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the first pass is made with 5ml suction technique

the first pass is made with modified wet suction technique

the first pass is made with 5ml suction technique, then modified wet suction technique / 5ml suction technique/ modified wet suction technique is operated successively.

the first pass is made with modified wet suction technique, then 5ml suction technique/ modified wet suction technique/ 5ml suction technique is operated successively.

Bin Cheng, Doctor

Yun Wang, Doctor

The purpose of this study is to compare the diagnosis accuracy of modified wet suction technique and 5ml dry suction technique on solid occupying lesions.

Patients will be divided into two groups, arm A and arm B according to two different methods adopted in their first needle, which refers to the modified wet suction technique or 5ml dry suction technique.Take the solid occupying lesion diagnosis accuracy as the research major indicator to compare the the modified wet suction technique or 5ml dry suction technique as optimal efficiency test. Take classⅠerror, a=0.05, class II error, β=0.2, power=0.8, suppose that the diagnostic accuracy of dry suction technique to the solid occupying lesions is 75%, the diagnostic accuracy of modified wet suction technique to the solid occupying lesions is 85%, the minimum sample size are 248 patients with 5ml dry suction technique and 248 patients with modified wet suction technique, the 2x2 cross-over design is adopted, namely, each arm has 124 patients respectively. Considering factors including defluxion, 20% cases will be added to two arms, therefore, each arm has 148 patients respectively, the total number of patients is 296.

The statistics experts generated randomized serial numbers（001-296）according to same-size allocation ratio between arm A and arm B with Statistical Analysis System 9.2(SAS 9.2), a statistical software in the randomized block method. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 8, totally 37 randomized block. 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 arm A or arm B .The research people and patients in all trial centers should not know the randomized grouping number and relevant arms. The arm 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 investigator will puncture the lesion for four needle passes for all of them:For Arm A,5ml dry suction technique is adopted in their first needle, then modified wet suction technique/5ml dry suction technique/modified wet suction technique is operated successively;For Arm B, modified wet suction technique is adopted in their first needle, then 5ml dry suction technique/ modified wet suction technique /5ml dry suction technique is operated successively.Well,the 5ml dry suction technique is conducted as follow:after the needle puncturing into the lesion under ultrasound scanning, remove the stylet and connect the needle to syringe with 5ml negative pressure aspiration, then the needle will be moved to-and-fro within the lesion 20 times. Suction will be released before the needle is withdrawn from the lesion.And the modified wet suction technique is conducted as follow:the needle whose stylet is pulled out will be flushed with 2ml saline solution before puncturing when the lesion has been found, then puncture into the lesions and replace syringe with 5ml negative pressure aspiration, then the needle will be moved to-and-fro within the lesion 20 times. Suction will be released before the needle is withdrawn from the lesion.If no core tissues obtained or the operator determine insufficient specimen according to Macroscopic rapid on-site(MOSE) after the operations above, then remedy procedures will be done, and the punctuation process should be continued with the appropriate punctuation methods until the satisfactory specimens are obtained.Experts in cytology and pathology evaluate the specimen quality and make a diagnosis under the condition that they do not know punctuation methods. The evaluation and diagnosis of each specimen are made by two experts independently. If the two experts hold different opinions, they will make a conclusion after full discussion. If there are two or more cytological smears with same punctuation method, the highest-rate smear should be taken as the standard smear.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.

