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

April 18, 2015 updated by: Łukasz Dobosz, Medical University of Gdansk

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland
        • Recruiting
        • Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgical treatment
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
No Intervention: Conservative Treatment
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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

January 2, 2015

First Submitted That Met QC Criteria

April 18, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 18, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUG10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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