Hollenbach Marcus, Ali Einas Abou, Auriemma Francesco, Gulla Aiste, Heise Christian, Regnér Sara, Gaujoux Sébastien
Medical Department II-Gastroenterology, Hepatology, Infectious Diseases, Pulmonology, University of Leipzig Medical Center, Leipzig, Germany.
Department of Gastroenterology, Digestive Oncology and Endoscopy, Cochin Hospital, Paris Descartes University, Paris, France.
Front Med (Lausanne). 2020 May 6;7:152. doi: 10.3389/fmed.2020.00152. eCollection 2020.
Lesions of the Ampulla of Vater are a rare condition and represent <10% of peri-ampullary neoplasms. Nevertheless, ampullary adenomas have the potential for malignant transformation to ampullary carcinomas by an adenoma-to-carcinoma sequence. Thus, adequate patient selection and complete resection (R0) of non-invasive ampullary lesions either by endoscopic papillectomy (EP), surgical ampullectomy (SA), or pancreaticoduodenectomy (PD) is essential. Although PD was traditionally performed, recent studies reported considerable efficacy and fewer complications following EP and SA. Since consistent comparative data are lacking, the Endoscopic Papillectomy vs. Surgical Ampullectomy vs. Pancreaticoduodectomy (ESAP) study will provide evidence for a therapeutic standard and post procedure morbidity in ampullary lesions. International multicenter retrospective study. Adult patients (>18 years of age) who underwent SA or PD for ampullary neoplasm between 2004 and 2018 or EP between 2007 and 2018 will be evaluated. Main inclusion criteria are ampullary lesions strictly located to the ampulla. This includes adenoma, adenocarcinoma (T and T), neuroendocrine tumors, gastrointestinal stroma tumors and other rare conditions. Exclusion criteria are peri-ampullary lesions, e.g., from the duodenal wall or the head of the pancreas, and interventions for tumor stages higher than T. The main objective of this study is to analyze rates of complete resection (R0), recurrence and necessity for complementary interventions following EP, SA, and PD. Treatment-quality for each procedure will be defined by morbidity, mortality and complication rates and will be compared between EP, SA, and PD. Secondary objectives include outcome for patients with incomplete resection or initially understated tumors, lesions of the minor papilla, hereditary syndromes, neuroendocrine tumors, mesenchymal lesions, and other rare conditions. Additionally, we will analyze therapy by argon plasma coagulation and radiofrequency ablation. Furthermore, outcome in curative and palliative interventions can be distinguished. The ESAP study will provide evidence for therapeutic algorithms and data for the implementation of guidelines in the treatment of different types of ampullary tumors, including recurrent, or incomplete resected lesions.
Vater壶腹病变是一种罕见疾病，占壶腹周围肿瘤的比例不到10%。然而，壶腹腺瘤有可能通过腺瘤-癌序列恶性转化为壶腹癌。因此，通过内镜乳头切除术（EP）、手术壶腹切除术（SA）或胰十二指肠切除术（PD）对非侵袭性壶腹病变进行充分患者选择和完整切除（R0）至关重要。虽然传统上采用PD，但最近的研究报告称，EP和SA术后疗效显著且并发症较少。由于缺乏一致的对比数据，内镜乳头切除术与手术壶腹切除术与胰十二指肠切除术（ESAP）研究将为壶腹病变的治疗标准和术后发病率提供证据。国际多中心回顾性研究。将对2004年至2018年间因壶腹肿瘤接受SA或PD或2007年至2018年间接受EP的成年患者（>18岁）进行评估。主要纳入标准是严格位于壶腹的壶腹病变。这包括腺瘤、腺癌（T和T）、神经内分泌肿瘤、胃肠道间质瘤和其他罕见疾病。排除标准是壶腹周围病变，例如来自十二指肠壁或胰头的病变，以及针对高于T期肿瘤的干预措施。本研究的主要目的是分析EP、SA和PD术后的完整切除（R0）率、复发率和辅助干预的必要性。每种手术的治疗质量将由发病率、死亡率和并发症发生率来定义，并在EP、SA和PD之间进行比较。次要目标包括不完全切除或最初低估肿瘤患者的结局、小乳头病变、遗传性综合征、神经内分泌肿瘤、间质性病变和其他罕见疾病。此外，我们将分析氩等离子体凝固和射频消融治疗。此外，可区分根治性和姑息性干预的结局。ESAP研究将为不同类型壶腹肿瘤（包括复发性或不完全切除病变）的治疗算法和指南实施数据提供证据。
