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CompletedNCT07014800POPFUpdated Jun 11, 2025

Tomoelastography in Predicting Postoperative Pancreatic Fistula

An observational study in Pancreatectomy, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
157
Sex
All
01

Study 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.

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Conditions studied

  • Pancreatectomy
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In context

Pancreatic Fistula

125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.

This study's enrollment of 157 is close to the median of 173 across 49 observational studies indexed under Pancreatic Fistula.

Browse Pancreatic Fistula studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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

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Exclusion Criteria:

without appropriate image quality; without available pathological data

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
157 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with postoperative pancreatic fistula
  • patients without postoperative pancreatic fistula
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What researchers measure

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.

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

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Study locations

1 site
  • Shi Siya
    Guangzhou, Guangdong 510000, China
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References and documents

Individual participant data

Plan to share: No — All data generated for this study are from the corresponding author upon reasonable request.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07014800
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Siya Shi (clinical doctor, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Jun 11, 2025
Start date
Nov 1, 2021
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Jun 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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