Open label randomized, multicentre, controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela0 个研究点目标入组 40 人开始时间: 2023年7月31日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
入组人数: 40

暂无简介。

•Patients older than 18 years, any gender, fulfilling all the following criteria will be considered for enrolment into the study, Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer., Tumour located in the head of the pancreas, Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS), Significant weight loss (=5% of the usual body weight) at screening, Life expectancy of at least six months at screening, Signed informed consent to the study

•Hypersensitivity to pancreatin of porcine origin or to any of the excipients, Inability to comply with the study visits and study protocol, whatever the reason, Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned, Patients already on PERT, Prior history of upper gastrointestinal or pancreatic surgery, Short life expectancy (shorter than 6 months), Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy), Patients in whom a pancreatic stent has been placed, Unsolved gastric outlet obstruction, Unwillingness to participate in the study

发起方