Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery

Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery

We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Anastomotic Leak
• Intervention / Treatment: Biological: Human albumin

Detailed Description

Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. Anastomotic leakage severely compromises the recovery after surgery. It increases the overall burden of patients and hospital resources. Postoperative mortality is higher in patients with anastomotic leakage.

Human albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

• Study Type: Observational
• Enrollment (Actual): 1049

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with gastric cancer who underwent gastrectomy with adequate lymph node dissection.

Description

Inclusion Criteria:

• Histologically confirmed gastric cancer
• Patients who underwent radical gastrectomy

Exclusion Criteria:

• Patient who did not undergo gastrectomy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Human albumin support; Patients who received intravenous human albumin after gastric cancer surgery	Biological: Human albumin; Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.
No human albumin support; Patients who did not receive intravenous human albumin after gastric cancer surgery	Biological: Human albumin; Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the rate of anastomotic leakage	The rate of anastomotic leakage were compared among both groups	Up to one months after the discharge of last patient

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Gastric Cancer; Anastomotic leakage; Human albumin
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Anastomotic Leak
• Other Study ID Numbers: RJ-GC-Postop-complication 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No