Liver TransplantationNCT04348721
INTERNATIONAL SURVEY ON COMPLEXITY IN LIVER TRANSPLANTATION
An observational study of Liver Transplantation, run by Pitié-Salpêtrière Hospital at 1 site in France.
Trial summary
The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- online survey
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 15 Sep 2020
- 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 years and older
- All sexes
- Adult, Older adult
Study population: International liver transplant surgeons who had published on liver transplantation
Who may be able to join
- surgeons in liver transplantation center
- all countries
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASSESSMENT OF COMPLEXITY AND TECHNICAL DIFFICULTIES IN LIVER TRANSPLANTATION: INTERNATIONAL SURVEY OF EXPERTS
The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification.
- Conditions
- Liver Transplantation
- Being tested
- online survey
- Keywords
- complexity, international survey, surgical difficulty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online surveyOther
An online survey including 8 case-vignettes was sent to international liver transplant surgeons who had published on liver transplantation. The first part is related to surgeon's own experience. In the second part, the surgeons were asked to rate the difficulty of various situations in liver transplantation on a scale of 1 to 10 (level 1 was labeled as "easier," and level 10 was labeled as "difficult"). In the third part, 8 case-vignettes corresponding to 8 clinical real-life situations are submitted to experts
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify preoperative criteria to evaluate the degree of technical difficulty during a liver transplantation.
Measured: five minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pitié-Salpêtrière Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Scatton, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348721
- Sponsor's protocol ID
- Pitié-Salpêtrière Hospital
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee MK 4th, Gao F, Strasberg SM. Perceived complexity of various liver resections: results of a survey of experts with development of a complexity score and classification. J Am Coll Surg. 2015 Jan;220(1):64-9. doi: 10.1016/j.jamcollsurg.2014.09.017. Epub 2014 Oct 15.
PubMed 25451665Lee MK 4th, Gao F, Strasberg SM. Completion of a Liver Surgery Complexity Score and Classification Based on an International Survey of Experts. J Am Coll Surg. 2016 Aug;223(2):332-42. doi: 10.1016/j.jamcollsurg.2016.03.039. Epub 2016 Apr 9.
PubMed 27072308Manceau G, Benoist S, Panis Y, Rault A, Mathonnet M, Goere D, Tuech JJ, Collet D, Penna C, Karoui M. Elective surgery for tumours of the splenic flexure: a French inter-group (AFC, SFCD, FRENCH, GRECCAR) survey. Tech Coloproctol. 2020 Feb;24(2):191-198. doi: 10.1007/s10151-019-02143-2. Epub 2020 Jan 14.
PubMed 31939046Reames BN, Blair AB, Krell RW, Groot VP, Gemenetzis G, Padussis JC, Thayer SP, Falconi M, Wolfgang CL, Weiss MJ, Are C, He J. Management of Locally Advanced Pancreatic Cancer: Results of an International Survey of Current Practice. Ann Surg. 2021 Jun 1;273(6):1173-1181. doi: 10.1097/SLA.0000000000003568.
PubMed 31449138
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF COMPLEXITY AND TECHNICAL DIFFICULTIES IN LIVER TRANSPLANTATION: INTERNATIONAL SURVEY OF EXPERTS
- ClinicalTrials.gov ID
- NCT04348721
- Acronym / sponsor ID
- Pitié-Salpêtrière Hospital
- Conditions
- Liver Transplantation
- Keywords
- complexity, international survey, surgical difficulty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pitié-Salpêtrière HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 16 Apr 2020 (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.
The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- International liver transplant surgeons who had published on liver transplantation
Key inclusion criteria (2 listed)
- surgeons in liver transplantation center
- all countries
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| online surveyAn online survey including 8 case-vignettes was sent to international liver transplant surgeons who had published on liver transplantation. The first part is related to surgeon's own experience. In the second part, the surgeons were asked to rate the difficulty of various situations in liver transplantation on a scale of 1 to 10 (level 1 was labeled as "easier," and level 10 was labeled as "difficult"). In the third part, 8 case-vignettes corresponding to 8 clinical real-life situations are submitted to experts | Other | – |
Primary outcome
Identify preoperative criteria to evaluate the degree of technical difficulty during a liver transplantation.
Time frame: five minuts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Background: PubMed 25451665Lee MK 4th, Gao F, Strasberg SM. Perceived complexity of various liver resections: results of a survey of experts with development of a complexity score and classification. J Am Coll Surg. 2015 Jan;220(1):64-9. doi: 10.1016/j.jamcollsurg.2014.09.017. Epub 2014 Oct 15.
- Background: PubMed 27072308Lee MK 4th, Gao F, Strasberg SM. Completion of a Liver Surgery Complexity Score and Classification Based on an International Survey of Experts. J Am Coll Surg. 2016 Aug;223(2):332-42. doi: 10.1016/j.jamcollsurg.2016.03.039. Epub 2016 Apr 9.
- Background: PubMed 31939046Manceau G, Benoist S, Panis Y, Rault A, Mathonnet M, Goere D, Tuech JJ, Collet D, Penna C, Karoui M. Elective surgery for tumours of the splenic flexure: a French inter-group (AFC, SFCD, FRENCH, GRECCAR) survey. Tech Coloproctol. 2020 Feb;24(2):191-198. doi: 10.1007/s10151-019-02143-2. Epub 2020 Jan 14.
- Background: PubMed 31449138Reames BN, Blair AB, Krell RW, Groot VP, Gemenetzis G, Padussis JC, Thayer SP, Falconi M, Wolfgang CL, Weiss MJ, Are C, He J. Management of Locally Advanced Pancreatic Cancer: Results of an International Survey of Current Practice. Ann Surg. 2021 Jun 1;273(6):1173-1181. doi: 10.1097/SLA.0000000000003568.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transplantation, run by Pitié-Salpêtrière Hospital at 1 site in France.
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 2 inclusion and 1 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 16 Apr 2020. 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 France. 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?
Identify preoperative criteria to evaluate the degree of technical difficulty during a liver transplantation. (time frame: five minuts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348721, which also lists 4 linked publications.
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 16 Apr 2020.