Periampullary NeoplasmsNCT07159672
Cohort Study on Nutritional, Metabolic, and Volumetric Assessment After Pancreaticoduodenectomy
An observational study of Periampullary Neoplasms and Pancreatic Cancer, run by Marco Aurélio Ribeiro, PhD at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periampullary Neoplasms, Pancreatic Cancer, Pancreaticoduodenectomy
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2023to 31 Dec 2024
- How long will I take part?
- 12 Months
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ribeirão Preto Medical School University of São Paulo
Ribeirão Preto, São Paulo, 14.048-900
About this study
Official title: Prospective Cohort Study of Nutritional, Metabolic, Molecular, and Volumetric Assessment of the Remnant Pancreas in Patients With Periampullary Malignancies Undergoing Pancreaticoduodenectomy
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.
Read the detailed description
Periampullary malignant neoplasms are lethal gastrointestinal tumors that are often diagnosed at advanced stages and require complex surgical intervention. Pancreaticoduodenectomy, the gold standard for resectable disease, has profound effects on nutritional status, exocrine pancreatic function, and the structural integrity of the remaining pancreas. Despite recent advances, significant gaps remain in our understanding of the volumetric and molecular alterations that occur postoperatively and how these alterations interact with body composition, resting energy expenditure, and biochemical markers.
This is a prospective, longitudinal, controlled, clinical-translational cohort study. Data on clinical, nutritional, biochemical, and plasma parameters will be collected at three time points for the experimental group (preoperatively and 3 and 6 months after hospital discharge) and one time point for the control group. Plasma samples will be stored at -80 °C and analyzed using validated techniques, including multiplex assays, spectrophotometry, ELISA, and tandem mass spectrometry (LC-MS/MS) to detect inflammatory biomarkers (IL-1β, , IL-6, TNF-α, and MCP-1; oxidative markers (MDA, GSH, TAC, and FRAP); proteomic targets (HSP70, fibronectin, and laminin); and lipidomic profiles (ceramides, sphingolipids, and cardiolipins). Abdominal imaging (CT and/or MRI) will be processed using 3D Slicer software to estimate the volume of the remnant pancreas via three-dimensional segmentation.
Statistical analyses will be conducted in RStudio. We will apply mixed linear models (MLM and MLMG), incorporating fixed and random effects to account for intra- and inter-individual variability. Missing not-at-random data will be addressed using multiple imputation by chained equations (MICE), and pooled estimates will be calculated according to Rubin's rules. We will set statistical significance at p < 0.05 with Holm-Bonferroni correction for multiple comparisons.
This integrative approach ensures methodological rigor, bias control, and robust inference. It has the potential to guide personalized, evidence-based nutritional strategies in the context of pancreatic cancer.
- Being tested
- Pancreaticoduodenectomy
- Keywords
- Nutritional Assessment, Resting Energy Expenditure, Bioimpedance Analysis, Molecular Biomarkers, Oxidative Stress, Proteomics, Lipidomics, Pancreatic Volume, 3D Imaging / 3D Slicer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyProcedure or surgery
Also called Whipple procedure, Pylorus-preserving 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0 (preoperative), 3 months post-discharge, and 6 months post-discharge
Secondary outcomes (50)
Fat-Free Mass (kg) measured by multifrequency bioimpedance analysis
Fat-free mass will be assessed using multifrequency bioimpedance (SECA mBCA 525®). Values will be reported in kilograms and normalized by body surface area.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Fat Mass (kg) measured by multifrequency bioimpedance analysis
Fat mass will be measured using SECA mBCA 525® bioimpedance. Results will be expressed in kilograms and monitored across study visits.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Hydration Status (%) assessed by bioimpedance analysis
Percentage of total body water will be determined by SECA mBCA 525® device using multifrequency bioimpedance.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Phase Angle (°) assessed by bioimpedance analys
Phase angle will be derived from resistance and reactance using multifrequency BIA with SECA mBCA 525®, as a proxy of cell membrane integrity.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Total Serum Protein (g/dL)
Measured using colorimetric assay with spectrophotometric reading at 540 nm. Reference range: 6.0-8.3 g/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Albumin (g/dL)
Quantified using specific colorimetric method with reading at 625 nm. Normal range: 3.5-5.0 g/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum C-Reactive Protein - CRP (mg/L)
Systemic inflammation marker measured via immunoturbidimetric assay with latex particles. Reference value: <3 mg/L.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Fasting Glucose (mg/dL)
Measured by enzymatic colorimetric method. Reference range: 70-99 mg/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Hemoglobin (g/dL)
Determined by automated hematology analyzer (ABX Pentra DX120), using impedance, photometry, and fluorescence. Reference: 13-17.5 g/dL (men), 12-15.5 g/dL (women).
