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

NCT07119463 | Recruiting Phase 2

• 1 other identifier: GOAI
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Hypoalbuminemia; Postoperative Complications; Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Complications (Clavien-Dindo Grade III or Above)

  The primary outcome measure is the incidence of severe postoperative complications graded as Clavien-Dindo Grade III or above. These complications include those requiring surgical, endoscopic, or radiological intervention, or resulting in life-threatening conditions or mortality. The measure aims to compare the effects of two different albumin infusion thresholds (25 g/L vs. 30 g/L) on the rate of severe complications within the study period.

  30 Days Post-Surgery

Secondary Outcomes (4)

• Serum Albumin Levels Post-Surgery

  7 Days Post-Surgery

• Length of Hospital Stay

  From the day of surgery to the day of discharge (up to 30days)

• Gastrointestinal Recovery

  Postoperative Day 1 to Day of Discharge (approximately Day 7）

• Overall Postoperative Complication Rate

  30 Days Post-Surgery

Study Arms (2)

Low Albumin Threshold Group（25g/L）（LAT Group）

EXPERIMENTAL

Participants in this group will receive albumin infusion when serum albumin levels fall below 25 g/L during the postoperative period. The intervention aims to maintain serum albumin levels above this threshold to evaluate its impact on complications and recovery.

Drug: Human Serum Albumin Infusion for LAT Group

High Albumin Threshold Group (30 g/L)(HAT Group)

ACTIVE COMPARATOR

Participants in this group will receive albumin infusion when serum albumin levels fall below 30 g/L during the postoperative period. This group serves as the control to compare the effects of a higher albumin threshold on complications and recovery.

Drug: Human Serum Albumin Infusion for HAT Group

Interventions

Human Serum Albumin Infusion for LAT Group DRUG

Participants in this group will receive human serum albumin infusion when their serum albumin level falls below 25 g/L. The infusion is goal-oriented, with the aim of maintaining albumin levels above 25 g/L during the postoperative period. The dose is calculated based on the albumin deficit and patient weight to ensure optimal therapeutic effect.

Low Albumin Threshold Group（25g/L）（LAT Group）

Human Serum Albumin Infusion for HAT Group DRUG

Participants in this group will receive human serum albumin infusion when their serum albumin level falls below 30 g/L. The intervention aims to maintain albumin levels above 30 g/L during the postoperative period. The dose is similarly calculated based on the albumin deficit and patient weight.

High Albumin Threshold Group (30 g/L)(HAT Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• Intraoperative blood loss is greater than 500ml.
• Preoperative hemoglobin \<70g/L.
• Receive neoadjuvant radiotherapy before surgery.
• Patients who require combined organ resection.
• Patients who are found to have distant metastasis during intraoperative exploration, or who can not undergo radical resection.
• Withdrawal Criteria:
• \) 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yuchen Guo, Ph.D.

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuchen Guo, Ph.D.

CONTACT

0086+13630598312; guoyuchen8688@jlu.edu.cn

Helei Wang, Ph.D.

CONTACT

0086+13944162278; helei@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 13, 2025
• Study Start: October 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after we complete our study.
• Access Criteria: Researchers can provide valid reasons or demonstrate a need for additional collaboration with us.

Locations

CN (1)