Pneumatic Reversible Portal Vein Diameter Modulation After Major Hepatectomy

NCT02390713 | Unknown Phase 1 DMC

• 1 other identifier: P131002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Failure; Major Hepatectomy

Keywords

hepatectomy; post-operative liver failure; portal vein; portal flow; portal pressure; modulation; surgical device

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Portal pressure measured upstream and downstream the MID-AVR

  intraoperative

• Portal flow measured downstream the MID-AVR

  intraoperative

• Liver perfusion assessed by intraoperative contrast enhanced ultrasonography

  intraoperative

• 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.

  intraoperative

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

  at postoperative day 3

Study Arms (1)

MID-AVR

EXPERIMENTAL

Tolerance and functionality of MID-AVR during surgery (Phase A) and after surgery (Phase B)

Device: MID-AVR

Interventions

MID-AVR DEVICE

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.

MID-AVR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Medical Innovation Developpement (MID): collaborator

Study Sites (1)

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

Villejuif, 94, France

RECRUITING

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Eric VIBERT, MD, PhD

  AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire, Villejuif, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric VIBERT, MD, PhD

CONTACT

+33 (0)6 60 64 96 97; eric.vibert@pbr.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: April 18, 2015
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

FR (1)