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

Primary Purpose

Pancreatic Cancer, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Splanchnicectomy
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring pancreatic cancer, pain, splanchnicectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Surgical treatment

Conservative Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life and pain intensity measurement (measured with the QLQ- C30, FACIT and BPI questionnaires)

Full Information

First Posted
January 2, 2015
Last Updated
April 18, 2015
Sponsor
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT02424279
Brief Title
Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder
Official Title
Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pain
Keywords
pancreatic cancer, pain, splanchnicectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conservative Treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Splanchnicectomy
Primary Outcome Measure Information:
Title
Change from baseline pain intensity at 1 year (BPI questionnaires)
Time Frame
one year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Łukasz Dobosz, M.D.
Phone
0048583493010
Email
lukaszdobosz@gumed.edu.pl
Facility Information:
Facility Name
Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk.
City
Gdansk
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Łukasz Dobosz, M.D.
Phone
+48604904644
Email
lukaszdobosz@gumed.edu.pl

12. IPD Sharing Statement

Citations:
PubMed Identifier
27090728
Citation
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.
Results Reference
derived

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

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