Tomoelastography in Predicting Postoperative Pancreatic Fistula

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.

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Key information

Conditions

Pancreatectomy

Sex eligibility

All sexes

Study type

Observational

Primary location

Shi Siya

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants diagnosed with postoperative pancreatic fistula who underwent both preoperative multi-frequency MRE and pancreaticoenteric anastomosis were included in the study.

Exclusion criteria

without appropriate image quality； without available pathological data

Treatment and study plan

Primary outcomes

Postoperative pancreatic fistula

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

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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Multi-frequency MR Elastography Based Tomoelastography: Additional New Imaging Tool for Postoperative Pancreatic Fistula Risk Stratification

Acronym: POPF

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jun 11, 2025
Registry last updated: Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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