Pancreatic Neoplasm
Conditions
Keywords
fine needle aspiration, core biopsy, endoscopic ultrasound, space occupying process mediastinal, perigastral, perihilar, suspect lymph nodes mediastinal, perigastral or perihilar, diagnostic accuracy of EUS guided core biopsy
Brief summary
The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS aspiration needle in GI-tumors.
Detailed description
Endoscopic ultrasound is an established examination method for tumors of the gastrointestinal tract and the pancreas. Since imaging by itself is limited in differential diagnosis of tumors, EUS guided fine needle aspiration is seen as a valid complementary method. Since fine-needle aspiration (FNA) is mainly based on cytological diagnostics, this method is limited also because of lacking supplementary immune- histochemical diagnostics. Here, the obtainment of little histologically evaluable tissue samples (punched barrels) would be of benefit. A new punch needle device called Pro-core needle (Cook)(22 / 19 gauges) offers the possibility of increasing numbers of valid extractions of histologically evaluable tissues due to a better targeted precision and maneuverability in comparison to other devices of that kind (tru-cut needles, e.g.). A little notch at the pinpoint allows the obtainment of little tissue samples, that will be kept within the device by aspiration. This study compares the obtainment of tissue by Proc-core needle and conventional aspiration punction systems.
Interventions
DEVICEEUS guided FNA and fine needle punction
punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* clinical indication for endoscopic ultrasound diagnostics with fine needle biopsies * age greater than 18 years
Exclusion criteria
* difficult or impossible approach to desired structures due to anatomy (postoperative anatomy, e.g.) * cystic lesion, e.g. cystic pancreas tumors * coagulopathy * severe general condition of the patient * other contraindications for endoscopical ultrasound aided fine needle punction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy | up to 1 year | Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts. The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EUS Pro Core FNA: Histology Samples | day 0 and day 14 | Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples |
| Complication Rates | day 0 and day 14 | Complication rates of EUS FNA |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EUS Guided FNA and Fine Needle Punction punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | EUS Guided FNA and Fine Needle Punction |
|---|---|
| Age, Continuous | 67.5 years |
| Region of Enrollment Germany | 56 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 |
Outcome results
Primary
Diagnostic Accuracy
Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts. The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard.
Time frame: up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EUS Guided Pro Core FNA | Diagnostic Accuracy | 84 Diagnostic accuracy (%) |
Secondary
Complication Rates
Complication rates of EUS FNA
Time frame: day 0 and day 14
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EUS Guided Pro Core FNA | Complication Rates | 0 participants |
Secondary
EUS Pro Core FNA: Histology Samples
Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples
Time frame: day 0 and day 14
Population: Histology (not cytology) samples for Pro-core Needle
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EUS Guided Pro Core FNA | EUS Pro Core FNA: Histology Samples | 36 participants |