Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery

Gastric Cancer Clinical Trial

Official title:

Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490668
• Other study ID #: RJ-GC-Postop-complication 3
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1049
• Est. completion date: December 30, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed gastric cancer

• Patients who underwent radical gastrectomy

Exclusion Criteria:

• Patient who did not undergo gastrectomy

Related Conditions & MeSH terms

• Anastomotic Leak
• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• Human albumin
Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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