AzTrials
AzTrials

Pancreas CancerHISTOPANNCT03567863

Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles

A study testing 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE® and 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE® in people with Pancreas Cancer and Pancreatic Adenocarcinoma, run by Société Française d'Endoscopie Digestive at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Pancreas Cancer, Pancreatic Adenocarcinoma
What is being tested?
20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE® and 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
24 Jun 2018to 29 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • David Karsenti

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

Other trials in France

About this study

Official title: Multicentric Randomized Study Comparing the Histological and Molecular Material Quality Obtained by EUS-FNB of Pancreatic Mass With Two "Biopsic" Needles: the 20-gauge Procore® (Cook) and the 22-gauge Acquire® (Boston Scientific)

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

Read the detailed description

Type of study:

Multicenter randomized prospective study

Criteria for inclusion:

Patients admitted for ENDOSCOPIC ULTRASOUND FINE NEEDLE BIOPSY (EUS-FNB) of a pancreatic mass

Exclusion criteria:

Patients with an extra-pancreatic mass puncture Echendoscopic puncture contraindication or vascular interposition

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.

Evaluation criteria :

Main criterion:

  • Biopsy core length of target tissue obtained by needle pass

Secondary criteria

  • Presence of a core biopsy specimen
  • Sensitivity of EUS-FNB for the diagnosis of adenocarcinoma of the pancreas
  • False negative rate, Negative predictive value for the diagnosis of pancreatic adenocarcinoma
  • Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All core biopsy specimens
  • Success rate of isolation of tumor cells and determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
  • Immediate complications of puncture
  • Variation in the quality of the puncture following the trans-duodenal or trans-gastric access route
  • Technical failure rate of puncture
  • Optional: inter and intra-observer evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle passage)

Number of patients:

60 patients

Duration of the study:

1 year

Being tested
20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®, 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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)

Study groups in NCT03567863
Study groupRoleWhat they receive
Group AActive comparatorThe 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®
Receives: Device: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
Group BActive comparatorThe 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®
Receives: Device: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cumulative length of tissue core biopsies per needle pass

    cumulative length of tissue core biopsies per needle pass in mm

    Measured: in the 7 days after procedure

Secondary outcomes (12)

  1. Presence of core biopsy specimen

    Presence of core biopsy specimen

    Measured: in the 7 days after procedure

  2. Sensitivity

    EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas

    Measured: in the 7 days or 6 months

  3. Specificity

    EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas

    Measured: in the 7 days or 6 months

  4. Positive Predictive Value

    EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas

    Measured: in the 7 days or 6 months

  5. Negative Predictive Value

    EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas

    Measured: in the 7 days or 6 months

  6. Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface

    Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All Core biopsies

    Measured: 6 months

  7. Success rate of isolation of tumor cells

    Success rate of isolation of tumor cells

    Measured: 6 months

  8. Morbidity

    Puncture Morbidity (acute pancreatitis, haemorrhage)

    Measured: 7 days

  9. Feasibility

    Technical failure rate of puncture because of a impossibility to access to pancreatic mass with the needle (due to the needle stiffness)

    Measured: during procedure

  10. inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)

    inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)

    Measured: 7 days

  11. determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes

    determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes

    Measured: 6 months

  12. intra-observer evaluation of the anatomopathological criteria used

    intra-observer evaluation of the anatomopathological criteria used

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start24 Jun 2018
  3. Primary completion29 Sep 2019
  4. Study completion29 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03567863
Sponsor's protocol ID
2018-A00276-49
Acronym
HISTOPAN
Status last verified
Sep 2019
First submitted
29 May 2018
Last updated
1 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36255027

  • 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.

    PubMed 36216266

  • 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.

    PubMed 34905795

  • 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.

    PubMed 33285582

  • 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.

    PubMed 33264811

  • 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.

    PubMed 32906162

  • 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.

    PubMed 32869230

  • 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.

    PubMed 32693411

  • 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.

    PubMed 32679602

  • 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.

    PubMed 32668474

  • 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.

    PubMed 32650346

  • 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.

    PubMed 32557475

  • 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.

    PubMed 32515006

  • 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.

    PubMed 32498100

  • 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.

    PubMed 32408361

Questions about this trial

What is this clinical trial studying?

A study testing 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE® and 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE® in people with Pancreas Cancer and Pancreatic Adenocarcinoma, run by Société Française d'Endoscopie Digestive at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cumulative length of tissue core biopsies per needle pass (time frame: in the 7 days after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03567863, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in