NCT05714475

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

January 26, 2023

Last Update Submit

February 5, 2023

Conditions

Pancreas MetastasesColorectal Cancer

Keywords

pancreaspancreatectomypancreas resectioncolorectal metastasiswhippleadenocarcinomafollow up

Outcome Measures

Primary Outcomes (4)

  • 30-day mortality

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

    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

    30 days

  • Overall survival

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

    6 months

  • Disease free survival

    disease free survival at 6 months

    6 months

Secondary Outcomes (2)

  • Overall survival (12)

    12 months

  • Disease free survival (12)

    12 months

Study Arms (1)

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

Pancreas surgeryPROCEDURE

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

Pancreas resection for colorectal metastasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients underwent pancreas surgery for colorectal metastasis

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Generale di zona Moriggia Pelascini

Gravedona, Como, 22015, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Francesco Palmieri, MD

CONTACT

+393488615589dr.francescopalmieri@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal investigator

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

January 1, 2023

Primary Completion

March 31, 2023

Study Completion

June 30, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

IT(1)