Usefulness of Contrast Enhanced Harmonic Endoscopic Ultrasound for Pancreatic Cysts

NCT04389892 | Completed

• 1 other identifier: 3803
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the role of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) for the differentiation of the pancreatic cysts and their malignant potential.

Conditions

Pancreatic Cyst

Keywords

contrast-enhanced harmonic endoscopic ultrasound (CH-EUS); EUS-FNA; pancreatic cyst; pancreas

Outcome Measures

Primary Outcomes (2)

• Specific imaging characteristics using CH-EUS

  To identify specific imaging characteristics using CH-EUS ( the contrast uptake pattern) in order to increase the diagnostic accuracy for the different type of the pancreatic cysts

  Baseline

• Differentiation between murale nodules and mucus clots or debris

  The role of CH-EUS for the identification of true mural nodules

  Baseline

Secondary Outcomes (1)

• Guiding EUS-FNA by the enhancement pattern

  One month

Study Arms (1)

study participants

EXPERIMENTAL

After a careful endoscopic ultrasound examination in B mode of the entire pancreas, contrast enhancement was administrated to the participants. The uptake and the wash-out of the agent were followed and then a morphological diagnose was established. EUS-fine needle aspiration of the cyst wall, septa or solid components was guided by the enhancing pattern.

Diagnostic Test: Contrast enhanced harmonic endoscopic ultrasound

Interventions

Contrast enhanced harmonic endoscopic ultrasound DIAGNOSTIC_TEST

During the echoendoscopy the image was fixed on the region of interest (pancreatic cyst) and the extended pure harmonic detection mode was selected. 2,4ml contrast enhancement (Sonovue-Bracco Italy) was injected in the right antecubital vein of the participants followed by a flush of 5ml 0.9% saline solution to ensure that the entire quantity of the agent goes in to the blood flow. After the administration the pancreatic cyst was observed for at least 120 seconds.We followed the enhancing behavior of the cyst wall, the septa and the solid components. Arterial enhancement (contrast uptake) was considered the first 25-30 seconds after injection and the venous phase (wah-out) 30-45 seconds after injection. EUS-FNA was performed in all patients without contraindications

study participants

Eligibility Criteria

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

You may qualify if:

• presence of an undetermined pancreatic cyst \>10mm (Computer tomography, Magnetic resonance imaging);
• written informed consent.

You may not qualify if:

• platelet count under 50.000 platelets per microliter (mcL)
• patients with cardiorespiratory instability
• refuse of the patient to participate.

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Regional Institite of Gastroenterology and hepatology

Cluj-Napoca, 400162, Romania

Location

Related Publications (6)

• Elta GH, Enestvedt BK, Sauer BG, Lennon AM. ACG Clinical Guideline: Diagnosis and Management of Pancreatic Cysts. Am J Gastroenterol. 2018 Apr;113(4):464-479. doi: 10.1038/ajg.2018.14. Epub 2018 Feb 27.

  PMID: 29485131 BACKGROUND

• Fusaroli P, Serrani M, De Giorgio R, D'Ercole MC, Ceroni L, Lisotti A, Caletti G. Contrast Harmonic-Endoscopic Ultrasound Is Useful to Identify Neoplastic Features of Pancreatic Cysts (With Videos). Pancreas. 2016 Feb;45(2):265-8. doi: 10.1097/MPA.0000000000000441.

  PMID: 26474428 BACKGROUND

• European Study Group on Cystic Tumours of the Pancreas. European evidence-based guidelines on pancreatic cystic neoplasms. Gut. 2018 May;67(5):789-804. doi: 10.1136/gutjnl-2018-316027. Epub 2018 Mar 24.

  PMID: 29574408 BACKGROUND

• van Huijgevoort NCM, Del Chiaro M, Wolfgang CL, van Hooft JE, Besselink MG. Diagnosis and management of pancreatic cystic neoplasms: current evidence and guidelines. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):676-689. doi: 10.1038/s41575-019-0195-x. Epub 2019 Sep 16.

  PMID: 31527862 BACKGROUND

• Kamata K, Kitano M. Endoscopic diagnosis of cystic lesions of the pancreas. Dig Endosc. 2019 Jan;31(1):5-15. doi: 10.1111/den.13257. Epub 2018 Sep 30.

  PMID: 30085364 BACKGROUND

• Seicean A, Mosteanu O, Seicean R. Maximizing the endosonography: The role of contrast harmonics, elastography and confocal endomicroscopy. World J Gastroenterol. 2017 Jan 7;23(1):25-41. doi: 10.3748/wjg.v23.i1.25.

  PMID: 28104978 BACKGROUND

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Andrada Seicean, MD,PhD

  Regional Institute of Gastroenterology and Hepatology Cluj-Napoca

  STUDY DIRECTOR

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: Principal Investigator

Model Details: Patients diagnosed with unclear cystic lesions who underwent CH-EUS at our Institute

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: April 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)