Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798560
Status:
UNKNOWN
Last Update Posted:
2021-03-15
First Post:
2021-03-02
Brief Title:
Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
Sponsor:
Dimitrios Vouros
Organization:
University of Athens
Study Overview
Official Title:
Risk Factors for Pancreaticojejunostomy Leakage Following Whipple Operation
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques Surgery is the only therapeutic option with an intend to treat Pancreaticoduodenectomy is indicated for malignancy in the pancreatic head as well as other periampullary tumors One of the most fatal complications after Whipple operation is postoperative pancreatic fistula as a result of pancreatojejunostomy leakage Various risk factors for pancreatojejunostomy leakage have been proposed while there are others less studied
Detailed Description:
This is a prospective observational study conducted in the 1st Propaedeutic Department of Surgery of the National and Kapodistrian University of Athens Greece Patients with imaging andor histologically proven periampullary tumors in which Whipple operation is indicated will be enrolled in the study after signing a consent designed by the Hospitals Ethics Commitee and the Department of Surgery Patients information and medical history will be recorded giving emphasis on clinical presentation signs and symptoms related to the patients disease Laboratory tests will afterwards take place including biochemical parameters such as total bilirubin levels serum albumin CA 19-9 CEA HbA1c and ferritine levels prior to operation During operation as soon as the specimen has been removed the horizontal and vertical dimension of the pancreatic cutting surface will be measured with the use of an one use sterile ruler and the area of the cutting surface will then be calculated as well as the ratio of the two dimensions horizontalvertical The diameter of the pancreatic duct will be measured either with the same ruler in case diameter is equal or greater than 3mm or with a use of a plastic stent in case diameter is less than 3mm Pancreatic texture will also be assesed Other intraoperative datas will be recorded such as the anastomosis technique duration of surgery amount of fluid administration transfusion with fresh frosen plasma or blood unitsPostoperatively amylase from the drains white blood cell count platelet count and serum crp levels will be recorded on the 1st 3rd and 5th postoperative day in all patients The definition used for postoperative pancreatic fistula POPF is based on the International Study Group of Pancreatic Fistula 2016 definition and patients will be categorised accordingly There will be two arms of patients The first arm will include patients with either no POPF or Biochemical Leak BL and the second arm patients with Grade B or C POPF
Any complication in the early postoperative period defined as the first 30 days after Whipple operation will be recorded and categorised according to Clavien Dindo classification including reoperation readmissions or prolongation of hospital stay After discharge follow up of the patients include the EORTC QLQ-C30 and EORTC QLQ-PAN 26 questionnaires that patients have to fill in one three six and twelve months after surgery Reccurence and survival rates will accordingly be recorded
Any complication in the early postoperative period defined as the first 30 days after Whipple operation will be recorded and categorised according to Clavien Dindo classification including reoperation readmissions or prolongation of hospital stay After discharge follow up of the patients include the EORTC QLQ-C30 and EORTC QLQ-PAN 26 questionnaires that patients have to fill in one three six and twelve months after surgery Reccurence and survival rates will accordingly be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None