Colorectal Liver MetastasesNCT00600522
Alternative Surgical Policy for Central Liver Tumors
An observational study of Colorectal Liver Metastases and Hepatocellular Carcinoma, run by University of Milan at 1 site in Italy.
Trial summary
Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade middle hepatic vein (MHV) at caval confluence major surgery is usually recommended. Ultrasound-guided hepatectomy might allow conservative approaches. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Liver Metastases, Hepatocellular Carcinoma
- What is being tested?
- Ultrasound-guided hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to May 2007
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients carriers of hepatocellular carcinoma or colorectal cancer liver metastases addressed to surgical resection
Who may be able to join
- Patients carriers of HCC or colorectal cancer liver metastases (CLM) who have macroscopic signs of vascular invasion (preoperative imaging and/IOUS) of the MHV close to the hepato-caval confluence (within 4 cm) demanding for that MHV resection.
- Minimum follow-up for patients' inclusion was established at 6-months from surgery.
Who cannot join
- Patients carriers of tumors occupying entirely the right paramedian section and the segment 4, for whom at least a MH would have been compulsorily carried out.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Conservative Heopatecomy for Tumors Invading the Middle Hepatic Vein at the Caval Confluence as Alternative to Mesohepatectomy and Trisectionectomy
Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade middle hepatic vein (MHV) at caval confluence major surgery is usually recommended. Ultrasound-guided hepatectomy might allow conservative approaches. We prospectively check its feasibility in a series of patients carriers of tumors invading the MHV at the caval confluence.
Read the detailed description
Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade middle hepatic vein (MHV) at caval confluence trisectionectomy (TS) is generally performed, and central hepatectomy or mesohepatectomy (MH) (Segments 4, 5 and 8), is considered by some authors to be the conservative alternative to the previously cited approach. Between these two surgical interventions there is not, up to now, any evidence that one of them should be clearly preferred; anyway both are mojor resections. We previously reported that a surgical approach based on ultrasound-guided hepatectomy might minimize the need for major resection, whose rates of morbidity and mortality are not negligible. This policy could be useful also for disclosing new, more conservative, and better tolerated approaches for tumors invading the MHV at caval confluence in alternative to MH and TS. This study analyses the feasibility, safety and effectiveness of ultrasound-guided resections applied to these patients enrolled prospectively from a cohort of consecutive patients who undergo hepatectomy for tumors.
- Being tested
- Ultrasound-guided hepatectomy
- Keywords
- intraoperative ultrasonography, hepatectomy, colorectal liver metastases, hepatocellular carcinoma, contrast enhanced intraoperative ultrasonography.
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided hepatectomyProcedure or surgery
After laparotomy and staging by intraoperative ultrasound (IOUS), anterior surface of the hepatocaval confluence is exposed. Than, compression by means of the surgeon's finger-tip is applied at the MHV caval confluence verifying at color-Doppler IOUS the disappearance of the blood flow in the MHV or its inversion. Then, MHV clamping itself is carried out, and parenchymal sparing resection would be selected if at least one of these 3 findings is confirmed:
- Reversal color-Doppler IOUS flow direction in the peripheral portion of the MHV, which suggests the drainage through collateral circulation in the RHV/LHV depending on the side of the MHV branch with reversal flow.
- Detectable shunting collaterals at color-Doppler IOUS with RHV or LHV.
- Hepatopetal flow in P5-8 and/or P4inf portal branches. If none of these finding is confirmed and in particular hepatofugal flow direction in the P5-8 and/or P4 inf is detected the hepatectomy has to be extended.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients selected for hepatectomy because carriers of hepatocellular carcinoma or colorectal cancer liver metastases invading the middle hepatic vein at caval confluence (last 4 cm). Receives: Procedure: Ultrasound-guided hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure was the rate of failure of conservative resection, i.e. the rate of patients who received TSs or MHs despite they fitted in the eligibility criteria.
Measured: January 2007
Secondary outcomes (1)
The secondary outcome measure was the safety of the procedure. For that, we studied morbidity, mortality, amount of blood loss, rate of blood transfusions, and postoperative trend of liver function tests.
Measured: January 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2004
- Primary completionJan 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- Guido Torzilli, MD, PhD, Principal investigator, University of Milan, Istituto Clinico Humanitas - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600522
- Sponsor's protocol ID
- HEP-MHV
- Other IDs
- NEWHEP-2
- Status last verified
- Jan 2008
- First submitted
- 14 Jan 2008
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46. doi: 10.1002/bjs.5321.
PubMed 16953487Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28. doi: 10.1016/j.jamcollsurg.2005.04.026.
PubMed 16183489Stratopoulos C, Soonawalla Z, Brockmann J, Hoffmann K, Friend PJ. Central hepatectomy: the golden mean for treating central liver tumors? Surg Oncol. 2007 Aug;16(2):99-106. doi: 10.1016/j.suronc.2007.05.002. Epub 2007 Jun 20.
PubMed 17583496Torzilli G, Palmisano A, Procopio F, Cimino M, Botea F, Donadon M, Del Fabbro D, Montorsi M. A new systematic small for size resection for liver tumors invading the middle hepatic vein at its caval confluence: mini-mesohepatectomy. Ann Surg. 2010 Jan;251(1):33-9. doi: 10.1097/SLA.0b013e3181b61db9.
