Pancreas MetastasesNCT05714475
Pancreas Resection for Colorectal Metastasis: Retrospective Study
An observational study of Pancreas Metastases and Colorectal Cancer, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Metastases, Colorectal Cancer
- What is being tested?
- Pancreas surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Jun 2023
- 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 underwent pancreas surgery for colorectal metastasis
Who may be able to join
- Isolated pancreatic metastases from Colorectal cancer
- Previous surgery for colorectal cancer
- Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas
- Other procedures:
- total-pancreatectomy distal-pancreatectomy other metastases resection
- R0 resection
- no signs of peritoneal metastasis or tumor manifestations outside of the pancreas.
- CT Scan before surgery
Who cannot join
- metastases from different malignancies
- other malignancies
- surgically unmanageable lesions
- Multiple synchronous colorectal metastasis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Generale di zona Moriggia Pelascini
Gravedona, Como, 22015
Francesco Palmieri, MD, 00393488615589, dr.francescopalmieri@gmail.com
Francesco Lancellotti, MD
About this study
Official title: Multicentre Retrospective Study on Pancreas Resection for Colorectal Cancer Metastasis
The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, we intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.
Primary objective;
- To evaluate feasibility and safety of pancreas resection in metastatic colorectal cancer
- To evaluate oncological outcome at six months from surgical procedure
Secondary objective:
- To evaluate oncological outcome at 12 months from surgical procedure
Read the detailed description
Metastases to the Pancreas are quite rare and account for less than 5% of pancreatic malignancies diagnosed in living patients.
In autopsy cases of malignant tumours, the incidence of pancreatic secondary tumours reaches 15%.
The metastases are predominantly of epithelial origin, most commonly from lung, stomach, small bowel, colon-rectum, kidney , breast , liver , ovary ,melanoma and urinary bladder.
It is largely described that resection of isolated metastasis to the lung or liver from primary tumour leads to improved survival; yet there is no consensus about the benefit of pancreas resection for metastases and the gold standard treatment is still not well defined.
The lack of data for pancreas metastases resections depends on low incidence and high perioperative risks. However, the improvement in morbidity and mortality rates after pancreaticoduodenectomy made the indication for this operation acceptable.
One of the larger series concluded that an aggressive surgical approach might be warranted if the patient can be rendered free of disease.
The majority of case series referred to renal cell carcinoma and resection for CCR are episodic. However there are several reports of solitary resected pancreatic metastases from colorectal cancer There is currently very limited experience with the surgical resection of isolated pancreatic colorectal metastases, and the role of surgery in the management of these patients is still debated.
To date, no prospective randomized or case-controlled studies have been performed to evaluate the role of surgical resection. Additionally, many of the existing retrospective studies are limited because of the small number of patients who were treated during prolonged periods of time.
Aim of the study The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, the investigators intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.
The investigators launched the study aiming at demonstrating that pancreatic resection for colorectal metastases may be a safe and feasible procedure in selected patients and may provide long-term survival. The investigators sought to address the role of surgical resection and survival benefit from surgery. The investigators suppose to achieve a good prognosis with a median survival close to that observed after resection of hepatic metastases.
The guidelines for the treatment of colorectal cancer recommend resection of hematogenous metastases if they are deemed resectable.
Study design This study is an international multicenter retrospective cohort study to assess the outcomes of patients that underwent pancreas resection for solitary colorectal metastasis.
Aim of surgical interventions is to remove metastases in association to radical lymphadenectomy thus to achieve R0 result.
Patient data will be retrospectively analyzed and demographic characteristics, comorbidity status, clinical and radiological findings, treatment strategies , 30-day morbidity and mortality, oncological outcomes at 6 and 12 months will be evaluated.
- Conditions
- Pancreas Metastases, Colorectal Cancer
- Being tested
- Pancreas surgery
- Keywords
- pancreas, pancreatectomy, pancreas resection, colorectal metastasis, whipple, adenocarcinoma, follow up
- Medical subject headings
- Colorectal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreas surgeryProcedure or surgery
Criteria
Inclusion Criteria:
- Isolated pancreatic metastases from Colorectal cancer
- Previous surgery for colorectal cancer
- Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas pancreaticoduodenectomy total-pancreatectomy distal-pancreatectomy other metastases resection
| Study group | Role | What they receive |
|---|---|---|
| Pancreas resection for colorectal metastasis | Patient underwent a pancreas resection (whipple, distal pancreasectomy ...) with inclusion criteria. Criteria
Inclusion Criteria:
* Isolated pancreatic metastases from Colorectal cancer
* Previous surgery for colorectal cancer
* Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas
* Other procedures:
total-pancreatectomy distal-pancreatectomy other metastases resection
* R0 resection
* no signs of peritoneal metastasis or tumor manifestations outside of the pancreas.
* CT Scan before surgery
Exclusion Criteria:
* metastases from different malignancies
* other malignancies
* surgically unmanageable lesions
* Multiple synchronous colorectal metastasis Receives: Procedure: Pancreas surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
assessed by the number of patients with pancreas resection deceased within 30-days from the surgical intervention
Measured: 30 days
30-day morbidity
assessed by the number of patients with pancreatic resection who experienced any type of postoperative complication within 30-days from the surgical intervention
Measured: 30 days
Overall survival
6 moths survival 3. Survival : 6 moths survival 4. Disease free survival at 6 months
Measured: 6 months
Disease free survival
disease free survival at 6 months
Measured: 6 months
Secondary outcomes (2)
Overall survival (12)
Overall survival at 12 months
Measured: 12 months
Disease free survival (12)
disease free survival at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Jan 2023
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Palmieri, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714475
- Sponsor's protocol ID
- MP1
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Retrospective Study on Pancreas Resection for Colorectal Cancer Metastasis
- ClinicalTrials.gov ID
- NCT05714475
- Acronym / sponsor ID
- MP1
- Conditions
- Pancreas Metastases, Colorectal Cancer
- Keywords
- pancreas, pancreatectomy, pancreas resection, colorectal metastasis, whipple, adenocarcinoma, follow up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Feb 2023 (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.
