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

Jilin University

Status and phase: Enrolling; Phase 2

Conditions: Postoperative Complications; Postoperative Hypoalbuminemia; Gastric Cancer

Treatments: Drug: Human Serum Albumin Infusion for LAT Group; Drug: Human Serum Albumin Infusion for HAT Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07119463

GOAI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age range: 18 to 80 years old, suitable for patients undergoing gastric cancer surgery.
2. Gastric cancer diagnosis: gastric cancer patients confirmed by pathology, regardless of pathological type.
3. Cancer staging: Patients with preoperative CT assessment of TNM stage I to III and undergoing laparoscopic gastric cancer surgery or open gastric cancer surgery can be included.
4. Preoperative nutritional status: serum albumin level ≥ 30g/L, NRS-2002 score ≤ 2.
5. Type of surgery: patients who undergo any radical gastric cancer surgery (no restriction on surgical type, covering partial gastrectomy, total gastrectomy, etc.).
6. The patient gave informed consent to this study and signed the corresponding informed consent form.
7. ASA classification I-III.
8. ECOG score ≤ 2

Exclusion criteria

1. Preoperative acute infection: Acute infection or acute complications (such as pneumonia, urinary tract infection, gastrointestinal bleeding, perforation, obstruction, etc.) have been diagnosed before surgery.
2. Immunosuppressed patients: such as long-term use of immunosuppressants (such as glucocorticoids), organ transplant patients, or those who have been diagnosed with HIV infection.
3. Serious basic diseases: such as severe liver insufficiency (Child Pugh class B or C), renal insufficiency (serum creatinine>133umol/L), severe cardiac insufficiency (NYHA class III and above), severe pulmonary insufficiency (preoperative blood gas analysis PaO2 ≤ 60mmHg).
4. Patients with a history of albumin allergy.
5. Intraoperative blood loss is greater than 500ml.
6. Preoperative hemoglobin <70g/L.
7. Receive neoadjuvant radiotherapy before surgery.
8. Patients who require combined organ resection.
9. Patients who are found to have distant metastasis during intraoperative exploration, or who can not undergo radical resection.

Withdrawal Criteria:

1. During the trial, the subjects suffered severe allergic reactions due to albumin infusion, such as acute anaphylactic shock, airway edema, hypotension, etc., and were not suitable for continued use of albumin. 2) If the subject clearly expresses his unwillingness to continue participating in the experiment due to personal reasons, even if his physical condition allows continued intervention, respect the patient's wishes and terminate his participation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Low Albumin Threshold Group（25g/L）（LAT Group）

Experimental group

Description:

Participants in this group will receive albumin infusion when serum albumin levels fall below 25 g/L during the postoperative period. The intervention aims to maintain serum albumin levels above this threshold to evaluate its impact on complications and recovery.

Treatment:

Drug: Human Serum Albumin Infusion for LAT Group

High Albumin Threshold Group (30 g/L)(HAT Group)

Active Comparator group

Description:

Participants in this group will receive albumin infusion when serum albumin levels fall below 30 g/L during the postoperative period. This group serves as the control to compare the effects of a higher albumin threshold on complications and recovery.

Treatment:

Drug: Human Serum Albumin Infusion for HAT Group