*Evaluating the feasibility of intraluminal oxygen administration at the site of the anastomosis in patients who underwent an esophagectomy; a pilot study*

Anastomotic leakage is a severe complication after esophagectomy and causes
high morbidity and mortality. Unfortunately, anastomotic leakage still occurs
in 20% of patients after an esophagectomy. The leakage of the anastomosis is
frequently caused by local ischemia of the gastric conduit postoperative.
Various methods have been tested in order to decrease the occurrence of
anastomotic leakage. None of these methods has been successful in reducing the
occurrence in a major manner. There is however a potential novel solution to
this problem, which is the intraluminal administration of oxygen at the site of
the anastomosis. This intraluminal oxygen diffuses into mucosa to prevent
ischemia, and also stimulate tissue regeneration. It is, however, unknown if
this oxygen administration might be harmful to patients after an esophagectomy.

To explore feasibility of intraluminal oxygen administration at the site of the
anastomosis in patients who underwent an esophagectomy.

Pilot feasibility study.

Introduction of an additional nasogastric tube at the site of the anastomosis.
In 3 patients assessment of the pressure in the esophagus.
In the next 10 patients oxygen delivery through the nasogastric tube with the
addition of a pressure valve system that will be set on a safe pressure,
probably 20 mmHg.

This amendement is for the inclusion of an additional 6 patients. After
inclusion of the first 13 patients, the results are that the placement of the
intervention nasogastric oxygen delivery tube is feasible and safe. In addition
to this we also measured the intraluminal pressure of the esophagus and gastric
tube near the anastomosis and we only saw a pressure that was always below 20
mm Hg. Therefore we would like to include another 6 patients and give a little
bit more oxygen and see the effect on the intraluminal pressure. In an
additional 3 patients we would like to give 2 ml of oxygen per minute and in
another 3 patients 4 ml of oxygen per minute. After the first of these
additional 3 patients we will check for all primairy and secondairy endpoints
and check for the intraluminal pressure.

The subjects can have benefit participating in this study. There are risks
present, but it is expected that these risks are surmountable or reversible.
Furthermore, the outcome of this study can greatly improve the knowledge on the
prevention of anastomotic leakage, not limited to leakages after
esophagectomies.