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Equality of results between the two groups at interim analysis
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This is a single-blinded randomized control trial trying to compare the effectiveness of diagnosis between two techniques employed in tissue sampling for subepithelial tumors (SETs) of the gastrointestinal tract. Over 2 years, patients having SET will be randomized to either get the EUS-guided core needle biopsy (EUS-CNB) or EUS-guided single-incision with needle knife (SINK) technique. This is of grave importance because the diagnosis of the myriad types of SETs is made histologically requiring a good sample.
Upper gastrointestinal (GI) subepithelial tumors (SETs) are tumors arising from subepithelial layers of esophageal, gastric or duodenal wall, mostly from the submucosa and muscular layer. The incidence of SETs on routine endoscopy is 0.36% The differential diagnosis of SETs include, though are not limited to: lipoma, leiomyoma, aberrant pancreas, varices, carcinoid, gastrointestinal stromal tumors (GISTs), and lymphomas . Therefore, a correct diagnosis of these tumors is important to guide subsequent management. These lesions are often not accurately diagnosed on cross-sectional imaging . Endoscopic ultrasound (EUS) aids in narrowing the differential diagnosis of the lesion as it is often able to establish the layer of origin . However, an accurate diagnosis and targeted therapy is not made solely on the morphological features but on histologic type and at times mitotic index. Thus the need for techniques to obtain histology is beneficial in guiding management.
Since standard endoscopy with pinch biopsies of the overlying mucosa often fails to provide an adequate sample for analysis, multiple other modalities to sample the lesion have been utilized: EUS-guided fine needle aspiration (EUS-FNA), EUS-guided core needle biopsy (EUS-CNB), bite-on-bite forceps biopsies, EUS-guided single-incision with needle knife (SINK) and endoscopic resection.
EUS-FNA is now considered to be the usual method of sampling; however, the diagnostic yield is low: 38% to 82% . Moreover, EUS-FNA often provides insufficient specimens which may not allow for immunohistochemistry that is often essential for diagnosis . Thus EUS-CNB has been assessed for the purpose of obtaining a core sample which allows for histological assessment. Published data reveals a diagnostic (though not histologic) yield using EUS-CNB of 75% In 2011, the SINK technique for sampling was presented with a reported diagnostic accuracy of 92.8% [8]. The technique utilizes a conventional needle-knife connected to an electrosurgical unit. A 6 to 12-mm mucosal incision is made over the lesion. Then conventional biopsy forceps are introduced to obtain 3-5 samples. Subsequently, the incision is closed with 2 to 3 endoclips.
The purpose of this study is to prospectively compare the efficacy and safety of EUS-CNB with SINK in patients with upper GI SETs. The investigators hypothesis is that the SINK technique will be superior to the EUS-CNB in obtaining a histological specimen. The results of the study would provide data which may improve the diagnostic ability for SETs. This in turn will guide appropriate surveillance or management (surgical or endoscopic) for patients with these lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-CNB | Active Comparator | Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that the procedure terminated. |
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| SINK | Active Comparator | Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC) | Device | Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that, the procedure terminated. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy | Diagnostic accuracy is defined as the percentage of true positive and true negative biopsy specimens combined divided by total number of specimens | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Histological Yield | This will be assessed by the percentage of patients whose samples were adequate for histopathological evaluation | 30 days |
| Technical Failure Rate | Percentage of procedures in whom sampling technique failed to take biopsy specimens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mouen Khashab, MD | Johns Hopkins University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Patients were excluded from the study because a predominantly cystic lesion was found; the lack of an appreciable mass at Endoscopic Ultrasound scan (EUS).
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| ID | Title | Description |
|---|---|---|
| FG000 | EUS-CNB | Endoscopic ultrasound-core needle biopsy technique 22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC): A core-needle was used to take a biopsy from the subepithelial lesion |
| FG001 | EUS-SINK |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2017 |
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| conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass) | Device | Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible. |
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| 1 day |
| Time of the Procedure | Time from the beginning of the incision or needle insertion, to completion of tissue acquisition by the techniques defined in the protocol. | Tissue sampling procedure, up to 60 minutes |
| Percent Sample Contribution to Immunohistochemistry Diagnosis | Percentage of all samples from participants in whom biopsy specimen was adequate enough to contribute to immunohistochemistry diagnosis | 30 days |
Endoscopic ultrasound- single incision needle knife technique
Conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass): Needle knife sphincterotome was used to take a biopsy of the subepithelial lesion
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EUS-CNB | Endoscopic ultrasound-core needle biopsy technique 22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC): A core-needle will be used to take a biopsy from the subepithelial lesion |
| BG001 | EUS-SINK | Endoscopic ultrasound- single incision needle knife technique conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass): Needle knife sphincterotome will be used to take a biopsy of the subepithelial lesion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Layer of origin | Number | participants |
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| Echogenicity | Tissue echogenicity is the ability of a tissue in reflection or transmission of the ultrasound waves as compared to its surrounding tissues. The higher the echogenicity of the tissue is, the whiter it will appear on the ultrasound screen as compared to its surrounding tissues. On the contrary, the lower the echogenicity of the tissue is, the blacker it will appear on the screen. | Number | participants |
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| Location of the lesion | Number | participants |
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| Calcification | Number | participants |
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| Greatest diameter of the lesion | Median | Inter-Quartile Range | millimeters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnostic Accuracy | Diagnostic accuracy is defined as the percentage of true positive and true negative biopsy specimens combined divided by total number of specimens | Posted | Number | 95% Confidence Interval | percentage of all samples | 30 days |
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| Secondary | Histological Yield | This will be assessed by the percentage of patients whose samples were adequate for histopathological evaluation | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days |
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| Secondary | Technical Failure Rate | Percentage of procedures in whom sampling technique failed to take biopsy specimens | Posted | Number | 95% Confidence Interval | percentage of procedures | 1 day |
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| Secondary | Time of the Procedure | Time from the beginning of the incision or needle insertion, to completion of tissue acquisition by the techniques defined in the protocol. | Posted | Median | Inter-Quartile Range | minutes | Tissue sampling procedure, up to 60 minutes |
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| Secondary | Percent Sample Contribution to Immunohistochemistry Diagnosis | Percentage of all samples from participants in whom biopsy specimen was adequate enough to contribute to immunohistochemistry diagnosis | Posted | Number | 95% Confidence Interval | percentage of all samples | 30 days |
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Adverse events were evaluated from the start of the procedure up to 1 week after the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EUS-CNB | Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that, the procedure terminated. | 0 | 26 | 0 | 26 | 2 | 26 |
| EG001 | SINK | Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible. | 0 | 30 | 0 | 30 | 3 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed bleeding | Surgical and medical procedures | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mouen A. Khashab | The Johns Hopkins Hospital | 410-502-0064 | mkhasha1@jhmi.edu |
| Sep 28, 2018 |
| Prot_SAP_000.pdf |
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| Muscularis propria |
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| Indeterminate |
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| Isoechoic |
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| Hyperechoic |
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| Mixed echogenicity |
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| Gastric fundus |
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| Gastric body |
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| Antrum |
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| Doudenum |
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| No |
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