Nutritional Route In Esophageal Resection trial

In the past decade, fast-track programs such as the enhanced recovery after
surgery (ERAS) program have changed the view on postoperative nutrition in
abdominal surgery. Many studies, especially in colorectal surgery, have shown
that there is no clear advantage to withhold enteral nutrition in the direct
postoperative phase. Early feeding may even be beneficial compared with the
traditionally applied nil-by-mouth strategy. Early start of postoperative
enteral nutrition has also been shown safe in other forms of abdominal surgery
such as in gynaecologic surgery.

However, for patients undergoing an esophagectomy it is unclear what the best
route of feeding is. There is a concern that early oral intake would result in
vomiting with subsequent aspiration pneumonia. Furthermore the sequelae of
anastomotic leakage are thought to be more severe if the leaked fluids contain
food besides to saliva. Although these arguments are generally applied, there
is no clear supporting scientific evidence. Interestingly, these arguments were
similarly used in colorectal surgery to support the nil-by-mouth regimen for
many years before introduction of fast-track protocols.

There is only one retrospective study that suggests anastomotic leak rates are
lower when a radiographic contrast swallow was omitted postoperatively and
patients are fed over a jejunostomy and kept nil-by-mouth for 4 weeks. However,
these data are difficult to interpret since it is unclear if their findings
result from a difference in anastomotic leak definitions between both groups,
timing of first enteral intake, timing of oral intake, or other, unknown
factors.

On the other hand some studies show that early oral intake is feasible and can
result in faster recovery of bowel function and a shorter hospitalization in
partial or total gastrectomy. Furthermore, it has been shown that early oral
intake directly after major upper abdominal surgery, including esophagectomy,
does not increase morbidity compared with traditional care consisting of
postoperative fasting. However, only few patients undergoing esophagectomy were
included in this trial. Finally, experimental evidence shows that early enteral
feeding above the anastomosis improves anastomotic healing after upper
abdominal surgery in rats.

Therefore, we questioned whether or not it is justified to delay the start of
oral intake after esophagectomy. Before a comparative study can be performed it
should be determined whether or not it is feasible to start oral intake early
after esophagectomy.

This study aims to determine whether early start of oral intake in patients
that underwent an esophagectomy is feasible and safe.

The NUTRIENT trial is a single-arm multicentre feasibility trial. All patients
will follow a standardised clinical pathway in which oral intake is allowed
directly after surgery.

direct oral feeding

The study group has performed a amongst Dutch Upper gastrointestinal surgeons
and this survey shows that some clinics stimulate early oral intake and others
advocate stimulated a delayed oral intake. Early oral feeding is traditionally
postponed in order to decrease the risk of aspiration pneumonia and prevent
harmful effects of oral intake in case of anastomotic leakage. Although this
has never been substantiated and clinical evidence is lacking, this is a
potential hazard for the patient. On the other hand, delayed oral intake
necessitates a feeding jejuonostomy which is also accompanied with
complications. This also is a potential risk for the patient besides the
discomfort to be kept nil by mouth for 7 days. For safety an independent Data
Safety Monitoring Board will monitor the study and evaluate potential safety
issues.