is to demonstrate that de-escalation is noninferior to the continuation of broad-spectrum antibiotics in terms of hospital mortality.

The secondary aims are to compare the two strategies in terms of mortality, duration of antimicrobial therapy, durations of mechanical ventilation, vasopressor use, numbers of superinfections, organ failure.

Antimicrobial de-escalation (ADE) of antimicrobial therapy is a strategy proposed to allow for the rational use of broad-spectrum antimicrobial therapy as the empiric treatment for infections and minimize the overall exposure to these broad-spectrum agents. The need for prompt, effective antimicrobial therapy for patients with known or suspected infections is widely accepted. This principle leads to the use of very broad-spectrum antimicrobial therapy to increase the odds that all suspected potential pathogens are adequately treated. However, the potential drawback is selection of multidrug-resistant (MDR) organisms.

ADE is widely recommended in the management of antimicrobial therapy in intensive care unit (ICU) patients. The Surviving Sepsis Campaign guidelines describe and recommend the process for selecting antimicrobial therapy as commencement of antimicrobials within the first hour, antimicrobial therapy broad enough to cover all likely pathogens, and daily reassessment for potential ADE.

To date, no randomized study assessing this strategy is available for this specific population of cancer critically ill patients. In a recent systematic review based on 13 observational studies and one randomized controlled trial, the authors conclude that the equipoise remains and a large randomized trial is required to assess the effect of the antibiotics de-escalation strategy on the bacterial ecosystem, on MDR carriage, and on patient outcomes.

An interim analysis planned after inclusion of 233 patients.

\* Subgroup analyses will be performed on patient subsets:

* Patients with allogeneic HCST,
* Neutropenic patients (Neutrophils \< 0.5 Giga/L),
* Hematological disease,
* Oncological disease,
* Polymicrobial sepsis,
* Multi-drug resistant organisms,
* Patients presenting with bacterial pneumoniae,
* Patients presenting with Intra-abdominal infection,
* Patients presenting with bacteraemia,
* Patients presenting with gram negative bacteria infection,
* Patients presenting with gram positive cocci infection,
* Patients presenting with septic shock,
* Patients presenting with sepsis.

Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock

death from any cause during hospital stay

death from any cause into the ICU, day 28 and day 90

A Sepsis-related Organ Failure Assessment (SOFA) score\>2 for each organ (respiratory, hematologic, cardiac, neurologic, hepatic, renal)

days without respiratory dysfunction (respiratory SOFA score\<3)

days without renal dysfunction (renal SOFA score\<3)

days without neurologic dysfunction (neurologic SOFA score\<3)

days without cardiac dysfunction (cardiac SOFA score\<3)

days without hepatic dysfunction (hepatic SOFA score\<3)

days without hematologic dysfunction (hematologic SOFA score\<3)

days without invasive mechanical ventilation

Duration between the first antibiotic initiation and the last antibiotic stop

Number of antibiotics de-escalated in each arm

Number of anfungal de-escalated in each arm

Number of antiviral de-escalated in each arm

For the entire cohort:(number of antibiotic days / number of ICU days)\*1000

For the entire cohort:(number of antifungal days / number of ICU days)\*1000

For the entire cohort:(number of antiviral days / number of ICU days)\*1000

Adverse events assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0

number of patients de-escalated/number of patients included in the experimental arm

number of patients not de-escalated/number of patients included in the continuation group

Percentage of emerging multidrug-resistant bacteria isolated from specimen taken for routine microbiological assessments

Institut Paoli-Calmettes

Behaviors and Mental Disorders

Quality of Life

Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of continuous renal replacement therapy (CRRT) 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU for the purpose of the study.

Control group: would receive EN reaching up to 20 % of daily nutritional requirements and late (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day ) in SPN on 7th day of stay in ICU if it is not already met via enteral route.

Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU. Central venous catheter placement would not be assessed as a part of intervention due to the fact that it is a part of routine medical activities performed during admission to ICU.

Early Supplemental Parenteral Nutrition

Paweł Piwowarczyk, MD PhD

Mirosław Czuczwar, MD PhD

Michał Borys, MD PhD

BACKGROUND: Nutrition plays a significant role in ICU treatment, and may influence mortality and length of stay in ICU. Enteral route (EN) is preferential to parenteral route (PN) in provision of daily nutritional requirements. When enteral route is insufficient, supplemental parenteral nutrition (SPN) is recommended. Optimal timing of SPN in acute phase of illness remains elusive. ICU patients suffer significant lean body mass loss, in majority, in the first 7-10 days of stay. Optimal provision of protein may prevent muscle wasting. Lean body mass is essential for optimal physical functioning after treatment. Although ICU mortality has been reduced lately, the number of patients going to rehabilitation after ICU stay has tripled. Patients after oncological surgery of the gastrointestinal tract may be threatened with impairment of physical functioning after ICU treatment.

AIM: To compare the influence of early and late supplemental parenteral nutrition on long-term physical functioning in ICU patients after oncological surgery of the gastrointestinal tract.

STUDY DESIGN: Prospective, randomised, multi-centre assessor-blinded study. METHODS \& ANALYSIS: Patients will be randomised into intervention group that would receive SPN on first day, and would be continued until 7th day of stay in ICU. Control group would receive SPN on 7th day of stay in ICU, when it is not then already met via enteral route. Physical Component of SF-36 Scale at 6 month after ICU admission will be assessed.

prospective, randomised, multi-centre assessor-blinded study

Influence of Early vs Late SPN on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery

Influence of Early vs Late Supplemental ParenteraL Nutrition on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery. A Prospective, Randomised, Multi-centre Assessor-blinded Study. hELPLiNe Trial

Long-term quality of life measured in physical component of 36 -SF questionnaire

Inability to administer up to 60% of protein needs on 3rd day via enteral route

Change from baseline in ultrasound measured thickness of diaphragm

Protein delivery defined as daily input of proteins via SPN

Energy delivery defined as daily input of calories via SPN

Insulin dose defined as summary daily input of insulin

Blood glucose profile defined as mean daily glucose level

Organic phosphorus level defined as result in blood test performed daily

We will collect data regarding changes from baseline SOFA score - to determine the extent of a person's organ function failure. SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients. Patient can be scored from 0 to 24. If the patient is scored 0 than the patient is in a good state and predicted mortality is low, while 24 is the worst result with expected very high mortality rate.

Numbers of days of mechanical ventilation

Numbers of days of patient stay in hospital

New onset of health-care associated infection

Number of days patient was not given the antibiotics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy	NCT05453760	Esophageal Neop...		18 Years -	University Hospital, Lille
Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock	NCT03683329	Critical Care Cancer	Antibiotic de-e... Standard treatm...	18 Years -	Institut Paoli-Calmettes
Influence of Early vs Late SPN on Long-term Quality of Life in ICU Patients After Gastrointestinal Oncological Surgery	NCT03699371	Nutrition Aspec...	Early Supplemen...	18 Years -	Medical University of Lublin
Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock	NCT03683329	Critical Care Cancer	Antibiotic de-e... Standard treatm...	18 Years -	Institut Paoli-Calmettes
Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock	NCT03683329	Critical Care Cancer	Antibiotic de-e... Standard treatm...	18 Years -	Institut Paoli-Calmettes

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