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

NCT07159672 | Completed DMC

• 5 other identifiers: 64695422.6.0000.544088887.827259/2023-00141784/2025-3Finance Code 00163993522.3.0000.5440
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Periampullary Neoplasms; Pancreatic Cancer; Pancreaticoduodenectomy

Keywords

Nutritional Assessment; Resting Energy Expenditure; Bioimpedance Analysis; Molecular Biomarkers; Oxidative Stress; Proteomics; Lipidomics; Pancreatic Volume; 3D Imaging / 3D Slicer

Outcome Measures

Primary Outcomes (1)

• Resting Energy Expenditure (REE) in kcal/day

  Resting energy expenditure will be measured using indirect calorimetry (Quark RMR®) following standardized protocols. Results will be expressed in kcal/day, and normalized to body weight and fat-free mass. Results will be compared with predictive equations (Harris-Benedict, Mifflin-St Jeor, FAO/WHO).

  Day 0 (preoperative), 3 months post-discharge, and 6 months post-discharge

Secondary Outcomes (50)

• Fat-Free Mass (kg) measured by multifrequency bioimpedance analysis

  Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge

• Fat Mass (kg) measured by multifrequency bioimpedance analysis

  Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge

• Hydration Status (%) assessed by bioimpedance analysis

  Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge

• Phase Angle (°) assessed by bioimpedance analys

  Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge

• Total Serum Protein (g/dL)

  Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge

Study Arms (2)

Pancreaticoduodenectomy Group

Patients aged 18-80 years with periampullary malignant neoplasms undergoing pancreaticoduodenectomy (classic Whipple or pylorus-preserving). This group will be followed prospectively for nutritional, metabolic, molecular, and volumetric assessments at baseline (preoperative), 3 months, and 6 months after hospital discharge.

Procedure: Pancreaticoduodenectomy

Control Group

Age- and sex-matched individuals without malignant gastrointestinal disease, selected among those undergoing routine upper gastrointestinal endoscopy with normal or nonspecific findings. This group will undergo a single-time evaluation for nutritional, metabolic, molecular, and imaging parameters.

Interventions

Pancreaticoduodenectomy PROCEDURE

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.

Also known as: Whipple procedure, Pylorus-preserving pancreaticoduodenectomy

Pancreaticoduodenectomy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 44 individuals. The experimental group will include 24 adults aged 18-80 years with histologically or radiologically confirmed resectable periampullary malignant neoplasms (e.g., pancreatic head adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma), undergoing pancreaticoduodenectomy (classic Whipple or pylorus-preserving), performed by the same institutional surgical team with standardized techniques (end-to-side duct-to-mucosa pancreaticojejunostomy). Participants will be evaluated at baseline (preoperative), 3 months, and 6 months post-discharge. The control group will include 20 age- and sex-matched individuals without gastrointestinal malignancy, selected among patients undergoing routine upper GI endoscopy with normal or nonspecific findings. Control subjects will be assessed once. All procedures will follow standardized clinical, nutritional, and laboratory protocols.

You may qualify if:

• Adults aged between 18 and 80 years;
• Histologically or radiologically confirmed diagnosis of resectable periampullary malignant neoplasms (e.g., pancreatic head adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma);
• Candidates for elective pancreaticoduodenectomy (either classic Whipple or pylorus-preserving technique), performed by the institutional surgical team following standardized protocols;
• ECOG Performance Status ≤2;
• Adequate cardiopulmonary function to undergo major surgery, as assessed preoperatively;
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Previous pancreatic surgery;
• Pancreaticoduodenectomy performed outside the study institution;
• Evidence of unresectable disease, distant metastases, or local tumor recurrence at baseline imaging or intraoperative assessment;
• Active inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease);
• Active malignancy other than periampullary cancer, or history of non-pancreatic cancer within the past 5 years;
• Use of systemic immunosuppressive therapy (e.g., corticosteroids \>10 mg/day prednisone equivalent, chemotherapy, biologics);
• Diagnosed malabsorption syndromes unrelated to pancreatic disease;
• Severe hepatic dysfunction or severe renal impairment (eGFR \<30 mL/min/1.73m²);
• Pregnancy or breastfeeding;
• Refusal or inability to attend scheduled follow-up visits within 6 months;

Sponsors & Collaborators

• Marco Aurélio Ribeiro, PhD: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Ribeirão Preto Medical School University of São Paulo

Ribeirão Preto, São Paulo, 14.048-900, Brazil

Location

Related Links

• Official website of the Ethics Committee - Hospital das Clínicas, Ribeirão Preto Medical School (HCRP-USP).
• Official website of the Ribeirão Preto Medical School, University of São Paulo (FMRP-USP).

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marco A Ribeiro, PhD, MSc, BSc, RD

  Ribeirão Preto Medical School University of São Paulo

  PRINCIPAL INVESTIGATOR

• Anderson M Navarro, Prof, PhD, MSc, BSc, RD

  Ribeirão Preto Medical School University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 8, 2025
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)