The Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Hepatocellular Carcinoma

NCT06549829 | Recruiting

• 1 other identifier: 2024-0344
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Interventions will continue for two weeks prior to surgery. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1,3,6 months postoperatively.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• Postoperative serum prealbumin

  peripheral blood

  One day after surgery, three days after surgery, five days after surgery

• Postoperative transferrin

  peripheral blood

  One day after surgery, three days after surgery, five days after surgery

• Postoperative retinol-binding protein

  peripheral blood

  One day after surgery, three days after surgery, five days after surgery

Secondary Outcomes (5)

• Postoperative Six-minute walk test (6MWT)

  One week after surgery

• grading and incidence of various types of complications

  one month after surgery

• postoperative length of stay

  stay hospital time, an average of 10 days

• 30-day readmission rate

  postoperative for 30 days

• patient long-term quality of life indicators (6 months)

  during postoperative for 6 month

Other Outcomes (1)

• Drainage tube removal time

  Postoperative, an average of 3 days

Study Arms (2)

Nutritional optimization-led triple prehabilitation Intervention

EXPERIMENTAL

Nutritional optimization-led triple prehabilitation

Other: Nutritional optimization-led triple prehabilitation Intervention

Conventional triple prehabilitation Intervention

OTHER

Conventional triple prehabilitation

Other: Conventional triple prehabilitation Intervention

Interventions

Nutritional optimization-led triple prehabilitation Intervention OTHER

The nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan. The experimental group used ordinary dietary supplementation + transoral nutritional supplementation, and the control group used ordinary dietary supplementation. The target energy was basal energy metabolism level \* physical activity level, physical activity level was male: 1.55 female: 1.56; basal energy level was basal metabolism standardized value \* body weight (basal metabolism standardized value for obese patients was 25; basal metabolism standardized value for normal or emaciated patients was 30). Add 600kcal capacity supplement to this. Exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance. Specialized psychological interventions.

Nutritional optimization-led triple prehabilitation Intervention

Conventional triple prehabilitation Intervention OTHER

Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions.

Conventional triple prehabilitation Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with primary liver cancer.
• Patients between the ages of 18 and 70.
• Patients who are feasible for surgical treatment after clinical evaluation. ④Major organ function meets the following conditions: neutrophil count \>1.5\*109/L; platelet count \>100\* 109/L; hemoglobin \>90g/L; transaminase and creatinine \<twice the upper limit.

You may not qualify if:

• Patients with liver metastases or combined with other tumors. ②Patients with allergy to the ingredients of nutritional preparations.
• Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (5)

• Lin Y, Zheng L, Fang K, Zheng Y, Wu J, Zheng M. Proportion of liver cancer cases and deaths attributable to potentially modifiable risk factors in China. Int J Epidemiol. 2023 Dec 25;52(6):1805-1814. doi: 10.1093/ije/dyad100.

  PMID: 37431632 BACKGROUND

• Zhou YM, Zhang XF, Li B, Sui CJ, Yang JM. Postoperative complications affect early recurrence of hepatocellular carcinoma after curative resection. BMC Cancer. 2015 Oct 14;15:689. doi: 10.1186/s12885-015-1720-0.

  PMID: 26466573 BACKGROUND

• Noba L, Rodgers S, Chandler C, Balfour A, Hariharan D, Yip VS. Enhanced Recovery After Surgery (ERAS) Reduces Hospital Costs and Improve Clinical Outcomes in Liver Surgery: a Systematic Review and Meta-Analysis. J Gastrointest Surg. 2020 Apr;24(4):918-932. doi: 10.1007/s11605-019-04499-0. Epub 2020 Jan 3.

  PMID: 31900738 BACKGROUND

• Forsmo HM, Pfeffer F, Rasdal A, Sintonen H, Korner H, Erichsen C. Pre- and postoperative stoma education and guidance within an enhanced recovery after surgery (ERAS) programme reduces length of hospital stay in colorectal surgery. Int J Surg. 2016 Dec;36(Pt A):121-126. doi: 10.1016/j.ijsu.2016.10.031. Epub 2016 Oct 22.

  PMID: 27780772 BACKGROUND

• Davis JF, van Rooijen SJ, Grimmett C, West MA, Campbell AM, Awasthi R, Slooter GD, Grocott MP, Carli F, Jack S. From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. Curr Anesthesiol Rep. 2022;12(1):129-137. doi: 10.1007/s40140-022-00516-2. Epub 2022 Feb 18.

  PMID: 35194410 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yuan Ding

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Yuan Ding

CONTACT

+86 18858101960; dingyuan@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: August 12, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)