The Impact of Hepatic Steatosis on Survival After Pancreaticoduodenectomy

NCT07182136 | Completed

• 1 other identifier: ChengKungUniversityTainan
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Nonalcoholic Fatty Liver Disease After Pancreaticoduodenectomy

Keywords

pancreatic ductal adenocarcinoma, pancreaticoduodenectomy, hepatic steatosis, nonalcoholic fatty liver disease, exocrine insufficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nonalcoholic fatty liver disease (NAFLD)

  6 months after pancreaticoduodenectomy

Interventions

Pancreaticoduodenectomy PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wei-Hsun Lu: lead

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: January 1, 2015
• Primary Completion: March 31, 2023
• Study Completion: January 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09