Liver CancerNCT01292330
A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
A study testing nutritional support before operation in people with Liver Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After Preoperative Nutritional Support. Study design: 1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking Union Medical College Hospital (PUMCH). Study arrangement: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- nutritional support before operation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Nov 2011
- Phase
- Interventional
- 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
Who may be able to join
- A diagnosis of hepatocellular carcinoma (HCC) was made before operation
- Nutritional Risk Screening 2002(NRS-2002) was Greater or equal 3 points with in 24 hours after admission
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yilei Mao
Beijing, Beijing Municipality, 100730
Yilei Mao, associate professor, 86-10-65296042, liying1272@126.com
About this study
Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After Preoperative Nutritional Support.
Study design:
1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking Union Medical College Hospital (PUMCH).
Study arrangement:
- The collection of patients with selected standard
- Preoperative evaluation included nutritional status,liver function and tumor characteristics
- The experimental group received Preoperative Nutritional Support for 4 days,the control group got nothing
- Both groups received conventional therapy after operation
- The comparation of the clinical outcomes in both groups
- Conditions
- Liver Cancer
- Being tested
- nutritional support before operation
- Keywords
- liver Tumor
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional support before operationProcedure or surgery
nutritional support before operation for more than 4 days
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
postoperative complications especially infectious complications
Measured: 2 years
Secondary outcomes (1)
hospitalization expenses and length of stay
hospitalization expenses:nutrition-related expenses length of stay:from the date of the operation to the date of Discharge
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292330
- Sponsor's protocol ID
- PUMCH-Liver surgery -Nutrition
- Status last verified
- Feb 2011
- First submitted
- 6 Feb 2011
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lu X, Li Y, Yang H, Sang X, Zhao H, Xu H, Du S, Xu Y, Chi T, Zhong S, Yu K, Mao Y. Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study. Hepatobiliary Surg Nutr. 2013 Feb;2(1):14-21. doi: 10.3978/j.issn.2304-3881.2012.11.04.
PubMed 24570910
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support
- ClinicalTrials.gov ID
- NCT01292330
- Acronym / sponsor ID
- PUMCH-Liver surgery -Nutrition
- Conditions
- Liver Cancer
- Keywords
- liver Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 9 Feb 2011 (estimated)
- 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.
Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After Preoperative Nutritional Support.
Study design:
1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking Union Medical College Hospital (PUMCH).
Study arrangement:
- The collection of patients with selected standard
- Preoperative evaluation included nutritional status,liver function and tumor characteristics
- The experimental group received Preoperative Nutritional Support for 4 days,the control group got nothing
- Both groups received conventional therapy after operation
- The comparation of the clinical outcomes in both groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of hepatocellular carcinoma (HCC) was made before operation
- Nutritional Risk Screening 2002(NRS-2002) was Greater or equal 3 points with in 24 hours after admission
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| nutritional support before operationnutritional support before operation for more than 4 days | Procedure or surgery | – |
Primary outcome
postoperative complications
Time frame: 2 years
postoperative complications especially infectious complications
1 secondary outcome
hospitalization expenses and length of stay
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
- Derived from this study: PubMed 24570910Lu X, Li Y, Yang H, Sang X, Zhao H, Xu H, Du S, Xu Y, Chi T, Zhong S, Yu K, Mao Y. Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study. Hepatobiliary Surg Nutr. 2013 Feb;2(1):14-21. doi: 10.3978/j.issn.2304-3881.2012.11.04.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional support before operation in people with Liver Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 0 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: status not confirmed, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292330, which also lists 1 linked publication.
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 9 Feb 2011.