Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Conditions
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Pancreatic Cancer, Pancreatic Duct Stricture

Intervention / Treatment
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* Procedure: ERCP
* Device: Covered Self-expandable Metal Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Covered Self-expandable Metal Stent<br>ERCP (endoscopic retrograde cholangiopancreatography) and placement of a pancreatic duct stent | Procedure: ERCP<br>* endoscopic retrograde cholangiopancreatography<br>Device: Covered Self-expandable Metal Stent<br>* Pancreatic duct stent<br>|
| No Intervention: Control group<br>control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Pancreatic Duct Stricture, Endoscopic treatment