NCT07349576

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 4, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 13, 2026

Last Update Submit

January 13, 2026

Conditions

Keywords

Primary liver cancer;Hepatectomy;Precision diet;Early feeding;Postoperative rehabilitation;Nutritional care

Outcome Measures

Primary Outcomes (2)

  • Prealbumin

    Six days after the operation

  • albumin

    Six days after the operation

Study Arms (2)

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

Interventions

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).

dietary intervention group

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.

standard care group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Provincal Hospital

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 20, 2026

Study Start

January 4, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations