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2017-11-17
2023-12
2023-12
40
NCT03069664
Helsinki University Central Hospital
Helsinki University Central Hospital
INTERVENTIONAL
Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-02-19 | N/A | 2022-08-15 |
2017-02-27 | N/A | 2022-08-16 |
2017-03-03 | N/A | 2022-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Covered Self-expandable Metal Stent ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent | PROCEDURE: ERCP
DEVICE: Covered Self-expandable Metal Stent
|
| NO_INTERVENTION: Control group control group |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in experienced quality of life | 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. | Enquiry at recruitment and every 4 weeks up to 24 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in experienced strength of pain in visual analogue scale | Patients evaluate the strength of pain in visual analogue scale | Enquiry at recruitment and every 4 weeks up to 24 weeks |
| Change in body weight | Patients report their body weight in kilograms at every point of survey. | Enquiry at recruitment and every 4 weeks up to 24 weeks |
| Change in need for pancreatic enzyme supplements | Patients report their need for pancreatic enzyme supplements at every point of survey | Enquiry at recruitment and every 4 weeks up to 24 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Leena Kylänpää, MD, PhD Phone Number: +358504272869 Email: leena.kylanpaa@hus.fi |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
