Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Surgery; Improvement of Perioperative Outcome
• Interventions: Procedure: antecolic reconstruction; Procedure: retrocolic reconstruction

• Registration Number: NCT01248663
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-04
• Study Start: 2007-04
• Primary Completion: 2009-11
• Study Completion: 2010-08
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Last Update Submitted: 2010-11-24
• Study First Posted: 2010-11-25
• Last Update Posted: 2010-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antecolic reconstruction	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
retrocolic reconstruction	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Paracetamol reabsorption test	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.
Measurement of plasma intestinal peptides	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria