Ignite Creation Date:
2024-05-05 @ 11:03 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01248663
Status:
COMPLETED
Last Update Posted:
2010-11-25
First Post:
2010-11-24
Brief Title:
Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Influence of the Reconstruction Method on the Incidence of Delayed Gastric Emptying After Pylorus Preserving Pancreaticoduodenectomy A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None