Case Report Form(CRF) will be filled by the researchers, every involved patient must have the CRF 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:（1）General principle①All statistical tests were two-sided. P\<0.05 is regarded that the difference is statistical significance.② Description of quantitative index will calculate the mean and the criteria deviation, description of classification index will describe the number and percentage of each type.（2） Statistical Analysis Method：① For measurement data, compare these data with baseline value during the screening period, adopt the deviation t-test, the variance analysis of cross-over experiment or the rank-sum test of cross-over experiment to make a comparison between these data and baseline value.② For enumeration data, adopt the paired x2-test(including CMH-x2 test) or Fisher's exact test to compare these data of each group.（3）Defluxion Analysis：The total defluxion rate of each group and the defluxion rate caused by adverse events are compared by x2-test or Fisher's exact test.（4）Analysis of baseline value balance：The indexes of some baseline values such as demographic data, vital signs, history of diseases and basic treatment are compared by group t-test and x2 test to measure the balance of each group. Baseline evaluation is made to full analysis set( FAS) and per-protocol set(PPS).（5）Validity Analysis：The primary index of validity analysis is the diagnostic accuracy of the 5ml dry pressure and modified wet pressure to the solid space-occupying lesions. The secondary indexes of validity analysis include the punctuation specimen quality of 5ml dry pressure and modified wet pressure, the diagnostic rate of the first needle of 5ml dry pressure / modified wet pressure and the incidence of complications for modified wet pressure and 5ml dry pressure. The rates of each two arms and Youden indexes are compared by the approximate normal z-test or the central-effect-considered Cochran Mantel Haenszel-x2(CMH-x2 )text.(6)Safety Analysis:The incidences of adverse events/ adverse reactions (including complications from punctuation) of each arm are compared by x2-test or Fisher's exact test and describe the adverse events occurred in this experiment by the list and the normal/abnormal changes of laboratory text results before and after test and the relationship between abnormal changes of laboratory text results and this diagnostic research.(7) All statistical analyses are completed by the professional statistical analysis software, SAS version 9.2.

Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions

Comparing of Modified Wet Suction Technique and Dry Suction Technique for Endoscopic Ultrasound -Guided Fine Needle Aspiration (EUS-FNA) of Solid Occupying Lesions: a Prospective Multi-center,Randomized,and Controlled Trial

The investigators' primary outcome measure is to compare the overall diagnostic accuracy of modified wet suction technique and dry suction technique to the solid occupying lesions.

The investigators'secondary outcome measure is to compare the diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the benign and malignant solid occupying pancreatic lesions and non-pancreatic lesions respectively.

The investigators'secondary outcome measure is to compare the cellularity and blood cell contamination of the solid occupying lesions with modified wet suction technique and 5ml dry suction technique.

Bin Cheng

professor

EUS-FNA (EchoTip Ultra)

EUS-FNB (EchoTip ProCore)

Jinlin Wang, Doctor

The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.

The study subjects are divided into two groups: the EUS-FNA(22G EchoTip Ultra needles) Group and EUS-FNB group(22G EchoTip ProCore needles).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 80%, while that of FNB is 93%. The two trial groups be randomly allocated in 1:1, suppose the malignancy cases take 70% of the whole case, and considering the shedding factors , extra 20% cases should be included. So the estimated cases numbers is 204 cases for EUS-FNB group and 204 cases for EUS-FNA group, totally 408 cases in this trial.

Done by professional statistical people with randomized block grouping method and SAS 9.2 statistical software to generate randomized serial number（001-408）for the two groups in 1:1 manner. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 8, totally 51 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 4 times for all of them:the 1-2 needle passes with Slow-Pull and the 3-4 needle passes with Vacuum 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 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.

Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion

Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB（Endoscopic Ultrasonography-Fine Needle Biopsy ） and EUS-FNA（Endoscopic Ultrasonography-Fine Needle Aspiration ） on Solid Occupying Lesion

The investigators' primary outcome measure is to compare the the diagnostic yield (%) on malignancy of EUS-FNA to EUS-FNB

The amount of blood contamination and cellularity at each sample according to EUS-FNA and EUS-FNB with slow-pull or suction will be measured.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions	NCT02789371	Pancreas Neopla... Lymphatic Metas... Neoplasm Metast... Unknown Primary... Infection Inflammation Sarcoid Lymphadenopathy	the first pass ... the first pass ...	18 Years - 80 Years	Huazhong University of Science and Technology
Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion	NCT02327065	Pancreas Neopla... Lymphatic Metas... Neoplasm Metast... Unknown Primary...	EUS-FNA (EchoTi... EUS-FNB (EchoTi...	18 Years -	Huazhong University of Science and Technology

Spots Global Cancer Trial Database for unknown primary neoplasm metastasis