Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381882
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-25
Brief Title:
The Role of the Human Microbiome in Patients After Pancreatic Resection
Sponsor:
St Antonius Hospital
Organization:
St Antonius Hospital
Study Overview
Official Title:
Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary PreMalignancy and Pancreatic Resection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
MiPac
Brief Summary:
The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva rectalfaecal tumor blood andor bile microbiome profiles
To identify the dynamics of the microbiome as well as the possibly related short-term and long-term complications multiple samples at different timepoints are needed from the patients
To identify the dynamics of the microbiome as well as the possibly related short-term and long-term complications multiple samples at different timepoints are needed from the patients
Detailed Description:
Rationale
Resection is the only potentially curative option for pancreatic and periampullary cancer a complex procedure with a high risk of complications of 30 to 73 Research shows the presence of altered bacterial populations within fecal pancreatic fluid bile and jejunal samples of patients after pancreatic resection compared to healthy samples Moreover specific gut microbial composition in the pre- and postoperative period were associated with a higher risk of developing complications after pancreatic resection in small studies Further research on a larger scale is necessary to validate these findings and to evaluate targeted microbiome modifications to improve outcomes in patients after pancreatic resection
Objective
The primary objective of this study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal microbiome profiles
Study design Prospective observational cohort study
Study population 200 adult patients with resectable pancreatic or periampullary presumed premalignancy
Main study parametersendpoints
The primary endpoint is a composite of postoperative complications including pancreatic fistula bleeding gastroenterostomy- bile- or chyle leakage delayed gastric emptying cholangitis sepsis and organ failure
Nature and extent of the burden and risks associated with participation benefit and group relatedness
All participants will be offered the standard of care In addition rectal swabs faeces salivary bile blood and tumor samples will be collected at different time points perioperatively Participating in this study carries no additional risks
Resection is the only potentially curative option for pancreatic and periampullary cancer a complex procedure with a high risk of complications of 30 to 73 Research shows the presence of altered bacterial populations within fecal pancreatic fluid bile and jejunal samples of patients after pancreatic resection compared to healthy samples Moreover specific gut microbial composition in the pre- and postoperative period were associated with a higher risk of developing complications after pancreatic resection in small studies Further research on a larger scale is necessary to validate these findings and to evaluate targeted microbiome modifications to improve outcomes in patients after pancreatic resection
Objective
The primary objective of this study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal microbiome profiles
Study design Prospective observational cohort study
Study population 200 adult patients with resectable pancreatic or periampullary presumed premalignancy
Main study parametersendpoints
The primary endpoint is a composite of postoperative complications including pancreatic fistula bleeding gastroenterostomy- bile- or chyle leakage delayed gastric emptying cholangitis sepsis and organ failure
Nature and extent of the burden and risks associated with participation benefit and group relatedness
All participants will be offered the standard of care In addition rectal swabs faeces salivary bile blood and tumor samples will be collected at different time points perioperatively Participating in this study carries no additional risks
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