NCT03567863

Brief Summary

Multicenter randomized prospective study Criteria for inclusion: Patients admitted for EUS-FNB of a pancreatic mass Goals of the study: To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific. Main criterion: \- Biopsy core length of target tissue obtained by needle pass Number of patients: 60 patients Duration of the study: 1 year

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

June 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

May 29, 2018

Last Update Submit

September 29, 2019

Conditions

Pancreas CancerPancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • cumulative length of tissue core biopsies per needle pass

    cumulative length of tissue core biopsies per needle pass in mm

    in the 7 days after procedure

Secondary Outcomes (12)

  • Presence of core biopsy specimen

    in the 7 days after procedure

  • Sensitivity

    in the 7 days or 6 months

  • Specificity

    in the 7 days or 6 months

  • Positive Predictive Value

    in the 7 days or 6 months

  • Negative Predictive Value

    in the 7 days or 6 months

  • +7 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®

Device: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®

Group B

ACTIVE COMPARATOR

The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK) 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®

Device: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®

Interventions

20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®DEVICE

The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)

Group A
22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®DEVICE

The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)

Group B

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient admitted to one of the investigative centers for endoscopic pancreatic puncture during the period from April 1, 2018 to April 1, 2019
  • Patient whose age is greater than or equal to 18 years and less than 90 years
  • Patient ASA 1, ASA 2, ASA 3 (ASA: American Society of Anaesthesiologists Classification)
  • Lack of participation in another clinical study
  • Signed informed consent

You may not qualify if:

  • Patients punctured with an extra-pancreatic mass
  • Patient under the age of 18 or over 90
  • Patient ASA 4, ASA 5
  • Pregnant woman
  • Patient with coagulation abnormalities preventing puncture: TP \<50%, Platelets \<50000 / mm3, effective anticoagulation in progress, clopidogrel in progress
  • Vascular or ductal or surgical fixation (Billroth II, Roux in Y) preventing endoscopic access to the lesion to be punctured
  • Patient unable to personally consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Karsenti

Charenton-le-Pont, Île-de-France Region, 94220, France

Location

Related Publications (15)

  • Chen TY, Cao JW, Jin C, Ji Y, Zhong L, Wang LM, Cui N, Di Y, Bao Y, Zhong N, Zhang YQ, Zhou PH. Comparison of specimen quality among the standard suction, slow-pull, and wet suction techniques for EUS-FNA: A multicenter, prospective, randomized controlled trial. Endosc Ultrasound. 2022 Sep-Oct;11(5):393-400. doi: 10.4103/EUS-D-21-00163.

    PMID: 36255027DERIVED

  • Ishikawa H, Yamada M, Sato Y, Tanaka S, Akiko C, Tajika M, Doyama H, Takayama T, Ohda Y, Horimatsu T, Sano Y, Tanakaya K, Ikematsu H, Saida Y, Ishida H, Takeuchi Y, Kashida H, Kiriyama S, Hori S, Lee K, Tashiro J, Kobayashi N, Nakajima T, Suzuki S, Mutoh M; J-FAPP Study III Group. Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study. Endoscopy. 2023 Apr;55(4):344-352. doi: 10.1055/a-1945-9120. Epub 2022 Oct 10.

    PMID: 36216266DERIVED

  • Motz VL, Lester C, Moyer MT, Maranki JL, Levenick JM. Hybrid argon plasma coagulation-assisted endoscopic mucosal resection for large sessile colon polyps to reduce local recurrence: a prospective pilot study. Endoscopy. 2022 Jun;54(6):580-584. doi: 10.1055/a-1677-3954. Epub 2021 Dec 14.

    PMID: 34905795DERIVED

  • Park E, Barge W, Kramer J, Alajati B, Jakate S, Cimbaluk D, Giusto D, Ritz E, Bishehsari F, Lee S, Singh S, Losurdo J, Brown M, DeMeo M, Abraham R, Ma K, Melson J. Interobserver reliability of methods to determine complete resection of adenomas in colonoscopy. Endoscopy. 2021 Dec;53(12):1250-1255. doi: 10.1055/a-1331-4446. Epub 2021 Feb 18.

    PMID: 33285582DERIVED

  • de Benito Sanz M, Hernandez L, Garcia Martinez MI, Diez-Redondo P, Joao Matias D, Gonzalez-Santiago JM, Ibanez M, Nunez Rodriguez MH, Cimavilla M, Tafur C, Mata L, Guardiola-Arevalo A, Feito J, Garcia-Alonso FJ; POLIPEC HOT-COLD Study Group. Efficacy and safety of cold versus hot snare polypectomy for small (5-9 mm) colorectal polyps: a multicenter randomized controlled trial. Endoscopy. 2022 Jan;54(1):35-44. doi: 10.1055/a-1327-8357. Epub 2021 Feb 18.

    PMID: 33264811DERIVED

  • Nakamura M, Yano T, Esaki M, Oka S, Mitsui K, Hirai F, Kawasaki K, Fujishiro M, Torisu T, Tanaka S, Iwakiri K, Kishi M, Matsumoto T, Yamamoto H. Novel ultrathin double-balloon endoscopy for the diagnosis of small-bowel diseases: a multicenter nonrandomized study. Endoscopy. 2021 Aug;53(8):802-814. doi: 10.1055/a-1243-0226. Epub 2020 Sep 9.

