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      Invasive treatment of pain associated with pancreatic cancer on different levels of WHO analgesic ladder

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          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/Design

          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.

          Discussion

          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.

          Trial registration

          ClinicalTrials.gov identifier: NCT02424279. Date of registration January 2, 2015.

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          Most cited references23

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          Neuronal plasticity: increasing the gain in pain.

          We describe those sensations that are unpleasant, intense, or distressing as painful. Pain is not homogeneous, however, and comprises three categories: physiological, inflammatory, and neuropathic pain. Multiple mechanisms contribute, each of which is subject to or an expression of neural plasticity-the capacity of neurons to change their function, chemical profile, or structure. Here, we develop a conceptual framework for the contribution of plasticity in primary sensory and dorsal horn neurons to the pathogenesis of pain, identifying distinct forms of plasticity, which we term activation, modulation, and modification, that by increasing gain, elicit pain hypersensitivity.
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            Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database.

            With the development of stage-specific treatments for pancreatic cancer, controversies exist concerning optimal clinical and pathologic staging. The most recent edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 6(th) Edition included some notable modifications. In anticipation of the 7(th) edition's publication, the authors evaluated the predictive ability of the current pancreatic adenocarcinoma staging system. By using the National Cancer Data Base (1992-1998), 121,713 patients were identified with pancreatic adenocarcinoma. All patients were restaged by AJCC 6(th) edition guidelines. Stage-specific overall survival was estimated by using the Kaplan-Meier method and compared with log-rank tests. Concordance indices were calculated to evaluate the discriminatory power of the staging system. Cox modeling was used to determine the relative impact of T, N, and M classification on survival. For all patients, there was 5-year survival discrimination by stage (P < .0001). For patients who underwent pancreatectomy, stage predicted 5-year survival: stage IA, 31.4%; IB, 27.2%; IIA, 15.7%; IIB, 7.7%; III, 6.8%; IV, 2.8% (P < .0001). The concordance index for the staging system was 0.631 for all patients, 0.613 for those who underwent pancreatectomy, and 0.596 for patients who did not undergo resection. In patients who underwent pancreatectomy, tumor size, nodal status, and distant metastases were independent predictors of survival (P < .0001). This is the first large-scale validation of the pancreatic cancer staging system. AJCC 6(th) edition staging guidelines are accurate with respect to survival. Further investigation is needed to integrate new molecular and biochemical markers into the staging scheme.
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              Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial.

              Pancreatic cancer is an aggressive tumor associated with high mortality. Optimal pain control may improve quality of life (QOL) for these patients. To test the hypothesis that neurolytic celiac plexus block (NCPB) vs opioids alone improves pain relief, QOL, and survival in patients with unresectable pancreatic cancer. Double-blind, randomized clinical trial conducted at Mayo Clinic, Rochester, Minn. Enrolled (October 1997 and January 2001) were 100 eligible patients with unresectable pancreatic cancer experiencing pain. Patients were followed up for at least 1 year or until death. Patients were randomly assigned to receive either NCPB or systemic analgesic therapy alone with a sham injection. All patients could receive additional opioids managed by a clinician blinded to the treatment assignment. Pain intensity (0-10 numerical rating scale), QOL, opioid consumption and related adverse effects, and survival time were assessed weekly by a blinded observer. Mean (SD) baseline pain was 4.4 (1.7) for NCPB vs 4.1 (1.8) for opioids alone. The first week after randomization, pain intensity and QOL scores were improved (pain intensity, P .10), and QOL (P =.46) were not significantly different between groups. In the first 6 weeks, fewer NCPB patients reported moderate or severe pain (pain intensity rating of > or =5/10) vs opioid-only patients (14% vs 40%, P =.005). At 1 year, 16% of NCPB patients and 6% of opioid-only patients were alive. However, survival did not differ significantly between groups (P =.26, proportional hazards regression). Although NCPB improves pain relief in patients with pancreatic cancer vs optimized systemic analgesic therapy alone, it does not affect QOL or survival.
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                Author and article information

                Contributors
                lukaszdobosz@gumed.edu.pl
                wujstef@gumed.edu.pl
                gosia.dob@gumed.edu.pl
                jwieczorek@gumed.edu.pl
                p.franczak@gumed.edu.pl
                dominiczka@gumed.edu.pl
                acmr111@gumed.edu.pl
                peter.kanyion@gmail.com
                Journal
                BMC Surg
                BMC Surg
                BMC Surgery
                BioMed Central (London )
                1471-2482
                18 April 2016
                18 April 2016
                2016
                : 16
                : 20
                Affiliations
                Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214 Gdansk, Poland
                Article
                136
                10.1186/s12893-016-0136-3
                4836189
                27090728
                97274a8c-7165-447a-a76d-143f76ae0355
                © Dobosz et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 7 September 2015
                : 8 April 2016
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Surgery
                splanchnicectomy,pancreatic cancer,pain
                Surgery
                splanchnicectomy, pancreatic cancer, pain

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