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The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS Strategy: a Prospective Investigation (ERAS)

Primary Purpose

Esophageal Cancer, Complication, Postoperative, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fluid therapy optimization
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Anesthesia,Esophagectomy,Esophageal cancer,Treatment outcome

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Patients with esophageal cancer
  • Patients will undergo video-assisted thoracic surgical (VATS) esophagectomy and laparoscopic gastric tube reconstruction

Exclusion criteria:

  • History of arrhythmia
  • History of chronic obstructive pulmonary disease (COPD)
  • With poor lung function test (FEV1 < 70% or FEV1/ forced vital capacity (FVC) < 70% of predicted)
  • Preoperative creatinine more than 1.5 mg/dl

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fluid therapy optimization

Fluid therapy normalization

Arm Description

Fluid loading to optimize stroke volume after induction.

No fluid loading after induction.

Outcomes

Primary Outcome Measures

Postoperative complications
Length of ICU stay, total hospitalization days, 30-day mortality, 90-day mortality, postoperative pulmonary complications, cardiovascular complications, renal complications, prolonged extubation, readmission, gastric tube related complications

Secondary Outcome Measures

Kidney injuries
Elevated plasma creatinine
Lung injuries
Change in the (PF ratio): ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2)
Inflammatory markers
Change in cytokines

Full Information

First Posted
May 11, 2017
Last Updated
June 2, 2017
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03176680
Brief Title
The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS Strategy: a Prospective Investigation
Acronym
ERAS
Official Title
The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS (Enhanced Recovery After Surgery) Strategy: a Prospective Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goals of this study are to testify the effectiveness on enhancement recovery by new anesthetic ERAS (Enhanced recovery after surgery) strategy.
Detailed Description
ERAS (Enhanced recovery after surgery) strategy is extremely important for patients receiving esophagectomy including the preoperative preparation (smoking cessation, exercise prescription and nutrition prescription), intraoperative management, and postoperative analgesia and respiratory rehabilitation. However, despite the less invasive thoracoscopic esophagectomy and laparoscopic gastric tube reconstruction was developed, respiratory complications including acute lung injury (ALI) were observed up to 20% and associate with 50% of mortality. A new preventive anesthetic ERAS strategy including precise perioperative fluid management and preventive management after tracheal extubation should be developed. Previous report indicated that none of the variables studied except fluid administration were shown as a risk factor for the development of respiratory complications on the multivariate analysis on esophageal surgery. However, there are rare prospective investigations of perioperative fluid administration strategy on postoperative complications after esophagectomy. Our group has studied on goal-directed fluid optimization and we found that the goal of optimization may differ for specific surgery. For esophagectomy, new anesthetic ERAS strategy should include precise preoptimized circulatory management and aggressive postoperative pulmonary care. Based on Frank-Starling law (stroke volume, SV, response to fluid therapy), a precise goal for perioperative goal-directed fluid therapy (GDFT) becomes possible in anesthetic practice. However, the effects of preoperative maximization of SV remain unknown. Following our study in last year, we planned to randomize 120 esophagectomy patients in the following 3 years into different GDFT groups (SV maximization and SV normalization groups). Postoperative THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) therapy will be take place immediately after tracheal extubation. Blood samples will be obtained preoperatively to postoperative day 1 to measure lung injuries, kidney injuries as well as the inflammatory and oxidative markers. The clinical records will be collected (including extubation time, ICU stay, hospitalization days, 30-day mortality, 90-day mortality, readmission, postoperative cardiovascular, pulmonary, and renal complications, gastric tube related complications etc. ). The goals of this study are to testify the effectiveness on enhance recovery by new anesthetic ERAS strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Complication, Postoperative, Anesthesia
Keywords
Anesthesia,Esophagectomy,Esophageal cancer,Treatment outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluid therapy optimization
Arm Type
Experimental
Arm Description
Fluid loading to optimize stroke volume after induction.
Arm Title
Fluid therapy normalization
Arm Type
No Intervention
Arm Description
No fluid loading after induction.
Intervention Type
Procedure
Intervention Name(s)
Fluid therapy optimization
Intervention Description
colloid 250 mL bolus to increase stroke volume index (SVI). If the increase of SVI is more than 10% of baseline, repeat the bolus. If the increase of SVI is less than 10% of baseline, stop the bolus.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
Length of ICU stay, total hospitalization days, 30-day mortality, 90-day mortality, postoperative pulmonary complications, cardiovascular complications, renal complications, prolonged extubation, readmission, gastric tube related complications
Time Frame
within 1 year after operation
Secondary Outcome Measure Information:
Title
Kidney injuries
Description
Elevated plasma creatinine
Time Frame
Preoperative to postoperative day 1
Title
Lung injuries
Description
Change in the (PF ratio): ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2)
Time Frame
Preoperative to postoperative day 1
Title
Inflammatory markers
Description
Change in cytokines
Time Frame
Preoperative to postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with esophageal cancer Patients will undergo video-assisted thoracic surgical (VATS) esophagectomy and laparoscopic gastric tube reconstruction Exclusion criteria: History of arrhythmia History of chronic obstructive pulmonary disease (COPD) With poor lung function test (FEV1 < 70% or FEV1/ forced vital capacity (FVC) < 70% of predicted) Preoperative creatinine more than 1.5 mg/dl
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Jung Cheng, PhD
Phone
+886-2-2312-3456
Ext
65523
Email
chengyj@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Jung Cheng
Organizational Affiliation
Anesthesiology Department, NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Test2
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya-Jung Cheng, PhD
Phone
+886-2-2312-3456
Ext
65523
Email
chengyj@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS Strategy: a Prospective Investigation

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