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Trial registered on ANZCTR


Registration number
ACTRN12617001197325
Ethics application status
Approved
Date submitted
27/07/2017
Date registered
16/08/2017
Date last updated
9/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) using a 19-gauge needle for solid lesions: a multicenter prospective randomized controlled study
Scientific title
Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during EUS-guided FNA using a 19-gauge needle for solid lesions: a multicenter prospective randomized controlled study
Secondary ID [1] 292526 0
none.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intestinal and Extra-intestinal lesions 304176 0
Condition category
Condition code
Oral and Gastrointestinal 303503 303503 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 303582 303582 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All aspects of the study will be discussed with each subject when approached by study staff. An information sheet will be provided, and each subject will be given the opportunity to seek medical advice or to discuss the study with friends or family prior to involvement. Each volunteer will give written, informed consent, in accordance with the attached form, and the subjects will be free to withdraw from the study at any time.
All patients who are referred to the principle investigator for EUS FNA will be seen in outpatient clinic for the procedure and will also be approached for the current study. All patients will be given information about the study and the agreement of participation in the study will be clarified on the day of the procedure. The patients will have the opportunity to raise any issues with the study by the provided phone number or in person on the day of procedure (prior to the procedure).
All patients will undergo standard preparation for EUS and will be kept nil per oral for 6 hours before procedure. EUS would be performed under conscious sedation or monitored anaesthesia. The lesion, including the regional vasculature, would be examined by EUS using the colour Doppler function to locate a site suitable for FNA. The lesion would then be punctured with a 19G Nitinol needle under EUS guidance. On site cytopathologic assessment would not available in any of the cases.
Macroscopic on-site evaluation (MOSE) would be performed by the following technique. EUS-FNA would be performed with a 19-gauge needle. The lesion is punctured and the needle is moved to and fro approximately 3-5 times within the lesion under 10cc of suction. After each pass, the needle is removed and the stylet would be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). MVC is defined as whitish or yellowish pieces of tissue with an apparent bulk. Paste-like or liquid-like specimens would not be included. The total length of the MVC is measured with a ruler before placement into a formalin bottle. When a MVC of 4mm or more is obtained, EUS-FNA is completed. If the obtained MVC is less than 4mm, then another pass of the lesion with the 19-gauge needle repeated. The procedure is repeated for a maximum of 7 passes until a MVC of 4mm or more is obtained.
Any remaining partially paste-like material after removal of MVC’s would be sent in a separate formalin bottle for histology; liquid material will be fixed in alcohol and sent for cytological analysis. Adequacy of this additional cytological material would not be macroscopically assessed.
One dedicated pathologist in each hospital will evaluate the obtained samples in terms of quantity (Grade 0: scant; Grade 1: inadequate; Grade 2: adequate), quality (Grade 0: poor; Grade 1: moderate; Grade 2: good), and blood contamination (Grade 0: significant; Grade 1: moderate; Grade 2: low), and provide a pathological diagnosis.
The final diagnosis would be based on the followings:
1. Surgical specimen for resectable cases.
2. Positive FNA diagnosis for malignancy with a compatible clinical course.
3. Negative FNA diagnosis for malignancy with a lack of deterioration or spontaneous resolution on radio-logical studies with a minimum clinical follow-up time of 3 months.

All staff for this study participating in this study have been trained and understand the study protocol, and will report any adverse events to the Human Research Ethics Committee within 24 hours.
Intervention code [1] 298716 0
Diagnosis / Prognosis
Comparator / control treatment
EUS-FNA will be performed with a 19-gauge needle. At least 3, and not more than 5, passes of the lesion would be performed with the needle, under 10cc of suction. After FNA, the needle is removed and the stylet would be introduced into the needle to extrude any aspirated material to a specimen bottle. Any solid material would be separated and sent in formalin bottle for histology; liquid material will be fixed in alcohol and sent for cytological analysis.

The treating surgeon determines the total number of passes, from 3 to 5, based on their clinical discretion on the quality of the samples obtained.
Control group
Active

Outcomes
Primary outcome [1] 302899 0
To compare diagnostic yields obtained, which is defined as the proportion of patients with adequate tissue for diagnosis obtained by EUS FNA. This will be determined via definite histological diagnoses from surgically resected specimens.
Timepoint [1] 302899 0
Within 2 days post procedure diagnoses are made.
Secondary outcome [1] 337374 0
To compare the quality of tissues obtained from each arm. One dedicated pathologist in each hospital will evaluate the obtained samples in terms of quality (Grade 0: poor; Grade 1: moderate; Grade 2: good).
Timepoint [1] 337374 0
Within 2 days post procedure diagnoses are made.
Secondary outcome [2] 337375 0
To compare the quantity of tissues obtained from each arm. One dedicated pathologist in each hospital will evaluate the obtained samples in terms of quantity (Grade 0: scant; Grade 1: inadequate; Grade 2: adequate).
Timepoint [2] 337375 0
Within 2 days post procedure diagnoses are made.
Secondary outcome [3] 337376 0
To compare the number of passes required to extrude material from the lesion, from each arm.
Timepoint [3] 337376 0
This is assessed during the procedure.
Secondary outcome [4] 337377 0
To observe any procedure related complications. All patients will be observed for immediate adverse events in the recovery room for 4 hours. Contact would be maintained for 24 hours after the procedure to monitor for any adverse events. The definition of adverse events for EUS FNA includes: Pain, Pancreatitis, Bleeding, Perforation.
Timepoint [4] 337377 0
This outcome is assessed 7 days post procedure via medical records.
Secondary outcome [5] 337380 0
To compare the diagnostic accuracy obtained from each arm assessed through sensitivity, specificity, positive and negative predictive values.
Trained cytologists and pathologists will assess the final processed samples from each group. This is assessed by definite histological diagnoses from surgically resected specimens.
Timepoint [5] 337380 0
This is determined 2 days following post-procedure

Eligibility
Key inclusion criteria
1. Consecutive patients referred for EUS-guided tissue acquisition for intestinal or extra- intestinal solid lesions more than 2cm in the largest diameter.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients on cagulopathy
2. Patients with altered intra- or extra- luminal anatomy
3. Contraindications for conscious sedation
4. Pregnancy
5. TYhose who cannot provide informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8616 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16724 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 297094 0
Hospital
Name [1] 297094 0
Royal Adelaide Hospital
Country [1] 297094 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 296103 0
None
Name [1] 296103 0
n/a
Address [1] 296103 0
n/a
Country [1] 296103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298272 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 298272 0
Ethics committee country [1] 298272 0
Date submitted for ethics approval [1] 298272 0
Approval date [1] 298272 0
16/01/2017
Ethics approval number [1] 298272 0
HREC/16/RAH/452

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76550 0
A/Prof Nam Nguyen
Address 76550 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 76550 0
Australia
Phone 76550 0
+61 422113598
Fax 76550 0
Email 76550 0
quocnam.nguyen@sa.gov.au
Contact person for public queries
Name 76551 0
Romina Safaeian
Address 76551 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 76551 0
Australia
Phone 76551 0
+61 8 7074 2189
Fax 76551 0
Email 76551 0
romina.safaeian@sa.gov.au
Contact person for scientific queries
Name 76552 0
Romina Safaeian
Address 76552 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 76552 0
Australia
Phone 76552 0
+61 8 7074 2189
Fax 76552 0
Email 76552 0
romina.safaeian@sa.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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