Clinical trial · Interventional
CE-IOUS for Patients With Pancreatic Cancer Undergoing Surgery: A Prospective, Proof-of-concept Trial
Evaluation of Contrast Enhanced Intraoperative Ultrasound (CE-IOUS) as a Clinical Decision-making Tool for Patients With Pancreatic Cancer Undergoing Surgery: A Prospective, Proof-of-concept Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced Intraoperative Ultrasound | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CE-IOUS
- description
- Patients with pancreatic cancer undergoing surgery with the performance of CE-IOUS
- interventionNames
- Other: Contrast-enhanced Intraoperative Ultrasound
Primary outcomes (1)
- measure
- Number of new liver metastases identified using CE-IOUS
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (5)
- measure
- Technical specifications of CE-IOUS regarding contrast agent dosage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \> 18 years * Patients with resectable pancreatic cancer * Patients with borderline resectable pancreatic cancer * Patients with locally advanced (+/- neoadjuvant-treatment) pancreatic cancer Exclusion Criteria: * Allergy * Uncontrolled ischemic heart disease * Severe arrhythmias * Pregnancy * Breastfeeding
References
Publications (5)
- RESULTAnsari 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
- RESULTMachi 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
- RESULTBotea 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
- RESULTNi 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
- RESULTDesolneux 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