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Absolute Lymphocyte Count (×10³/mm³)
Analyzed using automated hematology analyzer. Normal range: 1.0-4.0 ×10³/mm³.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Iron (µg/dL)
Determined by direct colorimetric method. Normal range: 65-175 µg/dL (men), 50-170 µg/dL (women).
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Ferritin (ng/mL)
Measured by chemiluminescence (Immulite 2000). Normal: 30-300 ng/mL (men), 15-150 ng/mL (women).
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Latent Iron-Binding Capacity - LIBC (µg/dL)
Assessed via direct colorimetric method. Reference: 240-450 µg/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Transferrin (mg/dL)
Calculated using Vannucchi et al. (1996): Transferrin = ((LIBC + Iron) × 0.8) - 43. Reference: 200-360 mg/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Transferrin Saturation (%)
Calculated by serum iron / LIBC ratio. Normal range: 20-50%.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Urea (mg/dL)
Measured using kinetic method and spectrophotometric reading at 340 nm. Reference: 10-40 mg/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Creatinine (mg/dL)
Quantified by kinetic method with reading at 500 nm. Reference: 0.7-1.3 mg/dL (men), 0.6-1.1 mg/dL (women).
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
AST (U/L)
Aspartate aminotransferase assessed via optimized UV method. Normal range: 10-40 U/L.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
ALT (U/L)
Alanine aminotransferase determined by UV method at 340 nm. Reference: 7-56 U/L.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Folate - Vitamin B9 (ng/mL)
Measured by chemiluminescence (Immulite 2000). Reference: 3.0-17.0 ng/mL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Vitamin B12 (pg/mL)
Cobalamin levels determined by chemiluminescence. Normal range: 200-900 pg/mL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Vitamin A - Retinol (µg/dL)
Determined by HPLC. Reference: 30-80 µg/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Vitamin E - Alpha-tocopherol (mg/dL)
Assessed by HPLC. Normal range: 0.5-2.0 mg/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Copper (µg/dL)
Measured by atomic absorption spectroscopy at 327.4 nm. Reference: 70-140 µg/dL (men), 80-155 µg/dL (women).
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Zinc (µg/dL)
Determined via atomic absorption spectroscopy at 213.9 nm. Reference: 60-120 µg/dL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Sudan III Stool Test (qualitative)
Microscopic evaluation of Sudan III-stained stool samples for detection of steatorrhea. Reported as positive or negative.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 1 beta (IL-1β), pg/mL
Plasma concentrations will be quantified using a multiplex immunoassay with magnetic beads (MagPix®, Luminex Corporation), following manufacturer's specifications.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 4 (IL-4), pg/mL
Quantified via bead-based multiplex fluorescence assay using the MagPix® system (Luminex®), allowing simultaneous detection of multiple cytokines.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 6 (IL-6), pg/mL
Measured by high-sensitivity magnetic bead-based immunoassay (Luminex® MagPix®), using standard calibration curves.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 8 (IL-8), pg/mL
Determined using multiplex fluorescence-based immunoassay with magnetic bead differentiation and spectral laser detection.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 10 (IL-10), pg/mL
Plasma levels will be assessed using a validated multiplex Luminex® panel, enabling parallel cytokine detection.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Tumor Necrosis Factor Alpha (TNF-α), pg/mL
Measured by multiplex immunoassay with magnetic beads on the Luminex® platform; assay sensitivity <1 pg/mL.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interferon Gamma (INF-γ), pg/mL
Quantified using bead-based multiplex immunoassay with MagPix® system and fluorophore-labeled secondary antibodies.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Vascular Endothelial Growth Factor (VEGF), pg/mL
Determined by multiplex immunoassay using magnetic beads, with detection by Luminex® MagPix® laser-based fluorescence reader.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Monocyte Chemoattractant Protein 1 (MCP-1), pg/mL
Assessed using a Luminex®-based multiplex immunoassay with internal controls and duplicate sampling.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Free Plasma Amino Acids (HPLC), nmol/mL
Quantified by high-performance liquid chromatography (HPLC) with pre-column derivatization using o-phthaldialdehyde (OPA) and fluorescence detection (excitation: 340 nm; emission: 450 nm).
