Pancreatic CancerNCT02424279
Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder
A study testing Splanchnicectomy in people with Pancreatic Cancer and Pain, run by Medical University of Gdansk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pain
- What is being tested?
- Splanchnicectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with pancreatic cancer
- Age over 18 years
- Signed informed consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk.
Gdansk
Łukasz Dobosz, M.D., +48604904644, lukaszdobosz@gumed.edu.pl
About this study
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
- Being tested
- Splanchnicectomy
- Keywords
- pancreatic cancer, pain, splanchnicectomy
- Medical subject headings
- Pancreatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplanchnicectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain intensity at 1 year (BPI questionnaires)
Measured: one year
Secondary outcomes (1)
Quality of life and pain intensity measurement (measured with the QLQ- C30, FACIT and BPI questionnaires)
Measured: From date of randomization until the date of death from any cause,assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Dobosz, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424279
- Sponsor's protocol ID
- MUG10
- Status last verified
- Apr 2015
- First submitted
- 2 Jan 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27090728
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder
- ClinicalTrials.gov ID
- NCT02424279
- Acronym / sponsor ID
- MUG10
- Conditions
- Pancreatic Cancer, Pain
- Keywords
- pancreatic cancer, pain, splanchnicectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Active comparator | Procedure: SplanchnicectomyPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with pancreatic cancer
- Age over 18 years
- Signed informed consent to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splanchnicectomy | Procedure or surgery | Surgical treatment |
Primary outcome
Change from baseline pain intensity at 1 year (BPI questionnaires)
Time frame: one year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Derived from this study: PubMed 27090728Dobosz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splanchnicectomy in people with Pancreatic Cancer and Pain, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Łukasz Dobosz, M.D. (0048583493010, lukaszdobosz@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain intensity at 1 year (BPI questionnaires) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.