Multicenter, randomized and double-blinded clinical trial on the use of antibiotic prophylaxis for EUS guided FNA of pancreatic cystic lesions

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau0 个研究点目标入组 218 人开始时间: 2014年6月6日最近更新: 2019年1月7日

适应症

试验速览

暂无简介。

•- Patients with a pancreatic cyst requiring EUS-FNA to complete evaluation.
•- Participant is willing and able to give informed consent for participation in the study.
•- Age 18 years or older.
•- Ability to understand study procedures and to comply with them for the entire length of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 218
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Patients with other co-morbidities requiring antibiotic prophylaxis for endoscopic invasive procedures (such as those with cardiac valve prosthesis).
•- Cystic lesion of the intestinal wall (foregut or duplication cyst).
•- Use of antibiotic treatment for any other indication during the 5 days prior to the procedure.
•- Pregnant woman.
•- Known allergy/sensitivity to ciprofloxacin.
•- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

发起方

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau