N/A Completed N=16 Randomized Single-blind Supportive Care

Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

Source: ClinicalTrials.gov NCT02033213 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcomePrimary: Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) — 345.01; 330.11; 315.51; 307.11 mmHg — p=0.410

Summary

An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)	345.01; 330.11; 315.51; 307.11	0.410
PRIMARY Creatinine Values During and After Esophageal Carcinoma Surgery	91.91; 90.88; 93.51; 100.88	0.791
PRIMARY Lactate Values During and After Esophageal Carcinoma Surgery	3.93; 3.26; 2.69; 2.40	0.322
PRIMARY Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.	3.93; 3.26; 2.69; 2.40	0.030 sig
SECONDARY Duration of Surgery	275.61; 324.41	0.362
SECONDARY Total Volume of Administered Intraoperative Fluid	2823.75; 3960.00	0.020 sig

Eligibility Criteria

Inclusion Criteria

esophageal carcinoma
Lewis Tanner procedure (median laparotomy and right thoracotomy)

Exclusion Criteria

younger than 18 years
severe lung disease
chronic renal insufficiency
a physical status classification > III on the American Society of Anesthesiologists (ASA) scale
impossible to perform epidural catheter placement
thoraco-phreno-laparotomy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02033213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.