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Enrolling by invitationNCT05224739Updated Mar 27, 2024

Validate the Difficulty Scoring System and Develop a Novel Scoring System for Laparoscopic and Robotic Liver Resections

An observational study in Liver Diseases, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Methodist Health System · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
150
Ages
18 Years to 79 Years
Sex
All
01

Study summary

To validate the Iwate difficulty scoring system and Institut Mutualiste Montsouris (IMM) scoring system (Appendix 2) in both laparoscopic and robotic liver resections

Read the detailed description

Minimally-invasive liver resections (MILR) are increasingly conducted world-wide today. Several international consensus meetings were convened to enable the safe dissemination of laparoscopic and robotic liver resections. The Iwate difficulty scoring system (Appendix 1) was formulated in Japan to grade the difficulty of liver resections. This was to allow beginners to adopt a stepwise approach to safely perform MILR according to their experience and competency level. Although this system has been recently validated in a recent Japanese multicenter study, it has not been externally validated in a large cohort of patients. Thus far, it has only been validated in several small single center studies. Furthermore, its utility for robotic liver resections has not been well-studied.

02

Conditions studied

  • Liver Diseases

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03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's planned enrollment of 150 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Hospital of patients who underwent Minimally Invasive Liver Resection from January 1, 2000 to December 31, 2020.

Inclusion criteria

  • All consecutive patients operated at a single institution during a fixed period
  • Most recent operation date allowed (up till December 31, 2020, to allow three months follow-up).
  • All minimally invasive hepatectomy approaches can be included, including lap- assisted (hybrid), hand-assisted, robotic-assisted and pure laparoscopy.
  • The data of all patients including those that had repeat liver resections, concomitant surgeries (e.g. colectomies, hilar lymph node dissection, enbloc resections) may be included
  • Patients with no "liver tumors" such as recurrent pyogenic cholangitis/ gallbladder may be included
  • The site of the "lesion/ pathology" will be considered as the tumor site, size will be considered less than 3 cm unless tumor invades the liver.

Exclusion criteria

Exclusion Criteria:

    • Patients \< 18 years of age

      • Patients with liver transplant living donor hepatectomies
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients who underwent MILR from January 1, 2000 to December 31, 2020

    Hospital of patients who underwent MILR from January 1, 2000 to December 31, 2020.

    Procedure: Minimally Invasive Liver Resection

Interventions

  • ProcedureMinimally Invasive Liver Resection

    laparoscopic and robotic liver resections

06

What researchers measure

Primary outcomes

  1. Iwate scores for laparoscopic and robotic liver resections

    To validate the Iwate difficulty scoring system IMM scoring system in both laparoscopic .and robotic liver resections. The IWATA measures the difficulty index from 0 to 12. The IMM scoring is from code 1 to 11.

    Time frame: January 1, 2000 to December 31, 2020

Secondary outcomes

  1. Propensity scores for robotic and laparoscopic liver resections

    To perform a propensity score matching (including adjustment for difficulty) comparing robotic and laparoscopic liver resections.

    Time frame: January 1, 2000 to December 31, 2020

07

Study locations

1 site
  • Liver Institute of Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05224739
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Jul 16, 2021
Primary completion
Nov 16, 2024 (estimated)
Completion
Nov 16, 2024 (estimated)
Last update
Mar 27, 2024

Study contacts

Alejandro Mejia, MD
principal investigator · Methodist Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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