Colorectal Liver MetastasesNCT00797251
Anatomical Right Posterior Sectionectomy of the Liver by IOUS-Guided Finger Compression
An observational study of Colorectal Liver Metastases and Hepatocellular Carcinoma, run by University of Milan at 1 site in Italy.
Trial summary
The use of intraoperative ultrasound (IOUS) allows us to perform new conservative hepatectomies. The investigators previously reported the systematic subsegmentectomy by IOUS-guided finger compression for segments 2-3, which is currently applied for patients with hepatocellular carcinoma (HCC)on cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Liver Metastases, Hepatocellular Carcinoma, Liver Malignancies
- What is being tested?
- Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Sep 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population include patients with primary or secondary liver tumors in the right posterior section of the liver eligible to a right posterior sectionectomy as a primary surgical procedure.
Who may be able to join
- Patients with tumors at least at 1 cm distally to the bifurcation of the right portal vein (bifurcation of P5-8 and P6-7) eligible for right posterior sectionectomy, namely the anatomical removal of segment 6 and 7, were considered potential candidates to this procedure. Precisely, these criteria were adopted:
- Patients with hepatocellular carcinoma (HCC) with infiltrative growing pattern in contact with P6-7;
- Patients with any type of HCC in contact with P6-7 with distal bile duct dilation;
- Patients with colorectal liver metastasis (CLM) in contact with P6-7.
Who cannot join
- Exclusion criteria for carrying out the herein described procedure was considered the presence of tumoral thrombosis in P6-7.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
Rozzano, Milan, 20089
About this study
Official title: A Novel Simple Technique for Performing Anatomical Right Posterior Sectionectomy of the Liver: the Ultrasound-Guided Finger Compression
The use of intraoperative ultrasound (IOUS) allows us to perform new conservative hepatectomies. The investigators previously reported the systematic subsegmentectomy by IOUS-guided finger compression for segments 2-3, which is currently applied for patients with hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel technique, which consists in the systematic right posterior sectionectomy by IOUS-guided finger compression.
Read the detailed description
A novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to accomplish a right posterior sectionectomy is described. Dissection or encirclement of the sectional pedicles for resection area demarcation is thus avoided. Ten patients underwent this technique successfully without mortality or major morbidity. IOUS-guided finger compression of sectional portal pedicle feeding the right posterior section is a feasible, safe, and effective method.
- Being tested
- Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.
- Keywords
- Colorectal liver metastasis, hepatocellular carcinoma, liver surgery, intraoperative ultrasound, finger-compression
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.Procedure or surgery
Also called anatomic resection of segment 6-7
The technique consists in IOUS-guided finger compression of the right posterior portal pedicle at the level closest to the tumor but oncologically suitable. This method allows us to anatomically mark the area of resection with nor hilar plate nor IOUS-guided puncture of vessels, which are up to date the only two techniques available to perform anatomical right posterior sectionectomy - namely the removal of segment 6 and 7.
| Study group | Role | What they receive |
|---|---|---|
| Right posterior section group | Patients with tumors in the right posterior section of the liver (segments 6-7) Receives: Procedure: Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the safety of the anatomical right posterior sectionectomy performed IOUS-guided finger compression.
Measured: 6 months
Secondary outcomes (1)
The secondary outcome is the efficacy of the anatomical right posterior sectionectomy performed by IOUS-guided finger compression.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- Guido Torzilli, MD, PhD, Principal investigator, University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797251
- Sponsor's protocol ID
- IOUS-Compression
- Status last verified
- Nov 2008
- First submitted
- 24 Nov 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torzilli 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, Donadon M, Montorsi M. The surgical margin in liver resection for hepatocellular carcinoma: a real problem or not? Ann Surg. 2007 Oct;246(4):690-1; author reply 691-2. doi: 10.1097/SLA.0b013e318156e286. No abstract available.
PubMed 17893508Torzilli 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, 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 14625736Takasaki K, Kobayashi S, Tanaka S, Saito A, Yamamoto M, Hanyu F. Highly anatomically systematized hepatic resection with Glissonean sheath code transection at the hepatic hilus. Int Surg. 1990 Apr-Jun;75(2):73-7.
