Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnglewood Hospital and Medical Center

About this trial

the investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection (2) to assess the production of CO in patients following liver resection and correlate these findings to the rate of liver regeneration and liver function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient plans to have partial liver resection for primary liver pathology or metastatic disease

Patient is able to comprehend and willing to sign the written consent form

Disqualifiers

Patients < 18 years

Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test

Trial design

Design model

Single group

Treatments tested in this trial

  • carbon monoxide measurement via smokerlyzer

    Other intervention

    participants in this study will provide breath samples for carbon monoxide measurements pre and post liver resection

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: all participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regeneration

patients will be asked to donate exhaled breath into a smokerlyzer device

Time frame
measurements will be taken pre, then 4 hours and 24 hours post resection

Secondary outcomes

1

level of carbon monoxide in exhaled air of patients

patients will be asked to donate exhaled breath into a smokerlyzer device

Time frame
measurements will be taken pre, then 4 hours and 24 hours post resection
2

quantity of liver regeneration, liver volume (ml)

CT liver volumetric studies

Time frame
one and three months after resection
3

quality of hepatic regeneration, normalized liver function

serum protein, albumin, AST and ALT, alkaline phosphatase, and bilirubin level

Time frame
one and three months post resection

Other outcomes

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