NCT07159672Completed

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 · Last updated 8 Sept 2025

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Observational
Enrollment: 44 (actual)
First submitted: 22 Aug 2025
Start date: 1 Jul 2023
Primary completion date: 31 Dec 2024
Lead sponsor: Marco Aurélio Ribeiro, PhD
Diseases: Pancreatic cancer
NCT number: NCT07159672

What you commit to

Study type: Observational
Participants enrolled: 44
From 1 Jul 2023 to the primary completion date, 31 Dec 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous pancreatic surgery;
Use of systemic immunosuppressive therapy (e.g., corticosteroids \>10 mg/day prednisone equivalent, chemotherapy, biologics);

Other illness

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;
Diagnosed malabsorption syndromes unrelated to pancreatic disease;

Lab values

Severe hepatic dysfunction or severe renal impairment (eGFR \<30 mL/min/1.73m²);

Other

Pancreaticoduodenectomy performed outside the study institution;
Pregnancy or breastfeeding;
Refusal or inability to attend scheduled follow-up visits within 6 months;

Who the study is looking for

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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Ribeirão Preto Medical School University of São Paulo Coordinator of this site? Confirm its status	Ribeirão Preto	Brazil	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.