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

NCT02789371 | Unknown DMC

• 1 other identifier: S135
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Neoplasms; Lymphatic Metastasis; Neoplasm Metastases; Unknown Primary Neoplasm Metastasis; Infection; Inflammation; Sarcoid; Lymphadenopathy

Keywords

EUS-FNA; modified wet suction technique; dry suction technique

Outcome Measures

Primary Outcomes (1)

• the overall diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the solid occupying lesions

  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.

  18 months

Secondary Outcomes (2)

• 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.

  18 months

• Blood contamination and cellularity in specimens obtained by modified wet suction technique and 5ml dry suction technique

  18 months

Study Arms (2)

Arm A

OTHER

the first pass is made with 5ml suction technique

Procedure: the first pass is made with 5ml suction technique

Arm B

OTHER

the first pass is made with modified wet suction technique

Procedure: the first pass is made with modified wet suction technique

Interventions

the first pass is made with 5ml suction technique PROCEDURE

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

Arm A

the first pass is made with modified wet suction technique PROCEDURE

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

Arm B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old,\<80 years old;
• Gender: Male or Female;
• The patients who have solid occupying pancreatic lesions and non-pancreatic lesions (the diameter\>1cm) within the range of imaging examination(MRI、CT、B-type ultrasonography) and ultrasonic endoscope examination and should conduct the biopsy to identify lesion nature;
• The patients who receive examinations in the research center;
• The patients who sign the informed consent.

You may not qualify if:

• Hemoglobin≤8.0 g/dl;
• Pregnant women;
• The patients who have coagulation disorders（PLT\<50,000/mm3,INR\>1.5,roughly calculation, INR\>1.5, is equivalent to PT\>18 seconds);
• The patients who took anticoagulants such as aspirin, warfarin in the latest week;
• The patients who suffered from acute pancreatitis in the past two weeks;
• The patients who have cardiopulmonary dysfunction, therefore cannot tolerate ultrasonic endoscope examination;
• The patients who cannot sign the informed consent(such as patients who have mental disease or drug addiction and so on).

Sponsors & Collaborators

• Bin Cheng: lead

Study Sites (1)

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (20)

• Furukawa H, Okada S, Kakizoe T. Early diagnosis of pancreatic cancer. Hepatogastroenterology. 1999 Jan-Feb;46(25):4-7.

  PMID: 10228757 RESULT

• Furukawa H, Okada S, Saisho H, Ariyama J, Karasawa E, Nakaizumi A, Nakazawa S, Murakami K, Kakizoe T. Clinicopathologic features of small pancreatic adenocarcinoma. A collective study. Cancer. 1996 Sep 1;78(5):986-90. doi: 10.1002/(SICI)1097-0142(19960901)78:53.0.CO;2-A.

  PMID: 8780535 RESULT

• DeWitt J, Jowell P, Leblanc J, McHenry L, McGreevy K, Cramer H, Volmar K, Sherman S, Gress F. EUS-guided FNA of pancreatic metastases: a multicenter experience. Gastrointest Endosc. 2005 May;61(6):689-96. doi: 10.1016/s0016-5107(05)00287-7.

  PMID: 15855973 RESULT

• Puli SR, Batapati Krishna Reddy J, Bechtold ML, Ibdah JA, Antillon D, Singh S, Olyaee M, Antillon MR. Endoscopic ultrasound: it's accuracy in evaluating mediastinal lymphadenopathy? A meta-analysis and systematic review. World J Gastroenterol. 2008 May 21;14(19):3028-37. doi: 10.3748/wjg.14.3028.

  PMID: 18494054 RESULT

• Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.

  PMID: 9087830 RESULT

• Savides TJ, Donohue M, Hunt G, Al-Haddad M, Aslanian H, Ben-Menachem T, Chen VK, Coyle W, Deutsch J, DeWitt J, Dhawan M, Eckardt A, Eloubeidi M, Esker A, Gordon SR, Gress F, Ikenberry S, Joyce AM, Klapman J, Lo S, Maluf-Filho F, Nickl N, Singh V, Wills J, Behling C. EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement. Gastrointest Endosc. 2007 Aug;66(2):277-82. doi: 10.1016/j.gie.2007.01.017.

