Liver CancerNCT07537205
The Effects of a Nurse-led TGA-based Pre-rehabilitation Planning on Perioperative Outcomes in Patients With Liver Cancer: Study and Protocol
A study testing A nurse-led TGA-based Pre-rehabilitation Planning in people with Liver Cancer, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to to learn if the nurse-led TGA-based Pre-rehabilitation planning can improve compliance, preoperative functional reserve, and reduce the incidence of postoperative complications in patients with hepatocellular carcinoma. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- A nurse-led TGA-based Pre-rehabilitation Planning
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Diagnosis of hepatocellular carcinoma based on the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition) or the Diagnosis Guidelines for Hepatic Metastases of Colorectal Cancer (2025 Edition).
- (2) Patients undergoing elective liver resection after medical evaluation.
- (3) Patients aged from 18-84 years;.
- (4) Voluntary participation in this study.
Who cannot join
- (1) Patients with severe cognitive impairment or psychiatric disorders.
- (2) Patients with severe cardiorenal or cerebral organ failure.
- (3) Patients who have participated in other research projects.
- (4) Patients requiring reoperation due to severe postoperative complications.
- (5) Patients who abandon surgical treatment midway.
- (6) Patients who voluntarily discontinue the implementation of prehabilitation programs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to to learn if the nurse-led TGA-based Pre-rehabilitation planning can improve compliance, preoperative functional reserve, and reduce the incidence of postoperative complications in patients with hepatocellular carcinoma.
The main questions it aims to answer are:
Read more
- Can this pre-rehabilitation program improve patients' perioperative motor function?
- Can this pre-rehabilitation program enhance patients' perioperative nutritional status?
- Can this pre-rehabilitation program improve patients' psychological state?
- Can this pre-rehabilitation program increase patients' overall compliance? Meanwhile, secondary outcome indicators included complication incidence rate, 30-day readmission rate, first anal flatus passage time, hospitalization duration, serum prealbumin, serum albumin, prothrombin time, total bilirubin, satisfaction and quality of Life.
Researchers will compare the control group received only ERAS care after the patient's admission to see if the program is effectiveness.
Participants who received the intervention group protocol will initiate pre-rehabilitation measures more than 7 days prior to hospital admission, including nutritional support, exercise and respiratory function training, psychological empowerment, pain pre-management, and smoking/alcohol cessation. These interventions will be recorded daily according to the achievement thresholds established by the research team based on outpatient assessment results. After admission, the patients in this group will receive the same EARS care as the control group.
- Conditions
- Liver Cancer
- Being tested
- A nurse-led TGA-based Pre-rehabilitation Planning, ERAS control group
- Keywords
- Liver Neoplasms, Prehabilitation
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A nurse-led TGA-based Pre-rehabilitation PlanningOther
Participants who received the intervention group protocol will initiate pre-rehabilitation measures more than 7 days prior to hospital admission, including nutritional support, exercise and respiratory function training, psychological empowerment, pain pre-management, and smoking/alcohol cessation. These interventions will be recorded daily according to the achievement thresholds established by the research team based on outpatient assessment results. After admission, the patients in this group will receive the same EARS care as the control group.
ERAS control groupOther
Management follows the standard ERAS nursing pathway for hepatoplastic surgery patients, with specific measures including: 1) Preoperative: ① Admission education and preoperative health education; ② Fasting for 2 hours and water restriction for 6 hours prior to surgery; ③ No intestinal preparation; ④ Preoperative administration of carbohydrate solution; ⑤ Guidance on respiratory function exercises; 2) Intraoperative: ① Selection of appropriate anesthesia method; ② No gastric tube placement; ③ Prevention of intraoperative hypothermia; ④ Control of low central venous pressure; ⑤ Targeted volume management; 3) Postoperative: ① Prophylactic analgesia; ② Prevention of deep vein thrombosis; ③ Early ambulation; ④ Early oral intake; ⑤ Early removal of urinary catheter and drainage tubes; ⑥ Early discharge.
| Study group | Role | What they receive |
|---|---|---|
| Pre-rehabilitation intervention group | Experimental | This group implemented preoperative pre-rehabilitation based on TGA and perioperative EARS measures. Receives: Other: A nurse-led TGA-based Pre-rehabilitation Planning |
| Control group | Other | This group implemented perioperative EARS measures after patient admission. Receives: Other: ERAS control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test distance
Measurement was performed using a 6-minute walk test
Measured: Day of admission, Postoperative day 4
Prognosis nutrition index
Prognostic nutritional index = Lymphocyte count × 5 + Serum albumin
Measured: Day of admission; Postoperative day 4
Anxiety
Anxiety levels of patients were measured using the Generalized Anxiety Disorder 7 (GAD-7).The scale ranges from a minimum score of 0 to a maximum score of 21. 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.