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Malondialdehyde (MDA), nmol/mL
Measured by the thiobarbituric acid reactive substances (TBARS) assay, with spectrophotometric reading at 532 nm.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Reduced Glutathione (GSH), µmol/L
Quantified by spectrophotometric method using DTNB (5,5'-dithiobis-(2-nitrobenzoic acid)), with absorbance measured at 412 nm.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Total Hydroperoxides (FOX), µmol/L
Measured using the Ferrous Oxidation-Xylenol Orange (FOX) method with absorbance at 560 nm.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Total Antioxidant Capacity (TAC), mmol/L
Assessed using the ABTS+ radical cation decolorization assay with spectrophotometric analysis.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Ferric Reducing Ability of Plasma (FRAP), mmol/L
Quantified using the FRAP assay, based on the reduction of Fe3+ to Fe2+, measured at 593 nm.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Heat Shock Protein 70 (HSP70), ng/mL
Plasma concentrations will be measured using sandwich-type enzyme-linked immunosorbent assay (ELISA), with detection at 450 nm after chromogenic substrate reaction.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Fibronectin, µg/mL
Quantified by high-sensitivity ELISA using monoclonal antibodies specific for fibronectin. Detection will be performed at 450 nm, using manufacturer-calibrated standard curves.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Laminin, µg/mL
Determined by validated ELISA sandwich assay with photometric quantification at 450 nm. Assay will be conducted in duplicate with quality controls and external calibrators.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Ceramides, ng/mL
Quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) after lipid extraction via the Folch method. Identification and quantification will be based on retention times and certified external standards.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Sphingolipids, ng/mL
Plasma concentrations will be determined using validated LC-MS/MS protocols with external calibrators, after sample preparation by chloroform/methanol extraction.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Cardiolipins, ng/mL
Quantified by LC-MS/MS using C18 chromatographic separation and tandem MS detection, with identification based on spectral patterns and standard curves.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Prostaglandins, pg/mL
Determined by LC-MS/MS with high-sensitivity detection and external calibration for absolute quantification. Sample preparation follows established lipidomic protocols.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Leukotrienes, pg/mL
Measured using targeted LC-MS/MS following Folch lipid extraction. Identification and quantification will be conducted against authentic leukotriene standards.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Pancreatic Remnant Volume, cm³
The remnant pancreatic volume will be measured using computed tomography (CT) and/or magnetic resonance imaging (MRI). Volumetric analysis will be performed through three-dimensional segmentation using 3D Slicer software.
Measured: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jul 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary NeoplasmsStudies 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
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Marco Aurélio Ribeiro, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor-investigator, Marco Aurélio Ribeiro, PhD, University of Sao Paulo
- Investigators
- Marco A Ribeiro, PhD, MSc, BSc, RD, Principal investigator, University of Sao PauloAnderson M Navarro, Prof, PhD, MSc, BSc, RD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159672
- Sponsor's protocol ID
- 64695422.6.0000.5440
- Other IDs
- 88887.827259/2023-00, 141784/2025-3, Finance Code 001, 63993522.3.0000.5440, 64695422.6.0000.5440
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to ethical considerations and institutional policy regarding data confidentiality. The dataset contains sensitive health information, and there are no current plans or infrastructure in place for secure external sharing.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Nutritional, Metabolic, Molecular, and Volumetric Assessment of the Remnant Pancreas in Patients With Periampullary Malignancies Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT07159672
- Acronym / sponsor ID
- 64695422.6.0000.5440
- Keywords
- Nutritional Assessment, Resting Energy Expenditure, Bioimpedance Analysis, Molecular Biomarkers, Oxidative Stress, Proteomics, Lipidomics, Pancreatic Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Marco Aurélio Ribeiro, PhDUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 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.
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.
Detailed description
Periampullary malignant neoplasms are lethal gastrointestinal tumors that are often diagnosed at advanced stages and require complex surgical intervention. Pancreaticoduodenectomy, the gold standard for resectable disease, has profound effects on nutritional status, exocrine pancreatic function, and the structural integrity of the remaining pancreas. Despite recent advances, significant gaps remain in our understanding of the volumetric and molecular alterations that occur postoperatively and how these alterations interact with body composition, resting energy expenditure, and biochemical markers.
