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

Retrospective International Multicenter Study to Validate the Difficulty Scoring System and Develop a Novel Scoring System for Laparoscopic and Robotic Liver Resections

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05224739
Enrollment
150
Registered
2022-02-04
Start date
2021-07-16
Completion date
2024-11-16
Last updated
2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

Brief summary

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

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.

Interventions

laparoscopic and robotic liver resections

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Iwate scores for laparoscopic and robotic liver resectionsJanuary 1, 2000 to December 31, 2020To 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.

Secondary

MeasureTime frameDescription
Propensity scores for robotic and laparoscopic liver resectionsJanuary 1, 2000 to December 31, 2020To perform a propensity score matching (including adjustment for difficulty) comparing robotic and laparoscopic liver resections.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026