Colon Cancer Liver MetastasisNCT02090816
Combined Liver and Right Lung Resection for Colorectal Metastases by Means of J-shaped Thoracophrenolaparotomy
An observational study of Colon Cancer Liver Metastasis and Multiple Pulmonary Nodules, run by University of Milan at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is effective in the surgical treatment of simultaneous liver and right lung metastases from colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Liver Metastasis, Multiple Pulmonary Nodules
- What is being tested?
- Surgery of liver and lung
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care clinic
Who may be able to join
- Controlled primary disease;
- No extrahepatic lesion other than resectable pulmonary metastases at preoperative investigation;
- No lymph-node metastases except for those eventually present at the hepatic hilum;
- Disregarding number and distribution of liver metastases, technical resectability leaving at least a remnant liver volume of at least 40% of the total liver volume (calculated excluding the tumoral volume) featured by preserved inflow, outflow and biliary drainage. Zero mm free margin was considered acceptable in case of contact or close adjacency (< 5 mm) with 1st or 2nd order portal pedicles and/or major hepatic veins at their caval confluence;
- Disregarding number and distribution of lung metastases, all of the detected nodules could be completely removed preserving enough functioning remnant lung based on the results of the preoperative cardio-pulmonary functional tests;
- Patients eligible for a J-shaped thoracophrenolaparotomy because carrier of liver metastases located at the caval confluence, or in the paracaval portion of segment 1 or in the upper right segments (4 superior, 7 and 8), or presenting strong-adhesion or infiltration of the diaphragm.
Who cannot join
- Patients not suitable for surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is effective in the surgical treatment of simultaneous liver and right lung metastases from colorectal cancer
Read the detailed description
Right-sided lung metastases are resected synchronously with liver metastases by means of a thoracophrenolaparotomy.
The pre-operative staging includes for all patients colonoscopy, thoracic and abdominal contrast enhanced computed tomography (CT), contrast enhanced magnetic resonance (MRI) of the upper abdomen, and 18-fluorodeoxyglucose PET scan.
Laboratory examinations including liver function tests, spirometry, cardiologic and anesthesiological evaluation are also performed in alla patients.
Surgical Procedures The patient is placed in supine position with the arms extended laterally. The anaesthesiologist for selective lung insufflation positions the double lumen endotracheal tube. The J-shaped abdominal incision conventionally adopted for liver surgery is performed. In case of tumors involving segment 1 or cranial segment portion of segments 4 superior, 7 and 8 close to the caval confluence, the incision is prolonged along the 9th right intercostal space allowing the access to thoracic cavity. The incision of the skin and the external oblique muscle reaches the anterior axillary line. A small portion, about 2 centimetres, of the cartilaginous costal arch is removed, and then the diaphragm is divided in a radial direction. The inner parietal incision, involving parietal pleura and intercostal muscles is prolonged up to the posterior axillary line preserving the intercostal neurovascular bundle.
Intraoperative ultrasound (IOUS) is performed in all patients to stage the liver involvement as well as to assess the relation between tumors and vascular structures and guidance in the dissection of hepatic parenchyma. If nodules are isoechoic in comparison to the surrounding tissue, the staging is completed with contrast-enhanced IOUS (CEIOUS); the contrast agent consists of 4.8 mL of microbubbles filled with sulfur hexafluoride (SonoVue®; Bracco Imaging, Italy), which is injected intravenously.
Once surgical strategy is defined, the liver mobilization is completed by dividing the right and/or left triangular and coronary ligaments as needed. For combining the abdominal and thoracic procedures the right liver has to be mobilized at least up to the exposure of the inferior vena cava allowing larger radial incision of the diaphragm and enlarged view field to the thoracic cavity.
At first the thoracic surgeon performs the pulmonary part. The bed is tilted to the left side and exposure of right thoracic cavity is gained to the entire lung and the lateral mediastinum. With deflation and gentle retraction of the ipsilateral lung, the mediastinum and pericardium are exposed. Pulmonary ligament and lobar fissures are divided as needed. Manual palpation of the lung to detect the metastatic lesion is carried out. Then, wedge resection of the lung metastases is performed by using disposable stapler. Allowing the lung to collapse facilitates application of the stapling device and achievement of an adequate margin. Absorbable monofilament sutures are used, if necessary, to ensure haemostasis and/or small air leaks.
