NCT07119463RecruitingPhase 2
Effect of Goal-Oriented Albumin Infusion on Postoperative Complication Management in 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
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 19 Jun 2025
- Start date
- 29 Oct 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07119463
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 112
- From 29 Oct 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receive neoadjuvant radiotherapy before surgery.
- Patients who require combined organ resection.
Other illness
- Preoperative acute infection: Acute infection or acute complications (such as pneumonia, urinary tract infection, gastrointestinal bleeding, perforation, obstruction, etc.) have been diagnosed before surgery.
- Immunosuppressed patients: such as long-term use of immunosuppressants (such as glucocorticoids), organ transplant patients, or those who have been diagnosed with HIV infection.
Lab values
- 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).
- Patients with a history of albumin allergy.
- Preoperative hemoglobin \<70g/L.
- 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.
Other
- Intraoperative blood loss is greater than 500ml.
Who the study is looking for
- Age range: 18 to 80 years old, suitable for patients undergoing gastric cancer surgery.
- Gastric cancer diagnosis: gastric cancer patients confirmed by pathology, regardless of pathological type.
- 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.
- Preoperative nutritional status: serum albumin level ≥ 30g/L, NRS-2002 score ≤ 2.
- Type of surgery: patients who undergo any radical gastric cancer surgery (no restriction on surgical type, covering partial gastrectomy, total gastrectomy, etc.).
- The patient gave informed consent to this study and signed the corresponding informed consent form.
- ASA classification I-III.
- ECOG score ≤ 2
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.