Liver CancerPhase 4NCT02321202
Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer
A Phase 4 study testing Omega-3 Fatty Acid-Based Parenteral Nutrition and Structolipid in people with Liver Cancer and Cirrhosis, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for cirrhotic patients with liver cancer underwent hepatectomy.. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer, Cirrhosis
- What is being tested?
- Omega-3 Fatty Acid-Based Parenteral Nutrition and Structolipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Nov 2013
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The cirrhotic malnourished patients who were diagnosed as liver cancer preoperatively and underwent hepatectomy were consecutively enrolled.
Who cannot join
- Contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C, indocyanine green retention rate at 15min (ICGR15)>30%(12), serum hepatitis B virus (HBV)-DNA>126 copies/ml and serum alanine aminotransferase (ALT) > 2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause
- Pregnancy
- Age of<18y or>75y
- Performed intraoperative ablation
- Unresectable tumor during operation
- Allergic reactions against fish or egg proteins
Trial locations and contacts
1 site in 1 country.
About this study
The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for cirrhotic patients with liver cancer underwent hepatectomy..
Read the detailed description
A new lipid emulsion enriched ω-3 fatty acid was manufactured, and was reported avoid hyperinflammatory situations in patients followed major surgery. However, the role of ω-3 fatty acid-based parenteral nutrition for postoperative patients with cirrhosis-related liver cancer is unclear. This study aims to evaluate the safety and efficacy of ω-3 fatty acid-based parenteral nutrition for cirrhotic patients with liver cancer followed hepatectomy.
A prospective randomized controlled clinical trial was conducted for cirrhotic patients with liver cancer underwent hepatectomy between March 2010 and September 2013 in the investigators institution. For postoperative parenteral nutrition, 20% Structolipid and 10% Omegaven were applied to the trial group, while only Structolipid to the control group for 5 consecutive days postoperatively.
- Conditions
- Liver Cancer, Cirrhosis
- Being tested
- Omega-3 Fatty Acid-Based Parenteral Nutrition, Structolipid
- Keywords
- omega-3, Progression, parenteral nutrition
- Medical subject headings
- Liver Neoplasms, Fibrosis, Disease Progression, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty Acid-Based Parenteral NutritionDrug
Also called trial
Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid [FA] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.
StructolipidDrug
Also called control
Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | For postoperative parenteral nutrition, only Structolipid applied for 5 consecutive days. Receives: Drug: Structolipid |
| Trial group | Experimental | For postoperative parenteral nutrition, Omega-3 Fatty Acid-Based Parenteral Nutrition (20% Structolipid and 10% Omegaven) were applied for 5 consecutive days. Receives: Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications (blood test for liver and renal function, urine output, postoperative complications)
blood test for liver and renal function, urine output, postoperative complications
Measured: 14 days postoperatively
hospital stay (time of hospital stay after surgery)
the time of hospital stay after surgery
Measured: 14 days postoperatively
Secondary outcomes (1)
mortality
death within 30 days after surgery
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startMar 2010
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, Huazhong University of Science and Technology
- Investigators
- Xiaoping Chen, M.D., Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321202
- Sponsor's protocol ID
- bhzhang001
- Status last verified
- Aug 2018
- First submitted
- 12 Dec 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Freund HR. Abnormalities of liver function and hepatic damage associated with total parenteral nutrition. Nutrition. 1991 Jan-Feb;7(1):1-5; discussion 5-6.
PubMed 1802177Carter BA, Shulman RJ. Mechanisms of disease: update on the molecular etiology and fundamentals of parenteral nutrition associated cholestasis. Nat Clin Pract Gastroenterol Hepatol. 2007 May;4(5):277-87. doi: 10.1038/ncpgasthep0796.
PubMed 17476210Verdery R. Perioperative total parenteral nutrition in surgical patients. N Engl J Med. 1992 Jan 23;326(4):273; author reply 274. No abstract available.
PubMed 1727984Plauth M, Cabre E, Campillo B, Kondrup J, Marchesini G, Schutz T, Shenkin A, Wendon J; ESPEN. ESPEN Guidelines on Parenteral Nutrition: hepatology. Clin Nutr. 2009 Aug;28(4):436-44. doi: 10.1016/j.clnu.2009.04.019. Epub 2009 Jun 11.
PubMed 19520466Koller M, Senkal M, Kemen M, Konig W, Zumtobel V, Muhr G. Impact of omega-3 fatty acid enriched TPN on leukotriene synthesis by leukocytes after major surgery. Clin Nutr. 2003 Feb;22(1):59-64. doi: 10.1054/clnu.2002.0592.
PubMed 12553951Zhang B, Wei G, Li R, Wang Y, Yu J, Wang R, Xiao H, Wu C, Leng C, Zhang B, Chen XP. n-3 fatty acid-based parenteral nutrition improves postoperative recovery for cirrhotic patients with liver cancer: A randomized controlled clinical trial. Clin Nutr. 2017 Oct;36(5):1239-1244. doi: 10.1016/j.clnu.2016.08.002. Epub 2016 Aug 31.
