Examining blood and interstitial fluid glucose levels in pancreatic surgery patients
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
This study is trying to see if tracking blood and fluid sugar levels can help predict the risk of complications after pancreatic surgery for patients undergoing certain procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06289530 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the risk factors for clinically relevant postoperative pancreatic fistula (CR-POPF) in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It aims to explore the correlation between perioperative blood and interstitial fluid glucose levels and the occurrence of CR-POPF. The study will enroll 600 patients over a 6-month period, utilizing non-invasive continuous glucose monitoring to track glucose trends. Participants will undergo standard postoperative follow-up without additional interventions.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective pancreaticoduodenectomy, distal pancreatectomy, or duodenum-preserving resection of the pancreatic head.
Not a fit: Patients with functional pancreatic neuroendocrine tumors, previous pancreatic surgery, or severe pancreatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for postoperative pancreatic fistula, potentially improving surgical outcomes.
How similar studies have performed: Other studies have explored glucose monitoring in surgical settings, but this specific approach to CR-POPF is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective pancreaticoduodenectomy * Patients scheduled for distal pancreatectomy * Patients scheduled for duodenum-preserving resection of pancreatic head. Exclusion Criteria: * Patients with functional pancreatic neuroendocrine tumors. * Patients with previous pancreatic surgery. * Patients with severe pancreatitis.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: YuGuang Huang, MD — Peking Union Medical College Hospital
- Study coordinator: Ling Lan, Md
- Email: lanling_1988@163.com
- Phone: +86-18515311407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.