Hepatocellular CarcinomaNCT00829335
Anatomical Resection of the Liver for Hepatocellular Carcinoma: a New Ultrasound Guided Approach
An observational study of Hepatocellular Carcinoma, run by University of Milan at 1 site in Italy.
Trial summary
Anatomical resection is the gold standard approach for liver resection in patients with HCC. A new method for that by means of IOUS-guided finger compression has been devised. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Jan 2009
- 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 reffered to our outpatient clinic for evaluation as carriers of HCC
Who may be able to join
- Patients suitable for surgical approach carries of HCC
- Serum bilirubin level lower than 1.5 mg/dl
Who cannot join
- Presence of ascites
- Serum bilirubin level equal or higher than 1.6 mg/dl
- Conditions (size, vascular relation, or infiltration) demanding resection larger than a segmental area
- Tumor thrombus in portal or hepatic veins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomical Segmental and Subsegmental Resection of the Liver for Hepatocellular Carcinoma: a New Approach by Means of Ultrasound-Guided Vessel Compression
Anatomical resection is the gold standard approach for liver resection in patients with HCC. A new method for that by means of IOUS-guided finger compression has been devised.
Read the detailed description
We herein describe a novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to systematically accomplish anatomical segmental and subsegmental resections.
Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION
- Keywords
- Intraoperative ultrasound, Segmentectomy, HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSIONProcedure or surgery
Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | According with the investigators previously reported selection flow-chart , patients suitable for surgical approach were those with HCC without ascites, without or with esophageal varices for which preoperative endoscopic eradication could be carried out successfully, and with serum bilirubin level lower than 1.5 mg/dl. Potential candidates to systematic segmental or subsegmental resection by IOUS-guided finger compression were considered patients with single HCC located in one or 2 adjacent segments without portal thrombosis, and anyway not demanding for its complete removal a sectional resection or wider. Receives: Procedure: IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility
Secondary outcomes (1)
Morbidity and mortality
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- GUIDO TORZILLI, MD, PHD, Study chair, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829335
- Sponsor's protocol ID
- IOUS-COMP GENERAL
- Status last verified
- Jan 2009
- First submitted
- 26 Jan 2009
- Last updated
- 27 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082.
PubMed 19015467Torzilli G, Palmisano A, Del Fabbro D, Marconi M, Donadon M, Spinelli A, Bianchi PP, Montorsi M. Contrast-enhanced intraoperative ultrasonography during surgery for hepatocellular carcinoma in liver cirrhosis: is it useful or useless? A prospective cohort study of our experience. Ann Surg Oncol. 2007 Apr;14(4):1347-55. doi: 10.1245/s10434-006-9278-3. Epub 2007 Jan 26.
PubMed 17253105Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. doi: 10.1007/s00464-003-9024-x. Epub 2003 Nov 21.
PubMed 14625736Torzilli G, Makuuchi M. Ultrasound-guided liver subsegmentectomy: the peculiarity of segment 4. J Am Coll Surg. 2001 Dec;193(6):706-8. doi: 10.1016/s1072-7515(01)01077-8. No abstract available.
PubMed 11768689Torzilli G, Takayama T, Hui AM, Kubota K, Harihara Y, Makuuchi M. A new technical aspect of ultrasound-guided liver surgery. Am J Surg. 1999 Oct;178(4):341-3. doi: 10.1016/s0002-9610(99)00193-2.
PubMed 10587196Torzilli G, Montorsi M, Gambetti A, Del Fabbro D, Donadon M, Bianchi P, Olivari N, Makuuchi M. Utility of the hooking technique for cases of major hepatectomy. Surg Endosc. 2005 Aug;19(8):1156-7. doi: 10.1007/s00464-004-2232-1. Epub 2005 May 26.
PubMed 16021373Torzilli 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 16183489Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.
PubMed 18362622Torzilli G, Procopio F, Cimino M, Del Fabbro D, Palmisano A, Donadon M, Montorsi M. Anatomical segmental and subsegmental resection of the liver for hepatocellular carcinoma: a new approach by means of ultrasound-guided vessel compression. Ann Surg. 2010 Feb;251(2):229-35. doi: 10.1097/SLA.0b013e3181b7fdcd.
