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

Not Applicable

• Conditions: Pancreatic Cancer; Pain
• Interventions: Procedure: Splanchnicectomy

• Registration Number: NCT02424279
• Lead Sponsor: Medical University of Gdansk

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-02
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-18
• Last Update Submitted: 2015-04-18
• Study First Posted: 2015-04-23
• Last Update Posted: 2015-04-23
• Primary Completion: 2017-05
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment	Splanchnicectomy	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline pain intensity at 1 year (BPI questionnaires)	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk.; 🇵🇱 Gdansk, Poland