Goal-oriented albumin infusion to reduce complications after 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
This test tries to see if giving albumin when blood levels drop below 25 g/L instead of 30 g/L after gastric cancer surgery reduces serious postoperative complications in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07119463 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with pathologically confirmed gastric cancer (preoperative CT stage I–III) who are scheduled for radical gastric surgery, have preoperative serum albumin ≥30 g/L, NRS-2002 ≤2, ASA I–III, and ECOG ≤2 are ideal candidates.
Not a fit: Patients with preoperative acute infections, emergency complications, preoperative albumin below 30 g/L, or other conditions preventing safe albumin infusion or follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce major postoperative complications and shorten hospital stays by targeting albumin replacement more effectively.
How similar studies have performed: Previous research on perioperative albumin supplementation has shown mixed results, and goal-oriented lower-threshold strategies like this are relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changchun, Jilin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.