Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07119463

PHASE2

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

Sponsor: The First Hospital of Jilin University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2024-10-29

Completion Date

2026-06-01

Last Updated

2025-08-13

Healthy Volunteers

Conditions

Postoperative Hypoalbuminemia Postoperative Complications Gastric Cancer

Interventions

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.

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.

Locations (1)

First Hospital of Jilin University

Changchun, Jilin, China