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

NCT ID: NCT05224739

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-16

Study Completion Date

2024-11-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Minimally Invasive Liver Resection

Intervention Type PROCEDURE

laparoscopic and robotic liver resections

Interventions

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Minimally Invasive Liver Resection

laparoscopic and robotic liver resections

Intervention Type PROCEDURE

Eligibility Criteria

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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

* • Patients \< 18 years of age

* Patients with liver transplant living donor hepatectomies
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Mejia, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

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Liver Institute of Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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020.HPB.2021.D

Identifier Type: -

Identifier Source: org_study_id

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