Colorectal Cancer Stage IVNCT06329700
Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy
An observational study of Colorectal Cancer Stage IV, run by Azienda Ospedaliero Universitaria Maggiore della Carita.
Trial summary
Major hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Stage IV
- What is being tested?
- Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2010to 30 Jun 2022
- 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: Patients affected by colorectal liver metastases awaiting liver surgery, and receiving before surgery systemic chemotherapy (neoadjuvant).
Who may be able to join
- Consecutive patients with multiple CLMs treated with preoperative chemotherapy and parenchymal sparing surgery;
- Only patients with available volumetry of the pre- and post-chemotherapy abdominal enhanced computed tomography (CT) images;
Who cannot join
- Patients who underwent preoperative PVE;
- Patients treated by major hepatectomies; Patients treated with thermal ablation alone or in association with hepatic resection.
About this study
Official title: Performance of Parenchymal Sparing Hepatectomy in Patients With CLM and Post-chemotherapy Liver Atrophy
Major hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. The aim of this study was to assess the clinical impact of post-chemotherapy liver atrophy on patients undergoing PSH for CLM. For this purpose, the occurrence of liver atrophy was recorded and then computed against the occurrence of postoperative morbidity and mortality.
Read the detailed description
Patients affected by CLMs and trated with neoadjuvant systemic chemotherapy and then hepatectomy were reviewed with the intent to assess the occurrence of liver atrophy, which is a sign of liver dysfunction and a source of morbidity expecially in patients treated with major or extended hepatectomy. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. Then, we planned to review our cases with the above mentioned endpoint.
- Conditions
- Colorectal Cancer Stage IV
- Being tested
- Hepatectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Also called Liver resection
Surgical removal of a part of the liver
| Study group | Role | What they receive |
|---|---|---|
| No post-chemotherapy liver atrophy | Patients treated with systemic chemotherapy, then hepatectomy for colorectal liver metastases. No occurrence of post-chemotherapy liver atrophy as measured by computed-tomography liver volumetry. Receives: Procedure: Hepatectomy | |
| Yes post-chemotherapy liver atrophy | Patients treated with systemic chemotherapy, then hepatectomy for colorectal liver metastases. Yes, occurrence of post-chemotherapy liver atrophy as measured by computed-tomography liver volumetry. Receives: Procedure: Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Any adverse event after surgery
Measured: From the date of surgery up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 May 2010
- Primary completion31 Dec 2019
- Study completion30 Jun 2022
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 Cancer Stage IVStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Donadon, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Matteo Donadon, MD, PhD, Principal investigator, University of Eastern Piedmont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329700
- Sponsor's protocol ID
- ParSparInLivAtrophy
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, after reasonable request.
Publications
Yamashita S, Shindoh J, Mizuno T, Chun YS, Conrad C, Aloia TA, Vauthey JN. Hepatic atrophy following preoperative chemotherapy predicts hepatic insufficiency after resection of colorectal liver metastases. J Hepatol. 2017 Jul;67(1):56-64. doi: 10.1016/j.jhep.2017.01.031. Epub 2017 Feb 10.
PubMed 28192187Omichi K, Yamashita S, Cloyd JM, Shindoh J, Mizuno T, Chun YS, Conrad C, Aloia TA, Vauthey JN, Tzeng CD. Portal Vein Embolization Reduces Postoperative Hepatic Insufficiency Associated with Postchemotherapy Hepatic Atrophy. J Gastrointest Surg. 2018 Jan;22(1):60-67. doi: 10.1007/s11605-017-3467-1. Epub 2017 Jun 5.
PubMed 28585106Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017.
PubMed 19541011Tani K, Shindoh J, Takamoto T, Shibahara J, Nishioka Y, Hashimoto T, Sakamoto Y, Hasegawa K, Makuuchi M, Kokudo N. Kinetic Changes in Liver Parenchyma After Preoperative Chemotherapy for Patients with Colorectal Liver Metastases. J Gastrointest Surg. 2017 May;21(5):813-821. doi: 10.1007/s11605-017-3359-4. Epub 2017 Jan 12.