The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, we intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.
Primary objective;
- To evaluate feasibility and safety of pancreas resection in metastatic colorectal cancer
- To evaluate oncological outcome at six months from surgical procedure
Secondary objective:
- To evaluate oncological outcome at 12 months from surgical procedure
Detailed description
Metastases to the Pancreas are quite rare and account for less than 5% of pancreatic malignancies diagnosed in living patients.
In autopsy cases of malignant tumours, the incidence of pancreatic secondary tumours reaches 15%.
The metastases are predominantly of epithelial origin, most commonly from lung, stomach, small bowel, colon-rectum, kidney , breast , liver , ovary ,melanoma and urinary bladder.
It is largely described that resection of isolated metastasis to the lung or liver from primary tumour leads to improved survival; yet there is no consensus about the benefit of pancreas resection for metastases and the gold standard treatment is still not well defined.
The lack of data for pancreas metastases resections depends on low incidence and high perioperative risks. However, the improvement in morbidity and mortality rates after pancreaticoduodenectomy made the indication for this operation acceptable.
One of the larger series concluded that an aggressive surgical approach might be warranted if the patient can be rendered free of disease.
The majority of case series referred to renal cell carcinoma and resection for CCR are episodic. However there are several reports of solitary resected pancreatic metastases from colorectal cancer There is currently very limited experience with the surgical resection of isolated pancreatic colorectal metastases, and the role of surgery in the management of these patients is still debated.
To date, no prospective randomized or case-controlled studies have been performed to evaluate the role of surgical resection. Additionally, many of the existing retrospective studies are limited because of the small number of patients who were treated during prolonged periods of time.
Aim of the study The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, the investigators intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.
The investigators launched the study aiming at demonstrating that pancreatic resection for colorectal metastases may be a safe and feasible procedure in selected patients and may provide long-term survival. The investigators sought to address the role of surgical resection and survival benefit from surgery. The investigators suppose to achieve a good prognosis with a median survival close to that observed after resection of hepatic metastases.
The guidelines for the treatment of colorectal cancer recommend resection of hematogenous metastases if they are deemed resectable.
Study design This study is an international multicenter retrospective cohort study to assess the outcomes of patients that underwent pancreas resection for solitary colorectal metastasis.
Aim of surgical interventions is to remove metastases in association to radical lymphadenectomy thus to achieve R0 result.
Patient data will be retrospectively analyzed and demographic characteristics, comorbidity status, clinical and radiological findings, treatment strategies , 30-day morbidity and mortality, oncological outcomes at 6 and 12 months will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreas resection for colorectal metastasis | – | Procedure: Pancreas surgeryPatient underwent a pancreas resection (whipple, distal pancreasectomy ...) with inclusion criteria. Criteria Inclusion Criteria: * Isolated pancreatic metastases from Colorectal cancer * Previous surgery for colorectal cancer * Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas * Other procedures: total-pancreatectomy distal-pancreatectomy other metastases resection * R0 resection * no signs of peritoneal metastasis or tumor manifestations outside of the pancreas. * CT Scan before surgery Exclusion Criteria: * metastases from different malignancies * other malignancies * surgically unmanageable lesions * Multiple synchronous colorectal metastasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients underwent pancreas surgery for colorectal metastasis
Key inclusion criteria (8 listed)
- Isolated pancreatic metastases from Colorectal cancer
- Previous surgery for colorectal cancer
- Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas
- Other procedures:
- total-pancreatectomy distal-pancreatectomy other metastases resection
Key exclusion criteria (4 listed)
- metastases from different malignancies
- other malignancies
- surgically unmanageable lesions
- Multiple synchronous colorectal metastasis
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 |
|---|---|---|
| Pancreas surgeryCriteria Inclusion Criteria: * Isolated pancreatic metastases from Colorectal cancer * Previous surgery for colorectal cancer * Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas pancreaticoduodenectomy total-pancreatectomy distal-pancreatectomy other metastases resection | Procedure or surgery | Pancreas resection for colorectal metastasis |
Primary outcome
30-day mortality
Time frame: 30 days
assessed by the number of patients with pancreas resection deceased within 30-days from the surgical intervention
30-day morbidity
Time frame: 30 days
assessed by the number of patients with pancreatic resection who experienced any type of postoperative complication within 30-days from the surgical intervention
Overall survival
Time frame: 6 months
6 moths survival 3. Survival : 6 moths survival 4. Disease free survival at 6 months
Disease free survival
Time frame: 6 months
disease free survival at 6 months
2 secondary outcomes
Overall survival (12)
Time frame: 12 months
Disease free survival (12)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes
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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.
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 Pancreas Metastases and Colorectal Cancer, run by Ospedale Generale Di Zona Moriggia-Pelascini 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 8 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Contact Francesco Palmieri, MD (+393488615589, dr.francescopalmieri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). The study lists 4 primary outcomes in all. 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 8 Feb 2023; AzTrials last refreshed its copy on 4 Nov 2026.