NCT05556434

Brief Summary

Postoperative complications seriously affect the recovery of patients undergoing hepatectomy. Identifying risk factors and develop predictive models of complications for patients with hepatolithiasis undergoing hepatectomy is important for clinical practice.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 1, 2011

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

13 years

First QC Date

September 23, 2022

Last Update Submit

September 11, 2023

Conditions

Liver DiseasesComplication

Keywords

liver resectioncomplicationrisk factormachine learninghepatolithiasis

Outcome Measures

Primary Outcomes (1)

  • Complications

    Postoperative complications and mortality are recorded according to the Clavien-Dindo classification system

    3 months

Secondary Outcomes (1)

  • Recurrence of hepatolithiasis

    1 year

Study Arms (2)

patients with postoperative complications

Patients who experienced postoperative complications were divided into the first group. The complications were defined according to the Clavien-Dindo classification system.

Diagnostic Test: radiological evaluation

patients without postoperative complications

Patients who didn't experience postoperative complications were divided into the second group.

Diagnostic Test: radiological evaluation

Interventions

radiological evaluationDIAGNOSTIC_TEST

All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters. diseases

patients with postoperative complicationspatients without postoperative complications

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hepatolithiasis who received liver resection for curative intent

You may qualify if:

  • pathologically diagnosed hepatolithiasis
  • without malignancies
  • receiving liver resection
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
  • Child-Pugh score of ≤7
  • complete clinical and follow-up information
  • age between 18-80 years old

You may not qualify if:

  • with malignancies
  • receiving other treatments
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) \>2
  • Child-Pugh score of \>7
  • incomplete clinical data
  • lost to follow up
  • age \<18 years old or \>80 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gang Chen

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (5)

  • Yang T, Lau WY, Lai EC, Yang LQ, Zhang J, Yang GS, Lu JH, Wu MC. Hepatectomy for bilateral primary hepatolithiasis: a cohort study. Ann Surg. 2010 Jan;251(1):84-90. doi: 10.1097/SLA.0b013e3181b2f374.

    PMID: 20032719BACKGROUND

  • Su CH, Shyr YM, Lui WY, P'Eng FK. Hepatolithiasis associated with cholangiocarcinoma. Br J Surg. 1997 Jul;84(7):969-73. doi: 10.1002/bjs.1800840717.

    PMID: 9240138BACKGROUND

  • Tabrizian P, Jibara G, Shrager B, Schwartz ME, Roayaie S. Hepatic resection for primary hepatolithiasis: a single-center Western experience. J Am Coll Surg. 2012 Nov;215(5):622-6. doi: 10.1016/j.jamcollsurg.2012.07.005. Epub 2012 Aug 24.

    PMID: 22921329BACKGROUND

  • Citterio D, Facciorusso A, Sposito C, Rota R, Bhoori S, Mazzaferro V. Hierarchic Interaction of Factors Associated With Liver Decompensation After Resection for Hepatocellular Carcinoma. JAMA Surg. 2016 Sep 1;151(9):846-53. doi: 10.1001/jamasurg.2016.1121.

    PMID: 27248425BACKGROUND

  • Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.

    PMID: 12368667BACKGROUND

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Gang Chen, MD,PhD

    First Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Principal Investigator

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 27, 2022

Study Start

July 1, 2011

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)