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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05224739
• Other study ID #: 020.HPB.2021.D
• Status: Enrolling by invitation
• Start date: July 16, 2021
• Est. completion date: November 16, 2024

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: November 16, 2024
• Est. primary completion date: November 16, 2024
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Procedure:
• Minimally Invasive Liver Resection
laparoscopic and robotic liver resections

Locations

Country	Name	City	State
United States	Liver Institute of Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	January 1, 2000 to December 31, 2020
Secondary	Propensity scores for robotic and laparoscopic liver resections	To perform a propensity score matching (including adjustment for difficulty) comparing robotic and laparoscopic liver resections.	January 1, 2000 to December 31, 2020