Antecolic versus Retrocolic Route of the Gastroenteric Anastomosis after Pancreatoduodenectomy: ARCO-trial.

ARCO-trial – Antecolic versus RetroCOlic route of the gastroenteric anastomosis after pancreatoduodenectomy – summary.



Background:

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.



Objective:

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.



Study design:

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



Study population:

Patients of >18 years old with suspicion of pancreatic or periampullary tumor, woh will undergo explorative laparotomy with resection (pancreatoduodenectomy) if possible.



Intervention:

Antecolic route.
Control: retrocolic route.



Primary outcome parameter:

Postoperative incidence of DGE according to the definition by the International Group of Pancreatic Surgery (ISGPS).



Secondary outcome parameters:

1. Gastric emptying measured by scintigraphy (AMC patients only);

2. Quality of life;

3. Postoperative complications;

4. Length of stay;

5. Costs.

An antecolic route of the gastroenteric anastomosis in pancreatoduodenectomy may lead to a lower postoperative incidence of delayed gastric emptying than a retrocolic route, thus reducing length of hospital stay, lowering medical costs and improving quality of life.

Delayed gastric emptying: according to ISGPS-criteria (International Study Group of Pancreatic Surgery).


Gastric emptying rate:

1. 1 week before operation;

2. 7th postoperative day;

Quality of life:

1. Before operation;

2. 2, 4 and 12 weeks after operation.

1. Antecolic route of gastroenteric anastomosis after pancreatoduodenectomy;

2. Retrocolic route of gastroenteric anastomosis after pancreatoduodenectomy.