Status:
COMPLETED
Cohort Study on Nutritional, Metabolic, and Volumetric Assessment After Pancreaticoduodenectomy
Lead Sponsor:
Marco Aurélio Ribeiro, PhD
Collaborating Sponsors:
University of Sao Paulo
Conditions:
Periampullary Neoplasms
Pancreatic Cancer
Eligibility:
All Genders
18-80 years
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 ...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07159672
Start Date
July 1 2023
End Date
December 31 2024
Last Update
September 8 2025
Active Locations (1)
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1
Ribeirão Preto Medical School University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14.048-900