Trial Title:
22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions
NCT ID:
NCT06563232
Condition:
Pancreatic Neoplasms
Mediastinal Neoplasms
Abdominal Neoplasm, Excluding Pancreas Neoplasm
Conditions: Official terms:
Neoplasms
Pancreatic Neoplasms
Abdominal Neoplasms
Mediastinal Neoplasms
Conditions: Keywords:
endoscopic ultrasound
fine-needle aspiration
fine-needle biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
FNA group
Description:
Fine-needle-aspiration (22G EchoTip Ultra Echo-3-22)
Arm group label:
FNA group
Intervention type:
Device
Intervention name:
Adapt FNB group
Description:
Fine-needle-biopsy (22G Adapt Aspiration)
Arm group label:
Adapt FNB group
Summary:
The investigators conduct a multicenter randomized controlled study to evaluate the
diagnostic value and safety of 22G Adapt Aspiration puncture needle for histopathology of
solid lesions.
Detailed description:
The study subjects are divided into two groups: the EUS-FNA(22G EchoTip Ultra needles)
Group and EUS-FNB group(22 Adapt Aspiration).Take the malignant occupying lesion
diagnosis accuracy as the research major indicator to compare the EUS-FNB group and
EUS-FNA group as optimal efficiency test. Take the class I error a=0.05, class II error
β=0.15, power=0.85. Suppose the malignancy diagnosis accuracy is 82%, while that of FNB
is 91%. The two trial groups be randomly allocated in 1:1, suppose the malignancy cases
take 85% of the whole case, and considering the shedding factors , extra 20% cases should
be included. So the estimated cases numbers is 328 cases for EUS-FNB group and 328 cases
for EUS-FNA group, totally 656 cases in this trial.
Done by professional statistical people with randomized block grouping method and SAS 9.4
statistical software to generate randomized serial number（001-656）for the two groups in
1:1 manner. The serial numbers are the randomized grouping numbers for the trial
patients, block capacity is 116, totally 41 randomized block. The randomized grouping
will be generated in duplicate copies and sealed. One copy send to trial centers for
patient allocating, and the another copy be saved by the trial applicant unit. Every
trail centers will be responsible for the screening of qualified patients, rank them in
visit time to get the randomized grouping number so as to determine them goes to the
EUS-FNA or EUS-FNB.The research people and patients in all trial centers should not know
the the randomized grouping number and relevant groups. The group name will be sealed
under scratch card. Every trial patients will get a unique randomized number, and it will
not change through out the whole trial.
Use the inclusion and exclusion criteria to observe the patients and do relative
inspections, and confirm if the patients qualified or not to the trial. Record the result
of last time test before the treatment. Although it is better to get the informed consent
before doing all kinds of observation and tests, if for some reason, the medical imaging
examination has completed, as long as the imaging examination was done within 3 weeks
before the needle biopsy, it can still be collect as baseline data (imaging examination
can be done at other hospitals, but the trial center should issue a new evaluation report
1 week before the patient join the trial group); other lab test items done at 2 weeks
before the needle biopsy can still be collect as baseline data for pre-research use, but
these tests should be done at the trail center hospital so as to guarantee the data trace
ability.
The investigators will do the needle passes for 3 times for all of them:the 1 needle
passes with Slow-Pull and the 2-3 needle passes with wide suction. If no core tissues
obtained or the operator/onsite pathologist determine insufficient specimen after the
operations above, then remedy procedures will be done, the operator use proper puncture
method to continue the remedy biopsy. After the first round of needle biopsy, if the
trial patient cannot be diagnosed, by getting the agreement of the patient, the patient
will be cross-over to another trial group and do needle biopsy again on the same lesion 1
week later with the method mentioned above. Without knowing the needle biopsy type, the
cytologist and pathologist evaluate the specimen quality and make diagnosis. Every
specimen will be independently evaluated and diagnosed by 2 experts. If the 2 experts
have different judgments, then these two experts discuss together and make the final
diagnose discussion. If the same sample has 2 or more cytology smear slides, than take
the highest score slide as the result. Follow up (outpatient follow up or telephone
follow up) the patients at 1 week, 12 weeks and 36 weeks after the needle biopsy and
collect the patients clinical data and confirm their final diagnosis.
During the trial, if severe adverse event occurs, the trialed center must take immediate
actions necessary to guarantee the trialed patients' safety. Once severe adverse event
occurs, the researchers should inform the trial applicant and the trail center's ethics
committee within 24 hours after the researchers gets to know the adverse event. And the
researchers should also fax the report to State Food and Drug Administration of China and
the local provincial food and drug administration. After receiving the report, the
applicant should inform other clinical trial centers within 24 hours. All the severe
adverse events should be filed at group leader medical center and other trial centers.
