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Liver FailurePhase 1/2MODHEP1NCT02390713

Pneumatic Reversible Portal Vein Diameter Modulation After Major Hepatectomy

A Phase 1/2 study testing MID-AVR in people with Liver Failure and Major Hepatectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This ring aimed to preserve an intra-hepatic porto-caval gradient inferior to 5 mm Hg during and after major hepatectomy (48h) to protect the liver during the initial phases of liver regeneration. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Liver Failure, Major Hepatectomy
What is being tested?
MID-AVR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteFrance
Study dates
18 Apr 2015to Dec 2020
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • French resident affiliated to Social Insurance
  • Major hepatectomy (Phase A)
  • Major hepatectomy that preserved only one hepatic vein (Phase B)
  • Remnant liver volume > 0.5% of the body weight

Who cannot join

  • Age > 80 (Phase A) and Age > 70 (Phase B)
  • Cirrhotic patient (F4)
  • Repeat hepatectomy
  • Patient who required a portal vein resection
  • History of deep venous thrombosis
  • History of portal thrombosis

Trial locations and contacts

1 site in 1 country.

Eric VIBERT, MD, PhD contact

+33 (0)6 60 64 96 97

eric.vibert@pbr.aphp.fr

France1 site, 1 recruiting

  • AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

    Villejuif, 94

    Laina N'DIAYE, +33 (0)1 45 21 31 72, laina.ndiaye@bct.aphp.fr

    Eric VIBERT, MD

    Recruiting

Other trials in France

About this study

Official title: Pneumatic Reversible Portal Vein Diameter Modulation After Major Hepatectomy in Non Cirrhotic Patient

This ring aimed to preserve an intra-hepatic porto-caval gradient inferior to 5 mm Hg during and after major hepatectomy (48h) to protect the liver during the initial phases of liver regeneration. Morphological features of MID-AVRTM allow its intra corporeal opening and percutaneously removal after an balloon inflation with 5 ml of physiological serum. MID-AVRTM had been developed in pig where it had proved its efficiency to improve liver function after 75% hepatectomy and its capacity to be removed percutaneously. Aim of this feasibility study (Phase I/II) is to prove in series of 3 evaluable patients (Phase A) then 6 evaluable patients (Phase B) that MID-AVRTM could be used in human without deleterious consequence. In phase A, MID-AVRTM is dispose around the portal vein before and during a major hepatectomy performed on healthy liver and removed before abdominal closure. If phase A results confirmed that MID-AVRTM well modulates portal pressure and is easily opened and removed by acute inflation, the phase B will be started. In phase B, MID-AVRTM will be dispose around the portal vein before major hepatectomy on healthy liver and conserved 48 hours before to be removed percutaneously at the operating room.

Read the detailed description

Preserving liver function is vital, especially after hepatectomy, the main curative treatment of liver tumor. An hepatectomy that preserved a remnant liver volume < 0.5% of the body weight is associated with a very high risk of post-operative liver failure. In such situation, liver volume is not sufficient to support local hemodynamic consequences of the hepatectomy that is responsible of intrahepatic endothelial cell injury that impaired liver function and regeneration. To date, preoperative vein embolization (PVE) associated or not to liver transection (ALPSS procedure) that increased future remnant liver from 20% to 90% is the only method to prevent this complication. Even this preparation is necessary for the moment, PVE increased cancer cell proliferation and is associated with lower recurrence free survival than without PVE. Despite a potential PVE, POLF occurred in 5% to 7% after major hepatectomy and stayed the first cause of death after hepatectomy. It has been demonstrated that portal pressure superior to 20 mm Hg and/or porto-caval gradient superior to 12 mm Hg at the end of hepatectomy was associated to the occurrence of POLF. Aim to avoid this acute intra hepatic portal hypertension associated to major hepatectomy that is associated with an early liver endothelial cell injury, we had developed an silicon ring to dispose around the portal vein that contained an circular inflatable balloon to narrow precisely the portal vein lumen (MID-AVRTM).

Phase A: Tolerance and functionality of MID-AVR during surgery Each procedure will be filmed. Phase B: Tolerance and functionality of MID-AVR after surgery Each procedure will be filmed.

Being tested
MID-AVR
Keywords
hepatectomy, post-operative liver failure, portal vein, portal flow, portal pressure, modulation, surgical device
Medical subject headings
Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MID-AVRDevice

    Phase A (4 patients): After laparotomy and dissection of hepatic pedicle, feasibility of MID-AVR positioning around the portal vein by hepato-biliary surgeon and visual evaluation of potential spatial conflict with hepatic artery and choledochal. Mid-AVR is removed at the end of surgery. Each procedure will be filmed.

    Phase B (12 patients): Mid-AVR is maintained at the end of surgery, and during 48 hours to evaluate the persistence of an hepatopetal portal flow without portal vein thrombosis upstream MID-AVR during the 48 hours after the liver surgery at bi-daily ultrasonography.

Study groups in NCT02390713
Study groupRoleWhat they receive
MID-AVRExperimentalTolerance and functionality of MID-AVR during surgery (Phase A) and after surgery (Phase B)
Receives: Device: MID-AVR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success of MID-AVR positioning

    Phase A: Feasibility of MID-AVR positioning around the portal vein by hepato-biliary surgeon and visual evaluation of potential spatial conflict with hepatic artery and choledochal. Each procedure will be filmed.

    Measured: intraoperative

  2. Persistence of an hepatopetal portal flow at bi-daily ultrasonography

    Phase B: Persistence of an hepatopetal portal flow without portal vein thrombosis upstream MID-AVR

    Measured: during the 48 hours after the liver surgery

Secondary outcomes (8)

  1. Portal pressure measured upstream and downstream the MID-AVR

    Phase A

    Measured: intraoperative

  2. Portal flow measured downstream the MID-AVR

    Phase A

    Measured: intraoperative

  3. Liver perfusion assessed by intraoperative contrast enhanced ultrasonography

    Phase A

    Measured: intraoperative

  4. Reliability of MID-AVR opening by balloon inflation and removal from the portal vein by smooth traction on the tube that is connected to MID-AVR.

    Phase A Each procedure will be filmed.

    Measured: intraoperative

  5. Occurrence of POLF (Bilirubin > 50 µmol/L and PT < 50% )

    Phase B

    Measured: at postoperative day 3

  6. Occurrence of post-operative hemorrhage (decrease in haemoglobin that required red pack cell transfusion)

    Phase B

    Measured: at postoperative day 3

  7. Occurrence of Post-operative biliary fistulae (Bilirubin concentration in fluid drainage greater than 3 fold the plasmatic bilirubin rate)

    Phase B

    Measured: at postoperative day 3

  8. Reliability of MID-AVR opening by balloon inflation and percutaneously removal from the portal vein by smooth traction on the tube that is connected to MID-AVR.

    Phase B Removal will be done at the operating room under neurolept analgesia and local anesthesia under radiological control. Each procedure will be filmed.

    Measured: at postoperative day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study start18 Apr 2015
  3. Primary completionApr 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390713
Sponsor's protocol ID
P131002
Acronym
MODHEP1
Status last verified
Apr 2019
First submitted
11 Mar 2015
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MID-AVR in people with Liver Failure and Major Hepatectomy, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 6 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 2019. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Eric VIBERT, MD, PhD (+33 (0)6 60 64 96 97, eric.vibert@pbr.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of MID-AVR positioning (time frame: intraoperative). The study lists 2 primary outcomes in all. 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 NCT02390713.

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 2019.

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