Objective Ampullary neoplastic lesions can be resected by endoscopic papillectomy (EP) or transduodenal surgical ampullectomy (TSA) while pancreaticoduodenectomy is reserved for more advanced lesions. We present the largest retrospective comparative study analysing EP and TSA. Design Of all patients in the database, lesions with prior interventions, benign histology advanced malignancy (T2 and more), patients with hereditary syndromes and those undergoing pancreatoduodenectomy were excluded. All remaining cases as well as a subgroup of them, after propensity-score matching (nearest-neighbour-method) based on age, gender, anthropometrics, comorbidities, size and histological subtype, were analysed. The median follow-up was 21 months (IQR 10–47) after the primary intervention. Primary outcomes were rates of complete resection (R0) and complications. Groups were compared by Fisher’s exact or χ2 test, Mann-Whitney-U-test and log-rank test for survival. Results Of 1673 patients in the database, 1422 underwent EP and 251 TSA. Of them, 23.2% were excluded for missing or inconclusive data and 19.8% of patients for prior interventions or hereditary syndromes. Final histology showed in 24.2% of EP and 14.8% of TSA patients a histology other than adenoma or adenocarcinoma while advanced cancers were recorded in 10.9% of EP and 36.6% of TSA patients. Finally, 569 EP and 63 TSA were included in the overall analysis, with a higher rate of more advanced cases and higher R0 resection rates in the TSA groups (90.5% vs 73.1%; p<0.01), with additional ablation in the EP group in 14.4%. Severe adverse event rates were 3.2% (TSA) vs 1.9% (EP). Recurrence after histological R0 resection was 16% (EP) vs 3.2% (TSA; p=0.01), and additional therapy for R1 resection was applied in 67% of the 159 cases. Propensity-score-based matching identified 62 pairs of EP/TSA patients with comparable baseline patient and lesion characteristics. The initial R0-rate was 72.6% (EP) compared with 90.3% (TSA, p=0.02) with recurrences found in 8% (EP) vs 3.2% (TSA; p=0.07); reinterventions were more frequent in the EP group. Overall survival was comparable. Conclusions The rate of patients with poor indications due to non-neoplastic disease or advanced cancer is still high for both EP and TSA; multiple retreatments were necessary for EP. Although EP can be considered an appropriate primary therapy for certain ampullary adenomas, case selection for both therapies (especially with regard to the best step-up approach) should be studied further. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information.

中文翻译：

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内窥镜下切除术与手术壶腹切除术治疗腺瘤和早期癌的比较：回顾性 Pancreas2000/European Pancreatic Club 分析


目的 壶腹肿瘤病灶可通过内镜下切除术 （EP） 或经十二指肠手术壶腹切除术 （TSA） 切除，而胰十二指肠切除术仅用于更晚期的病灶。我们提出了分析 EP 和 TSA 的最大型回顾性比较研究。设计 在数据库中的所有患者中，排除了既往干预的病灶、良性组织学晚期恶性肿瘤 （T2 等）、遗传综合征患者和接受胰十二指肠切除术的患者。在基于年龄、性别、人体测量学、合并症、大小和组织学亚型的倾向评分匹配（最近邻法）之后，分析了所有剩余病例及其亚组。初次干预后中位随访时间为 21 个月 （IQR 10-47）。主要结局是完全切除率 （R0） 和并发症。通过 Fisher 精确检验或 χ2 检验、 Mann-Whitney-U 检验和 log-rank 检验比较各组的生存率。结果 数据库中的 1673 例患者中，1422 例接受了 EP，251 例接受了 TSA。其中，23.2% 的患者因数据缺失或不确定而被排除在外，19.8% 的患者因既往干预或遗传综合征而被排除在外。最终组织学显示 24.2% 的 EP 和 14.8% 的 TSA 患者存在腺瘤或腺癌以外的组织学，而 10.9% 的 EP 和 36.6% 的 TSA 患者记录了晚期癌症。最后，569 例 EP 和 63 例 TSA 被纳入总体分析，TSA 组更晚期病例的发生率更高，R0 切除率更高 （90.5% vs 73.1%;p<0.01），EP 组的额外消融率为 14.4%。严重不良事件发生率为 3.2% （TSA） 和 1.9% （EP）。组织学 R0 切除术后的复发率为 16% （EP） vs 3.2% （TSA;p=0。01），67 例病例中的 159% 应用了 R1 切除的额外治疗。基于倾向评分的匹配确定了 62 对 EP/TSA 患者，这些患者具有可比的基线患者和病变特征。初始 R0 率为 72.6% （EP） 与 90.3% （TSA，p=0.02） 相比，复发率为 8% （EP） 对 3.2% （TSA;p=0.07）;EP 组的再干预更频繁。总生存期相当。结论 EP 和 TSA 因非肿瘤性疾病或晚期癌症导致适应症不佳的患者比例仍然很高;EP 需要多次再治疗。虽然 EP 可被认为是某些壶腹腺瘤的合适主要治疗，但应进一步研究两种疗法的病例选择（尤其是关于最佳升级方法）。数据可应合理要求提供。与研究相关的所有数据都包含在文章中或作为在线补充信息上传。