Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder

Study Overview
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Brief Summary
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Pancreatic cancer is a difficult to treat disease, mainly due to the fact that diagnosis is made usually in the late stage of this condition. One of the treatment methods of pain accompanying this neoplasm is thoracoscopic splanchnicectomy. It has been shown that it is a safe procedure with a small percentage of complications, nevertheless it is often use as the last stage in pain management what significantly decreases its effectiveness. The aim of this study is to determinate the effect of invasive pain treatment (splanchnicectomy) in patients with advanced pancreatic cancer on subjective pain perception at rest, in movement and after meals (measured with the BPI, QLQ- C30 and FACIT questionnaires), and suffering (measured with PRISM projection test), the use of painkillers during the disease and patients' overall survival. Moreover the investigators want to check if early performance of splanchnicectomy (on lower steps of analgesic ladder WHO) is combined with better therapeutic effect of this treatment.

Official Title
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Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder

Conditions
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Pancreatic Cancer, Pain

Intervention / Treatment
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* Procedure: Splanchnicectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with pancreatic cancer Age over 18 years Signed informed consent to participate in the study Exclusion Criteria: Age under 18 years Intellectual inability to fill the questionnaires Co-occurrence of a disease in which significant chronic pain exists, which was recognized before the onset of pancreatic cancer

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: Surgical treatment<br>Patients from the first group will undergo thoracoscopic splanchnicectomy. The surgery will be performed in general anaesthesia, with tracheal intubation in prone position. The greater splanchnic nerve will be identified at its origin in sympathetic trunk, dissected together with all collaterals all the way down to the diaphragm and excised. Additional splanchnic nerves (smaller, minimus) will be incised or excised if connected to the greater splanchnic nerve. Single sutures will be applied to the skin. Then the procedure will be repeated on the contralateral side. | Procedure: Splanchnicectomy<br> <br> |
| No Intervention: Conservative Treatment<br>Patients from the second group will be offered best available conservative pain treatment. The list of medication on stage 1 will include: paracetamol, ibuprofen, diclofenac. On stage 2: stage 1 + codeine and tramadol. On stage 3: stage 2 + morphine, fentanyl, oxycodone, pethidine. Oral and transcutaneous routes will be preferred to intravenous, intramuscular and subcutaneous. A need for elevation to the next step of analgesic ladder will be considered when the pain will be stronger than 6 points in Numeric Rating Scale (NRS) and will be present for more than 5 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pain intensity at 1 year (BPI questionnaires) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and pain intensity measurement (measured with the QLQ- C30, FACIT and BPI questionnaires) |  | From date of randomization until the date of death from any cause,assessed up to 100 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, splanchnicectomy, pancreatic cancer