NCT04490668

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,049

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

July 26, 2020

Last Update Submit

July 26, 2020

Conditions

Gastric CancerAnastomotic Leak

Keywords

Gastric CancerAnastomotic leakageHuman albumin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Human albumin support

Patients who received intravenous human albumin after gastric cancer surgery

Biological: Human albumin

No human albumin support

Patients who did not receive intravenous human albumin after gastric cancer surgery

Biological: Human albumin

Interventions

Human albuminBIOLOGICAL

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

Human albumin supportNo human albumin support

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Histologically confirmed gastric cancer
  • Patients who underwent radical gastrectomy

You may not qualify if:

  • Patient who did not undergo gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsAnastomotic Leak

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Birendra K Sah, PH D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

  • Chen Li, PH D

    Ruijin Hospital

    STUDY DIRECTOR

  • Zhenggang Zhu, PH D

    Ruijin Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 26, 2020

First Posted

July 29, 2020

Study Start

January 1, 2016

Primary Completion

July 31, 2018

Study Completion

December 30, 2019

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share