This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.
Aged 18-80 years old;
ECOG PS 0~1;
NRS 2002 score ≥3;
Malnutrition diagnosed according to the GLIM criteria;
NRS 2002 score < 3;
Upfront surgery without neoadjuvant treatment;
Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
Receiving any other nutritional support during the study;
Parallel
Goal-directed EN therapy
Dietary supplementThe participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.
Conventional EN therapy
Dietary supplementThe participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).
Rate of postoperative pulmonary complications
According to the Esophagectomy Complications Consensus Group (ECCG) standardization of complications reporting, pulmonary complications include pneumonia, pleural effusion, pneumothorax, atelectasis, mucous plugging, respiratory failure, acute respiratory distress syndrome, acute aspiration, tracheobronchial injury, and prolonged air-leak.
Rate of unplanned hospital admissions
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute hospital admission.
Rate of unplanned ICU admission
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute ICU admission.
Overall survival
The time from randomization to death. Any patients lost to follow up or still alive at the time of evaluation are censored.
Rate of postoperative non-pulmonary complications
Non-pulmonary complications according to the ECCG standardization of complications reporting.
Level of serum prealbumin
Prealbumin, also known as transthyretin, has a half-life in plasma of ∼2 days, much shorter than that of albumin. Prealbumin is therefore more sensitive to changes in protein-energy status than albumin, and its concentration closely reflects recent dietary intake rather than overall nutritional status.
Body mass index (BMI)
A person's weight in kilograms divided by the square of height in meters.
Lean body mass
The weight of the body minus the fat content, representing the amount of muscle, bone, and organs in the body.
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