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Search / Trial NCT07119463

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

Launched by THE FIRST HOSPITAL OF JILIN UNIVERSITY · Aug 12, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Gastric Cancer Postoperative Hypoalbuminemia Albumin Infusion Goal Oriented Therapy Postoperative Complications Clavien Dindo Classification Nutritional Support

ClinConnect Summary

This clinical trial is studying whether giving patients a medicine called albumin, based on specific blood levels, can help reduce serious complications after stomach cancer surgery. Albumin is a protein in the blood that can drop after surgery, which might affect recovery. The study compares two groups: one gets albumin when their blood levels fall below a certain low point (25 g/L), and the other when levels fall below a slightly higher point (30 g/L). Researchers want to see if this “goal-oriented” approach helps patients recover better, have fewer serious problems, and spend less time in the hospital.

Adults aged 18 to 80 with confirmed stomach cancer who are having surgery to remove the cancer may be eligible. To join, patients need to have good nutritional status before surgery and no serious infections or other major health problems like severe liver or kidney issues. During the study, participants will have their blood albumin levels monitored closely, and albumin will be given based on the group they’re in. The study will track complications that happen within 30 days after surgery and look at how well patients recover overall. If you’re considering joining, it’s important to know that the research team will respect your decision if you choose to stop at any time, and they will watch carefully for any side effects from the albumin treatment.

Gender

ALL

Eligibility criteria

  • 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.

About The First Hospital Of Jilin University

The First Hospital of Jilin University is a prestigious academic medical center located in Changchun, China, dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a leading institution in medical education and research, the hospital actively engages in a wide range of clinical trials aimed at improving treatment outcomes and enhancing patient safety across various specialties. With a commitment to excellence, the First Hospital collaborates with multidisciplinary teams of healthcare professionals, leveraging cutting-edge technologies and methodologies to contribute to the global body of medical knowledge.

Locations

Changchun, Jilin, China

Patients applied

0 patients applied

Trial Officials

Yuchen Guo, Ph.D.

Principal Investigator

The First Hospital of Jilin University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported