RecruitingPhase 2NCT07119463

Effect of Goal-Oriented Albumin Infusion on Postoperative Complication Management in Gastric Cancer Surgery

The Application and Effect of Goal-oriented Albumin Infusion in the Control of Postoperative Complications in Patients With Gastric Cancer - a Single-center Prospective Non- Randomized Controlled Study

Sponsor

The First Hospital of Jilin University

Enrollment

112 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Postoperative Complications Postoperative Hypoalbuminemia

Summary

This study aims to evaluate the impact of goal-oriented albumin infusion on short-term postoperative outcomes in gastric cancer patients. It is a single-center, prospective, non-randomized controlled study. Patients are divided into two groups: the experimental group receives albumin infusion when serum albumin levels fall below 25 g/L, while the control group receives albumin infusion when levels fall below 30 g/L. The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days post-surgery. Secondary endpoints include nutritional recovery, gastrointestinal function recovery, hospital stay duration, and overall complication rates. The study seeks to optimize perioperative albumin management strategies and improve clinical outcomes.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving albumin infusions (a protein-based IV fluid) in a targeted, goal-directed way can reduce complications after stomach cancer surgery. Albumin levels often drop after major surgery, and researchers want to know if keeping them within a specific range helps patients recover better. **You may be eligible if...** - You are aged 18–80 and scheduled for laparoscopic or open gastric (stomach) cancer surgery - Your cancer has been confirmed by pathology - Your cancer is stage I–III based on pre-surgery CT scan - Your pre-surgery albumin level and nutrition score are within acceptable ranges **You may NOT be eligible if...** - You have severe heart, kidney, or liver disease that would make fluid management risky - You have a known allergy to albumin - You are pregnant - You have stage IV (metastatic) cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman Serum Albumin Infusion for LAT Group

Participants in this group will receive human serum albumin infusion when their serum albumin level falls below 25 g/L. The infusion is goal-oriented, with the aim of maintaining albumin levels above 25 g/L during the postoperative period. The dose is calculated based on the albumin deficit and patient weight to ensure optimal therapeutic effect.

DRUGHuman Serum Albumin Infusion for HAT Group

Participants in this group will receive human serum albumin infusion when their serum albumin level falls below 30 g/L. The intervention aims to maintain albumin levels above 30 g/L during the postoperative period. The dose is similarly calculated based on the albumin deficit and patient weight.

Locations(1)

First Hospital of Jilin University

Changchun, Jilin, China

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NCT07119463

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