Clinical trial · Observational
Cohort Study on Nutritional, Metabolic, and Volumetric Assessment After Pancreaticoduodenectomy
Prospective Cohort Study of Nutritional, Metabolic, Molecular, and Volumetric Assessment of the Remnant Pancreas in Patients With Periampullary Malignancies Undergoing Pancreaticoduodenectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreaticoduodenectomy | — | UNRESOLVED | — |
| Periampullary Neoplasms | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pancreaticoduodenectomy Group
- description
- 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.
- interventionNames
- Procedure: Pancreaticoduodenectomy
- label
- Control Group
- description
- 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.
Primary outcomes (1)
- measure
- Resting Energy Expenditure (REE) in kcal/day
- timeFrame
- Day 0 (preoperative), 3 months post-discharge, and 6 months post-discharge
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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;
References
Publications (0)
Data not yet available