PancreatectomyPOPFNCT07014800
Tomoelastography in Predicting Postoperative Pancreatic Fistula
An observational study of Pancreatectomy, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatectomy
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who underwent both preoperative multi-frequency MRE and pancreaticoenteric anastomosis were included in the study.
Who may be able to join
None listed.
Who cannot join
- without appropriate image quality； without available pathological data
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-frequency MR Elastography Based Tomoelastography: Additional New Imaging Tool for Postoperative Pancreatic Fistula Risk Stratification
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with postoperative pancreatic fistula | Not described | |
| patients without postoperative pancreatic fistula | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The participants were routinely examined on days 1, 3, 5, and 7 after surgery to determine fluid volumes and serum amylase levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Nov 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siya Shi, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014800
- Sponsor's protocol ID
- FirstSunYetSen123
- Acronym
- POPF
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data generated for this study are from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-frequency MR Elastography Based Tomoelastography: Additional New Imaging Tool for Postoperative Pancreatic Fistula Risk Stratification
- ClinicalTrials.gov ID
- NCT07014800
- Acronym / sponsor ID
- POPF / FirstSunYetSen123
- Conditions
- Pancreatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with postoperative pancreatic fistula | – | – |
| patients without postoperative pancreatic fistula | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who underwent both preoperative multi-frequency MRE and pancreaticoenteric anastomosis were included in the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- without appropriate image quality； without available pathological data
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No. All data generated for this study are from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatectomy, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.