CClinicalTrials.gg
Status unknownNCT05714475Updated Feb 8, 2023

Pancreas Resection for Colorectal Metastasis: Retrospective Study

An observational study in Pancreas Metastases and Colorectal Cancer, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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
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.

02

Conditions studied

  • Pancreas Metastases
  • Colorectal Cancer

Keywords

  • pancreas
  • pancreatectomy
  • pancreas resection
  • colorectal metastasis
  • whipple
  • adenocarcinoma
  • follow up
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients underwent pancreas surgery for colorectal metastasis

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

Exclusion Criteria:

  • metastases from different malignancies
  • other malignancies
  • surgically unmanageable lesions
  • Multiple synchronous colorectal metastasis
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Procedure: Pancreas surgery

Interventions

  • ProcedurePancreas 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

05

What researchers measure

Primary outcomes

  1. 30-day mortality

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

    Time frame: 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

    Time frame: 30 days

  3. Overall survival

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

    Time frame: 6 months

  4. Disease free survival

    disease free survival at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Overall survival (12)

    Overall survival at 12 months

    Time frame: 12 months

  2. Disease free survival (12)

    disease free survival at 12 months

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Ospedale Generale di zona Moriggia Pelascini
    Gravedona, Como 22015, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05714475
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible party
Francesco Palmieri (MD, Principal investigator, Ospedale Generale Di Zona Moriggia-Pelascini) — Principal investigator
First posted
Feb 6, 2023
Start date
Jan 1, 2023
Primary completion
Mar 31, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Feb 8, 2023

Study contacts

Francesco Palmieri, MD
Contact
dr.francescopalmieri@gmail.com
+393488615589

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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