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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cumulative length of tissue core biopsies per needle pass
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
the order of use of the 2 needles is not communicated to the cytologist
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group A
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®
干预措施: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE® (Device)
Group B
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®
干预措施: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE® (Device)
结局指标
主要结局
cumulative length of tissue core biopsies per needle pass
时间窗: in the 7 days after procedure
cumulative length of tissue core biopsies per needle pass in mm
次要结局
- Presence of core biopsy specimen(in the 7 days after procedure)
- intra-observer evaluation of the anatomopathological criteria used(7 days)
- Negative Predictive Value(in the 7 days or 6 months)
- Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface(6 months)
- inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass)(7 days)
- Sensitivity(in the 7 days or 6 months)
- determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes(6 months)
- Specificity(in the 7 days or 6 months)
- Positive Predictive Value(in the 7 days or 6 months)
- Success rate of isolation of tumor cells(6 months)
- Morbidity(7 days)
- Feasibility(during procedure)
研究者
KARSENTI
MD, Principal Investigator
Société Française d'Endoscopie Digestive