Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pancreatic Cancer
- Pancreatic Duct Stricture
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
In this prospective study all patients have inoperable pancreatic cancer. In these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. Patients also suffer from chronic abdominal pain caused by pancreat...
In this prospective study all patients have inoperable pancreatic cancer. In these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. Patients also suffer from chronic abdominal pain caused by pancreatic cancer. The strength of the pain the patients are experiencing is evaluated with visual analogue scale (VAS). Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 4 at the time of recruitment. In this pilot study a total of 40 patients are recruited. Patients are divided into to two 20 patient groups. First group will receive a pancreatic duct stent followed by pain medication if needed and the control group will go with conventional pain relief methods only. All patients are asked to evaluate the strength of experienced pain with visual analogue scale at the time of recruitment, and then every 4 weeks up to 24 weeks. The patients will also be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 quality of life questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. The patients are also asked to report their body weight, and the amount of pancreatic enzyme supplements needed at every point of survey.
Tracking Information
- NCT #
- NCT03069664
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Leena Kylänpää, MD, PhD Helsinki UniversityHospital Study Chair: Sini M Vehviläinen, MD Helsinki University Central Hospital Study Chair: Hanna Seppänen, MD, PhD Helsinki University Central Hospital Study Chair: Marianne Udd, MD, PhD Helsinki University Central Hospital Study Chair: Outi Lindström, MD, PhD Helsinki University Central Hospital