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OpenTrials
Completed

NCT Number: NCT07182136

The Impact of Hepatic Steatosis on Survival After Pancreaticoduodenectomy

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:

1. Provide clear written information sheets about the purpose of the study and its findings. 2. Use diagrams or plain-language explanations of terms like "pancreatic exocrine function" and "fatty liver." 3. Share results with healthcare providers so they can guide patients in nutrition, enzyme replacement, diabetes monitoring, and follow-up care. 4. Offer contact information for the research team to answer questions.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease After Pancreaticoduodenectomy Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Preoperative hepatic steatosis
  • Incomplete clinical or imaging data
  • Death within 6 months after surgery

Treatment and study plan

Pancreaticoduodenectomy

Procedure

Retrospective study evaluating postoperative NAFLD and metabolic outcomes in patients with stage I-II pancreatic cancer after PD.

Primary outcomes

  1. Incidence of postoperative nonalcoholic fatty liver disease (NAFLD)

    Time frame: 6 months after pancreaticoduodenectomy

Sponsors and collaborators

Lead sponsor

Wei-Hsun Lu

Other

Registry information

Official study title

The Impact of Hepatic Steatosis on Survival After Pancreaticoduodenectomy for Resectable Pancreatic Cancer. A Multifactorial Analysis of Metabolic Dysfunction

Important dates

Study start
2015
Primary completion
2023
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Sep 19, 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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