Gastric CancerNCT04490668
Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery
An observational study of Gastric Cancer and Anastomotic Leak, run by Ruijin Hospital.
Trial summary
We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer, Anastomotic Leak
- What is being tested?
- Human albumin
- Type of treatment
- Injection or infusion
- How many people
- 1,049 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastric cancer who underwent gastrectomy with adequate lymph node dissection.
Who may be able to join
- Histologically confirmed gastric cancer
- Patients who underwent radical gastrectomy
Who cannot join
- Patient who did not undergo gastrectomy
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer, Anastomotic Leak
- Being tested
- Human albumin
- Keywords
- Gastric Cancer, Anastomotic leakage, Human albumin
- Medical subject headings
- Stomach Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminBiological
Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Human albumin support | Patients who received intravenous human albumin after gastric cancer surgery Receives: Biological: Human albumin | |
| No human albumin support | Patients who did not receive intravenous human albumin after gastric cancer surgery Receives: Biological: Human albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of anastomotic leakage
The rate of anastomotic leakage were compared among both groups
Measured: Up to one months after the discharge of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Jan 2016
- Primary completion31 Jul 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BIRENDRA KUMAR SAH, Ruijin Hospital
- Investigators
- Birendra K Sah, PH D, Principal investigator, Ruijin HospitalChen Li, PH D, Study director, Ruijin HospitalZhenggang Zhu, PH D, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490668
- Sponsor's protocol ID
- RJ-GC-Postop-complication 3
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT04490668
- Acronym / sponsor ID
- RJ-GC-Postop-complication 3
- Conditions
- Gastric Cancer, Anastomotic Leak
- Keywords
- Gastric Cancer, Anastomotic leakage, Human albumin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,049 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human albumin support | – | Biological: Human albuminPatients who received intravenous human albumin after gastric cancer surgery |
| No human albumin support | – | Biological: Human albuminPatients who did not receive intravenous human albumin after gastric cancer surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastric cancer who underwent gastrectomy with adequate lymph node dissection.
Key inclusion criteria (2 listed)
- Histologically confirmed gastric cancer
- Patients who underwent radical gastrectomy
Key exclusion criteria (1 listed)
- Patient who did not undergo gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human albuminPatients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded. | Biological | Human albumin support, No human albumin support |
Primary outcome
Comparison of the rate of anastomotic leakage
Time frame: Up to one months after the discharge of last patient
The rate of anastomotic leakage were compared among both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birendra K Sah, PH D principal investigator
Ruijin Hospital
Chen Li, PH D study director
Ruijin Hospital
Zhenggang Zhu, PH D study chair
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Anastomotic Leak, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the rate of anastomotic leakage (time frame: Up to one months after the discharge of last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.