Nonalcoholic Fatty Liver Disease After PancreaticoduodenectomyNCT07182136
The Impact of Hepatic Steatosis on Survival After Pancreaticoduodenectomy
An observational study of Nonalcoholic Fatty Liver Disease After Pancreaticoduodenectomy, run by Wei-Hsun Lu.
Trial summary
We will use simple summaries, educational handouts, and discussions with doctors and nurses to explain this study. The study looks at patients with early-stage pancreatic cancer who undergo pancreaticoduodenectomy (Whipple surgery). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease After Pancreaticoduodenectomy
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2025
- 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: Two hundred patients with stage I-II pancreatic ductal adenocarcinoma who underwent pancreaticoduodenectomy between 2015 and 2023 at two Taiwanese tertiary centers were included; those with preoperative fatty liver, incomplete data, or early death were excluded
Who may be able to join
- Adults with stage I-II pancreatic ductal adenocarcinoma.
- Underwent curative-intent pancreaticoduodenectomy (conventional or pylorus-preserving).
- Surgery between January 2015 and May 2023.
- Complete clinical and imaging data available.
- Survived at least 6 months postoperatively.
Who cannot join
- Preoperative hepatic steatosis
- Incomplete clinical or imaging data
- Death within 6 months after surgery
About this study
Official title: The Impact of Hepatic Steatosis on Survival After Pancreaticoduodenectomy for Resectable Pancreatic Cancer. A Multifactorial Analysis of Metabolic Dysfunction
We will use simple summaries, educational handouts, and discussions with doctors and nurses to explain this study. The study looks at patients with early-stage pancreatic cancer who undergo pancreaticoduodenectomy (Whipple surgery). We found that some patients develop fatty liver (non-alcoholic fatty liver disease, NAFLD) within six months after surgery, which can affect nutrition, blood sugar control, and long-term survival.
To help patients and families understand, we will:
- Provide clear written information sheets about the purpose of the study and its findings.
- Use diagrams or plain-language explanations of terms like "pancreatic exocrine function" and "fatty liver."
- Share results with healthcare providers so they can guide patients in nutrition, enzyme replacement, diabetes monitoring, and follow-up care.
- Offer contact information for the research team to answer questions.
- Being tested
- Pancreaticoduodenectomy
- Keywords
- pancreatic ductal adenocarcinoma, pancreaticoduodenectomy, hepatic steatosis, nonalcoholic fatty liver disease, exocrine insufficiency
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyProcedure or surgery
Retrospective study evaluating postoperative NAFLD and metabolic outcomes in patients with stage I-II pancreatic cancer after PD.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nonalcoholic fatty liver disease (NAFLD)
Measured: 6 months after pancreaticoduodenectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Jan 2015
- Primary completion31 Mar 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver Disease After PancreaticoduodenectomyStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei-Hsun Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei-Hsun Lu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182136
- Sponsor's protocol ID
- ChengKungUniversityTainan
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hepatic Steatosis on Survival After Pancreaticoduodenectomy for Resectable Pancreatic Cancer. A Multifactorial Analysis of Metabolic Dysfunction
- ClinicalTrials.gov ID
- NCT07182136
- Acronym / sponsor ID
- ChengKungUniversityTainan
- Keywords
- pancreatic ductal adenocarcinoma, pancreaticoduodenectomy, hepatic steatosis, nonalcoholic fatty liver disease, exocrine insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wei-Hsun LuUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Sep 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.
We will use simple summaries, educational handouts, and discussions with doctors and nurses to explain this study. The study looks at patients with early-stage pancreatic cancer who undergo pancreaticoduodenectomy (Whipple surgery). We found that some patients develop fatty liver (non-alcoholic fatty liver disease, NAFLD) within six months after surgery, which can affect nutrition, blood sugar control, and long-term survival.
To help patients and families understand, we will:
- Provide clear written information sheets about the purpose of the study and its findings.
- Use diagrams or plain-language explanations of terms like "pancreatic exocrine function" and "fatty liver."
- Share results with healthcare providers so they can guide patients in nutrition, enzyme replacement, diabetes monitoring, and follow-up care.
- Offer contact information for the research team to answer questions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two hundred patients with stage I-II pancreatic ductal adenocarcinoma who underwent pancreaticoduodenectomy between 2015 and 2023 at two Taiwanese tertiary centers were included; those with preoperative fatty liver, incomplete data, or early death were excluded
Key inclusion criteria (5 listed)
- Adults with stage I-II pancreatic ductal adenocarcinoma.
- Underwent curative-intent pancreaticoduodenectomy (conventional or pylorus-preserving).
- Surgery between January 2015 and May 2023.
- Complete clinical and imaging data available.
- Survived at least 6 months postoperatively.
Key exclusion criteria (3 listed)
- Preoperative hepatic steatosis
- Incomplete clinical or imaging data
- Death within 6 months after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreaticoduodenectomyRetrospective study evaluating postoperative NAFLD and metabolic outcomes in patients with stage I-II pancreatic cancer after PD. | Procedure or surgery | – |
Primary outcome
Incidence of postoperative nonalcoholic fatty liver disease (NAFLD)
Time frame: 6 months after pancreaticoduodenectomy
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 19 Sep 2025.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease After Pancreaticoduodenectomy, run by Wei-Hsun Lu.
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 5 inclusion and 3 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of postoperative nonalcoholic fatty liver disease (NAFLD) (time frame: 6 months after pancreaticoduodenectomy). 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 19 Sep 2025.