Measured: Day of admission, Postoperative day 4
Depression
Depression levels of patients were measured using the Patient Health Questionnaire-9 (PHQ-9). The scale ranges from a minimum score of 0 to a maximum score of 27. Scores of ≤4 indicate no depression, 5-9 indicate mild depression, 10-14 indicate moderate depression, and scores of ≥15 indicate severe depression.
Measured: Day of admission, Postoperative day 4
Overall adherence
Overall adherence = (Exercise adherence + Nutritional adherence + Psychological adherence) / 3.
①Exercise adherence = Mean value of daily actual exercise time / exercise target.
②Nutritional adherence = Mean value of daily actual protein intake / protein target.
③Psychological adherence = Mean value of daily times of listening to psychological audio / 3. (For patients without anxiety or depression in psychological assessment, psychological adherence is set at 1 by default.)
Measured: Day of admission
Secondary outcomes (10)
Complication incidence rate
Measured: 30 days after discharge
30-day readmission rate
Measured: 30 days after discharge
First anal flatus time
When the patient reports first flatus after surgery, the nurse records the exact time.Time to first flatus = Time of first flatus - Time of surgery completion (Note: Add days as 24 h × number of days where applicable.)
Measured: Patient reports at the time of their first flatus after surgery
Length of hospital stay
Measured: On the day of discharge
Serum prealbumin
Measured: 1 day before surgery and 4 days after surgery
Seralbumin
Measured: 1 day before surgery and 4 days after surgery
Prothrombin time
Measured: 1 day before surgery and 4 days after surgery
Total bilirubin
Measured: 1 day before surgery and 4 days after surgery
Degree of satisfaction
Patient satisfaction was assessed using a numerical rating scale, with a minimum score of 0 and a maximum score of 100. Higher scores indicated higher levels of satisfaction.
Measured: Postoperative day 4
Quality of life
Quality of life was assessed using the Quality of Life Scale for Liver Cancer Patients. This scale consists of 22 items, each scored from 1 to 10.Items 1, 2, 3, 7, 18 and 22 are reverse-scored.The total score ranges from 22 to 220, with higher scores representing better quality of life.
Measured: Postoperative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start8 Oct 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingjing Guo, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537205
- Sponsor's protocol ID
- hlb-gzwk-2026-01
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nurse-led TGA-based Pre-rehabilitation Planning on Perioperative Outcomes in Patients With Liver Cancer: Study and Protocol
- ClinicalTrials.gov ID
- NCT07537205
- Acronym / sponsor ID
- hlb-gzwk-2026-01
- Conditions
- Liver Cancer
- Keywords
- Liver Neoplasms, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 17 Apr 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.
The goal of this clinical trial is to to learn if the nurse-led TGA-based Pre-rehabilitation planning can improve compliance, preoperative functional reserve, and reduce the incidence of postoperative complications in patients with hepatocellular carcinoma.
The main questions it aims to answer are:
- Can this pre-rehabilitation program improve patients' perioperative motor function?
- Can this pre-rehabilitation program enhance patients' perioperative nutritional status?
- Can this pre-rehabilitation program improve patients' psychological state?
- Can this pre-rehabilitation program increase patients' overall compliance? Meanwhile, secondary outcome indicators included complication incidence rate, 30-day readmission rate, first anal flatus passage time, hospitalization duration, serum prealbumin, serum albumin, prothrombin time, total bilirubin, satisfaction and quality of Life.
Researchers will compare the control group received only ERAS care after the patient's admission to see if the program is effectiveness.
Participants who received the intervention group protocol will initiate pre-rehabilitation measures more than 7 days prior to hospital admission, including nutritional support, exercise and respiratory function training, psychological empowerment, pain pre-management, and smoking/alcohol cessation. These interventions will be recorded daily according to the achievement thresholds established by the research team based on outpatient assessment results. After admission, the patients in this group will receive the same EARS care as the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-rehabilitation intervention group | Experimental | Other: A nurse-led TGA-based Pre-rehabilitation PlanningThis group implemented preoperative pre-rehabilitation based on TGA and perioperative EARS measures. |
| Control group | Other | Other: ERAS control groupThis group implemented perioperative EARS measures after patient admission. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) Diagnosis of hepatocellular carcinoma based on the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition) or the Diagnosis Guidelines for Hepatic Metastases of Colorectal Cancer (2025 Edition).