PubMed 28083837
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Parenchymal Sparing Hepatectomy in Patients With CLM and Post-chemotherapy Liver Atrophy
- ClinicalTrials.gov ID
- NCT06329700
- Acronym / sponsor ID
- ParSparInLivAtrophy
- Conditions
- Colorectal Cancer Stage IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Mar 2024 (actual)
- 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 hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. The aim of this study was to assess the clinical impact of post-chemotherapy liver atrophy on patients undergoing PSH for CLM. For this purpose, the occurrence of liver atrophy was recorded and then computed against the occurrence of postoperative morbidity and mortality.
Detailed description
Patients affected by CLMs and trated with neoadjuvant systemic chemotherapy and then hepatectomy were reviewed with the intent to assess the occurrence of liver atrophy, which is a sign of liver dysfunction and a source of morbidity expecially in patients treated with major or extended hepatectomy. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. Then, we planned to review our cases with the above mentioned endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No post-chemotherapy liver atrophy | – | Procedure: HepatectomyPatients treated with systemic chemotherapy, then hepatectomy for colorectal liver metastases. No occurrence of post-chemotherapy liver atrophy as measured by computed-tomography liver volumetry. |
| Yes post-chemotherapy liver atrophy | – | Procedure: HepatectomyPatients treated with systemic chemotherapy, then hepatectomy for colorectal liver metastases. Yes, occurrence of post-chemotherapy liver atrophy as measured by computed-tomography liver volumetry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by colorectal liver metastases awaiting liver surgery, and receiving before surgery systemic chemotherapy (neoadjuvant).
Key inclusion criteria (2 listed)
- Consecutive patients with multiple CLMs treated with preoperative chemotherapy and parenchymal sparing surgery;
- Only patients with available volumetry of the pre- and post-chemotherapy abdominal enhanced computed tomography (CT) images;
Key exclusion criteria (2 listed)
- Patients who underwent preoperative PVE;
- Patients treated by major hepatectomies; Patients treated with thermal ablation alone or in association with hepatic resection.
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 |
|---|---|---|
| HepatectomyAlso: Liver resectionSurgical removal of a part of the liver | Procedure or surgery | No post-chemotherapy liver atrophy, Yes post-chemotherapy liver atrophy |
Primary outcome
Postoperative complications
Time frame: From the date of surgery up to 90 days
Any adverse event after surgery
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 26 Mar 2024.
- Results publication: PubMed 28192187Yamashita S, Shindoh J, Mizuno T, Chun YS, Conrad C, Aloia TA, Vauthey JN. Hepatic atrophy following preoperative chemotherapy predicts hepatic insufficiency after resection of colorectal liver metastases. J Hepatol. 2017 Jul;67(1):56-64. doi: 10.1016/j.jhep.2017.01.031. Epub 2017 Feb 10.
- Results publication: PubMed 28585106Omichi K, Yamashita S, Cloyd JM, Shindoh J, Mizuno T, Chun YS, Conrad C, Aloia TA, Vauthey JN, Tzeng CD. Portal Vein Embolization Reduces Postoperative Hepatic Insufficiency Associated with Postchemotherapy Hepatic Atrophy. J Gastrointest Surg. 2018 Jan;22(1):60-67. doi: 10.1007/s11605-017-3467-1. Epub 2017 Jun 5.
- Results publication: PubMed 19541011Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017.
- Results publication: PubMed 28083837Tani K, Shindoh J, Takamoto T, Shibahara J, Nishioka Y, Hashimoto T, Sakamoto Y, Hasegawa K, Makuuchi M, Kokudo N. Kinetic Changes in Liver Parenchyma After Preoperative Chemotherapy for Patients with Colorectal Liver Metastases. J Gastrointest Surg. 2017 May;21(5):813-821. doi: 10.1007/s11605-017-3359-4. Epub 2017 Jan 12.
- Individual participant dataSharing planned: Yes. Yes, after reasonable request.
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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.
Matteo Donadon, MD, PhD principal investigator
University of Eastern Piedmont
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Stage IV, run by Azienda Ospedaliero Universitaria Maggiore della Carita.
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 2 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 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative complications (time frame: From the date of surgery up to 90 days). 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 NCT06329700, 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 26 Mar 2024.