Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery
|ClinicalTrials.gov Identifier: NCT01248663|
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : November 25, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Surgery Improvement of Perioperative Outcome||Procedure: antecolic reconstruction Procedure: retrocolic reconstruction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial.|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||August 2010|
Active Comparator: antecolic reconstruction
After completion of pancreaticoduodenectomy and reconstruction of the pancreaticojejunostomy and hepaticojejunostomy, the reconstruction of the intestinal passage will be conducted by performing an antecolic duodeno-jejunostomy
Procedure: antecolic reconstruction
see study arm description
Experimental: retrocolic reconstruction
After completion of pancreaticoduodenectomy and reconstruction of the pancreaticojejunostomy and hepaticojejunostomy, the reconstruction of the intestinal passage will be conducted by performing a retrocolic duodeno-jejunostomy
Procedure: retrocolic reconstruction
see study arm description
- Delayed gastric emptying [ Time Frame: Postoperative day 10 ]Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy.
- Paracetamol reabsorption test [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248663
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Michael Gnant, MD||Medical University of Vienna|