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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02424279
• Other study ID #: MUG10
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2015
• Last updated: April 18, 2015
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: April 2015
• Source: Medical University of Gdansk
• Contact: Lukasz Dobosz, M.D.
• Phone: 0048583493010
• Email: lukaszdobosz[@]gumed.edu.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Splanchnicectomy

Locations

Country	Name	City	State
Poland	Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk.	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline pain intensity at 1 year (BPI questionnaires)		one year	No
Secondary	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	No