Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248663
• Other study ID #: 2006-020
• Status: Completed
• Phase: N/A
• First received: November 24, 2010
• Last updated: November 24, 2010
• Start date: April 2007
• Est. completion date: August 2010

Study information

• Verified date: April 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gastroparesis
• Improvement of Perioperative Outcome
• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery

Intervention

Procedure:
• antecolic reconstruction
see study arm description
• retrocolic reconstruction
see study arm description

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed gastric emptying	Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy.	Postoperative day 10	No
Secondary	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.	postoperative day 10	No
Secondary	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.	postoperative day 10	No