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

NCT02424279 | Unknown

• 1 other identifier: MUG10
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Pain

Keywords

pancreatic cancer; pain; splanchnicectomy

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain intensity at 1 year (BPI questionnaires)

  one year

Secondary Outcomes (1)

• 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

Study Arms (2)

Surgical treatment

ACTIVE COMPARATOR

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

Conservative Treatment

NO INTERVENTION

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.

Interventions

Splanchnicectomy PROCEDURE

Surgical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with pancreatic cancer
• Age over 18 years
• Signed informed consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk.

Gdansk, Poland

RECRUITING

Related Publications (1)

• Dobosz L, Stefaniak T, Dobrzycka M, Wieczorek J, Franczak P, Ptaszynska D, Zasada K, Kanyion P. Invasive treatment of pain associated with pancreatic cancer on different levels of WHO analgesic ladder. BMC Surg. 2016 Apr 18;16:20. doi: 10.1186/s12893-016-0136-3.

  PMID: 27090728 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pain

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Łukasz Dobosz, M.D.

CONTACT

0048583493010; lukaszdobosz@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: April 23, 2015
• Study Start: September 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

PL (1)