PubMed 27614675
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer
- ClinicalTrials.gov ID
- NCT02321202
- Acronym / sponsor ID
- bhzhang001
- Conditions
- Liver Cancer, Cirrhosis
- Keywords
- omega-3, Progression, parenteral nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Dec 2014 (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.
The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for cirrhotic patients with liver cancer underwent hepatectomy..
Detailed description
A new lipid emulsion enriched ω-3 fatty acid was manufactured, and was reported avoid hyperinflammatory situations in patients followed major surgery. However, the role of ω-3 fatty acid-based parenteral nutrition for postoperative patients with cirrhosis-related liver cancer is unclear. This study aims to evaluate the safety and efficacy of ω-3 fatty acid-based parenteral nutrition for cirrhotic patients with liver cancer followed hepatectomy.
A prospective randomized controlled clinical trial was conducted for cirrhotic patients with liver cancer underwent hepatectomy between March 2010 and September 2013 in the investigators institution. For postoperative parenteral nutrition, 20% Structolipid and 10% Omegaven were applied to the trial group, while only Structolipid to the control group for 5 consecutive days postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: StructolipidFor postoperative parenteral nutrition, only Structolipid applied for 5 consecutive days. |
| Trial group | Experimental | Drug: Omega-3 Fatty Acid-Based Parenteral NutritionFor postoperative parenteral nutrition, Omega-3 Fatty Acid-Based Parenteral Nutrition (20% Structolipid and 10% Omegaven) were applied for 5 consecutive days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The cirrhotic malnourished patients who were diagnosed as liver cancer preoperatively and underwent hepatectomy were consecutively enrolled.
Key exclusion criteria (6 listed)
- Contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C, indocyanine green retention rate at 15min (ICGR15)>30%(12), serum hepatitis B virus (HBV)-DNA>126 copies/ml and serum alanine aminotransferase (ALT) > 2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause
- Pregnancy
- Age of<18y or>75y
- Performed intraoperative ablation
- Unresectable tumor during operation
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 |
|---|---|---|
| Omega-3 Fatty Acid-Based Parenteral NutritionAlso: trialGlucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid [FA] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively. | Drug | Trial group |
| StructolipidAlso: controlGlucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an "All-In-One" manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively. | Drug | Control group |
Primary outcome
complications (blood test for liver and renal function, urine output, postoperative complications)
Time frame: 14 days postoperatively
blood test for liver and renal function, urine output, postoperative complications
hospital stay (time of hospital stay after surgery)
Time frame: 14 days postoperatively
the time of hospital stay after surgery
1 secondary outcome
mortality
Time frame: 30 days postoperatively
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 22 Aug 2018.
- Background: PubMed 1802177Freund HR. Abnormalities of liver function and hepatic damage associated with total parenteral nutrition. Nutrition. 1991 Jan-Feb;7(1):1-5; discussion 5-6.
- Background: PubMed 17476210Carter BA, Shulman RJ. Mechanisms of disease: update on the molecular etiology and fundamentals of parenteral nutrition associated cholestasis. Nat Clin Pract Gastroenterol Hepatol. 2007 May;4(5):277-87. doi: 10.1038/ncpgasthep0796.
- Background: PubMed 1727984Verdery R. Perioperative total parenteral nutrition in surgical patients. N Engl J Med. 1992 Jan 23;326(4):273; author reply 274. No abstract available.
- Background: PubMed 19520466Plauth M, Cabre E, Campillo B, Kondrup J, Marchesini G, Schutz T, Shenkin A, Wendon J; ESPEN. ESPEN Guidelines on Parenteral Nutrition: hepatology. Clin Nutr. 2009 Aug;28(4):436-44. doi: 10.1016/j.clnu.2009.04.019. Epub 2009 Jun 11.
- Background: PubMed 12553951Koller M, Senkal M, Kemen M, Konig W, Zumtobel V, Muhr G. Impact of omega-3 fatty acid enriched TPN on leukotriene synthesis by leukocytes after major surgery. Clin Nutr. 2003 Feb;22(1):59-64. doi: 10.1054/clnu.2002.0592.
- Derived from this study: PubMed 27614675Zhang B, Wei G, Li R, Wang Y, Yu J, Wang R, Xiao H, Wu C, Leng C, Zhang B, Chen XP. n-3 fatty acid-based parenteral nutrition improves postoperative recovery for cirrhotic patients with liver cancer: A randomized controlled clinical trial. Clin Nutr. 2017 Oct;36(5):1239-1244. doi: 10.1016/j.clnu.2016.08.002. Epub 2016 Aug 31.
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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.
Xiaoping Chen, M.D. study chair
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 Fatty Acid-Based Parenteral Nutrition and Structolipid in people with Liver Cancer and Cirrhosis, run by Huazhong University of Science and Technology 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 1 inclusion and 6 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 22 Aug 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
complications (blood test for liver and renal function, urine output, postoperative complications) (time frame: 14 days postoperatively). The study lists 2 primary outcomes in all. 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 NCT02321202, which also lists 6 linked publications.
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 22 Aug 2018.