Peking Union Medical College, Beijing, People's Republic of China.
Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, People's Republic of China.
BMJ Open. 2024 Apr 2;14(4):e078516. doi: 10.1136/bmjopen-2023-078516.
The surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct.
This is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the Χ test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests.
The study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal.
NCT05523778.
毗邻主胰管的胰岛素瘤的手术干预方法仍存在争议。几项指南推荐标准胰腺切除术；然而，尽管术后胰瘘（POPF）发生率较高，但由于发生外分泌/内分泌不足的风险较低，仍吸引着外科医生选择肿瘤切除术（EN）。最近，术前放置胰管支架在 EN 中的疗效和安全性已得到证实。因此，正在进行一项多中心、开放性、优效性临床试验，以评估支架置入在改善毗邻主胰管的胰岛素瘤 EN 治疗结局方面的疗效和安全性。
这是在中国多家三级中心进行的一项前瞻性、随机、开放性、优效性临床试验。主要入选标准是存在位于胰腺头部和颈部的胰岛素瘤，且与主胰管的距离（≤2mm）。将采用区组随机化方法将患者分配到支架 EN 组和直接 EN 组。支架 EN 组的患者将在 EN 手术前 24 小时内由内镜医生进行支架置入，而其他患者将直接进行 EN 手术。主要结局是评估支架置入在降低国际胰腺外科研究组标准测量的 POPF 发生率方面的优越性。两种干预措施均在住院环境中进行，并进行常规随访。主要结局（POPF 发生率）将采用 Χ 检验进行优效性检验。两组间次要结局的差异将采用适当的检验进行分析。
该研究已获得北京协和医学院医院伦理委员会（K23C0195）、瑞金医院伦理委员会（2023-314）、北京大学第一医院伦理委员会（2024033-001）、首都医科大学宣武医院伦理委员会（2023223-002）、西安交通大学第一附属医院伦理委员会（XJTU1AF2023LSK-473）、华中科技大学同济医学院附属同济医院伦理委员会（TJ-IRB202402059）、华中科技大学同济医学院附属协和医院伦理委员会（2023-0929）和上海癌症中心伦理委员会（2309282-16）的批准。研究结果将发表在国际同行评议期刊上。
NCT05523778。
