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To evaluate the timing and efficacy of parenteral nutrition supplemented with ?-3 triglyceride in the early stage after gastrointestinal reconstruction

To evaluate the timing and efficacy of parenteral nutrition supplemented with ?-3 triglyceride in the early stage after gastrointestinal reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095665
Enrollment
Unknown
Registered
2025-01-10
Start date
2025-01-24
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

After gastrointestinal reconstruction surgery

Interventions

Experimental group:The first initiation of parenteral nutrition supplemented with ?-3 triglycerides occurred between 24 and 48 hours postoperatively
Control group:The first initiation of parenteral nutrition supplemented with ?-3 triglycerides occurred between 48 and 72 hours postoperatively

Sponsors

The Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 80 years old, regardless of gender; (2) Diagnosed with gastric cancer, pancreatic cancer, lower bile duct cancer, or duodenal cancer by pathology, without distant metastasis, and scheduled to undergo gastrointestinal anastomosis (subtotal/total gastrectomy) or pancreatoduodenectomy. The surgery should be performed by a senior surgeon (associate chief physician or above), and the surgical approach can be robotic-assisted, laparoscopic, or open. (3)Expected to require parenteral nutrition support for =5 days postoperatively; (4) American Society of Anesthesiologists (ASA) physical status classification I-III; (5)The patient or their family member has signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Allergy to ?-3 triglycerides or other components of the medication (such as egg or soybean protein, peanut protein, or other ingredients in the prescription); (2) Presence of severe malnutrition (e.g., body mass index <18.5 kg/m², or serum albumin <30 g/L); (3) Contraindications for enteral nutrition; (4) Concurrent severe dysfunction of important organs such as the heart, liver, or kidneys; (5) Coagulation dysfunction; (6) Suffering from immune system diseases or undergoing immunosuppressive therapy, or having undergone splenectomy; (7) Pregnant or lactating women; (8) Patients with mental disorders or unable to cooperate with treatment and follow-up; (9) Presence of general intravenous infusion contraindications, electrolyte and fluid balance disorders, metabolic disorders (including protein metabolism disorders, lipid metabolism disorders, and hyperglycemia unresponsive to a 6-unit insulin/hour dose) during the screening period; (10) Occurrence of severe complications during surgery (such as hemorrhagic shock, acute single-organ or multiple-organ dysfunction, etc.); (11) Other factors deemed unsuitable for participation in this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Nutritional Indicators: Prognostic nutritional index (PNI) = serum albumin (g/L) +5× total peripheral blood lymphocytes (× 109/L);Inflammatory Indicators;

Secondary

MeasureTime frame
Nutritional Indicators: Serum albumin, prealbumin, transferrin, retinol-binding protein, nitrogen balance, Body mass index, triceps skinfold thickness and mid-upper arm muscle circumference;Immunological Indicators;Clinical Indicators;Recovery Indicators;

Countries

China

Contacts

Public ContactZhou Wence

The Second Hospital of Lanzhou University

zhouwc129@163.com+86 138 9369 9909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026