PubMed 19838106
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Segmental and Subsegmental Resection of the Liver for Hepatocellular Carcinoma: a New Approach by Means of Ultrasound-Guided Vessel Compression
- ClinicalTrials.gov ID
- NCT00829335
- Acronym / sponsor ID
- IOUS-COMP GENERAL
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Intraoperative ultrasound, Segmentectomy, HCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Jan 2009 (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.
Anatomical resection is the gold standard approach for liver resection in patients with HCC. A new method for that by means of IOUS-guided finger compression has been devised.
Detailed description
We herein describe a novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to systematically accomplish anatomical segmental and subsegmental resections.
Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Procedure: IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSIONAccording with the investigators previously reported selection flow-chart , patients suitable for surgical approach were those with HCC without ascites, without or with esophageal varices for which preoperative endoscopic eradication could be carried out successfully, and with serum bilirubin level lower than 1.5 mg/dl. Potential candidates to systematic segmental or subsegmental resection by IOUS-guided finger compression were considered patients with single HCC located in one or 2 adjacent segments without portal thrombosis, and anyway not demanding for its complete removal a sectional resection or wider. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients reffered to our outpatient clinic for evaluation as carriers of HCC
Key inclusion criteria (2 listed)
- Patients suitable for surgical approach carries of HCC
- Serum bilirubin level lower than 1.5 mg/dl
Key exclusion criteria (4 listed)
- Presence of ascites
- Serum bilirubin level equal or higher than 1.6 mg/dl
- Conditions (size, vascular relation, or infiltration) demanding resection larger than a segmental area
- Tumor thrombus in portal or hepatic veins
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 |
|---|---|---|
| IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSIONUsing the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver. | Procedure or surgery | HCC patients |
Primary outcome
Technical feasibility
1 secondary outcome
Morbidity and mortality
Time frame: 30 and 90 days
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 27 Jan 2009.
- Background: PubMed 19015467Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082.
- Background: PubMed 17253105Torzilli G, Palmisano A, Del Fabbro D, Marconi M, Donadon M, Spinelli A, Bianchi PP, Montorsi M. Contrast-enhanced intraoperative ultrasonography during surgery for hepatocellular carcinoma in liver cirrhosis: is it useful or useless? A prospective cohort study of our experience. Ann Surg Oncol. 2007 Apr;14(4):1347-55. doi: 10.1245/s10434-006-9278-3. Epub 2007 Jan 26.
- Background: PubMed 14625736Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. doi: 10.1007/s00464-003-9024-x. Epub 2003 Nov 21.
- Background: PubMed 11768689Torzilli G, Makuuchi M. Ultrasound-guided liver subsegmentectomy: the peculiarity of segment 4. J Am Coll Surg. 2001 Dec;193(6):706-8. doi: 10.1016/s1072-7515(01)01077-8. No abstract available.
- Background: PubMed 10587196Torzilli G, Takayama T, Hui AM, Kubota K, Harihara Y, Makuuchi M. A new technical aspect of ultrasound-guided liver surgery. Am J Surg. 1999 Oct;178(4):341-3. doi: 10.1016/s0002-9610(99)00193-2.
- Background: PubMed 16021373Torzilli G, Montorsi M, Gambetti A, Del Fabbro D, Donadon M, Bianchi P, Olivari N, Makuuchi M. Utility of the hooking technique for cases of major hepatectomy. Surg Endosc. 2005 Aug;19(8):1156-7. doi: 10.1007/s00464-004-2232-1. Epub 2005 May 26.
- 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 18362622Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.
- Derived from this study: PubMed 19838106Torzilli G, Procopio F, Cimino M, Del Fabbro D, Palmisano A, Donadon M, Montorsi M. Anatomical segmental and subsegmental resection of the liver for hepatocellular carcinoma: a new approach by means of ultrasound-guided vessel compression. Ann Surg. 2010 Feb;251(2):229-35. doi: 10.1097/SLA.0b013e3181b7fdcd.
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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 study chair
University of Milan
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 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 4 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 27 Jan 2009. 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?
Technical feasibility. 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 NCT00829335, which also lists 10 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 27 Jan 2009.