Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery

NCT01248663 | Completed

• 1 other identifier: 2006-020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Surgery; Improvement of Perioperative Outcome

Keywords

pancreatic cancer; pylorus-preserving pancreaticoduodenectomy; delayed gastric emptying; reconstruction

Outcome Measures

Primary Outcomes (1)

• Delayed gastric emptying

  Gastric emptying will be assessed by clinical criteria on postoperative day 10 after pylorus-preserving pancreatico-duodenectomy.

  Postoperative day 10

Secondary Outcomes (2)

• Paracetamol reabsorption test

  postoperative day 10

• Measurement of plasma intestinal peptides

  postoperative day 10

Study Arms (2)

antecolic reconstruction

ACTIVE COMPARATOR

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

retrocolic reconstruction

EXPERIMENTAL

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

Interventions

antecolic reconstruction PROCEDURE

see study arm description

antecolic reconstruction

retrocolic reconstruction PROCEDURE

see study arm description

retrocolic reconstruction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Gastroparesis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Gnant, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: April 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: August 1, 2010
• Last Updated: November 25, 2010

Record last verified: 2007-04

Locations

AU (1)