This is a prospective, longitudinal, controlled, clinical-translational cohort study. Data on clinical, nutritional, biochemical, and plasma parameters will be collected at three time points for the experimental group (preoperatively and 3 and 6 months after hospital discharge) and one time point for the control group. Plasma samples will be stored at -80 °C and analyzed using validated techniques, including multiplex assays, spectrophotometry, ELISA, and tandem mass spectrometry (LC-MS/MS) to detect inflammatory biomarkers (IL-1β, , IL-6, TNF-α, and MCP-1; oxidative markers (MDA, GSH, TAC, and FRAP); proteomic targets (HSP70, fibronectin, and laminin); and lipidomic profiles (ceramides, sphingolipids, and cardiolipins). Abdominal imaging (CT and/or MRI) will be processed using 3D Slicer software to estimate the volume of the remnant pancreas via three-dimensional segmentation.
Statistical analyses will be conducted in RStudio. We will apply mixed linear models (MLM and MLMG), incorporating fixed and random effects to account for intra- and inter-individual variability. Missing not-at-random data will be addressed using multiple imputation by chained equations (MICE), and pooled estimates will be calculated according to Rubin's rules. We will set statistical significance at p < 0.05 with Holm-Bonferroni correction for multiple comparisons.
This integrative approach ensures methodological rigor, bias control, and robust inference. It has the potential to guide personalized, evidence-based nutritional strategies in the context of pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreaticoduodenectomy Group | – | Procedure: PancreaticoduodenectomyPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| PancreaticoduodenectomyAlso: Whipple procedure, Pylorus-preserving pancreaticoduodenectomyPancreaticoduodenectomy (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. | Procedure or surgery | Pancreaticoduodenectomy Group |
Primary outcome
Resting Energy Expenditure (REE) in kcal/day
Time frame: Day 0 (preoperative), 3 months post-discharge, and 6 months post-discharge
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).
50 secondary outcomes
Fat-Free Mass (kg) measured by multifrequency bioimpedance analysis
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Fat Mass (kg) measured by multifrequency bioimpedance analysis
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Hydration Status (%) assessed by bioimpedance analysis
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Phase Angle (°) assessed by bioimpedance analys
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Total Serum Protein (g/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Albumin (g/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum C-Reactive Protein - CRP (mg/L)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Fasting Glucose (mg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Hemoglobin (g/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Absolute Lymphocyte Count (×10³/mm³)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Iron (µg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Ferritin (ng/mL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Latent Iron-Binding Capacity - LIBC (µg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Transferrin (mg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Transferrin Saturation (%)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Urea (mg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Creatinine (mg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
AST (U/L)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
ALT (U/L)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Folate - Vitamin B9 (ng/mL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Serum Vitamin B12 (pg/mL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Vitamin A - Retinol (µg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Vitamin E - Alpha-tocopherol (mg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Copper (µg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Plasma Zinc (µg/dL)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Sudan III Stool Test (qualitative)
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 1 beta (IL-1β), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 4 (IL-4), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 6 (IL-6), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 8 (IL-8), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interleukin 10 (IL-10), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Tumor Necrosis Factor Alpha (TNF-α), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Interferon Gamma (INF-γ), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Vascular Endothelial Growth Factor (VEGF), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Monocyte Chemoattractant Protein 1 (MCP-1), pg/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Free Plasma Amino Acids (HPLC), nmol/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Malondialdehyde (MDA), nmol/mL
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Reduced Glutathione (GSH), µmol/L
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Total Hydroperoxides (FOX), µmol/L
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
Total Antioxidant Capacity (TAC), mmol/L
Time frame: Day 0 (preoperative), 3 months post-discharge, 6 months post-discharge
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 8 Sep 2025.
- Official website of the Ribeirão Preto Medical School, University of São Paulo (FMRP-USP).Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared due to ethical considerations and institutional policy regarding data confidentiality. The dataset contains sensitive health information, and there are no current plans or infrastructure in place for secure external sharing.
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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.
Marco A Ribeiro, PhD, MSc, BSc, RD principal investigator
University of Sao Paulo
Anderson M Navarro, Prof, PhD, MSc, BSc, RD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periampullary Neoplasms and Pancreatic Cancer, run by Marco Aurélio Ribeiro, PhD at 1 site in Brazil.
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 6 inclusion and 10 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Resting Energy Expenditure (REE) in kcal/day (time frame: Day 0 (preoperative), 3 months post-discharge, and 6 months post-discharge). 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 8 Sep 2025.