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Cohort Study on Nutritional, Metabolic, and Volumetric Assessment After Pancreaticoduodenectomy

NCT07159672 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2025-09-08

No results posted yet for this study

Summary

Periampullary malignant neoplasms are among the most lethal gastrointestinal tumors. They are usually diagnosed at advanced stages and require complex surgical treatment. Pancreaticoduodenectomy, the standard procedure for resectable cases, significantly impacts nutritional status, pancreatic function, and the structural integrity of the remaining pancreas. However, there are still significant knowledge gaps regarding the volumetric and molecular changes that occur postoperatively and how these changes interact with body composition, resting energy expenditure, and biochemical markers.

This prospective, controlled, cohort study aims to integrate clinical, nutritional, metabolic, molecular, and imaging data to investigate changes in the remnant pancreas and their associations with postoperative outcomes. The study is expected to provide novel insights to support personalized, evidence-based nutritional and metabolic care for patients undergoing pancreaticoduodenectomy.

Conditions

Interventions

PROCEDURE

Pancreaticoduodenectomy

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) performed as part of standard clinical care for patients with periampullary malignant neoplasms. This procedure is not assigned by the study protocol, but is the exposure of interest. The study observes nutritional, metabolic, molecular, and imaging outcomes at baseline (preoperative), and at 3 and 6 months after hospital discharge.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Marco Aurélio Ribeiro, PhD

    lead OTHER

Principal Investigators

  • Marco A Ribeiro, PhD, MSc, BSc, RD · Ribeirão Preto Medical School University of São Paulo

  • Anderson M Navarro, Prof, PhD, MSc, BSc, RD · Ribeirão Preto Medical School University of São Paulo

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159672 on ClinicalTrials.gov