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Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial.


N/A
18 Years
90 Years
Not Enrolling
Both
Pancreatic Cancer, Surgery, Improvement of Perioperative Outcome

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Trial Information

Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Delayed gastric emptying

Outcome Description:

Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy.

Outcome Time Frame:

Postoperative day 10

Safety Issue:

No

Principal Investigator

Michael Gnant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna

Authority:

Austria: Ethikkommission

Study ID:

2006-020

NCT ID:

NCT01248663

Start Date:

April 2007

Completion Date:

August 2010

Related Keywords:

  • Pancreatic Cancer
  • Surgery
  • Improvement of Perioperative Outcome
  • pancreatic cancer
  • pylorus-preserving pancreaticoduodenectomy
  • delayed gastric emptying
  • reconstruction
  • Pancreatic Neoplasms
  • Gastroparesis

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