- (2) Patients undergoing elective liver resection after medical evaluation.
- (3) Patients aged from 18-84 years;.
- (4) Voluntary participation in this study.
Key exclusion criteria (6 listed)
- (1) Patients with severe cognitive impairment or psychiatric disorders.
- (2) Patients with severe cardiorenal or cerebral organ failure.
- (3) Patients who have participated in other research projects.
- (4) Patients requiring reoperation due to severe postoperative complications.
- (5) Patients who abandon surgical treatment midway.
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 |
|---|---|---|
| A nurse-led TGA-based Pre-rehabilitation PlanningParticipants who received the intervention group protocol will initiate pre-rehabilitation measures more than 7 days prior to hospital admission, including nutritional support, exercise and respiratory function training, psychological empowerment, pain pre-management, and smoking/alcohol cessation. These interventions will be recorded daily according to the achievement thresholds established by the research team based on outpatient assessment results. After admission, the patients in this group will receive the same EARS care as the control group. | Other | Pre-rehabilitation intervention group |
| ERAS control groupManagement follows the standard ERAS nursing pathway for hepatoplastic surgery patients, with specific measures including: 1) Preoperative: ① Admission education and preoperative health education; ② Fasting for 2 hours and water restriction for 6 hours prior to surgery; ③ No intestinal preparation; ④ Preoperative administration of carbohydrate solution; ⑤ Guidance on respiratory function exercises; 2) Intraoperative: ① Selection of appropriate anesthesia method; ② No gastric tube placement; ③ Prevention of intraoperative hypothermia; ④ Control of low central venous pressure; ⑤ Targeted volume management; 3) Postoperative: ① Prophylactic analgesia; ② Prevention of deep vein thrombosis; ③ Early ambulation; ④ Early oral intake; ⑤ Early removal of urinary catheter and drainage tubes; ⑥ Early discharge. | Other | Control group |
Primary outcome
6-minute walk test distance
Time frame: Day of admission, Postoperative day 4
Measurement was performed using a 6-minute walk test
Prognosis nutrition index
Time frame: Day of admission; Postoperative day 4
Prognostic nutritional index = Lymphocyte count × 5 + Serum albumin
Anxiety
Time frame: Day of admission, Postoperative day 4
Anxiety levels of patients were measured using the Generalized Anxiety Disorder 7 (GAD-7).The scale ranges from a minimum score of 0 to a maximum score of 21. 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.
Depression
Time frame: Day of admission, Postoperative day 4
Depression levels of patients were measured using the Patient Health Questionnaire-9 (PHQ-9). The scale ranges from a minimum score of 0 to a maximum score of 27. Scores of ≤4 indicate no depression, 5-9 indicate mild depression, 10-14 indicate moderate depression, and scores of ≥15 indicate severe depression.
Overall adherence
Time frame: Day of admission
Overall adherence = (Exercise adherence + Nutritional adherence + Psychological adherence) / 3. ①Exercise adherence = Mean value of daily actual exercise time / exercise target. ②Nutritional adherence = Mean value of daily actual protein intake / protein target. ③Psychological adherence = Mean value of daily times of listening to psychological audio / 3. (For patients without anxiety or depression in psychological assessment, psychological adherence is set at 1 by default.)
10 secondary outcomes
Complication incidence rate
Time frame: 30 days after discharge
30-day readmission rate
Time frame: 30 days after discharge
First anal flatus time
Time frame: Patient reports at the time of their first flatus after surgery
Length of hospital stay
Time frame: On the day of discharge
Serum prealbumin
Time frame: 1 day before surgery and 4 days after surgery
Seralbumin
Time frame: 1 day before surgery and 4 days after surgery
Prothrombin time
Time frame: 1 day before surgery and 4 days after surgery
Total bilirubin
Time frame: 1 day before surgery and 4 days after surgery
Degree of satisfaction
Time frame: Postoperative day 4
Quality of life
Time frame: Postoperative day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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.
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 A nurse-led TGA-based Pre-rehabilitation Planning in people with Liver Cancer, run by Fudan University 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 4 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
6-minute walk test distance (time frame: Day of admission, Postoperative day 4). The study lists 5 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 17 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.