Status Approved
First Submitted Date
2016/03/08
Registered Date
2016/03/11
Last Updated Date
2017/10/14
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0001840 |
|---|---|
| Unique Protocol ID | GAIRB2016-026 |
| Public/Brief Title | The efficacy of contrast-enhanced endoscopic ultrasound fine-needle aspiration for diagnosis of solid pancreatic lesions |
| Scientific Title | The efficacy of contrast-enhanced endoscopic ultrasound fine-needle aspiration for diagnosis of solid pancreatic lesions |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | GAIRB2016-026 |
| Approval Date | 2016-02-16 |
| Institutional Review Board Name | Gachon University Gil Medical Center Institutional Review Board |
| Institutional Review Board Address | |
| Institutional Review Board Telephone | |
| Data Monitoring Committee |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Jae Hee Cho |
| Title | Associate professor |
| Telephone | +82-32-460-3778 |
| Affiliation | |
| Address | 21, Namdong-daero 774beon-gil, Namdong-gu, Incheon |
| Contact Person for Public Queries | |
| Name | Su Young Kim |
| Title | Fellow |
| Telephone | +82-32-460-3778 |
| Affiliation | |
| Address | 21, Namdong-daero 774beon-gil, Namdong-gu, Incheon |
| Contact Person for Updating Information | |
| Name | Su Young Kim |
| Title | Fellow |
| Telephone | +82-32-460-3778 |
| Affiliation | |
| Address | 21, Namdong-daero 774beon-gil, Namdong-gu, Incheon |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2016-03-14 Anticipated | |
| Target Number of Participant | 200 | |
| Primary Completion Date | 2017-12-31 , Anticipated | |
| Study Completion Date | 2017-12-31 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | ||
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2016-03-14 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | |
| Organization Type | Medical Institute |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a test was first published in the early 1990s. After 1992 years, this test is a method that is widely used to obtain a specimen for the gastrointestinal lesion. According to a recently published meta-analysis, the EUS-FNA for pancreatic neoplasm, it has emphasized its role as initial tests with diagnostic tests with high accuracy. However, sometimes, the specimens are inadequate for proper pathological diagnossis due to sampling error. Contrast enhanced endoscopic ultrasound (CE-EUS) imaging increase improves the observation of a pancreatic tumor, help to identify other pathological lesion portion of the pancreas, is particularly useful in the differential diagnosis of pancreatic lesions of small size. Diagnostic accuracy of the EUS-FNA is influenced by the various technical factors, such as the operator experience, pathologist's presence, the lesion in the field and aspects, types or size of needle. However, research into appropriate sample collection and diagnosis of pancreatic tumor contrast enhanced endoscopic ultrasound-guided fine-needle aspiration (CE EUS-FNA) was not nearly done. Therefore, in this study, we conducted the prospectively comparison analysis of CE EUS-FNA with traditional EUS-FNA for diagnostic efficacy, especially in diagnostic accuracy appropriate needle passes affecting the number of tests on the tumor lesions of the pancreas. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Diagnosis |
| Phase | Not applicable |
| Intervention Model | Parallel |
| Blinding/Masking | Single |
| Blinded Subject | Subject |
| Allocation | RCT |
| Intervention Type | /Procedure/Surgery |
| Intervention Description | Implemented method of EUS FNA is as follows. First, by using the ultrasonic endoscope (EUS), esophagus and stomach through the mouth of the patient, it enters securely in the duodenum. Looking for lesions to enforce a procedure after entering the endoscope placed in the proper position. Course to visit the lesion is observed surrounding organs and structures going make it a starting point for the main blood vessel along the vessel slowly at each position. In some cases, followed up the pancreatic duct or the bile duct. We find an observed lesion, and plan for appropriate EUS-FNA plan using by lesion characteristics (shape, range, form of vascular status, whether necrosis). Straighten the endoscope as possible and needle naturally towards the lesion between 4-6 o'clock in the ultrasound image. Fine needle aspiration fully prepared to do so, and then select the appropriate needle (19, 22, 25G) shall be implemented according to the situation puncture. In the group of patients where conventional ways to conduct a brief puncture while retaining the B-mode state. In the group of patients underwent contrast-enhanced way of contrast agent (Sonovue) is injected into a vein of the patient before puncture. After contrast injection and then to compare contrast-enhanced mode and B-mode real-time, find the most appropriate lesion advances puncture. All of the other methods are the same in both groups. After fine-needle aspiration is to keep always visible in the ultrasound image and finish the test being careful. |
