Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery

NCT ID: NCT04490668

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1049 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer Anastomotic Leak

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Human albumin support

Patients who received intravenous human albumin after gastric cancer surgery

Human albumin

Intervention Type BIOLOGICAL

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

Human albumin

Intervention Type BIOLOGICAL

Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.

Interventions

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Human albumin

Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed gastric cancer
* Patients who underwent radical gastrectomy

Exclusion Criteria

* Patient who did not undergo gastrectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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BIRENDRA KUMAR SAH

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birendra K Sah, PH D

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Chen Li, PH D

Role: STUDY_DIRECTOR

Ruijin Hospital

Zhenggang Zhu, PH D

Role: STUDY_CHAIR

Ruijin Hospital

Other Identifiers

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RJ-GC-Postop-complication 3

Identifier Type: -

Identifier Source: org_study_id

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