PREVENTION OF POSTOPERATIVE PANCREATIC FISTULA BY SOMATOSTATIN (PREFIPS) - PREFIPS

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 654 人开始时间: 2016年10月20日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•o Men or women aged 18 years or greater
•o Signed informed consent
•o Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy
•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 654
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•o Patient with neoadjuvant chemo and/or radiation therapy
•o Pregnancy
•o Breastfeeding
•o Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
•o Patients with abnormal coagulation (INR>1.5) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated thromboplastin time)
•o Patients with WBC <3 X 109/L; PLT <100 X 109/L
•o Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
•o Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion
•o Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
•o Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
•o Patients treated by ciclosporine
•o Patient without health insurance or social security
•o Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study

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