Goal-oriented albumin infusion to reduce complications after gastric cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, non-randomized controlled Phase 2 trial enrolling adults (18–80) undergoing radical gastric cancer surgery. Participants are assigned to two groups: one receives albumin infusion when serum albumin falls below 25 g/L and the other when it falls below 30 g/L, with dosing based on weight and albumin level. The primary outcome is the rate of major complications (Clavien-Dindo grade III or higher) within 30 days after surgery. Secondary outcomes include early nutritional recovery, return of gastrointestinal function, overall complication rate, and length of hospital stay.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Principal investigator: Yuchen Guo, Ph.D. — The First Hospital of Jilin University
• Study coordinator: Yuchen Guo, Ph.D.
• Email: guoyuchen8688@jlu.edu.cn
• Phone: 0086+13630598312

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.