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Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

Primary Purpose

Pancreatic Cancer, Surgery, Improvement of Perioperative Outcome

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
antecolic reconstruction
retrocolic reconstruction
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Cancer focused on measuring pancreatic cancer, pylorus-preserving pancreaticoduodenectomy, delayed gastric emptying, reconstruction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

antecolic reconstruction

retrocolic reconstruction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Paracetamol reabsorption test
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
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.

Full Information

First Posted
November 24, 2010
Last Updated
November 24, 2010
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01248663
Brief Title
Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery
Official Title
Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Surgery, Improvement of Perioperative Outcome
Keywords
pancreatic cancer, pylorus-preserving pancreaticoduodenectomy, delayed gastric emptying, reconstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
antecolic reconstruction
Arm Type
Active Comparator
Arm Description
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
Arm Title
retrocolic reconstruction
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
antecolic reconstruction
Intervention Description
see study arm description
Intervention Type
Procedure
Intervention Name(s)
retrocolic reconstruction
Intervention Description
see study arm description
Primary Outcome Measure Information:
Title
Delayed gastric emptying
Description
Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy.
Time Frame
Postoperative day 10
Secondary Outcome Measure Information:
Title
Paracetamol reabsorption test
Description
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.
Time Frame
postoperative day 10
Title
Measurement of plasma intestinal peptides
Description
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.
Time Frame
postoperative day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gnant, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

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