Retrograde in situ hypothermic perfusion of the liver during right hemihepatectomy

Retrograde in situ hypothermic perfusion of the liver during right hemihepatectomy - Hypothermic perfusion during hepatectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35734

Enrollment

Registered

2012-01-03

Start date

2012-05-22

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic tumors primary/secondary hepatic malignancies

Interventions

During right hemihepatectomy, the ipsilateral branches of the portal vein and hepatic artery are clamped and cut prior to parenchymal transection. A catheter is introduced in the cut end of both the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Primary or secondary hepatic malignancy, sceduled for right hepatectomy under vascular inflow occlusion, ASA classification I-III, no hepatic co-morbidity (i.e., cirrhosis, severe steatosis, cholestasis, an/or hepatitis B/C infection)

Exclusion criteria

Exclusion criteria: ASA classification IV/V, combined surgical procedure, hepatic co-morbidity (listed under inclusion criteria)

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is defined as parenchymal damage of the liver remnant expressed as postoperative alterations in biochemical- (AST, ALT, conjugated/total bilirubin, and INR) and inflammatory parameters (IL-6, IL-8, C5a, MPO, LTB4, GSH/GSSG ratio, syndecan-1, 8-OHG, 8-OHdG, MDA, 4-HNE, PCC, and 3-nitrotyrosine). In addition, functional tests (99mTc-mebrofenin hepatobiliary scintigraphy with single photon emission computed tomography, HBS-SPECT) and CT-volumetry are performed to assess the effects of R-IHP on regeneration of liver function and -volume. Furthermore, two biopsies will be taken from the FRL. These will be used for assessment of the hepatic energy pool (i.e., the amount of adenine nucleotides, ATP/ADP), as well as transcription of acute phase oxidative stress response genes by PCR. In summary: - Preoperatively. HBS-SPECT, biochemical/inflammatory parameters, and CT-volumetry. - Intraoperatively. Pre-ischemic and post-reperfusion biopsies of the FRL. - Postoperatively. HBS-SPECT, biochemical/inflammatory parameters, and CT-volumetry.	—

Measure

Time frame

The primary endpoint of this study is defined as parenchymal damage of the liver remnant expressed as postoperative alterations in biochemical- (AST, ALT, conjugated/total bilirubin, and INR) and inflammatory parameters (IL-6, IL-8, C5a, MPO, LTB4, GSH/GSSG ratio, syndecan-1, 8-OHG, 8-OHdG, MDA, 4-HNE, PCC, and 3-nitrotyrosine). In addition, functional tests (99mTc-mebrofenin hepatobiliary scintigraphy with single photon emission computed tomography, HBS-SPECT) and CT-volumetry are performed to assess the effects of R-IHP on regeneration of liver function and -volume. Furthermore, two biopsies will be taken from the FRL. These will be used for assessment of the hepatic energy pool (i.e., the amount of adenine nucleotides, ATP/ADP), as well as transcription of acute phase oxidative stress response genes by PCR. In summary: - Preoperatively. HBS-SPECT, biochemical/inflammatory parameters, and CT-volumetry. - Intraoperatively. Pre-ischemic and post-reperfusion biopsies of the FRL. - Postoperatively. HBS-SPECT, biochemical/inflammatory parameters, and CT-volumetry.

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Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)