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

NCT04683497 | Unknown DMC

• 1 other identifier: 41742/15-10-20
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Pancreatic Cancer; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Number of new liver metastases identified using CE-IOUS

  Evaluation of clinical utility (CU) of CE-IOUS. CU is defined as the justified change in planned surgical strategy (conversion from therapeutic to palliative surgery) using CE-IOUS, based on the identification of new liver metastases that were not described by preoperative imaging modalities.

  2 years

Secondary Outcomes (5)

• Technical specifications of CE-IOUS regarding contrast agent dosage

  2 years

• Technical specifications of CE-IOUS regarding time period between contrast agent administration and imaging

  2 years

• Number of patients newly staged with non-resectable pancreatic cancer using CE-IOUS.

  2 years

• Comparison with CT, MRI, IOUS

  2 years

• Number of new liver metastases using CE-IOUS in the subgroup of patients with missing metastases.

  2 years

Study Arms (1)

CE-IOUS

EXPERIMENTAL

Patients with pancreatic cancer undergoing surgery with the performance of CE-IOUS

Other: Contrast-enhanced Intraoperative Ultrasound

Interventions

Contrast-enhanced Intraoperative Ultrasound OTHER

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

Also known as: CE-IOUS

CE-IOUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \> 18 years
• Patients with resectable pancreatic cancer
• Patients with borderline resectable pancreatic cancer
• Patients with locally advanced (+/- neoadjuvant-treatment) pancreatic cancer

You may not qualify if:

• Allergy
• Uncontrolled ischemic heart disease
• Severe arrhythmias
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• University of Thessaly: lead

Related Publications (5)

• Ansari D, Tingstedt B, Andersson B, Holmquist F, Sturesson C, Williamsson C, Sasor A, Borg D, Bauden M, Andersson R. Pancreatic cancer: yesterday, today and tomorrow. Future Oncol. 2016 Aug;12(16):1929-46. doi: 10.2217/fon-2016-0010. Epub 2016 Jun 1.

  PMID: 27246628 RESULT

• Machi J, Sigel B, Zaren HA, Kurohiji T, Yamashita Y. Operative ultrasonography during hepatobiliary and pancreatic surgery. World J Surg. 1993 Sep-Oct;17(5):640-5; discussion 645-6. doi: 10.1007/BF01659130.

  PMID: 8273386 RESULT

• Botea F, Sarbu V, Dima S, Iusuf T, Unc O, Toldisan D, Pasare R. [The role of intraoperative ultrasound in the diagnosis and treatment of hydatid liver disease]. Chirurgia (Bucur). 2006 Nov-Dec;101(6):593-8. Romanian.

  PMID: 17283834 RESULT

• Ni Mhuircheartaigh JM, Sun MR, Callery MP, Siewert B, Vollmer CM, Kane RA. Pancreatic surgery: a multidisciplinary assessment of the value of intraoperative US. Radiology. 2013 Mar;266(3):945-55. doi: 10.1148/radiol.12120201. Epub 2012 Dec 6.

  PMID: 23220893 RESULT

• Desolneux G, Isambert M, Mathoulin-Pelissier S, Dupre A, Rivoire M, Cattena V, Palussiere J, Dinart D, Bellera C, Evrard S. Contrast-enhanced intra-operative ultrasound as a clinical decision making tool during surgery for colorectal liver metastases: The ULIIS study. Eur J Surg Oncol. 2019 Jul;45(7):1212-1218. doi: 10.1016/j.ejso.2019.03.002. Epub 2019 Mar 10.

  PMID: 30879929 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Dimitris Zacharoulis, MD, PhD

  University of Thessaly

  STUDY CHAIR

Central Study Contacts

Dimitrios E. Magouliotis, MD, MSc

CONTACT

+306947156881; dimitrios.magouliotis.18@ucl.ac.uk

Maria P. Fergadi, MD

CONTACT

+306980694635; mfergadi@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: No later than 3 years after the 1-year postoperative follow-up, data will become available for a period of one year
• Access Criteria: There are no access criteria to be declared