title: Invasive treatment of pain associated with pancreatic cancer on different levels of WHO analgesic ladder.
abstract: BACKGROUND
  Pancreatic cancer is a malignant neoplasm with a high mortality rate, often associated with a delayed diagnosis, the early occurrence of metastasis and an overall, poor response to chemotherapy and radiotherapy. Pain management in pancreatic cancer consists mainly of pharmacological treatment according to the WHO analgesic ladder. Surgical treatment for pain relief, such as splanchnicectomy, is considered amongst the final step of pain management. It has been proven that splanchnicectomy is a safe procedure with a small percentage of complications, nevertheless, it is often used as a last resort, which can significantly decrease its effectiveness. Performance of thoracoscopic splanchnicectomy along the first step of the analgesic ladder may lead to long-lasting protection against the presence and severity of pain.
  
  
  METHODS
  A prospective, open label, 1:1 randomized, controlled trial, conducted at a single institution to determine the effectiveness of invasive treatment of pain via splanchnicectomy, in patients with advanced pancreatic cancer. The size of tested group will consist of 26 participants in each arm of the trial, to evaluate the level of pain relief and its impact on quality of life. To evaluate the influence on patients' rate of overall survival, a sample size of 105 patients is necessary, in each trial arm. Assessments will not only include the usage of analgesic pharmacotherapy throughout the course of disease, and overall patient survival, but also subjective pain perception at rest, in movement, and after meals (measured by NRS score questionnaire), the patient's quality of life (measured using the QLQ-C30 and FACIT questionnaires), and any pain-related suffering (measured with the PRISM projection test). The primary endpoint will consist of pain intensity. Questionnaires will be obtained upon the initial visit, the day of surgery, the day after surgery, as well as during long-term follow-up visits, held every two weeks thereafter.
  
  
  CONCLUSIONS
  Earlier implementation of invasive treatment, such as thoracoscopic splanchnicectomy, can provide a higher efficacy of pain management, prevent deterioration in the patient's quality of life, and lengthen their overall survival.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT02424279. Date of registration January 2, 2015.
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland. lukaszdobosz@gumed.edu.pl.
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Dobosz
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Stefaniak
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Dobrzycka
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
authors.forename: Jagoda
authors.initials: J
authors.lastname: Wieczorek
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
authors.forename: Paula
authors.initials: P
authors.lastname: Franczak
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
authors.forename: Dominika
authors.initials: D
authors.lastname: Ptaszyńska
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Zasada
authors.affiliation: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
authors.forename: Peter
authors.initials: P
authors.lastname: Kanyion
mesh_terms: D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010148:Intractable Pain / Q000209:etiology* / Q000628:therapy*; D010190:Pancreatic Neoplasms / Q000150:complications* / Q000175:diagnosis / Q000628:therapy; D011446:Prospective Studies; D011788:Quality of Life; D013153:Splanchnic Nerves / Q000601:surgery*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014944:World Health Organization
chemical_list: D000700:Analgesics
keywords: Pain; Pancreatic cancer; Splanchnicectomy