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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Francesco Palmieri, MD contact

+393488615589

dr.francescopalmieri@gmail.com

Italy1 site, 1 recruiting
  • Ospedale Generale di zona Moriggia Pelascini

    Gravedona, Como, 22015

    Francesco Palmieri, MD, 00393488615589, dr.francescopalmieri@gmail.com

    Francesco Lancellotti, MD

    Recruiting

Other trials in Italy

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;

  1. To evaluate feasibility and safety of pancreas resection in metastatic colorectal cancer
  2. To evaluate oncological outcome at six months from surgical procedure

Secondary objective:

  1. 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.

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 groups in NCT05714475
Study groupRoleWhat they receive
Pancreas resection for colorectal metastasisPatient 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.

  1. 30-day mortality

    assessed by the number of patients with pancreas resection deceased within 30-days from the surgical intervention

    Measured: 30 days

  2. 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

  3. Overall survival

    6 moths survival 3. Survival : 6 moths survival 4. Disease free survival at 6 months

    Measured: 6 months

  4. Disease free survival

    disease free survival at 6 months

    Measured: 6 months

Secondary outcomes (2)
  1. Overall survival (12)

    Overall survival at 12 months

    Measured: 12 months

  2. 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.

  1. First posted6 Feb 2023
  2. Study start1 Jan 2023
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

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)
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

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.

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