Improvement of Perioperative Outcome, Pancreatic Cancer, Surgery
Conditions
Keywords
pancreatic cancer, pylorus-preserving pancreaticoduodenectomy, delayed gastric emptying, reconstruction
Brief summary
Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater. For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and oncologically equivalent to the traditional whipple operation. One issue with this technique is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging between day 4 and 14 after surgery. Patients with severe DGE can not only experience prolonged length of hospital stay, but are also at increased risk for other complications like aspiration or other issues related to the inability to ingest nutrition. There is vast retrospective evidence and one prospective study indicating that antecolic reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric emptying. The investigators have conducted a prospective randomized trial in order to test this hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a test meal including 1g paracetamol was administered to check for clinically inapparent DGE. Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos measured.
Interventions
PROCEDUREantecolic reconstruction
see study arm description
PROCEDUREretrocolic reconstruction
see study arm description
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* verified cancer of the pancreatic head/neck/uncinate process or distal bile duct, radiographically suspicious tumor requiring pancreaticoduodenectomy * pylorus-preserving reconstruction planned * no evidence of distant metastases * written informed consent
Exclusion criteria
* age \<18 or \>90 years * status post surgical resection of stomach or duodenum * locally unresectable: * invasion of the hepatic artery/superior mesenteric artery * \>180 deg invasion of portal vein/superior mesenteric vein * gastric invasion * hypersensitivity to paracetamol * clinically significant anastomotic dehiscence * postoperative pancreatitis \> day 10 * preoperative evidence of gastroparesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delayed gastric emptying | Postoperative day 10 | Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paracetamol reabsorption test | postoperative day 10 | On day 10 after pylorus-preserving pancreaticoduodenectomy, a test meal of a commercially available dietary product (Fresubin protein energy(c)) and 1g paracetamol will be administered. Serum levels of paracetamol will be measured at 0, 15, 30, 60 and 90 minutes after administration. |
| Measurement of plasma intestinal peptides | postoperative day 10 | On day 10 after pylorus-preserving pancreaticoduodenectomy, a test meal of a commercially available dietary product (Fresubin protein energy(c)) and 1g paracetamol will be administered. Serum levels of glucagon-like peptide-1 (GLP-1), peptide YY (PYY) and Glucagon will be measured at 0, 15, 30, 60 and 90 minutes after administration. |
Countries
Austria
Outcome results
None listed