Clinical trial NCT05714475: Pancreas Resection for Colorectal Metastasis: Retrospective Study
Official title: Multicentre Retrospective Study on Pancreas Resection for Colorectal Cancer Metastasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Metastases
Colorectal Cancer
Keywords: pancreas
pancreatectomy
pancreas resection
colorectal metastasis
whipple
adenocarcinoma
follow up
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent pancreas surgery for colorectal metastasis

Brief 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. 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

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.

Eligibility 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
measure: 30-day morbidity
timeFrame: 30 days
measure: Overall survival
timeFrame: 6 months
measure: Disease free survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival (12)
timeFrame: 12 months
measure: Disease free survival (12)
timeFrame: 12 months
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Ospedale Generale di zona Moriggia Pelascini
state: Como
Study officials:
References: