Dobosz Łukasz, Stefaniak Tomasz, Dobrzycka Małgorzata, Wieczorek Jagoda, Franczak Paula, Ptaszyńska Dominika, Zasada Katarzyna, Kanyion Peter
Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, ul. Smoluchowskiego 17, 80-214, Gdansk, Poland.
BMC Surg. 2016 Apr 18;16:20. doi: 10.1186/s12893-016-0136-3.
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.
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.
ClinicalTrials.gov identifier: NCT02424279. Date of registration January 2, 2015.
胰腺癌是一种死亡率很高的恶性肿瘤，常与诊断延迟、早期转移以及对化疗和放疗的总体不良反应相关。胰腺癌的疼痛管理主要包括根据世界卫生组织镇痛阶梯进行药物治疗。诸如内脏神经切除术等用于缓解疼痛的手术治疗被视为疼痛管理的最后手段之一。事实证明，内脏神经切除术是一种安全的手术，并发症发生率较低，然而，它常被用作最后的手段，这可能会显著降低其有效性。在镇痛阶梯的第一步就进行胸腔镜内脏神经切除术可能会长期预防疼痛的出现和减轻疼痛的严重程度。
方法/设计：一项前瞻性、开放标签、1:1随机对照试验，在单一机构进行，以确定内脏神经切除术对晚期胰腺癌患者进行疼痛侵入性治疗的有效性。试验的每个组将由26名参与者组成，以评估疼痛缓解程度及其对生活质量的影响。为了评估对患者总生存率的影响，每个试验组需要105名患者的样本量。评估不仅将包括疾病全过程中镇痛药物治疗的使用情况和患者的总生存率，还将包括静息、活动和餐后的主观疼痛感受（通过数字评分量表问卷测量）、患者的生活质量（使用QLQ-C30和FACIT问卷测量）以及任何与疼痛相关的痛苦（通过PRISM投射测试测量）。主要终点将是疼痛强度。问卷将在初次就诊、手术当天、手术后一天以及此后每两周进行的长期随访就诊时获取。
早期实施侵入性治疗，如胸腔镜内脏神经切除术，可以提供更高的疼痛管理效果，防止患者生活质量恶化，并延长其总生存期。试验注册：ClinicalTrials.gov标识符：NCT02424279。注册日期：2015年1月2日。