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  • Meng W, Yue P, Leung JW, Wang H, Wang X, Wang F, Zhu K, Zhang L, Zhu X, Wang Z, Zhang H, Zhou W, Li X. Impact of mechanical simulator practice on clinical ERCP performance by novice surgical trainees: a randomized controlled trial. Endoscopy. 2020 Nov;52(11):1004-1013. doi: 10.1055/a-1217-6727. Epub 2020 Aug 31.

    PMID: 32869230DERIVED

  • Kovacevic B, Klausen P, Rift CV, Toxvaerd A, Grossjohann H, Karstensen JG, Brink L, Hassan H, Kalaitzakis E, Storkholm J, Hansen CP, Hasselby JP, Vilmann P. Clinical impact of endoscopic ultrasound-guided through-the-needle microbiopsy in patients with pancreatic cysts. Endoscopy. 2021 Jan;53(1):44-52. doi: 10.1055/a-1214-6043. Epub 2020 Jul 21.

    PMID: 32693411DERIVED

  • Subramaniam S, Kandiah K, Chedgy F, Fogg C, Thayalasekaran S, Alkandari A, Baker-Moffatt M, Dash J, Lyons-Amos M, Longcroft-Wheaton G, Brown J, Bhandari P. A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2021 Jan;53(1):27-35. doi: 10.1055/a-1198-0558. Epub 2020 Jul 17.

    PMID: 32679602DERIVED

  • Zhang Y, Liu L, Wang Q, Guo L, Ye L, Zeng H, Zeng X, Yuan X, Li Y, Zhang Y, Zhou E, Hu B. Endoscopic submucosal dissection with additional radiotherapy in the treatment of T1a esophageal squamous cell cancer: randomized controlled Trial. Endoscopy. 2020 Dec;52(12):1066-1074. doi: 10.1055/a-1198-5232. Epub 2020 Jul 15.

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  • Seicean A, Samarghitan A, Bolboaca SD, Pojoga C, Rusu I, Rusu D, Sparchez Z, Gheorghiu M, Al Hajjar N, Seicean R. Contrast-enhanced harmonic versus standard endoscopic ultrasound-guided fine-needle aspiration in solid pancreatic lesions: a single-center prospective randomized trial. Endoscopy. 2020 Dec;52(12):1084-1090. doi: 10.1055/a-1193-4954. Epub 2020 Jul 10.

    PMID: 32650346DERIVED

  • Alvarez-Gonzalez MA, Pantaleon Sanchez MA, Bernad Cabredo B, Garcia-Rodriguez A, Frago Larramona S, Nogales O, Diez Redondo P, Puig Del Castillo I, Romero Mascarell C, Caballero N, Romero Sanchez-Miguel I, Perez Berbegal R, Hernandez Negrin D, Bujedo Sadornill G, Perez Oltra A, Casals Urquiza G, Amoros Martinez J, Seoane Urgorri A, Ibanez Zafon IA, Gimeno-Garcia AZ. Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial. Endoscopy. 2020 Nov;52(11):1026-1035. doi: 10.1055/a-1178-9844. Epub 2020 Jun 17.

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  • Struyvenberg M, Kahn A, Fleischer D, Swager AF, Bouma B, Ganguly EK, Konda V, Lightdale CJ, Pleskow D, Sethi A, Smith M, Trindade AJ, Wallace MB, Wang K, Wolfsen HC, Tearney GJ, Curvers WL, Leggett CL, Bergman JJ. Expert assessment on volumetric laser endomicroscopy full scans in Barrett's esophagus patients with or without high grade dysplasia or early cancer. Endoscopy. 2021 Mar;53(3):218-225. doi: 10.1055/a-1194-0397. Epub 2020 Jun 17.

    PMID: 32515006DERIVED

  • Zwager LW, Bastiaansen BAJ, Bronzwaer MES, van der Spek BW, Heine GDN, Haasnoot KJC, van der Sluis H, Perk LE, Boonstra JJ, Rietdijk ST, Wolters HJ, Weusten BLAM, Gilissen LPL, Ten Hove WR, Nagengast WB, Bekkering FC, Schwartz MP, Terhaar Sive Droste JS, Vlug MS, Houben MHMG, Rando Munoz FJ, Seerden TCJ, Beaumont H, de Ridder R, Dekker E, Fockens P; Dutch eFTR Group. Endoscopic full-thickness resection (eFTR) of colorectal lesions: results from the Dutch colorectal eFTR registry. Endoscopy. 2020 Nov;52(11):1014-1023. doi: 10.1055/a-1176-1107. Epub 2020 Jun 4.

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  • Karsenti D, Palazzo L, Perrot B, Zago J, Lemaistre AI, Cros J, Napoleon B. 22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy. Endoscopy. 2020 Sep;52(9):747-753. doi: 10.1055/a-1160-5485. Epub 2020 May 14.

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MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • David Karsenti, MD

    Société Française d'Endoscopie Digestive

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
the order of use of the 2 needles is not communicated to the cytologist
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 26, 2018

Study Start

June 24, 2018

Primary Completion

September 29, 2019

Study Completion

September 29, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)