Clinical trial · Interventional
Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles
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)
NCT03567863CI-TRIAL-00040942HISTOPANcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE® | Device | — | UNRESOLVED |
| 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- 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®
- interventionNames
- Device: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- 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®
- interventionNames
- Device: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
Primary outcomes (1)
- measure
- cumulative length of tissue core biopsies per needle pass
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (15)
- DERIVEDChen 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 36255027
- DERIVEDIshikawa 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 36216266
- DERIVEDMotz 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 34905795
- DERIVEDPark 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 33285582
- DERIVEDde 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 33264811