Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries
NCT ID: NCT06289530
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-03-01
2025-04-30
Brief Summary
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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
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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 81.3% to detect an odds ratio (OR) greater than 1.34 or less than 0.75.
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 Fisher's 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 \< 0.05 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 15.0; stata Corp., Texas, USA ) and R 3.6.1 software ( R Foundation for Statistical Computing, Vienna, Austria ), bilateral P \< 0.05 was considered statistically significant.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for distal pancreatectomy
* Patients scheduled for duodenum-preserving resection of pancreatic head.
Exclusion Criteria
* Patients with previous pancreatic surgery.
* Patients with severe pancreatitis.
18 Years
85 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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YuGuang Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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LING LAN, MD
Role: primary
References
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Lan L, Zhang Y, Zhang L, Zhang Y, Shen L, Huang Y. Association between perioperative continuous glucose monitoring and clinically relevant postoperative pancreatic fistula (CR-POPF) in pancreatic surgery: a protocol for a prospective cohort study. BMJ Open. 2025 Jun 17;15(6):e092046. doi: 10.1136/bmjopen-2024-092046.
Other Identifiers
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2023XAGG0070-1
Identifier Type: -
Identifier Source: org_study_id