NCT05970159

Brief Summary

This is an observational and retrospective cohort study to evaluate the impact of the preoperative serum albumin concentration on postoperative outcomes among hepatocellular carcinoma (HCC) patients who received hepatectomy or liver transplantation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 18, 2023

Last Update Submit

August 1, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaAlbuminHepatectomyLiver transplantationPostoperative outcomes

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Complications following surgery that occurred during hospitalization. For the hepatectomy cohort of patients, postoperative complications included incision, urinary tract and abdominal infections, pleural fluid, ascites, post-hepatectomy hemorrhage bile leakage, post hepatectomy liver failure, renal insufficiency, multiple organ dysfunction syndrome, pneumonia and pulmonary embolism, etc. For the LT cohort of patients, postoperative complications included primary nonfunction, hemorrhage, hepatic artery thrombosis, hepatic vein thrombosis, bile leakage, acute kidney injury, deep wound infections and catheter-related infections.

    up to 2 weeks

Secondary Outcomes (1)

  • Mortality

    up to 2 weeks

Other Outcomes (2)

  • Days of hospital stay

    up to 2 weeks

  • Days of ICU stay

    up to 4 weeks

Study Arms (2)

Hypoalbuminemia group

Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are \< 36g/L.

Normal group

Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are ≥ 36g/L.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who met the criteria for inclusion in this real-world study from Zhongshan Hospital, Fudan University will be included. According to a preliminary feasibility department investigation, a sample size of approximately 480 subjects will be enrolled in this study.

You may qualify if:

  • Patients who diagnosed with HCC confirmed by histology/cytology or clinically criteria regardless of gender.
  • HCC Patients who had received the first hepatectomy or liver transplantation (LT).
  • Age ≥18 years at the start date of the hepatectomy or LT.
  • HCC patients who had the value of serum albumin within 7 days prior to the surgery.
  • HCC patients who had exemption of informed consent.

You may not qualify if:

  • HCC Patients with extrahepatic metastasis or other malignant tumours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (2)

  • Ma KW, Cheung TT, She WH, Chok KSH, Chan ACY, Dai WC, Lo CM. Risk prediction model for major complication after hepatectomy for malignant tumour - A validated scoring system from a university center. Surg Oncol. 2017 Dec;26(4):446-452. doi: 10.1016/j.suronc.2017.08.007. Epub 2017 Sep 9.

    PMID: 29113664RESULT

  • Poon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective database. Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10. doi: 10.1097/01.sla.0000141195.66155.0c.

    PMID: 15383797RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Huichuan Sun

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huichuan Sun

CONTACT

+86-21-64041990sun.huichuan@zs-hospital.sh.cn

Hui Li

CONTACT

+86-21-64041990lihui0801@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 1, 2023

Study Start

August 1, 2023

Primary Completion

June 1, 2024

Study Completion

March 1, 2025

Last Updated

August 3, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)