|- candidate number||5422|
|- NTR Number||NTR1697|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mrt-2009|
|- Secondary IDs||09/005 Medical Ethics Committee of the Academic Medical Center, Amsterdam|
|- Public Title||Antecolic versus Retrocolic Route of the Gastroenteric Anastomosis after Pancreatoduodenectomy: ARCO-trial.|
|- Scientific Title||Antecolic versus Retrocolic Route of the Gastroenteric Anastomosis after Pancreatoduodenectomy: ARCO-trial.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Pancreas tumor, Periampullary tumor|
|- Inclusion criteria||1. Planned explorative laparotomy for suspected pancreatic or periampullary disease, with intention of resection;|
2. Age >/= 18 yrs;
3. Willing and able to give written informed consent.
|- Exclusion criteria||Peroperative findings of unresectability.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-mrt-2009|
|- planned closingdate||1-jul-2010|
|- Target number of participants||182|
|- Interventions||1. Antecolic route of gastroenteric anastomosis after pancreatoduodenectomy;|
2. Retrocolic route of gastroenteric anastomosis after pancreatoduodenectomy.
|- Primary outcome||Postoperative incidence of delayed gastric emptying.|
|- Secondary outcome||1. Gastric emptying rate assessed by scintigraphy (subset of patients);|
2. Postoperative complications;
3. Length of stay;
4. Quality of life;
|- Timepoints||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.
|- Trial web site||www.arcotrial.nl (from medio 2009)|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||arts-onderzoeker W.J. Eshuis|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. D.J. Gouma|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Medical Research B.V.|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Medical Research B.V.|
|- Brief summary||ARCO-trial – Antecolic versus RetroCOlic route of the gastroenteric anastomosis after pancreatoduodenectomy – summary.
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.
An antecolic route of gastroenteric anastomosis after pancreatoduodenectomy leads to lower postoperative DGE incidence than a retrocolic route.
To determine the relationship of route of gastroenteric anastomosis after PD and postoperative incidence of DGE.
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.
Patients of >18 years old with suspicion of pancreatic or periampullary tumor, woh will undergo explorative laparotomy with resection (pancreatoduodenectomy) if possible.
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;
|- Main changes (audit trail)|
|- RECORD||6-mrt-2009 - 14-sep-2009|