Primary Liver CancerNCT07349576
Precision Dietary Intervention Improves Postoperative Energy Intake, Nutritional Status, and Recovery in Patients Undergoing Hepatectomy for Liver Cancer: A Randomized Controlled Trial
A study testing Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancer and Conventional dietary intervention in people with Primary Liver Cancer, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Objective:To explore the application effect of postoperative refined early dietary plan in the enhanced recovery of patients undergoing hepatectomy for primary liver cancer, and to provide scientific evidence for optimizing postoperative dietary structure and increasing oral energy intake of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancer and Conventional dietary intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2024to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Pathologically confirmed diagnosis of primary hepatocellular carcinoma; (2) Underwent elective (partial) hepatectomy; (3) Age 18-80 years; (4) Basically normal renal function and preoperative Child-Pugh liver function grade A or B; (5) Voluntary participation in the study and signed informed consent.
Who cannot join
- (1) Concurrent malignant tumors; (2) Postoperative deterioration or contraindications to oral intake (e.g., dysphagia, intestinal obstruction); (3) Severe malnutrition or other disorders affecting nutritional metabolism; (4) Major intraoperative complications (e.g., massive hemorrhage, bile leakage, intra-abdominal adhesions); (5) Postoperative transfer to the ICU.
Trial locations and contacts
1 site in 1 country.
About this study
Objective:To explore the application effect of postoperative refined early dietary plan in the enhanced recovery of patients undergoing hepatectomy for primary liver cancer, and to provide scientific evidence for optimizing postoperative dietary structure and increasing oral energy intake of patients.
Methods:In this randomized, parallel-controlled trial, 142 colorectal cancer survivors meeting inclusion criteria were recruited from a tertiary hospital in Hefei, Anhui Province. Participants were randomly assigned in a 1:1 ratio to either the dietary intervention group or the conventional diet group. Both the standard care group and the dietary intervention group received 5 days of routine dietary care. The dietary intervention group additionally received specialized meal plans and whole protein supplements beyond the standard care regimen. Dietary intake, nutritional status, and postoperative recovery outcomes were measured and compared between the two groups.
- Conditions
- Primary Liver Cancer
- Being tested
- Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancer, Conventional dietary intervention
- Keywords
- Primary liver cancer;Hepatectomy;Precision diet;Early feeding;Postoperative rehabilitation;Nutritional care
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancerDietary supplement
The intervention group, based on the control group, followed the "Chinese Clinical Practice Guidelines for Enhanced Recovery After Surgery (Part II)"and evidence-based summaries, combined with the "Chinese Expert Consensus on Perioperative Management for Hepatectomy in Hepatocellular Carcinoma (2021 Edition)" and oral nutritional supplementation guidelines, Based on the patient's comorbidities, liver characteristics, and gastrointestinal recovery patterns, a specialized 5-day post-hepatectomy diet plan for liver cancer patients has been developed. Postoperatively, oral nutritional supplements (ONS) were administered at 9:30 AM and 3:00 PM between meals, and at 9:00 PM after dinner, using the whole protein preparation NUTRICIA(specification: 320g/can, manufacturer: Milupa GmbH, Germany, production batch: HJ20170172).
Conventional dietary interventionOther
After returning to the ward after the operation under the traditional dietary guidance model, the patient regained consciousness under anesthesia without nausea, vomiting, etc., and began to try drinking water. If there are no special conditions such as gastrointestinal discomfort, then starting according to the dietary principles, that is, a liquid diet on the first day after the operation, a semi-liquid diet on the second day, and gradually transitioning to a regular diet from the third day after the operation until discharge based on the patient's tolerance. One to two days after the operation, parenteral nutrition mixtures are routinely infused.
| Study group | Role | What they receive |
|---|---|---|
| dietary intervention group | Experimental | Not described Receives: Dietary Supplement: Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancer |
| standard care group | Experimental | Not described Receives: Other: Conventional dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prealbumin
Measured: Six days after the operation
albumin
Measured: Six days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start4 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349576
- Sponsor's protocol ID
- 2024KY-013
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Dietary Intervention Improves Postoperative Energy Intake, Nutritional Status, and Recovery in Patients Undergoing Hepatectomy for Liver Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07349576
- Acronym / sponsor ID
- 2024KY-013
- Conditions
- Primary Liver Cancer
- Keywords
- Primary liver cancer;Hepatectomy;Precision diet;Early feeding;Postoperative rehabilitation;Nutritional care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Jan 2026 (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.
