Status Approved
First Submitted Date
2017/05/11
Registered Date
2017/05/24
Last Updated Date
2018/08/22
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002338 |
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Unique Protocol ID | 2017-020-I |
Public/Brief Title | torque technique for EUS-guided FNB in solid pancreatic masses |
Scientific Title | Prospective randomized study comparing torque by twisting the scope and standard technique for EUS-guided tissue acquisition using core biopsy needles in solid pancreatic masses |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2017-020-I |
Approval Date | 2017-02-15 |
Institutional Review Board Name | Dongtan Sacred heart hospital Institutional Review Board/Ethics Committee |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Se Woo Park |
Title | Prof. |
Telephone | +82-31-8086-2858 |
Affiliation | Hallym University Medical Center-Dongtan |
Address | 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do, 18450, Korea |
Contact Person for Public Queries | |
Name | Se Woo Park |
Title | Prof. |
Telephone | +82-31-8086-2858 |
Affiliation | Hallym University Medical Center-Dongtan |
Address | 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do, 18450, Korea |
Contact Person for Updating Information | |
Name | Se Woo Park |
Title | Prof. |
Telephone | +82-31-8086-2858 |
Affiliation | Hallym University Medical Center-Dongtan |
Address | 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do, 18450, Korea |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-04-25 Actual | |
Target Number of Participant | 118 | |
Primary Completion Date | 2018-01-31 , Anticipated | |
Study Completion Date | 2018-03-30 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Hallym University Medical Center-Dongtan | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-04-25 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-05-08 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Hallym University Medical Center-Dongtan |
Organization Type | Medical Institute |
Project ID | 2017-020-I |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hallym University Medical Center-Dongtan |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Although the several techniques for improved outcomes in EUS-guided tissue acquisition are reported, the reported diagnostic yield for pancreatic solid tumors to date is not satisfactory. Among these technique, fanning method is well known superior to the standard approach in clinical practice. Instead of this, the effects of torque technique by twisting of scope to clock-wise or counter clock-wise direction during EUS-guided tissue acquisition of pancreatic mass lesions is not known. This study compared diagnostic yield obtained from EUS-guided tissue acquisition of pancreatic masses using torque technique and standard technique. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | /Procedure/Surgery |
Intervention Description | Torque technique During each needle passage, the needle can be firstly advanced into the counterclockwise margin within the lesion under ultrasound guidance. And then, the endosonographer tried to make repetitive back-and-forth thrusting movements at the same time as twisting the body of the echoendoscope to the right (clockwise) with the lesion without using the left/right control knob. For individual needle passage, 10 uniform back-and-forth movements were performed within the lesion. The number of needle passages had been decided upon as only three times and was maintained constant based on previous noted reportsand our experience. Standard technique After puncture, the needle was repeatedly moved back and forth within the lesion 10 times with a thrusting and pulling force to scrape off the histologic tissue. The endosonographer paid more attention to pushing the needle sharply in to shear off tissue and pulling back slowly so that they enter the needle. Once a passage has been completed, deactivate suction and withdraw the needle completely into the sheath. And then, endosonographer repeat all the procedure from needle puncture to withdrawal, 3 times. In subsequent passes, a different margin of the mass was targeted but the needle movement was confined to the same area. |
Number of Arms | 2 |
Arm 1 |
Arm Label Torque technique group |
Target Number of Participant 59 |
|
Arm Type Experimental |
|
Arm Description During each needle passage, the needle can be firstly advanced into the counterclockwise margin within the lesion under ultrasound guidance. And then, the endosonographer tried to make repetitive back-and-forth thrusting movements at the same time as twisting the body of the echoendoscope to the right (clockwise) with the lesion without using the left/right control knob. For individual needle passage, 10 uniform back-and-forth movements were performed within the lesion. The number of needle passages had been decided upon as only three times and was maintained constant based on previous noted reports and our experience. |
|
Arm 2 |
Arm Label Standard technique group |
Target Number of Participant 59 |
|
Arm Type Active comparator |
|
Arm Description Standard technique After puncture, the needle was repeatedly moved back and forth within the lesion 10 times with a thrusting and pulling force to scrape off the histologic tissue. The endosonographer paid more attention to pushing the needle sharply in to shear off tissue and pulling back slowly so that they enter the needle. Once a passage has been completed, deactivate suction and withdraw the needle completely into the sheath. And then, endosonographer repeat all the procedure from needle puncture to withdrawal, 3 times. In subsequent passes, a different margin of the mass was targeted but the needle movement was confined to the same area. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (K00-K93)Diseases of the digestive system (K86.2)Cyst of pancreas |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age No Limit~No Limit |
|
Description Patients were eligible for the study based on the following criteria: suspected solid pancreatic masses based on clinical work up and image modality that required cytopathological confirmation. |
|
Exclusion Criteria |
Exclusion criteria included: (a) cystic pancreatic lesions without the evidence of solid component suspected with malignant transformation; (b) cardiopulmonary instability; (c) severe coagulopathy (international normalized ratio > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]); (d) inability to suspend antithrombotic therapy; (e) pregnancy; (f) refusal to provide informed consent or participate in the study. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | the procurement rates of histologic cores that the cyto-pathologist considered to be of optimal quality for histological evaluation of the needle gauge used for the EUS-FNB procedure |
|
Timepoint | 1-2 weeks after interventional EUS (after confirmation of final pathologic report) |
|
Secondary Outcome(s) 1 | ||
Outcome | diagnostic performance: diagnostic accuracy, sensitivity, specificity, PPV, NPV |
|
Timepoint | 1-2 weeks after interventional EUS (after confirmation of final pathologic report) |
|
Secondary Outcome(s) 2 | ||
Outcome | Technical failure |
|
Timepoint | 1-2 weeks after interventional EUS (after confirmation of final pathologic report) |
|
Secondary Outcome(s) 3 | ||
Outcome | Procedure related adverse events |
|
Timepoint | 1-2 weeks after interventional EUS (after confirmation of final pathologic report) |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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