Език: EN EN
← Назад към резултатите
Активно (без набиране) NCT03729453

Intra-operative Pancreatoscopy in Patients With IPMN

Заболявания: Intraductal Papillary Mucinous Neoplasm

Спонсор: Boston Scientific Corporation

Налично на: БГ
Обобщение
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.
Описание
The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection
Кой може да участва
Inclusion Criteria: 1. Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment 2. Diameter of pancreatic main duct \>5mm on pre-operative MRI or CT 3. Written informed consent from patient to participate in the study, including compliance with study procedures Exclusion Criteria: 1. Contraindication for pancreatoscopy 2. Age: less than 18 years 3. Pregnant women, evaluated per local clinical standard
Интервенции
SpyGlass
DEVICE
Места на провеждане 8
Китай (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Индия (1)
Asian Institute of Gastroenterology
Hyderabad
Япония (1)
Kansai Medical University
Hirakata , Osaka
Нидерландия (1)
Academic Medical Center
Amsterdam
Швеция (1)
University Hospital of UMEA
Umeå
САЩ (3)
Johns Hopkins Hospital University
Baltimore , Maryland
University of Colorado Hospital
Denver , Colorado
Indiana University Health
Indianapolis , Indiana
Технически детайли
Статус
Активно (без набиране)
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.03.2019
Крайна дата
01.05.2027
Регистрационен номер
NCT03729453
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.