Clinical trial NCT03176680: The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS Strategy: a Prospective Investigation
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
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Complication, Postoperative
Anesthesia
Keywords: Anesthesia,Esophagectomy,Esophageal cancer,Treatment outcome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative complications
timeFrame: within 1 year after operation
Secondary outcomes:
measure: Kidney injuries
timeFrame: Preoperative to postoperative day 1
measure: Lung injuries
timeFrame: Preoperative to postoperative day 1
measure: Inflammatory markers
timeFrame: Preoperative to postoperative day 1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Test2
Study officials:
affiliation: Anesthesiology Department, NTUH
name: Ya-Jung Cheng
role: PRINCIPAL_INVESTIGATOR
References: