MedTrace Logo

CE-IOUS for Patients With Pancreatic Cancer Undergoing Surgery: A Prospective, Proof-of-concept Trial

NCT04683497 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-06

No results posted yet for this study

Summary

BACKGROUND: Pancreatic Cancer (PC) is one of the leading cancer-related causes of death worldwide, with the majority of patients undergoing potentially curative surgery. In this context, the implementation of an accurate imaging modality is crucial in order to facilitate the clinical decision-making on the basis of tumor resectability. The contrast enhanced intraoperative ultrasound (CE-IOUS) is a relatively new imaging modality that has been employed in the detection mainly of colorectal liver metastases, but not for those of pancreatic origin.

AIM: The purpose of the present study is to validate the CE-IOUS in adult patients undergoing pancreatic surgery.

METHODS: Prospective single-center analysis of all consecutive patients with PC undergoing pancreatic surgery from a single hepato-pancreato-biliary (HPB) surgery team between December 1st, 2020 and December 31st, 2022 will be performed. Baseline characteristics, type of surgery, intraoperative parameters, hospital length of stay (LOS), intensive care unit (ICU) stay, postoperative morbidity and 30-day mortality data will be obtained from the database. The primary outcome is the clinical utility, defining its ability to change surgical operation on the basis of its findings.

LIMITATIONS: The key limitation is the inclusion of only one HPB surgery team from one center.

STRENGTHS: This study will potentially be the first to evaluate EC-IOUS and to compare it with the IOUS, CT and MRI for pancreatic surgical patients.

Conditions

Interventions

OTHER

Contrast-enhanced Intraoperative Ultrasound

Intraoperative ultrasound with the administration of a contrast agent I.V.

Sponsors & Collaborators

  • University of Thessaly

    lead OTHER

Principal Investigators

  • Dimitris Zacharoulis, MD, PhD · University of Thessaly

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-12-31
Completion
2023-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04683497 on ClinicalTrials.gov