Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00316

2 Trial Registration Date

2012-04-24

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

None

5 Primary Sponsor

None

6 Secondary Sponsor

None

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Charing Chong

ii Address

Department of Surgery, 4/F Clinical Science Building, Prince of Wales Hospital

iii Phone

2632 1411

iv Email

chongcn@surgery.cuhk.edu.hk

v Affiliation

PWH Surgery / CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Charing Chong

ii Address

Department of Surgery, 4/F Clinical Science Building, Prince of Wales Hospital

iii Phone

2632 1411

iv Email

chongcn@surgery.cuhk.edu.hk

v Affiliation

PWH Surgery / CUHK

vi Country

9 Official Scientific Title of the Study

Prospective comparative study on Endoscopic Ultrasonography (EUS) – Guided Fine-Needle Aspiration (FNA) using the 22G Conventional needles or Procore Needles without immediate on-site cytopathologic examination.

10 Public Title

Prospective comparative study on Endoscopic Ultrasonography (EUS) – Guided Fine-Needle Aspiration (FNA) using the 22G Conventional needles or Procore Needles without immediate on-site cytopathologic examination.

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

EUS-FNA with 22G Procore Needle

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-03-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Neoplasm

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

EUS-FNA with 22G Procore needle

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30-60minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

EUS-FNA with 22G Conventional needle

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for evaluating intestinal or extra-intestinal mass lesions more than 2cm in the largest diameter would be included.

ii Exclusion Criteria

Patients with coagulopathy, previous history of upper gastrointestinal surgery, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-05-01

21 Target Sample Size

76

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

proportion of patients with cyto-histopathology confirmed neoplasms diagnosed by EUS-guided FNA

24 Secondary Outcome

sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-05-26

27 Primary Registry and Trial Identifying Number

ChiCTR-TTRCC-12002136

28 Date of Registration in Primary Registry

2012-05-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2012-12-07