Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries

NCT06289530 | Recruiting

• 1 other identifier: 2023XAGG0070-1
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:

1. 1.What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries?
2. 2.What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries？

Conditions

Postoperative Pancreatic Fistula

Keywords

clinically relevant postoperative pancreatic fistula; pancreatic surgery; perioperative interstitial fluid glucose level

Outcome Measures

Primary Outcomes (1)

• Clinically relevant postoperative pancreatic fistula

  Clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.

  30 days after surgery

Secondary Outcomes (5)

• Bile leakage

  30 days after surgery

• Chyle leak

  30 days after surgery

• Postpancreatectomy hemorrhage

  30 days after surgery

• Abdominal infection

  30 days after surgery

• Delayed gastric emptying

  30 days after surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy from March 2024 to October 2024.

You may qualify if:

• Patients scheduled for elective pancreaticoduodenectomy
• Patients scheduled for distal pancreatectomy
• Patients scheduled for duodenum-preserving resection of pancreatic head.

You may not qualify if:

• Patients with functional pancreatic neuroendocrine tumors.
• Patients with previous pancreatic surgery.
• Patients with severe pancreatitis.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40527571 DERIVED

Study Officials

• YuGuang Huang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LING LAN, MD

CONTACT

+86-18515311407; lanling_1988@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 4, 2024
• Study Start: March 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)