Liver Failure Clinical Trial
— MODHEP1Official 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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | December 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Medical Innovation Developpement (MID) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | intraoperative | |
Primary | 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 | during the 48 hours after the liver surgery | |
Secondary | Portal pressure measured upstream and downstream the MID-AVR | Phase A | intraoperative | |
Secondary | Portal flow measured downstream the MID-AVR | Phase A | intraoperative | |
Secondary | Liver perfusion assessed by intraoperative contrast enhanced ultrasonography | Phase A | intraoperative | |
Secondary | 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. | intraoperative | |
Secondary | Occurrence of POLF (Bilirubin > 50 µmol/L and PT < 50% ) | Phase B | at postoperative day 3 | |
Secondary | Occurrence of post-operative hemorrhage (decrease in haemoglobin that required red pack cell transfusion) | Phase B | at postoperative day 3 | |
Secondary | Occurrence of Post-operative biliary fistulae (Bilirubin concentration in fluid drainage greater than 3 fold the plasmatic bilirubin rate) | Phase B | at postoperative day 3 | |
Secondary | 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. | at postoperative day 3 |
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