Liver DiseasesNCT05224739
Validate the Difficulty Scoring System and Develop a Novel Scoring System for Laparoscopic and Robotic Liver Resections
An observational study of Liver Diseases, run by Methodist Health System at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Minimally Invasive Liver Resection
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 16 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Adult, Older adult
Study population: Hospital of patients who underwent Minimally Invasive Liver Resection from January 1, 2000 to December 31, 2020.
Who may be able to join
- 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.
Who cannot join
- • Patients < 18 years of age
- Patients with liver transplant living donor hepatectomies
Trial locations and contacts
1 site in 1 country.
United States1 site
Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Retrospective International Multicenter Study to Validate the Difficulty Scoring System and Develop a Novel Scoring System for Laparoscopic and Robotic Liver Resections
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.
- Conditions
- Liver Diseases
- Being tested
- Minimally Invasive Liver Resection
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Liver ResectionProcedure or surgery
laparoscopic and robotic liver resections
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Minimally Invasive Liver Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: January 1, 2000 to December 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start16 Jul 2021
- Primary completion16 Nov 2024 (estimated)
- Study completion16 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Mejia, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224739
- Sponsor's protocol ID
- 020.HPB.2021.D
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective International Multicenter Study to Validate the Difficulty Scoring System and Develop a Novel Scoring System for Laparoscopic and Robotic Liver Resections
- ClinicalTrials.gov ID
- NCT05224739
- Acronym / sponsor ID
- 020.HPB.2021.D
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 16 Nov 2024 (estimated)
- Study completion
- 16 Nov 2024 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent MILR from January 1, 2000 to December 31, 2020 | – | Procedure: Minimally Invasive Liver ResectionHospital of patients who underwent MILR from January 1, 2000 to December 31, 2020. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospital of patients who underwent Minimally Invasive Liver Resection from January 1, 2000 to December 31, 2020.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- • Patients < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Liver Resectionlaparoscopic and robotic liver resections | Procedure or surgery | Patients who underwent MILR from January 1, 2000 to December 31, 2020 |
Primary outcome
Iwate scores for laparoscopic and robotic liver resections
Time frame: January 1, 2000 to December 31, 2020
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.
1 secondary outcome
Propensity scores for robotic and laparoscopic liver resections
Time frame: January 1, 2000 to December 31, 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Mejia, MD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iwate scores for laparoscopic and robotic liver resections (time frame: January 1, 2000 to December 31, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.