Pancreatic Cancer, Pancreatic Duct Stricture
Conditions
Keywords
Pancreatic Cancer, Pancreatic Duct Stricture, Endoscopic treatment
Brief summary
Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. The study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.
Detailed 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 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.
Interventions
PROCEDUREERCP
endoscopic retrograde cholangiopancreatography
DEVICECovered Self-expandable Metal Stent
Pancreatic duct stent
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients have inoperable pancreatic cancer. * Pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. * Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 6 (Visual Analogue Scale) at the time of recruitment.
Exclusion criteria
* Patients are not fit enough to undergo ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in experienced quality of life | Enquiry at recruitment and every 4 weeks up to 24 weeks | The patients will be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in experienced strength of pain in visual analogue scale | Enquiry at recruitment and every 4 weeks up to 24 weeks | Patients evaluate the strength of pain in visual analogue scale |
| Change in body weight | Enquiry at recruitment and every 4 weeks up to 24 weeks | Patients report their body weight in kilograms at every point of survey. |
| Change in need for pancreatic enzyme supplements | Enquiry at recruitment and every 4 weeks up to 24 weeks | Patients report their need for pancreatic enzyme supplements at every point of survey |
Countries
Finland
Contacts
Primary ContactLeena Kylänpää, MD, PhD
Outcome results
None listed