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

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

The goals of this study are to testify the effectiveness on enhancement recovery by new anesthetic ERAS (Enhanced recovery after surgery) strategy.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer; Anesthesia; Complication, Postoperative
• Intervention / Treatment: Procedure: Fluid therapy optimization

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Test2
    • Taipei, Test2, Taiwan, 100
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluid therapy optimization; Fluid loading to optimize stroke volume after induction.	Procedure: Fluid therapy optimization; 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.
No Intervention: Fluid therapy normalization; No fluid loading after induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 1 year after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney injuries	Elevated plasma creatinine	Preoperative to postoperative day 1
Lung injuries	Change in the (PF ratio): ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2)	Preoperative to postoperative day 1
Inflammatory markers	Change in cytokines	Preoperative to postoperative day 1

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ya-Jung Cheng, Anesthesiology Department, NTUH

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Anesthesia,Esophagectomy,Esophageal cancer,Treatment outcome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Postoperative Complications; Esophageal Neoplasms
• Other Study ID Numbers: 201612093RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No