Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle

Pancreatic Neoplasm Clinical Trial

— COS  

Official title:

Prospective Evaluation of the Significance of the Pro-core® Needle in Differential Diagnosis of Tumorous and Inflammatory Processes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181140
• Other study ID #: PV 3835
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: October 2014

Study information

• Verified date: April 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (23)

Aithal GP, Anagnostopoulos GK, Tam W, Dean J, Zaitoun A, Kocjan G, Ragunath K, Pereira SP. EUS-guided tissue sampling: comparison of "dual sampling" (Trucut biopsy plus FNA) with "sequential sampling" (Trucut biopsy and then FNA as required). Endoscopy. 2007 Aug;39(8):725-30. Epub 2007 Jul 10. — View Citation

Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. Epub 2007 Dec 4. — View Citation

Bournet B, Migueres I, Delacroix M, Vigouroux D, Bornet JL, Escourrou J, Buscail L. Early morbidity of endoscopic ultrasound: 13 years' experience at a referral center. Endoscopy. 2006 Apr;38(4):349-54. — View Citation

Buscarini E, De Angelis C, Arcidiacono PG, Rocca R, Lupinacci G, Manta R, Carucci P, Repici A, Carrara S, Vallisa D, Buscarini L, Cosentino F, Pera A, Rizzetto M, Testoni PA, Zambelli A. Multicentre retrospective study on endoscopic ultrasound complications. Dig Liver Dis. 2006 Oct;38(10):762-7. Epub 2006 Jul 13. — View Citation

Iglesias-Garcia J, Dominguez-Munoz E, Lozano-Leon A, Abdulkader I, Larino-Noia J, Antunez J, Forteza J. Impact of endoscopic ultrasound-guided fine needle biopsy for diagnosis of pancreatic masses. World J Gastroenterol. 2007 Jan 14;13(2):289-93. — View Citation

Jenssen C, Faiss S, Nürnberg D. [Complications of endoscopic ultrasound and endoscopic ultrasound-guided interventions - results of a survey among German centers]. Z Gastroenterol. 2008 Oct;46(10):1177-84. doi: 10.1055/s-2008-1027334. Epub 2008 Oct 20. German. — 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

Mortensen MB, Fristrup C, Holm FS, Pless T, Durup J, Ainsworth AP, Nielsen HO, Hovendal C. Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography. Endoscopy. 2005 Feb;37(2):146-53. — View Citation

O'Toole D, Palazzo L, Arotçarena R, Dancour A, Aubert A, Hammel P, Amaris J, Ruszniewski P. Assessment of complications of EUS-guided fine-needle aspiration. Gastrointest Endosc. 2001 Apr;53(4):470-4. — View Citation

Parikh P, Shiloach M, Cohen ME, Bilimoria KY, Ko CY, Hall BL, Pitt HA. Pancreatectomy risk calculator: an ACS-NSQIP resource. HPB (Oxford). 2010 Sep;12(7):488-97. doi: 10.1111/j.1477-2574.2010.00216.x. — View Citation

Saftoiu A, Vilmann P, Guldhammer Skov B, Georgescu CV. Endoscopic ultrasound (EUS)-guided Trucut biopsy adds significant information to EUS-guided fine-needle aspiration in selected patients: a prospective study. Scand J Gastroenterol. 2007 Jan;42(1):117-25. — 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

Shah SM, Ribeiro A, Levi J, Jorda M, Rocha-Lima C, Sleeman D, Hamilton-Nelson K, Ganjei-Azar P, Barkin J. EUS-guided fine needle aspiration with and without trucut biopsy of pancreatic masses. JOP. 2008 Jul 10;9(4):422-30. — View Citation

Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28. — View Citation

Sterlacci W, Sioulas AD, Veits L, Gönüllü P, Schachschal G, Groth S, Anders M, Kontos CK, Topalidis T, Hinsch A, Vieth M, Rösch T, Denzer UW. 22-gauge core vs 22-gauge aspiration needle for endoscopic ultrasound-guided sampling of abdominal masses. World — View Citation

Storch I, Jorda M, Thurer R, Raez L, Rocha-Lima C, Vernon S, Ribeiro A. Advantage of EUS Trucut biopsy combined with fine-needle aspiration without immediate on-site cytopathologic examination. Gastrointest Endosc. 2006 Oct;64(4):505-11. Epub 2006 Jun 6. — View Citation

Storch I, Shah M, Thurer R, Donna E, Ribeiro A. Endoscopic ultrasound-guided fine-needle aspiration and Trucut biopsy in thoracic lesions: when tissue is the issue. Surg Endosc. 2008 Jan;22(1):86-90. Epub 2007 May 4. — View Citation

Südhoff T, Hollerbach S, Wilhelms I, Willert J, Reiser M, Topalidis T, Schmiegel W, Graeven U. [Clinical utility of EUS-FNA in upper gastrointestinal and mediastinal disease]. Dtsch Med Wochenschr. 2004 Oct 15;129(42):2227-32. German. — View Citation

Takahashi K, Yamao K, Okubo K, Sawaki A, Mizuno N, Ashida R, Koshikawa T, Ueyama Y, Kasugai K, Hase S, Kakumu S. Differential diagnosis of pancreatic cancer and focal pancreatitis by using EUS-guided FNA. Gastrointest Endosc. 2005 Jan;61(1):76-9. — View Citation

van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230. — View Citation

Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. — View Citation

Williams DB, Sahai AV, Aabakken L, Penman ID, van Velse A, Webb J, Wilson M, Hoffman BJ, Hawes RH. Endoscopic ultrasound guided fine needle aspiration biopsy: a large single centre experience. Gut. 1999 May;44(5):720-6. — View Citation

Wittmann J, Kocjan G, Sgouros SN, Deheragoda M, Pereira SP. Endoscopic ultrasound-guided tissue sampling by combined fine needle aspiration and trucut needle biopsy: a prospective study. Cytopathology. 2006 Feb;17(1):27-33. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 1 year
Secondary	EUS Pro Core FNA: Histology Samples	Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples	day 0 and day 14
Secondary	Complication Rates	Complication rates of EUS FNA	day 0 and day 14