Objective:To explore the application effect of postoperative refined early dietary plan in the enhanced recovery of patients undergoing hepatectomy for primary liver cancer, and to provide scientific evidence for optimizing postoperative dietary structure and increasing oral energy intake of patients.
Methods:In this randomized, parallel-controlled trial, 142 colorectal cancer survivors meeting inclusion criteria were recruited from a tertiary hospital in Hefei, Anhui Province. Participants were randomly assigned in a 1:1 ratio to either the dietary intervention group or the conventional diet group. Both the standard care group and the dietary intervention group received 5 days of routine dietary care. The dietary intervention group additionally received specialized meal plans and whole protein supplements beyond the standard care regimen. Dietary intake, nutritional status, and postoperative recovery outcomes were measured and compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary intervention group | Experimental | Dietary Supplement: Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancer |
| standard care group | Experimental | Other: Conventional dietary intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Pathologically confirmed diagnosis of primary hepatocellular carcinoma; (2) Underwent elective (partial) hepatectomy; (3) Age 18-80 years; (4) Basically normal renal function and preoperative Child-Pugh liver function grade A or B; (5) Voluntary participation in the study and signed informed consent.
Key exclusion criteria (1 listed)
- (1) Concurrent malignant tumors; (2) Postoperative deterioration or contraindications to oral intake (e.g., dysphagia, intestinal obstruction); (3) Severe malnutrition or other disorders affecting nutritional metabolism; (4) Major intraoperative complications (e.g., massive hemorrhage, bile leakage, intra-abdominal adhesions); (5) Postoperative transfer to the ICU.
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 |
|---|---|---|
| Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancerThe intervention group, based on the control group, followed the "Chinese Clinical Practice Guidelines for Enhanced Recovery After Surgery (Part II)"and evidence-based summaries, combined with the "Chinese Expert Consensus on Perioperative Management for Hepatectomy in Hepatocellular Carcinoma (2021 Edition)" and oral nutritional supplementation guidelines, Based on the patient's comorbidities, liver characteristics, and gastrointestinal recovery patterns, a specialized 5-day post-hepatectomy diet plan for liver cancer patients has been developed. Postoperatively, oral nutritional supplements (ONS) were administered at 9:30 AM and 3:00 PM between meals, and at 9:00 PM after dinner, using the whole protein preparation NUTRICIA(specification: 320g/can, manufacturer: Milupa GmbH, Germany, production batch: HJ20170172). | Dietary supplement | dietary intervention group |
| Conventional dietary interventionAfter returning to the ward after the operation under the traditional dietary guidance model, the patient regained consciousness under anesthesia without nausea, vomiting, etc., and began to try drinking water. If there are no special conditions such as gastrointestinal discomfort, then starting according to the dietary principles, that is, a liquid diet on the first day after the operation, a semi-liquid diet on the second day, and gradually transitioning to a regular diet from the third day after the operation until discharge based on the patient's tolerance. One to two days after the operation, parenteral nutrition mixtures are routinely infused. | Other | standard care group |
Primary outcome
Prealbumin
Time frame: Six days after the operation
albumin
Time frame: Six days after the operation
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Special diet plan and whole protein preparation NUTRICIA for 5 days after liver resection for liver cancer and Conventional dietary intervention in people with Primary Liver Cancer, run by Anhui Provincial 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 1 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 20 Jan 2026. 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?
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?
Prealbumin (time frame: Six days after the operation). 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?
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 20 Jan 2026.