| Number of Arms | 2 |
| Arm 1 |
Arm Label The patient group who underwent conventional endoscopic ultrasound fine needle aspiration (EUS-FNA) |
|
Target Number of Participant 100 |
|
|
Arm Type Active comparator |
|
|
Arm Description Implemented method of EUS FNA is as follows. First, by using the ultrasonic endoscope (EUS), esophagus and stomach through the mouth of the patient, it enters securely in the duodenum. Looking for lesions to enforce a procedure after entering the endoscope placed in the proper position. Course to visit the lesion is observed surrounding organs and structures going make it a starting point for the main blood vessel along the vessel slowly at each position. In some cases, followed up the pancreatic duct or the bile duct. We find an observed lesion, and plan for appropriate EUS-FNA plan using by lesion characteristics (shape, range, form of vascular status, whether necrosis). Straighten the endoscope as possible and needle naturally towards the lesion between 4-6 o'clock in the ultrasound image. Fine needle aspiration fully prepared to do so, and then select the appropriate needle (19, 22, 25G) shall be implemented according to the situation puncture. In the group of patients where conventional ways to conduct a brief puncture while retaining the B-mode state. After fine-needle aspiration is to keep always visible in the ultrasound image and finish the test being careful. |
|
| Arm 2 |
Arm Label The patient group who underwent contrast enhanced endoscopic ultrasound fine needle aspiration (CE EUS-FNA) |
|
Target Number of Participant 100 |
|
|
Arm Type Experimental |
|
|
Arm Description Implemented method of EUS FNA is as follows. First, by using the ultrasonic endoscope (EUS), esophagus and stomach through the mouth of the patient, it enters securely in the duodenum. Looking for lesions to enforce a procedure after entering the endoscope placed in the proper position. Course to visit the lesion is observed surrounding organs and structures going make it a starting point for the main blood vessel along the vessel slowly at each position. In some cases, followed up the pancreatic duct or the bile duct. We find an observed lesion, and plan for appropriate EUS-FNA plan using by lesion characteristics (shape, range, form of vascular status, whether necrosis). Straighten the endoscope as possible and needle naturally towards the lesion between 4-6 o'clock in the ultrasound image. Fine needle aspiration fully prepared to do so, and then select the appropriate needle (19, 22, 25G) shall be implemented according to the situation puncture. In the group of patients underwent contrast-enhanced way of contrast agent (Sonovue) is injected into a vein of the patient before puncture. After contrast injection and then to compare contrast-enhanced mode and B-mode real-time, find the most appropriate lesion advances puncture. After fine-needle aspiration is to keep always visible in the ultrasound image and finish the test being careful. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (K00-K93)Diseases of the digestive system (K86.2)Cyst of pancreas |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 18Year~No Limit |
|
|
Description The patient needed that endoscopic ultrasound fine needle aspiration (EUS-FNA) for the purposes of diagnosis the solid lesion in pancreas |
|
| Exclusion Criteria |
1.The patient was required endoscopic ultrasound guided fine needle aspiration because pancreatic cystic lesion which needed diagnostic purposes or therapeutic purposes 2. Patients aged less than18 3. Patients who underwent gastrectomy in the previous 4. Hemodynamically unstable patients 5. Patients with severe blood clotting disorder 6. Unable to sustain the anticoagulant treated patients 7. Pregnant Patient 8. The patient did not consent informed 9. Refused to participate in the study patients |
| Healthy Volunteers |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Diagnostic accuracy of fine needle aspiration in first time |
|
| Timepoint | After the biopsy results confirmed |
|
| Secondary Outcome(s) 1 | ||
| Outcome | The size of the lesion |
|
| Timepoint | After endoscopic ultrasound procedure |
|
| Secondary Outcome(s) 2 | ||
| Outcome | The number of needle passes during inspection |
|
| Timepoint | After endoscopic ultrasound procedure |
|
| Secondary Outcome(s) 3 | ||
| Outcome | The size and type of needle |
|
| Timepoint | After endoscopic ultrasound procedure |
|
11. Study Results and Publication
| Result Registered |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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