The Role of Intraoperative Hepatic Ultrasonography in Gastrointestinal or Pancreatic Neuroendocrine Tumor (ECHO-NET)

January 13, 2025 updated by: Istituto Clinico Humanitas

ECHO-NET Study: Role of Intraoperative Hepatic Ultrasonography in Patients with Gastrointestinal or Pancreatic Neuroendocrine Tumor Without Liver Metastases At Preoperative Imaging

Background: Liver metastases are common in patients with neuroendocrine neoplasms, but often underestimated by preoperative imaging. Intraoperative ultrasound (IOUS) is the reference standard for staging of primary and metastatic liver tumors, with a diagnostic accuracy superior to that of CT and MRI. Rationale: The present study aims to evaluate the contribution of IOUS to staging of liver disease in patients with neuroendocrine tumor candidates for primary tumor resection classified as cM0 at preoperative imaging.

The study will collect a prospective series of 99 patients undegoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres in the period 2020-2023. All patients had to be cM0 tumor at preoperative imaging. Additional inclusion criteria: age>18 years, ability to give the informed consent for study participation; no other malignancies in the previous 5 years; preoperative staging including abdominal CT and DOTATOC PET-CT performed ≤60 days before surgery.

This prospective observational multicentre study aims to elucidate the proportion of patients with gastro-intestinal or pancreatic neuroendocrine tumor cM0 at preoperative imaging that have intraoperative detection of liver metastases at IOUS.

Primary endpoint:

- Performances of IOUS in identifying liver metastases in patients with neuroendocrine tumor classified as cM0 at preoperative imaging

Secondary endpoints:

  • Impact of IOUS on the therapeutic strategy
  • Performances of preoperative imaging (CT, MRI and PET-CT) in comparison with those of IOUS

The study will collect a prospective series of 99 patients undergoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres in the period 2020-2023.

The study includes the following steps:

Preoperative / enrollment: All patients candidates to resection of gastro-intestinal or pancreatic neuroendocrine tumor will be considered for the study. Only cM0 patients will be enrolled. All patients enrolled in the study must have performed a preoperative abdominal CT scan with contrast medium and a DOTATOC-PET-CT (both performed ≤60 days before surgery).

Intraoperative: During surgery, the investigator will perform, as standard in our clinical practice, an accurate exploration of the liver by inspection, palpation and IOUS. The investigator will record the identification of any liver lesion. If one or more nodules suspect of being neuroendocrine liver metastases are identified, it will be necessary, whenever possible, as already routinely performed, to carry out a biopsy or to remove it (if superficial) for histological confirmation of the diagnosis. After completion of liver staging, the primary tumor will be resected.

Postoperative / follow-up: Enrolled patients will have standard postoperative management.

Standard statistical analyses will be performed. Per-patient and per-lesion analyses will be performed to asses performances of preoperative imaging modalities (CT, MRI, PET-CT) and of intraoperative ones (inspection, palpation, and IOUS).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will collect a prospective series of 99 patients undergoing surgery for gastro-intestinal or pancreatic neuroendocrine tumor at the Humanitas Clinical Institute (coordinating centre) or at one of the participating centres (see the Appendix for list of the centres) in the period 2020-2023.

Description

Inclusion Criteria:

  • Patients undergoing open or minimally-invasive surgery for primary neuroendocrine gastro-intestinal or pancreatic tumor.
  • cM0 tumor at preoperative imaging
  • Preoperative staging including abdominal CT and DOTATOC PET-CT
  • Age ≥18 years
  • No other malignancies in the previous 5 years

Exclusion Criteria:

  • Preoperative imaging performed >60 days before surgery
  • Patient refusal to participate the study
  • Incomplete intraoperative hepatic staging (peri-hepatic adhesions, IOUs not available…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver metastases
Time Frame: 2020-2023
Performances of IOUS in identifying liver metastases in patients with neuroendocrine tumor classified as cM0 at preoperative imaging
2020-2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on therapeutic strategies
Time Frame: 2020-2023
2020-2023
Comparison with radiological preoperative evaluation
Time Frame: 2020-2023
Performances of preoperative imaging (CT, MRI and PET-CT) in comparison with those of IOUS
2020-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 748/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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