Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07119463

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

Led by The First Hospital of Jilin University · Updated on 2025-08-13

112

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Diagnosed with gastric cancer confirmed by pathology
  • Preoperative CT staging of TNM stage I to III
  • Undergoing laparoscopic or open radical gastric cancer surgery
  • Preoperative serum albumin level at least 30 g/L
  • Nutritional Risk Screening 2002 (NRS-2002) score of 2 or less
  • Undergoing any type of radical gastric cancer surgery (partial or total gastrectomy)
  • Provided informed consent for the study
  • American Society of Anesthesiologists (ASA) classification I to III
  • Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
Not Eligible

You will not qualify if you...

  • Having acute infections or acute complications before surgery (e.g., pneumonia, urinary tract infection, gastrointestinal bleeding, perforation, obstruction)
  • Using immunosuppressants long-term, organ transplant recipient, or diagnosed with HIV infection
  • Severe liver insufficiency (Child Pugh class B or C)
  • Renal insufficiency with serum creatinine over 133 umol/L
  • Severe cardiac insufficiency (NYHA class III or above)
  • Severe pulmonary insufficiency with preoperative blood gas PaO2 60 mmHg or less
  • History of albumin allergy
  • Intraoperative blood loss over 500 ml
  • Preoperative hemoglobin below 70 g/L
  • Received neoadjuvant radiotherapy before surgery
  • Requiring combined organ resection
  • Found to have distant metastasis during surgery or unable to undergo radical resection

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

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Research Team

Y

Yuchen Guo, Ph.D.

CONTACT

H

Helei Wang, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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