PubMed 19858707
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Conservative Heopatecomy for Tumors Invading the Middle Hepatic Vein at the Caval Confluence as Alternative to Mesohepatectomy and Trisectionectomy
- ClinicalTrials.gov ID
- NCT00600522
- Acronym / sponsor ID
- HEP-MHV
- Keywords
- intraoperative ultrasonography, hepatectomy, colorectal liver metastases, hepatocellular carcinoma, contrast enhanced intraoperative ultrasonography.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade middle hepatic vein (MHV) at caval confluence major surgery is usually recommended. Ultrasound-guided hepatectomy might allow conservative approaches. We prospectively check its feasibility in a series of patients carriers of tumors invading the MHV at the caval confluence.
Detailed description
Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade middle hepatic vein (MHV) at caval confluence trisectionectomy (TS) is generally performed, and central hepatectomy or mesohepatectomy (MH) (Segments 4, 5 and 8), is considered by some authors to be the conservative alternative to the previously cited approach. Between these two surgical interventions there is not, up to now, any evidence that one of them should be clearly preferred; anyway both are mojor resections. We previously reported that a surgical approach based on ultrasound-guided hepatectomy might minimize the need for major resection, whose rates of morbidity and mortality are not negligible. This policy could be useful also for disclosing new, more conservative, and better tolerated approaches for tumors invading the MHV at caval confluence in alternative to MH and TS. This study analyses the feasibility, safety and effectiveness of ultrasound-guided resections applied to these patients enrolled prospectively from a cohort of consecutive patients who undergo hepatectomy for tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Ultrasound-guided hepatectomyPatients selected for hepatectomy because carriers of hepatocellular carcinoma or colorectal cancer liver metastases invading the middle hepatic vein at caval confluence (last 4 cm). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients carriers of hepatocellular carcinoma or colorectal cancer liver metastases addressed to surgical resection
Key inclusion criteria (2 listed)
- Patients carriers of HCC or colorectal cancer liver metastases (CLM) who have macroscopic signs of vascular invasion (preoperative imaging and/IOUS) of the MHV close to the hepato-caval confluence (within 4 cm) demanding for that MHV resection.
- Minimum follow-up for patients' inclusion was established at 6-months from surgery.
Key exclusion criteria (1 listed)
- Patients carriers of tumors occupying entirely the right paramedian section and the segment 4, for whom at least a MH would have been compulsorily carried out.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided hepatectomyAfter laparotomy and staging by intraoperative ultrasound (IOUS), anterior surface of the hepatocaval confluence is exposed. Than, compression by means of the surgeon's finger-tip is applied at the MHV caval confluence verifying at color-Doppler IOUS the disappearance of the blood flow in the MHV or its inversion. Then, MHV clamping itself is carried out, and parenchymal sparing resection would be selected if at least one of these 3 findings is confirmed: 1. Reversal color-Doppler IOUS flow direction in the peripheral portion of the MHV, which suggests the drainage through collateral circulation in the RHV/LHV depending on the side of the MHV branch with reversal flow. 2. Detectable shunting collaterals at color-Doppler IOUS with RHV or LHV. 3. Hepatopetal flow in P5-8 and/or P4inf portal branches. If none of these finding is confirmed and in particular hepatofugal flow direction in the P5-8 and/or P4 inf is detected the hepatectomy has to be extended. | Procedure or surgery | 1 |
Primary outcome
The primary outcome measure was the rate of failure of conservative resection, i.e. the rate of patients who received TSs or MHs despite they fitted in the eligibility criteria.
Time frame: January 2007
1 secondary outcome
The secondary outcome measure was the safety of the procedure. For that, we studied morbidity, mortality, amount of blood loss, rate of blood transfusions, and postoperative trend of liver function tests.
Time frame: January 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
- Background: PubMed 16953487Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46. doi: 10.1002/bjs.5321.
- Background: PubMed 16183489Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28. doi: 10.1016/j.jamcollsurg.2005.04.026.
- Background: PubMed 17583496Stratopoulos C, Soonawalla Z, Brockmann J, Hoffmann K, Friend PJ. Central hepatectomy: the golden mean for treating central liver tumors? Surg Oncol. 2007 Aug;16(2):99-106. doi: 10.1016/j.suronc.2007.05.002. Epub 2007 Jun 20.
- Derived from this study: PubMed 19858707Torzilli G, Palmisano A, Procopio F, Cimino M, Botea F, Donadon M, Del Fabbro D, Montorsi M. A new systematic small for size resection for liver tumors invading the middle hepatic vein at its caval confluence: mini-mesohepatectomy. Ann Surg. 2010 Jan;251(1):33-9. doi: 10.1097/SLA.0b013e3181b61db9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Torzilli, MD, PhD principal investigator
University of Milan, Istituto Clinico Humanitas - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastases and Hepatocellular Carcinoma, run by University of Milan at 1 site in Italy.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jan 2008. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was the rate of failure of conservative resection, i.e. the rate of patients who received TSs or MHs despite they fitted in the eligibility criteria. (time frame: January 2007). 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 NCT00600522, which also lists 4 linked publications.
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 25 Jan 2008.