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Usefulness of Contrast Enhanced Harmonic Endoscopic Ultrasound for Pancreatic Cysts

Primary Purpose

Pancreatic Cyst

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Contrast enhanced harmonic endoscopic ultrasound
Sponsored by
Iuliu Hatieganu University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cyst focused on measuring contrast-enhanced harmonic endoscopic ultrasound (CH-EUS), EUS-FNA, pancreatic cyst, pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Regional Institite of Gastroenterology and hepatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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
Differentiation between murale nodules and mucus clots or debris
The role of CH-EUS for the identification of true mural nodules

Secondary Outcome Measures

Guiding EUS-FNA by the enhancement pattern
To asses the improvement of the EUS-FNA results if the lesions are targeted through the enhancement pattern

Full Information

First Posted
May 12, 2020
Last Updated
June 20, 2022
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT04389892
Brief Title
Usefulness of Contrast Enhanced Harmonic Endoscopic Ultrasound for Pancreatic Cysts
Official Title
Usefulness of Contrast-enhanced Harmonic Endoscopic Ultrasound (CH-EUS) for the Differentiation of the Pancreatic Cysts and for Guiding Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) From Murale Nodules.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Due to the increase use of cross-sectional imaging techniques for varied medical conditions more and more pancreatic cysts are incidentally found. Magnetic resonance imaging revealed a prevalence of incidental pancreatic cystic neoplasm (PCN) in adults between 2,4-49,1% and autopsy studies showed that half of the individuals had pancreatic cysts. There is a great variety of pancreatic cysts, they are mainly divided in neoplastic or non-neoplastic (i.e pseudocyst). Pseudocysts appear after acute or chronic pancreatitis and represent only 20% of all pancreatic cysts.. PCN include a diverse group of pancreatic cysts including mucin-producing (Intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN)) and nonmucin-producing lesions (Serous cystadenoma (SCN), Solid pseudopapillary neoplasm(SPN) cystic neuroendocrine tumor(cNET)) with different morphology and progression to malignancy. SPN's,cNET are considered premalignant or malignant conditions and require surveillance or surgical resection. SCN instead are benign and surveillance is not necessary. Resection is considered only if symptoms are present. The discrimination between the different cyst types is crucial for the therapeutic approach. Their morphology can be similar and sometimes it's a challenge to diagnose them.There are many tools but none is good enough to be used alone. Contrast-enhanced harmonic endoscopic ultrasound using low mechanical index (0.12-0.4) is an additional test to assess the vascularization of the cystic wall and the septa and solid component for the differential diagnosis of PCN. Our aim was to identify specific imaging characteristics using CH-EUS in order to increase the diagnostic accuracy for potential malignant pancreatic cysts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst
Keywords
contrast-enhanced harmonic endoscopic ultrasound (CH-EUS), EUS-FNA, pancreatic cyst, pancreas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients diagnosed with unclear cystic lesions who underwent CH-EUS at our Institute
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast enhanced harmonic endoscopic ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Specific imaging characteristics using CH-EUS
Description
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
Time Frame
Baseline
Title
Differentiation between murale nodules and mucus clots or debris
Description
The role of CH-EUS for the identification of true mural nodules
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Guiding EUS-FNA by the enhancement pattern
Description
To asses the improvement of the EUS-FNA results if the lesions are targeted through the enhancement pattern
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presence of an undetermined pancreatic cyst >10mm (Computer tomography, Magnetic resonance imaging); written informed consent. Exclusion Criteria: platelet count under 50.000 platelets per microliter (mcL) patients with cardiorespiratory instability refuse of the patient to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrada Seicean, MD,PhD
Organizational Affiliation
Regional Institute of Gastroenterology and Hepatology Cluj-Napoca
Official's Role
Study Director
Facility Information:
Facility Name
Regional Institite of Gastroenterology and hepatology
City
Cluj-Napoca
ZIP/Postal Code
400162
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29485131
Citation
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.
Results Reference
background
PubMed Identifier
26474428
Citation
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.
Results Reference
background
PubMed Identifier
29574408
Citation
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.
Results Reference
background
PubMed Identifier
31527862
Citation
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.
Results Reference
background
PubMed Identifier
30085364
Citation
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.
Results Reference
background
PubMed Identifier
28104978
Citation
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.
Results Reference
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Usefulness of Contrast Enhanced Harmonic Endoscopic Ultrasound for Pancreatic Cysts

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