Comparsion of WT and SNP Techniques of EUS-FNB in Pancreatic Solid Mass (WESP-PSM)

Pancreatic Neoplasms Clinical Trial

— WESP-PSM  

Official title:

A Multicenter Prospective Clinical Study of Wet-suction Technique and Standard Negative Pressure Technique in EUS-FNB for the Diagnosis of Pancreatic Solid Mass

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04605042
• Other study ID #: RuijinH2020301
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2020
• Source: Ruijin Hospital
• Contact: DuoWu Zou, Ph.D,M.D
• Phone: +86 13901617608
• Email: zdw_pi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions.

Description:

This is a multi-center, single-blind, randomized, controlled trial. two hundred and ninety six patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to two groups. For group A which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is WS-SNP-WS-SNP technique. For group B with 22G EUS Procore fine needle biopsy device, the pass sequence is SNP-WS-SNP-WS. All procedures will be performed by experienced echo-endoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 296
• Est. completion date: September 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. informed consent

2. Subjects over 18 years old

3. Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm

Exclusion Criteria:

1. Unable or refused to sign informed consent

2. suspended anticoagulant/antiplatelet therapy

3. Being pregnant or breastfeeding

4. Cystic lesions of the pancreas

5. coagulation disorders (PLT <50×103/ L, INR > 1.5)

6. A history of mental illness

7. other medical conditions that are not suitable for FNB puncture

Related Conditions & MeSH terms

• Diagnoses Disease
• Pancreatic Neoplasms

Intervention

Procedure:
• wet suction
Before pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe
• standard negative pressure suction
after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ruijin Hospital	Changhai Hospital, Second Affiliated Hospital of Soochow University

References & Publications (11)

Alatawi A, Beuvon F, Grabar S, Leblanc S, Chaussade S, Terris B, Barret M, Prat F. Comparison of 22G reverse-beveled versus standard needle for endoscopic ultrasound-guided sampling of solid pancreatic lesions. United European Gastroenterol J. 2015 Aug;3(4):343-52. doi: 10.1177/2050640615577533. — View Citation

Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27. — View Citation

Banafea O, Mghanga FP, Zhao J, Zhao R, Zhu L. Endoscopic ultrasonography with fine-needle aspiration for histological diagnosis of solid pancreatic masses: a meta-analysis of diagnostic accuracy studies. BMC Gastroenterol. 2016 Aug 31;16:108. doi: 10.1186/s12876-016-0519-z. — View Citation

Dumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czakó L, Fernández-Esparrach G, Fockens P, Ginès À, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16. — View Citation

Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21. — View Citation

Li DF, Wang JY, Yang MF, Xiong F, Zhang DG, Xu ZL, Luo MH, Jing ZD, Wang KX, Wang LS, Yao J. Factors associated with diagnostic accuracy, technical success and adverse events of endoscopic ultrasound-guided fine-needle biopsy: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2020 Aug;35(8):1264-1276. doi: 10.1111/jgh.14999. Epub 2020 Feb 23. — View Citation

Möller K, Papanikolaou IS, Toermer T, Delicha EM, Sarbia M, Schenck U, Koch M, Al-Abadi H, Meining A, Schmidt H, Schulz HJ, Wiedenmann B, Rösch T. EUS-guided FNA of solid pancreatic masses: high yield of 2 passes with combined histologic-cytologic analysis. Gastrointest Endosc. 2009 Jul;70(1):60-9. doi: 10.1016/j.gie.2008.10.008. Epub 2009 Apr 25. — View Citation

Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernández-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12. — View Citation

Puli SR, Bechtold ML, Buxbaum JL, Eloubeidi MA. How good is endoscopic ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid pancreatic mass?: A meta-analysis and systematic review. Pancreas. 2013 Jan;42(1):20-6. doi: 10.1097/MPA.0b013e3182546e79. Review. — View Citation

Sakamoto H, Kitano M, Komaki T, Noda K, Chikugo T, Dote K, Takeyama Y, Das K, Yamao K, Kudo M. Prospective comparative study of the EUS guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle in patients with solid pancreatic masses. J Gastroenterol Hepatol. 2009 Mar;24(3):384-90. doi: 10.1111/j.1440-1746.2008.05636.x. Epub 2008 Nov 20. — View Citation

Wang Y, Wang RH, Ding Z, Tan SY, Chen Q, Duan YQ, Zhu LR, Cao JW, Wang J, Shi G, Wu XL, Wang JL, Zhao YC, Tang SJ, Cheng B. Wet- versus dry-suction techniques for endoscopic ultrasound-guided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial. Endoscopy. 2020 Nov;52(11):995-1003. doi: 10.1055/a-1167-2214. Epub 2020 May 15. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic sensitivity of WS technique and SNP technique by EUS-FNB	Sensitivity will be calculated as the probability of actually having pancreatic diasease and being diagnosed by WS technique during EUS-FNB	6 month
Primary	diagnostic specificity of WS technique and SNP technique by EUS-FNB	specificity will be calculated as the probability of actually not having the pancreatic disease and being diagnosed as being free of the disease by WS or SNP technique during EUS-FNB	6 month
Secondary	Sample adequacy of WS technique and SNP technique by EUS-FNB	The tissue integrity assessments of specimens will be evaluated by score 0-3. Score 3, sufficient material for adequate histological interpretation; Score 2, samples allowing limited histological assessment; Score 1,samples not providing histological information.	6 month
Secondary	Cell density of WS technique and SNP technique by EUS-FNB	The Cell density assessments of specimens will be evaluated by score A-C. Score A:Satisfactory, more than 4 clusters of cells, each cluster more than 10 cells.; Score B:Sufficient, approximately 2-4 clusters, each with more than 10 cells Score C: :Unsatisfactory, less than 2 clusters or no cells on slide	6 month