Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514198
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2020-08-12
Brief Title:
Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy- A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-01
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:
AIM
To determine association between postoperative pancreatitis and pancreatic fistula
OBJECTIVES
1 To determine incidence of Clinically relevant pancreatic fistula grade BC after pancreaticoduodenectomy
2 To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula
3 To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula
Primaryendpoint
Incidence of post operative pancreatitis and post operative pancreatic fistula
Secondaryendpoints
1 to identify the possible predictors of post operative pancreatitis
2 to investigate the association between post operative pancreatitis and post operative pancreatic fistula
MATERIAL AND METHODS
Study centre
Inpatient admissions in Department of gastroenterology Asian institute of gastroenterology Hyderabad
Study population
Patients who are supposed to undergo pancreaticoduodenectomy Study design Prospective observational study
Study period
Study will be conducted till desired sample size achieved or March 2020 to march 2022
To determine association between postoperative pancreatitis and pancreatic fistula
OBJECTIVES
1 To determine incidence of Clinically relevant pancreatic fistula grade BC after pancreaticoduodenectomy
2 To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula
3 To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula
Primaryendpoint
Incidence of post operative pancreatitis and post operative pancreatic fistula
Secondaryendpoints
1 to identify the possible predictors of post operative pancreatitis
2 to investigate the association between post operative pancreatitis and post operative pancreatic fistula
MATERIAL AND METHODS
Study centre
Inpatient admissions in Department of gastroenterology Asian institute of gastroenterology Hyderabad
Study population
Patients who are supposed to undergo pancreaticoduodenectomy Study design Prospective observational study
Study period
Study will be conducted till desired sample size achieved or March 2020 to march 2022
Detailed Description:
STUDY PROCEDURE
Demographic pathological and intraoperative data will be recorded in a prospectively maintained database populated from a combination of electronic patient records preoperative imaging and anaesthetic charts Preoperative clinical data included age gender body mass index BMI and the results of serum biochemical investigations including serum bilirubin urea and amylase The serum amylase measured throughout the study period is total amylase Preoperative computed tomography images will beanalyzed to calculate pancreatic duct diameter at the line of transection of the pancreas anterior to the portal vein Intraoperative data included reconstruction technique texture of the pancreatic remnant and estimated blood loss Blood loss data will be compiled from a combination of anaesthetic charts and perioperative blood transfusion data Specimens will be dichotomized according to whether their pathology was associated with hard pancreatic parenchyma pancreatic ductal adenocarcinoma PDAC and chronic pancreatitis or with soft or normal pancreatic parenchyma ampullary carcinoma duodenal carcinoma cholangiocarcinoma neuroendocrine tumours and other lesions Outcome data included length of stay in a critical care environment defined as either an intensive care unit ICU or a surgical high-dependency unit SHDU and length of postoperative hospital stay All postoperative complications will be prospectively recorded and graded according to the International Study Group on Pancreatic Fistula ISGPF and International Study Group of Pancreatic Surgery ISGPS classifications and the Clavien-Dindo classification Complications of ISGPS Grades B and C and Clavien-Dindo Grades III-V are considered clinically significant Mortality will be recorded at 30-day and 90-day time-points
Serum amylase will be systematically measured on POD1 and POD3 according to our institutional policy No additional radiological or laboratory studies are required for the diagnosis of postoperative pancreatitis No specific protocols for the treatment of POP will be followed during the study period because none are available Due to the absence of a widely accepted definition POP is defined according to Connors definition1 as an elevation in serum pancreatic amylase above the upper limit of normal on postoperative day POD 0 or 1 At our institution the upper limit of normal for serum pancreatic amylase is 100 UL
Demographic pathological and intraoperative data will be recorded in a prospectively maintained database populated from a combination of electronic patient records preoperative imaging and anaesthetic charts Preoperative clinical data included age gender body mass index BMI and the results of serum biochemical investigations including serum bilirubin urea and amylase The serum amylase measured throughout the study period is total amylase Preoperative computed tomography images will beanalyzed to calculate pancreatic duct diameter at the line of transection of the pancreas anterior to the portal vein Intraoperative data included reconstruction technique texture of the pancreatic remnant and estimated blood loss Blood loss data will be compiled from a combination of anaesthetic charts and perioperative blood transfusion data Specimens will be dichotomized according to whether their pathology was associated with hard pancreatic parenchyma pancreatic ductal adenocarcinoma PDAC and chronic pancreatitis or with soft or normal pancreatic parenchyma ampullary carcinoma duodenal carcinoma cholangiocarcinoma neuroendocrine tumours and other lesions Outcome data included length of stay in a critical care environment defined as either an intensive care unit ICU or a surgical high-dependency unit SHDU and length of postoperative hospital stay All postoperative complications will be prospectively recorded and graded according to the International Study Group on Pancreatic Fistula ISGPF and International Study Group of Pancreatic Surgery ISGPS classifications and the Clavien-Dindo classification Complications of ISGPS Grades B and C and Clavien-Dindo Grades III-V are considered clinically significant Mortality will be recorded at 30-day and 90-day time-points
Serum amylase will be systematically measured on POD1 and POD3 according to our institutional policy No additional radiological or laboratory studies are required for the diagnosis of postoperative pancreatitis No specific protocols for the treatment of POP will be followed during the study period because none are available Due to the absence of a widely accepted definition POP is defined according to Connors definition1 as an elevation in serum pancreatic amylase above the upper limit of normal on postoperative day POD 0 or 1 At our institution the upper limit of normal for serum pancreatic amylase is 100 UL
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