NCT04100304

Brief Summary

  • Review the outcomes of the current treatments modalities.
  • Give an effective treatment .
  • Improve the outcome of these patients and decease rate of recurrence and complications.
  • An adequate future liver remnant (FLR) reduces the risk of postoperative liver failure after major hepatectomy.
  • incurs a risk of postoperative liver dysfunction and infection and there is a lack of objective evidence relating residual liver volume to these complications

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

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

September 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

September 17, 2019

Last Update Submit

September 20, 2019

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

  • Evaluation

    Evaluation of the remaining part of the liver by CTvolumetry for further management as liver transplant

    preoperative

Secondary Outcomes (4)

  • energy expenditure

    [ Time Frame: 30 days ]

  • Procedural parameters

    intraoperative

  • Long-term outcomes

    5 years

  • Perioperative liver function

    30 days preoperative

Study Arms (1)

patient under going liver resection

OTHER
Diagnostic Test: resection

Interventions

resectionDIAGNOSTIC_TEST

CT volumetry,liver function,biopsy before resection

patient under going liver resection

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing liver resection for benign or malignant hepatic neoplasm at the time of study(two years)
  • Patient consent.
  • Age of the patient : Any age

You may not qualify if:

  • patients has contraindication to do liver resection surgery.
  • patients who are unfit for any surgical interventions.
  • patients who refuse the operation or refusing to share his data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wang Z, Sun H, Li K, Yao W, Dong K, Ma Y, Zheng S. Prognostic factor analysis of stage 4S neuroblastoma in infant patients: A single center study. J Pediatr Surg. 2019 Dec;54(12):2585-2588. doi: 10.1016/j.jpedsurg.2019.08.031. Epub 2019 Aug 30.

    PMID: 31521373BACKGROUND

  • Horiuchi T, Haruki K, Shiba H, Sakamoto T, Saito N, Shirai Y, Iwase R, Fujiwara Y, Yanaga K. Assessment of Outcome of Hepatic Resection for Extremely Elderly Patients With a Hepatic Malignancy. Anticancer Res. 2019 Sep;39(9):5143-5148. doi: 10.21873/anticanres.13709.

    PMID: 31519626BACKGROUND

  • Rotellar F, Marti-Cruchaga P, Zozaya G, Tuero C, Lujan J, Benito A, Hidalgo F, Lopez-Olaondo L, Pardo F. Standardized laparoscopic central hepatectomy based on hilar caudal view and root approach of the right hepatic vein. J Hepatobiliary Pancreat Sci. 2020 Jan;27(1):E7-E8. doi: 10.1002/jhbp.669. Epub 2019 Oct 10.

    PMID: 31518491BACKGROUND

  • Huiskens J, Bolhuis K, Engelbrecht MR, De Jong KP, Kazemier G, Liem MS, Verhoef C, de Wilt JH, Punt CJ, van Gulik TM; Dutch Colorectal Cancer Group. Outcomes of Resectability Assessment of the Dutch Colorectal Cancer Group Liver Metastases Expert Panel. J Am Coll Surg. 2019 Dec;229(6):523-532.e2. doi: 10.1016/j.jamcollsurg.2019.08.1445. Epub 2019 Sep 11.

    PMID: 31520695BACKGROUND

MeSH Terms

Conditions

Liver Diseases

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Moaz Ahmed, master

CONTACT

01097179297moathahmad294@gmail.com

Salah Ibrahim, professor

CONTACT

01061616104salah.ibrahim@med.au.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at general surgery department

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 24, 2019

Study Start

October 1, 2019

Primary Completion

March 30, 2022

Study Completion

July 30, 2022

Last Updated

September 24, 2019

Record last verified: 2019-09