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
  Purpose

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 Intervention
Pancreatic Cancer
Surgery
Improvement of Perioperative Outcome
Procedure: antecolic reconstruction
Procedure: retrocolic reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy. A Prospective, Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 64
Study Start Date: April 2007
Study Completion Date: August 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248663

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Gnant, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Michael Gnant, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01248663     History of Changes
Other Study ID Numbers: 2006-020
Study First Received: November 24, 2010
Last Updated: November 24, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
pancreatic cancer
pylorus-preserving pancreaticoduodenectomy
delayed gastric emptying
reconstruction

Additional relevant MeSH terms:
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Pancreatic Diseases
Stomach Diseases
Gastroparesis
Pancreatic Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Neoplasms
Neoplasms by Site
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014