Antecolic versus retrocolic route of the gastroenteric anastomosis after pancreatoduodenectomy: ARCO-trial

Though mortality has dropped below 5%, morbidity of pancreatic surgery remains
high (30%-50%). One of the most common complications after
pancreatoduodenectomy (PD) is delayed gastric emptying (DGE). In recent
literature, incidences vary from 19% to 57%. DGE leads to longer hospital stay,
higher costs and decreases quality of life. This pertains especially to DGE
grade B ("moderate") and C ("severe") according to the recently published
definition by the International Study Group of Pancreatic Surgery (ISGPS).
The causative mechanisms of DGE are unknown. Some retrospective studies suggest
a role for the route of gastroenteric anastomosis: antecolic or retrocolic
gastrojejunostomy/duodenojejunostomy. A recent randomized trial by Tani et al.
from Japan showed a tenfold difference in postoperative DGE incidence, in
favour of the antecolic route (5% versus 50%). Small patient numbers and
unclear definitions make it difficult to understand this enormous difference. A
new methodologically sound randomized trial seems required to compare the
antecolic and retrocolic route.

Hypothesis: an antecolic route of gastroenteric anastomosis after
pancreatoduodenectomy leads to lower postoperative DGE incidence than a
retrocolic route.

Primary objective:
To determine the relationship of route of gastroenteric anastomosis after PD
and postoperative incidence of DGE.

Secondary objectives:
To determine the relationship of route of gastroenteric anastomosis after PD
and gastric emptying (measured by scintigraphy), quality of life, postoperative
complications, length of stay and costs.

Randomized controlled trial with blinding for treatment allocation of patient
and medical personnel except surgeon.

Antecolic route.
Control: retrocolic route.

There are no risks involved in study participation. Intervention and control
methods are both safe and commonly accepted methods of gastroenteric
reconstruction. Except a possible difference in postoperative incidence of DGE,
no differences in complications have been described between antecolic and
retrocolic reconstruction.
A possible disadvantage is that the surgeon will use another method of
reconstruction than usual.
Gastric emptying scintigraphy is a non-invasive investigation with low
radiation load.