PubMed 2166006Launois B, Jamieson GG. The posterior intrahepatic approach for hepatectomy or removal of segments of the liver. Surg Gynecol Obstet. 1992 Feb;174(2):155-8.
PubMed 1734576Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.
PubMed 2996162
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Simple Technique for Performing Anatomical Right Posterior Sectionectomy of the Liver: the Ultrasound-Guided Finger Compression
- ClinicalTrials.gov ID
- NCT00797251
- Acronym / sponsor ID
- IOUS-Compression
- Keywords
- Colorectal liver metastasis, hepatocellular carcinoma, liver surgery, intraoperative ultrasound, finger-compression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 25 Nov 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.
The use of intraoperative ultrasound (IOUS) allows us to perform new conservative hepatectomies. The investigators previously reported the systematic subsegmentectomy by IOUS-guided finger compression for segments 2-3, which is currently applied for patients with hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel technique, which consists in the systematic right posterior sectionectomy by IOUS-guided finger compression.
Detailed description
A novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to accomplish a right posterior sectionectomy is described. Dissection or encirclement of the sectional pedicles for resection area demarcation is thus avoided. Ten patients underwent this technique successfully without mortality or major morbidity. IOUS-guided finger compression of sectional portal pedicle feeding the right posterior section is a feasible, safe, and effective method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right posterior section group | – | Procedure: Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.Patients with tumors in the right posterior section of the liver (segments 6-7) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population include patients with primary or secondary liver tumors in the right posterior section of the liver eligible to a right posterior sectionectomy as a primary surgical procedure.
Key inclusion criteria (4 listed)
- Patients with tumors at least at 1 cm distally to the bifurcation of the right portal vein (bifurcation of P5-8 and P6-7) eligible for right posterior sectionectomy, namely the anatomical removal of segment 6 and 7, were considered potential candidates to this procedure. Precisely, these criteria were adopted:
Key exclusion criteria (1 listed)
- Exclusion criteria for carrying out the herein described procedure was considered the presence of tumoral thrombosis in P6-7.
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 |
|---|---|---|
| Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.Also: anatomic resection of segment 6-7The technique consists in IOUS-guided finger compression of the right posterior portal pedicle at the level closest to the tumor but oncologically suitable. This method allows us to anatomically mark the area of resection with nor hilar plate nor IOUS-guided puncture of vessels, which are up to date the only two techniques available to perform anatomical right posterior sectionectomy - namely the removal of segment 6 and 7. | Procedure or surgery | Right posterior section group |
Primary outcome
The primary outcome is the safety of the anatomical right posterior sectionectomy performed IOUS-guided finger compression.
Time frame: 6 months
1 secondary outcome
The secondary outcome is the efficacy of the anatomical right posterior sectionectomy performed by IOUS-guided finger compression.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2008.
- 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.
- Background: PubMed 17893508Torzilli G, Donadon M, Montorsi M. The surgical margin in liver resection for hepatocellular carcinoma: a real problem or not? Ann Surg. 2007 Oct;246(4):690-1; author reply 691-2. doi: 10.1097/SLA.0b013e318156e286. No abstract available.
- 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 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 2166006Takasaki K, Kobayashi S, Tanaka S, Saito A, Yamamoto M, Hanyu F. Highly anatomically systematized hepatic resection with Glissonean sheath code transection at the hepatic hilus. Int Surg. 1990 Apr-Jun;75(2):73-7.
- Background: PubMed 1734576Launois B, Jamieson GG. The posterior intrahepatic approach for hepatectomy or removal of segments of the liver. Surg Gynecol Obstet. 1992 Feb;174(2):155-8.
- Background: PubMed 2996162Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.
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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 School of Medicine, IRCCS Istituto Clinico Humanitas
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 4 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: status not confirmed, as of the sponsor's last update on 25 Nov 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?
Results are not available in the source record.
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 is the safety of the anatomical right posterior sectionectomy performed IOUS-guided finger compression. (time frame: 6 months). 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 NCT00797251, which also lists 8 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 Nov 2008.