Liver Transplant; ComplicationsMSPLDNCT04182256
Magnetic Spiderman for Preparation of Liver Donation
A study testing MS in people with Liver Transplant; Complications and Surgical Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Due to many vascular branches on the supra-hepatic vena cava (SHVC) and infra-hepatic vena cava (IHVC), in the whole procedures of preparation of liver donation, preparation of hepatic vena cava (HVC) is the most key and troublesome step. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Transplant; Complications, Surgical Injury
- What is being tested?
- MS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Mar 2021
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients receiving donation after cardiac death in the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University.
Who cannot join
- patients whose age<18, or >60
- patients who do not have intact clinical data
- patients who are inability to participate in follow-up
- patients who undergo split liver transplantation
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
About this study
Official title: A Prospective Study: Magnetic Spiderman for Preparation of Donor Livers' Inferior Vena Cava
Due to many vascular branches on the supra-hepatic vena cava (SHVC) and infra-hepatic vena cava (IHVC), in the whole procedures of preparation of liver donation, preparation of hepatic vena cava (HVC) is the most key and troublesome step. Magnetic Spiderman (MS) is a novel surgical instrument, designed and created to solve the vital problems of preparation of liver donation's HVC. Therefore, the aim of this study is to evaluate the feasibility and security of MS when using it prepare the liver donation's HVC.
Read the detailed description
From January 1 2020 to June 30 2020, after inclusion and exclusion, donors' livers will be divided to MS group and manual (MA) group. In MS group, MS grips the SHVC and IHVC, respectively. MS's magnets are adsorbed on the wall of the basin and MS can pull the HVC accordingly. By changing the position of MS on the wall of the basin, the attending can expose the surgical field that make the operation convenient. In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements. In both groups, right adrenal vein, phrenic veins and other branches of the HVC are isolated and ligated, then SHVC and IHVC where MS's clamps gripped are cut off. After preparation, the SHVC and IHVC remain at least 1.5 cm. Excess diaphragms are removed. Outcomes of two groups are compared.
- Conditions
- Liver Transplant; Complications, Surgical Injury
- Being tested
- MS
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSDevice
Magnetic Spiderman (MS) is a novel surgical instrumentIt. It consists of a circular neodymium iron boron magnet packed in a stainless-steel case with a spring and a jagged clamp, which gives it a spider-like appearance.
| Study group | Role | What they receive |
|---|---|---|
| MS group | Experimental | In the MS group, the MS grips the HVC through the magnet adsorbed onto the wall of the basin containing the liver. By changing the position of the MS on the wall of the basin, the surgeon is able to expose the surgical field. Receives: Device: MS |
| MA group | No intervention | In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of damaged points on HVC
the number of damaged points on the HVC during the preparation
Measured: measured at the time of the end of preparation HVC; up to 1 hour
Operation time
operation time of preparation of HVC
Measured: measured at the time of the end of preparation HVC; up to 1 hour
The number of assistants
the number of assistants ensuring smooth operation according to attending's requirement
Measured: measured at the time of the end of preparation HVC; up to 1 hour
Leak test
we use nondestructive vascular forceps to occlude the SHVC and IHVC, and perfused about 100 ml organ preservation solution through portal vein. If HVC and portal vein bulge and does not leak, the leak test is negative. Otherwise, it is positive.
Measured: measured at the time of the end of preparation HVC; up to 1 hour
HVC hemorrhage
Whether HVC hemorrhage after implantation
Measured: measured at the time of liver implanted to the recipient; up to 1 hour
Secondary outcomes (1)
Frequency of MS's detachment
the frequency of MS's detachment from the vasculature and basin wall.
Measured: measured at the time of the end of preparation HVC; up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Oct 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182256
- Sponsor's protocol ID
- XJYFY-2017ZD1-01
- Acronym
- MSPLD
- Status last verified
- Aug 2021
- First submitted
- 25 Nov 2019
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study: Magnetic Spiderman for Preparation of Donor Livers' Inferior Vena Cava
- ClinicalTrials.gov ID
- NCT04182256
- Acronym / sponsor ID
- MSPLD / XJYFY-2017ZD1-01
- Conditions
- Liver Transplant; Complications, Surgical Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 2 Dec 2019 (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.
Due to many vascular branches on the supra-hepatic vena cava (SHVC) and infra-hepatic vena cava (IHVC), in the whole procedures of preparation of liver donation, preparation of hepatic vena cava (HVC) is the most key and troublesome step. Magnetic Spiderman (MS) is a novel surgical instrument, designed and created to solve the vital problems of preparation of liver donation's HVC. Therefore, the aim of this study is to evaluate the feasibility and security of MS when using it prepare the liver donation's HVC.
Detailed description
From January 1 2020 to June 30 2020, after inclusion and exclusion, donors' livers will be divided to MS group and manual (MA) group. In MS group, MS grips the SHVC and IHVC, respectively. MS's magnets are adsorbed on the wall of the basin and MS can pull the HVC accordingly. By changing the position of MS on the wall of the basin, the attending can expose the surgical field that make the operation convenient. In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements. In both groups, right adrenal vein, phrenic veins and other branches of the HVC are isolated and ligated, then SHVC and IHVC where MS's clamps gripped are cut off. After preparation, the SHVC and IHVC remain at least 1.5 cm. Excess diaphragms are removed. Outcomes of two groups are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS group | Experimental | Device: MSIn the MS group, the MS grips the HVC through the magnet adsorbed onto the wall of the basin containing the liver. By changing the position of the MS on the wall of the basin, the surgeon is able to expose the surgical field. |
| MA group | No intervention | –In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients receiving donation after cardiac death in the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University.
Key exclusion criteria (4 listed)
- patients whose age<18, or >60
- patients who do not have intact clinical data
- patients who are inability to participate in follow-up
- patients who undergo split liver transplantation
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 |
|---|---|---|
| MSMagnetic Spiderman (MS) is a novel surgical instrumentIt. It consists of a circular neodymium iron boron magnet packed in a stainless-steel case with a spring and a jagged clamp, which gives it a spider-like appearance. | Device | MS group |
Primary outcome
The number of damaged points on HVC
Time frame: measured at the time of the end of preparation HVC; up to 1 hour
the number of damaged points on the HVC during the preparation
Operation time
Time frame: measured at the time of the end of preparation HVC; up to 1 hour
operation time of preparation of HVC
The number of assistants
Time frame: measured at the time of the end of preparation HVC; up to 1 hour
the number of assistants ensuring smooth operation according to attending's requirement
Leak test
Time frame: measured at the time of the end of preparation HVC; up to 1 hour
we use nondestructive vascular forceps to occlude the SHVC and IHVC, and perfused about 100 ml organ preservation solution through portal vein. If HVC and portal vein bulge and does not leak, the leak test is negative. Otherwise, it is positive.
HVC hemorrhage
Time frame: measured at the time of liver implanted to the recipient; up to 1 hour
Whether HVC hemorrhage after implantation
1 secondary outcome
Frequency of MS's detachment
Time frame: measured at the time of the end of preparation HVC; up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- 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.
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?
A study testing MS in people with Liver Transplant; Complications and Surgical Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 Aug 2021. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of damaged points on HVC (time frame: measured at the time of the end of preparation HVC; up to 1 hour). The study lists 5 primary outcomes in all. 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 30 Aug 2021.