CRF(Case Report Form ) will be filled by the researchers, every involved patient must
have the CRF(Case Report Form ) filled. This will be audited by clinical monitor and
handed over to data administrator to input and manage data, the first copy will be kept
by the applicant, the second copy will go to the trial center, and the third copy will be
kept by the trail researchers.The data input and management will be taken care by
specially assigned person. In order to guarantee the data accuracy, data input will be
done twice by two independent data administrators, by computerized and manual verifying,
hand over the data to statistical experts to do blind check and statistic analyzing.For
the questions and doubts within the case report form, the data administrator make DRQ and
via the clinical monitor asking the researchers. The researchers will answer and feed
back as soon as possible. According to the researchers answer, data administrator will do
the data modifying, confirming or inputting, and when necessary send out DRQ again.After
blind audition and confirming that the established data base is correct, major
researchers, applicant and the statistic analyzing people lock the data. The locked data
will not be changed, and the data base will be handed over to statistical analyzer to do
the statistic analyze according to the statistic analyzing plan. Problems found after
data locking can be modified during the statistic analyzing procedure.This will be done
by specialized statistic analyzing people according to the predetermined statistic
analyzing plan. The statistic analyze will be carried out according to intention
principle confirmed full analysis set and per-protocol set principle. After completing
the statistic analyzing, the statistic analyzer issue the statistic analysis report and
send this to major researchers to write the study report.
Statistic analyzing plan:⑴ General principle:① all the statistic tests are use the
two-tailed-test method, P<0.05 will be thought as the tested difference is statistical
significance. ② the quantitative indicator description will calculate the Mean and
Standard deviation. The classification indicator description will describe the cases and
percentage of all types of cases. ⑵ Statistic analyzing method:① for the measurement
data, compare it with the baseline value at selection period, use paired t-test or symbol
rank sum test to compare with the before-after-difference within the group.② for the
counting data, use x2 test or Fisher's exact test method to compare the groups. ⑶
Shedding analysis:Comparison of groups'total shedding rates and the shedding rates caused
by adverse events will use x2 test or Fisher's exact test method. ⑷ The baseline value's
equilibrium analysis: Use group t test or x2 test to compare the demography info and
vital signs, disease history, and basic treatment and other indicators of baseline value,
so as to measure the balance of the groups. The baseline evaluation will be done on
FAS（full analysis set) and PPs(per-protocol set). ⑸ Effectiveness analysis:The major
indicator of effectiveness analysis is the diagnostic accuracy on malignant disease, and
the indicators of second effectiveness include the percentage of Grade A specimen and
complications rate etc. while the two groups rate and the Youden index comparison will
use approximate normal Z test or use central effect x2 test.(6) Safety analysis:Use x2
test or Fisher's exact test to compare the adverse event/adverse reaction (include biopsy
complications) rates between the groups. And use table to describe the adverse events
during this trial project; the lab test results before and after the trial, the
normal/abnormal changing condition and the relationship with this trial research when
abnormal changes happened.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Over 18 years old and under 85 years old;
- Imaging examinations (MRI, CT, B-ultrasound) reveal the presence of solid masses
(with a diameter > 1 cm) within the regions accessible by endoscopic ultrasound in
the pancreas, peripancreatic area, liver, adrenal gland, kidney, mediastinum, lung,
and gastrointestinal submucosa. Biopsy is necessary for the diagnosis of these
lesions;
- Must be able to receive examinations in the research center;
- Must be able to sign the informed consent.
Exclusion Criteria:
- Hemoglobin ≤8.0 g/dL;
- Pregnant women;
- Coagulation disorders (PLT <50,000/mm3,INR > 1.5);
- Took anticoagulants such as aspirin, warfarin in the latest week;
- Acute pancreatitis in the past two weeks;
- inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental
diseases, or drug addiction); refusal or inability to provide an informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Tongji Medical College, HUST
Address:
City:
Wuhan
Zip:
430030
Country:
China
Contact:
Last name:
Bin Cheng, Professor
Phone:
86-027-8366-3333
Email:
b.cheng@tjh.tjmu.edu.cn
Contact backup:
Last name:
Qingxiong Ma
Phone:
+8613588580316
Email:
u202110372@hust.edu.cn
Start date:
September 1, 2024
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
Huazhong University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06563232
