Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

November 24, 2010 updated by: Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative day 10
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.
postoperative day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael Gnant, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2010

Last Update Submitted That Met QC Criteria

November 24, 2010

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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