NCT07119463

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Detailed Description: This study evaluates the application and impact of goal-oriented albumin infusion in managing postoperative complications in gastric cancer patients. It is designed as a single-center, prospective, non-randomized controlled trial. The study population includes adult patients (18-80 years) undergoing radical gastric cancer surgery. Patients are divided into two groups: Experimental Group: Albumin infusion is initiated when serum albumin levels fall below 25 g/L, aiming to maintain levels above this threshold. Control Group: Albumin infusion is initiated when serum albumin levels fall below 30 g/L, maintaining levels above this threshold. The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days postoperatively. Secondary endpoints include nutritional status recovery (albumin levels within the first 7 days), hospital stay duration, gastrointestinal recovery (first flatus and bowel movement), and overall complication rates. This study dynamically monitors albumin levels and evaluates the effects of different infusion standards on short-term postoperative outcomes. By analyzing these outcomes, the research aims to provide evidence-based recommendations for optimizing perioperative albumin management strategies in gastric cancer patients. Albumin infusions are conducted following established protocols, with dosage calculated based on the patient's serum albumin levels and weight. Strict inclusion and exclusion criteria ensure participant safety and study validity. Adverse events are monitored closely, and any serious events are reported to the ethics committee promptly. Data will be collected using electronic case report forms (eCRFs) and analyzed using appropriate statistical methods, including propensity score matching and multivariable regression, to control for potential confounding factors. The study's findings will contribute to improving postoperative care in gastric cancer patients.

Conditions

• Postoperative Hypoalbuminemia
• Postoperative Complications
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Human 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.
DRUG	Human 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.

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: China