NCT03534843

Brief Summary

To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma

Trial Health

100
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2005

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

10.6 years

First QC Date

May 12, 2018

Last Update Submit

May 24, 2018

Conditions

Keywords

Spontaneous rupturesurvivalhepatocellular carcinomaChild-PughAlbumin-bilirubin

Outcome Measures

Primary Outcomes (1)

  • Overall survival of all patients

    Overall survival of all patients among different Child-Pugh and albumin-bilirubin scores

    5 years

Secondary Outcomes (3)

  • Short-term mortality of all patients

    Ninety days

  • Short-term mortality of surgical subgroup

    Ninety days

  • Short-term mortality of non-surgical subgroup

    Ninety days

Study Arms (2)

Surgical treatment

Patients who received liver resection or palliative surgery, such as microwave coagulation therapy, hepatic artery ligation, or suturing ligation.

Procedure: Liver resection

Non-surgical treatment

Patients who received transcatheter arterial embolization (or transcatheter arterial chemoembolization) or conservative treatment

Other: Transcatheter arterial embolization

Interventions

Liver resection was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.

Surgical treatment

Transcatheter arterial embolization or transcatheter arterial chemoembolization can localize the bleeding point and provide interventional embolization.

Non-surgical treatment

Eligibility Criteria

Age15 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From January 2005 to August 2015, all patients complied with the criteria mentioned above who received surgical treatment or non-surgical treatment at the investigator's center were included in this study.

You may qualify if:

  • Be diagnosed as hepatocellular carcinoma pathologically; had a tumor rupture confirmed by Intraperitoneal exploration or clinical signs and symptoms in combination with imaging examination.

You may not qualify if:

  • Be diagnosed as not hepatocellular carcinoma pathologically;had repeated transcatheter arterial chemoembolization(TACE) or a long history (more than 1 year) of cancer treatment; loss of follow up or without complete data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wu JJ, Zhang ZG, Zhu P, Mba'nbo-Koumpa AA, Zhang BX, Chen XP, Shu C, Zhang WG, Feng RJ, Li GX. Comparative liver function models for ruptured hepatocellular carcinoma: A 10-year single center experience. Asian J Surg. 2019 Sep;42(9):874-882. doi: 10.1016/j.asjsur.2018.12.015. Epub 2019 Jan 28.

MeSH Terms

Conditions

Rupture, SpontaneousCarcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Xiao-ping Chen, Prof. PHD

    Huazhong University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2018

First Posted

May 23, 2018

Study Start

January 1, 2005

Primary Completion

August 1, 2015

Study Completion

January 1, 2018

Last Updated

May 29, 2018

Record last verified: 2018-05