Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01248663
First received: November 24, 2010
Last updated: NA
Last verified: April 2007
History: No changes posted

November 24, 2010
November 24, 2010
April 2007
November 2009   (final data collection date for primary outcome measure)
Delayed gastric emptying [ Time Frame: Postoperative day 10 ] [ Designated as safety issue: No ]
Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy.
Same as current
No Changes Posted
  • Paracetamol reabsorption test [ Time Frame: postoperative day 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery
Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pancreatic Cancer
  • Surgery
  • Improvement of Perioperative Outcome
  • Procedure: antecolic reconstruction
    see study arm description
  • Procedure: retrocolic reconstruction
    see study arm description
  • 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
    Intervention: Procedure: antecolic reconstruction
  • 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
    Intervention: Procedure: retrocolic reconstruction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
August 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01248663
2006-020
No
Michael Gnant, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Michael Gnant, MD Medical University of Vienna
Medical University of Vienna
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP