NCT07119463 Effect of Goal-Oriented Albumin Infusion on Postoperative Complication Management in Gastric Cancer Surgery
| NCT ID | NCT07119463 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Hospital of Jilin University |
| Condition | Postoperative Hypoalbuminemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2024-10-29 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Yuchen Guo, Ph.D.
PRINCIPAL INVESTIGATOR
The First Hospital of Jilin University
Frequently Asked Questions
Who can join the NCT07119463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Postoperative Hypoalbuminemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07119463 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07119463 currently recruiting?
Yes, NCT07119463 is actively recruiting participants. Contact the research team at guoyuchen8688@jlu.edu.cn for enrollment information.
Where is the NCT07119463 trial being conducted?
This trial is being conducted at Changchun, China.
Who is sponsoring the NCT07119463 clinical trial?
NCT07119463 is sponsored by The First Hospital of Jilin University. The principal investigator is Yuchen Guo, Ph.D. at The First Hospital of Jilin University. The trial plans to enroll 112 participants.