  PMID: 17643700 RESULT

• Sadeghi A, Mohamadnejad M, Islami F, Keshtkar A, Biglari M, Malekzadeh R, Eloubeidi MA. Diagnostic yield of EUS-guided FNA for malignant biliary stricture: a systematic review and meta-analysis. Gastrointest Endosc. 2016 Feb;83(2):290-8.e1. doi: 10.1016/j.gie.2015.09.024. Epub 2015 Sep 28.

  PMID: 26422979 RESULT

• 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.

  PMID: 23433878 RESULT

• Ogura T, Yamao K, Sawaki A, Mizuno N, Hara K, Hijioka S, Niwa Y, Tajika M, Kondo S, Shimizu Y, Bhatia V, Higuchi K, Hosoda W, Yatabe Y. Clinical impact of K-ras mutation analysis in EUS-guided FNA specimens from pancreatic masses. Gastrointest Endosc. 2012 Apr;75(4):769-74. doi: 10.1016/j.gie.2011.11.012. Epub 2012 Jan 28.

  PMID: 22284089 RESULT

• Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.

  PMID: 21420083 RESULT

• Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.

  PMID: 19117242 RESULT

• 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.

  PMID: 25733127 RESULT

• Villa NA, Berzosa M, Wallace MB, Raijman I. Endoscopic ultrasound-guided fine needle aspiration: The wet suction technique. Endosc Ultrasound. 2016 Jan-Feb;5(1):17-20. doi: 10.4103/2303-9027.175877.

  PMID: 26879162 RESULT

• Iwashita T, Nakai Y, Samarasena JB, Park DH, Zhang Z, Gu M, Lee JG, Chang KJ. High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions. Gastrointest Endosc. 2013 Jun;77(6):909-15. doi: 10.1016/j.gie.2013.01.001. Epub 2013 Feb 20.

  PMID: 23433596 RESULT

• Fabbri C, Luigiano C, Maimone A, Tarantino I, Baccarini P, Fornelli A, Liotta R, Polifemo A, Barresi L, Traina M, Virgilio C, Cennamo V. Endoscopic ultrasound-guided fine-needle biopsy of small solid pancreatic lesions using a 22-gauge needle with side fenestration. Surg Endosc. 2015 Jun;29(6):1586-90. doi: 10.1007/s00464-014-3846-6. Epub 2014 Oct 11.

  PMID: 25303907 RESULT

• 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.

  PMID: 26279842 RESULT

• Layfield LJ, Schmidt RL, Hirschowitz SL, Olson MT, Ali SZ, Dodd LL. Significance of the diagnostic categories "atypical" and "suspicious for malignancy" in the cytologic diagnosis of solid pancreatic masses. Diagn Cytopathol. 2014 Apr;42(4):292-6. doi: 10.1002/dc.23078. Epub 2014 Feb 28.

  PMID: 24578254 RESULT

• Nguyen TQ, Kalade A, Prasad S, Desmond P, Wright G, Hart D, Conron M, Chen RY. Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) of mediastinal lesions. ANZ J Surg. 2011 Jan;81(1-2):75-8. doi: 10.1111/j.1445-2197.2010.05266.x.

  PMID: 21299803 RESULT

• 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.

  PMID: 32413915 DERIVED

• Wang Y, Chen Q, Wang J, Wu X, Duan Y, Yin P, Guo Q, Hou W, Cheng B. Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial. Trials. 2018 Jan 17;19(1):45. doi: 10.1186/s13063-017-2380-y.

  PMID: 29343303 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Lymphatic Metastasis; Neoplasm Metastasis; Neoplasms, Unknown Primary; Infections; Inflammation; Sarcoidosis; Lymphadenopathy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Bin Cheng, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Yun Wang, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Cheng, Doctor

CONTACT

86-027-8366-3334; bcheng@tjh.tjmu.edu.cn

Yun Wang, Doctor

CONTACT

86-027-8366-3334; 820308045@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 21, 2016
• First Posted: June 3, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

CN (1)