Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05714475 |
| Other study ID # |
MP1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Ospedale Generale Di Zona Moriggia-Pelascini |
| Contact |
Francesco Palmieri, MD |
| Phone |
+393488615589 |
| Email |
dr.francescopalmieri[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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
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.