The hepatic resection is then started. Briefly, definition of the resection area with the main purpose of surrounding the tumor at its deepest portion combining the minimal parenchymal sacrifice and the flattest cut surface is performed under IOUS guidance. The hilar pedicle is then encircled with a tourniquet if dissection is not intended. Otherwise, in case of major hepatectomy, hilar dissection is performed. For all patients, parenchymal transection is obtained under intermittent clamping by Pringle maneuver continued for 15 minutes followed by 5 minutes of reperfusion without preconditioning. After 4 clamping cycles, reperfusion time is prolonged for 10 minutes. Liver dissection is accomplished using crush clamping technique, ligating with sutures all the vessels but those thinner which are coagulated using bipolar electrocautery . Before abdominal closure, the cut surface of the liver is sealed with haemostatic agent.
Closed suction abdominal drains are inserted in every patient around the liver, in variable number depending to the number and the size of liver cut surfaces. They are removed on the 7th postoperative day (POD) if the bilirubin level in the drain discharge sampled routinely on the 3rd, 5th, and 7th POD showed a decrement, and in any case was below 10 mg/ml.
One or two chest tube are placed in the pleural cavity, being removed from the 3rd POD, in absence of air leak within the bottle and if the serous output is below 200 mL/24h.
The ribs are approximated with pericostal sutures using braided absorbable sutures size 2. The diaphragm is closed with a single layer running suture. Peritoneum and fasciae of the chest and abdominal wall are closed in an anatomic pattern. Subcutaneous layer and skin are finally closed in the routine manner.
- Being tested
- Surgery of liver and lung
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery of liver and lungProcedure or surgery
Simultaneous resection of liver and right lung metastases in a single surgical session through a new approach
| Study group | Role | What they receive |
|---|---|---|
| Surgery of liver and lung | Patients carriers of both liver and right lung metastases in the same time Receives: Procedure: Surgery of liver and lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of metastases removed
Evaluation of the resectability of whole metastases in liver and right lung in the same operation by means of the same surgical incision (J-shaped thoracophrenolaparotomy)
Measured: Baseline: date of surgical operation
Secondary outcomes (2)
Number of patients that received interventional treatments after surgery
Measured: Participants will be followed from the baseline (date of surgery) to 90 days after the operation
Number of re-operated patients
Measured: Participants will be followed from the baseline (date of surgery) to 90 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startSep 2004
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Liver MetastasisStudies 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
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
- Investigators
- Guido Torzilli, MD PhD FACS, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090816
- Sponsor's protocol ID
- Liver-lung-001
- Status last verified
- Mar 2014
- First submitted
- 4 Feb 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Liver and Right Lung Resection for Colorectal Metastases by Means of J-shaped Thoracophrenolaparotomy
- ClinicalTrials.gov ID
- NCT02090816
- Acronym / sponsor ID
- Liver-lung-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Mar 2014 (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 purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is effective in the surgical treatment of simultaneous liver and right lung metastases from colorectal cancer
Detailed description
Right-sided lung metastases are resected synchronously with liver metastases by means of a thoracophrenolaparotomy.
The pre-operative staging includes for all patients colonoscopy, thoracic and abdominal contrast enhanced computed tomography (CT), contrast enhanced magnetic resonance (MRI) of the upper abdomen, and 18-fluorodeoxyglucose PET scan.
Laboratory examinations including liver function tests, spirometry, cardiologic and anesthesiological evaluation are also performed in alla patients.
Surgical Procedures The patient is placed in supine position with the arms extended laterally. The anaesthesiologist for selective lung insufflation positions the double lumen endotracheal tube. The J-shaped abdominal incision conventionally adopted for liver surgery is performed. In case of tumors involving segment 1 or cranial segment portion of segments 4 superior, 7 and 8 close to the caval confluence, the incision is prolonged along the 9th right intercostal space allowing the access to thoracic cavity. The incision of the skin and the external oblique muscle reaches the anterior axillary line. A small portion, about 2 centimetres, of the cartilaginous costal arch is removed, and then the diaphragm is divided in a radial direction. The inner parietal incision, involving parietal pleura and intercostal muscles is prolonged up to the posterior axillary line preserving the intercostal neurovascular bundle.
Intraoperative ultrasound (IOUS) is performed in all patients to stage the liver involvement as well as to assess the relation between tumors and vascular structures and guidance in the dissection of hepatic parenchyma. If nodules are isoechoic in comparison to the surrounding tissue, the staging is completed with contrast-enhanced IOUS (CEIOUS); the contrast agent consists of 4.8 mL of microbubbles filled with sulfur hexafluoride (SonoVue®; Bracco Imaging, Italy), which is injected intravenously.
