Tomoelastography in Predicting Postoperative Pancreatic Fistula

NCT07014800 | Completed

• 1 other identifier: FirstSunYetSen123
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pancreatic fistula (POPF) is a prevalent and severe complication of pancreaticoenteric anastomosis; however, its accurate preoperative prediction is challenging. Multi-frequency MR elastography-based tomoelastography can quantify pancreatic mechanical properties (stiffness and fluidity), thus further improving the predictive performance of conventional MRI for postoperative pancreatic fistulas.

Conditions

Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative pancreatic fistula

  Any measurable drainage of amylase levels above three times the upper limit of the normal amylase level on or after the third postoperative day was considered the essential threshold of diagnosing postoperative pancreatic fistula.

  The participants were routinely examined on days 1, 3, 5, and 7 after surgery to determine fluid volumes and serum amylase levels.

Study Arms (2)

patients with postoperative pancreatic fistula

patients without postoperative pancreatic fistula

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who underwent both preoperative multi-frequency MRE and pancreaticoenteric anastomosis were included in the study.

You may not qualify if:

• without appropriate image quality； without available pathological data

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Shi Siya

Guangzhou, Guangdong, 510000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: November 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)