Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289530
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-02-25
Brief Title:
Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Multicenter Prospective Cohort Study on the Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries
Status:
RECRUITING
Status Verified Date:
2024-03
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:
CR-POPF
Brief Summary:
This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy It mainly answers the following two main questions
1 What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries
2 What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries
Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery No control group was set in this study and no additional clinical intervention was performed
1 What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries
2 What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries
Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery No control group was set in this study and no additional clinical intervention was performed
Detailed Description:
CR-POPF is a multi-center observational prospective cohort study The research team focuses on whether perioperative abnormal hyperglycemia can independently predict the occurrence of CR-POPF It is proposed to realize the dynamic monitoring of perioperative blood glucose level by non-invasive continuous glucose monitoring CGM and perioperative continuous glucose monitoring can reflect the overall blood glucose trend and mode which is helpful to further explore the correlation between perioperative abnormal blood glucose level and CR-POPF
The investigators expect to enroll 600 patients Based on our previous clinical experience the incidence of postoperative pancreatic fistula is approximately 20 We planned to enroll 600 patients during the 6-month enrollment period in three participating hospitals The sample size would have a statistical power of 813 to detect an odds ratio OR greater than 134 or less than 075
Measurement data consistent with normal distribution were expressed as mean standard deviation and t-test was used for comparison between groups When not consistent with normal distribution the measurement data were expressed as quartiles and the Wilcoxon-Mann-Whitney rank sum test was used for comparison between groups Count data were expressed as frequency and percentage Pearson chi-square test or Fishers exact test was used for comparison between groups The binary logistic regression method was used to screen the risk factors and stratify the risk levels P 005 was considered statistically significant A generalized estimation equation model was constructed to analyze the correlation between continuous blood glucose monitoring values and postoperative pancreatic fistula The dependent variable in the model is whether there is pancreatic fistula after operation The dependent variable in the model was the presence or absence of postoperative pancreatic fistula and the main variable was the continuous glucose monitoring CGM value The connection function uses the binomial distribution logit function The multiple measurements of the same patient are set as the group-level variable and the autocorrelation matrix is selected according to the Quasi-likelihood under Independence Model Criterion QIC value of the model In addition to analysis using generalized estimating equations continuous glucose monitoring data will be constructed such as an analysis of the association between pancreatic fistula and the area under the curve for measurement and time beyond normal glucose values The statistical software was STATA version 150 stata Corp Texas USA and R 361 software R Foundation for Statistical Computing Vienna Austria bilateral P 005 was considered statistically significant
The investigators expect to enroll 600 patients Based on our previous clinical experience the incidence of postoperative pancreatic fistula is approximately 20 We planned to enroll 600 patients during the 6-month enrollment period in three participating hospitals The sample size would have a statistical power of 813 to detect an odds ratio OR greater than 134 or less than 075
Measurement data consistent with normal distribution were expressed as mean standard deviation and t-test was used for comparison between groups When not consistent with normal distribution the measurement data were expressed as quartiles and the Wilcoxon-Mann-Whitney rank sum test was used for comparison between groups Count data were expressed as frequency and percentage Pearson chi-square test or Fishers exact test was used for comparison between groups The binary logistic regression method was used to screen the risk factors and stratify the risk levels P 005 was considered statistically significant A generalized estimation equation model was constructed to analyze the correlation between continuous blood glucose monitoring values and postoperative pancreatic fistula The dependent variable in the model is whether there is pancreatic fistula after operation The dependent variable in the model was the presence or absence of postoperative pancreatic fistula and the main variable was the continuous glucose monitoring CGM value The connection function uses the binomial distribution logit function The multiple measurements of the same patient are set as the group-level variable and the autocorrelation matrix is selected according to the Quasi-likelihood under Independence Model Criterion QIC value of the model In addition to analysis using generalized estimating equations continuous glucose monitoring data will be constructed such as an analysis of the association between pancreatic fistula and the area under the curve for measurement and time beyond normal glucose values The statistical software was STATA version 150 stata Corp Texas USA and R 361 software R Foundation for Statistical Computing Vienna Austria bilateral P 005 was considered statistically significant
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