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Completed

NCT Number: NCT01248663

Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Improvement of Perioperative Outcome Neoplasms Neoplasms by Site Neurologic Manifestations Pancreatic Diseases Pancreatic Neoplasms Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antecolic reconstruction

Procedure

see study arm description

retrocolic reconstruction

Procedure

see study arm description

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Nov 25, 2010
Registry last updated
Nov 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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