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


- candidate number5422
- NTR NumberNTR1697
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2009
- Secondary IDs09/005 Medical Ethics Committee of the Academic Medical Center, Amsterdam
- Public TitleAntecolic versus Retrocolic Route of the Gastroenteric Anastomosis after Pancreatoduodenectomy: ARCO-trial.
- Scientific TitleAntecolic versus Retrocolic Route of the Gastroenteric Anastomosis after Pancreatoduodenectomy: ARCO-trial.
- ACRONYMARCO-trial
- hypothesisAn 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) studiedPancreas tumor, Periampullary tumor
- Inclusion criteria1. 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 criteriaPeroperative findings of unresectability.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-mrt-2009
- planned closingdate1-jul-2010
- Target number of participants182
- Interventions1. Antecolic route of gastroenteric anastomosis after pancreatoduodenectomy;
2. Retrocolic route of gastroenteric anastomosis after pancreatoduodenectomy.
- Primary outcomePostoperative incidence of delayed gastric emptying.
- Secondary outcome1. Gastric emptying rate assessed by scintigraphy (subset of patients);
2. Postoperative complications;
3. Length of stay;
4. Quality of life;
5. Costs.
- TimepointsDelayed 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 sitewww.arcotrial.nl (from medio 2009)
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESarts-onderzoeker W.J. Eshuis
- CONTACT for SCIENTIFIC QUERIESProf. Dr. D.J. Gouma
- Sponsor/Initiator Academic Medical Center (AMC), Medical Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Medical Research B.V.
- PublicationsN/A
- Brief summaryARCO-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.
- Main changes (audit trail)
- RECORD6-mrt-2009 - 14-sep-2009


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