Digestive Health Institute, Orlando Health, 1720 Orange Ave., Suite 200, Orlando, FL, 32806, USA.
Keck Medicine of USC, Los Angeles, USA.
Trials. 2024 Oct 14;25(1):676. doi: 10.1186/s13063-024-08478-y.
Celiac plexus block has been commonly utilized for the treatment of chronic pancreatitis-associated abdominal pain. Prospective studies suggest efficacy in 30 to 50% of patients, although no randomized sham-controlled trials have been performed. The objective of this study is to assess the effect of endoscopic ultrasound (EUS)-guided celiac plexus block on abdominal pain in patients with documented chronic pancreatitis.
This is a two-arm randomized sham-controlled trial with blinded evaluators. The study will be conducted at multiple academic sites in the United States who are members of the United States Pancreatic Disease Study Group (USPG). Patients referred for EUS to exclude chronic pancreatitis as a cause of abdominal pain as well as those with established painful chronic pancreatitis undergoing EUS for another indication will be eligible. At the time of EUS with confirmation of chronic pancreatitis by standard EUS diagnostic criteria, patients will be randomized to either celiac plexus block or sham whereby an anesthetic and steroid combination will be injected into the celiac plexus or saline will be injected into the gastric lumen with the same type of needle as used for celiac plexus block, respectively. The main outcome measure will be a 50% reduction in abdominal pain using the Brief Pain Inventory Short Form (BPI-SF) at 1 month post-intervention. A number of secondary outcomes will be measured including visual analog scale (VAS), Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) pain scores, and quality of life using a pancreas-specific validated measure (PANQOLI).
In this study, the effect of celiac plexus block on abdominal pain in patients with chronic pancreatitis will be compared to a sham intervention. This randomized trial will offer a definitive assessment of the role of celiac plexus block for the treatment of abdominal pain in this setting. TRIAL REGISTRATION {2}: ClinicalTrials.gov NCT06178315. Registered on December 21, 2023.
腹腔神经丛阻滞已广泛应用于治疗慢性胰腺炎相关腹痛。前瞻性研究表明其在 30%至 50%的患者中有效，尽管尚未进行随机假对照试验。本研究旨在评估内镜超声（EUS）引导下腹腔神经丛阻滞对有明确诊断的慢性胰腺炎患者腹痛的影响。
这是一项在多个美国学术中心进行的、采用双臂随机假对照设计且评估人员设盲的研究。这些学术中心均为美国胰腺疾病研究组（USPG）的成员。有 EUS 检查适应证的患者将被纳入研究，这些患者包括因腹痛而行 EUS 检查以排除慢性胰腺炎，或因其他适应证而行 EUS 检查且已确诊为慢性胰腺炎的患者。在进行 EUS 检查时，将通过标准的 EUS 诊断标准确认慢性胰腺炎，并将患者随机分为腹腔神经丛阻滞组或假手术组，分别将麻醉和皮质类固醇混合物注入腹腔神经丛或用相同类型的针将生理盐水注入胃腔。主要观察指标是干预后 1 个月时采用简明疼痛量表（BPI-SF）评估腹痛缓解 50%。还将测量包括视觉模拟评分（VAS）、综合疼痛评估工具简明量表（COMPAT-SF）疼痛评分以及采用特定于胰腺的有效量表（PANQOLI）评估的生活质量在内的多个次要结局。
在本研究中，将比较腹腔神经丛阻滞与假手术干预对慢性胰腺炎患者腹痛的影响。这项随机试验将对腹腔神经丛阻滞在该治疗环境下治疗腹痛的作用进行明确评估。
[2]ClinicalTrials.gov NCT06178315。于 2023 年 12 月 21 日注册。