Once surgical strategy is defined, the liver mobilization is completed by dividing the right and/or left triangular and coronary ligaments as needed. For combining the abdominal and thoracic procedures the right liver has to be mobilized at least up to the exposure of the inferior vena cava allowing larger radial incision of the diaphragm and enlarged view field to the thoracic cavity.
At first the thoracic surgeon performs the pulmonary part. The bed is tilted to the left side and exposure of right thoracic cavity is gained to the entire lung and the lateral mediastinum. With deflation and gentle retraction of the ipsilateral lung, the mediastinum and pericardium are exposed. Pulmonary ligament and lobar fissures are divided as needed. Manual palpation of the lung to detect the metastatic lesion is carried out. Then, wedge resection of the lung metastases is performed by using disposable stapler. Allowing the lung to collapse facilitates application of the stapling device and achievement of an adequate margin. Absorbable monofilament sutures are used, if necessary, to ensure haemostasis and/or small air leaks.
The hepatic resection is then started. Briefly, definition of the resection area with the main purpose of surrounding the tumor at its deepest portion combining the minimal parenchymal sacrifice and the flattest cut surface is performed under IOUS guidance. The hilar pedicle is then encircled with a tourniquet if dissection is not intended. Otherwise, in case of major hepatectomy, hilar dissection is performed. For all patients, parenchymal transection is obtained under intermittent clamping by Pringle maneuver continued for 15 minutes followed by 5 minutes of reperfusion without preconditioning. After 4 clamping cycles, reperfusion time is prolonged for 10 minutes. Liver dissection is accomplished using crush clamping technique, ligating with sutures all the vessels but those thinner which are coagulated using bipolar electrocautery . Before abdominal closure, the cut surface of the liver is sealed with haemostatic agent.
Closed suction abdominal drains are inserted in every patient around the liver, in variable number depending to the number and the size of liver cut surfaces. They are removed on the 7th postoperative day (POD) if the bilirubin level in the drain discharge sampled routinely on the 3rd, 5th, and 7th POD showed a decrement, and in any case was below 10 mg/ml.
One or two chest tube are placed in the pleural cavity, being removed from the 3rd POD, in absence of air leak within the bottle and if the serous output is below 200 mL/24h.
The ribs are approximated with pericostal sutures using braided absorbable sutures size 2. The diaphragm is closed with a single layer running suture. Peritoneum and fasciae of the chest and abdominal wall are closed in an anatomic pattern. Subcutaneous layer and skin are finally closed in the routine manner.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery of liver and lung | – | Procedure: Surgery of liver and lungPatients carriers of both liver and right lung metastases in the same time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic
Key inclusion criteria (6 listed)
- Controlled primary disease;
- No extrahepatic lesion other than resectable pulmonary metastases at preoperative investigation;
- No lymph-node metastases except for those eventually present at the hepatic hilum;
- Disregarding number and distribution of liver metastases, technical resectability leaving at least a remnant liver volume of at least 40% of the total liver volume (calculated excluding the tumoral volume) featured by preserved inflow, outflow and biliary drainage. Zero mm free margin was considered acceptable in case of contact or close adjacency (< 5 mm) with 1st or 2nd order portal pedicles and/or major hepatic veins at their caval confluence;
- Disregarding number and distribution of lung metastases, all of the detected nodules could be completely removed preserving enough functioning remnant lung based on the results of the preoperative cardio-pulmonary functional tests;
Key exclusion criteria (1 listed)
- Patients not suitable for surgery
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 |
|---|---|---|
| Surgery of liver and lungSimultaneous resection of liver and right lung metastases in a single surgical session through a new approach | Procedure or surgery | Surgery of liver and lung |
Primary outcome
Number of metastases removed
Time frame: Baseline: date of surgical operation
Evaluation of the resectability of whole metastases in liver and right lung in the same operation by means of the same surgical incision (J-shaped thoracophrenolaparotomy)
2 secondary outcomes
Number of patients that received interventional treatments after surgery
Time frame: Participants will be followed from the baseline (date of surgery) to 90 days after the operation
Number of re-operated patients
Time frame: Participants will be followed from the baseline (date of surgery) to 90 days after the operation
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 18 Mar 2014.
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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 FACS principal investigator
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 Colon Cancer Liver Metastasis and Multiple Pulmonary Nodules, 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 6 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 18 Mar 2014. 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?
Number of metastases removed (time frame: Baseline: date of surgical operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2014.