Pancreaticoduodenectomy with or without distal gastrectomy and extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma, part 2 - Randomized controlled trial evaluating survival, morbidity, and mortality
Pancreaticoduodenectomy with or without distal gastrectomy and extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma, part 2 - Randomized controlled trial evaluating survival, morbidity, and mortality
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DOI：
10.1097/00000658-200209000-00012
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发表时间：
2002-09-01
影响因子：
9
通讯作者：
Hruban, RH
中科院分区：
文献类型：
--
作者：
Yeo, CJ;Cameron, JL;Hruban, RH
目的通过一项前瞻性、随机、单中心临床试验，评价手术并发症、手术死亡率、接受标准和根治性化疗的患者（延长）大量的回顾性报告和一些前瞻性随机试验表明，与胰十二指肠切除术相关的扩大淋巴结切除术的表现可能会提高胰腺癌患者的生存率。方法1996年4月至2001年6月，299例壶腹周围腺癌患者参加了一项前瞻性、随机单机构试验。术中确认（通过冰冻切片）切缘阴性的壶腹周围腺癌切除后，患者随机接受标准胰腺切除术（仅整块切除胰周淋巴结和标本）或根治性（扩大）胰腺切除术（标准切除加远端胃切除术和腹膜后淋巴结切除术）。对所有病理学标本进行审查、完全分类和分期。术后发病率，死亡率和生存数据进行了分析。结果299例患者随机，5（1.7%）随后被排除，因为他们的最终病理未能揭示壶腹周围腺癌，留下294例进行分析（146标准与148根治性）。两组在年龄（中位数67岁）和性别（54%为男性）方面具有统计学相似性。根治组所有患者均行远端胃切除术，而标准组86%的患者行幽门保留术（P <0.0001）。根治组的平均手术时间为6.4小时，而标准组为5.9小时（P = .002）。两组在术中失血量、输血需求（中位数为0单位）、原发性肿瘤位置（57%胰腺、22%壶腹、17%远端胆管、3%十二指肠）、平均肿瘤大小（2.6 cm）、阳性淋巴结状态（74%）或最终永久切片上的阳性边缘状态（10%）方面无显著差异。根治组的平均淋巴结切除总数明显高于根治组。根治组148例中，仅15%（n = 22）的患者在切除的腹膜后淋巴结中存在转移腺癌，并且没有腹膜后淋巴结是唯一的淋巴结受累部位。根治组1例胰十二指肠切除术标本淋巴结阴性，1个胃周淋巴结微转移。标准组有6例围手术期死亡（4%），而根治组有3例围手术期死亡（2%）（P = NS）。标准组的总体并发症发生率为29%，而根治组为43%（P = 0.01），根治组患者的早期胃排空延迟和胰瘘发生率显著较高，平均术后住院时间显著较长。平均患者随访24个月，有没有显着差异，1，3，或5年和中位生存率比较标准和radical groups.Conclusions根治性（扩大）pancreaticostomy可以进行类似的死亡率，但一些增加发病率相比，标准pancreaticostomy。迄今为止的数据未能表明保留幽门的胰管切除术中增加远端胃切除术和腹膜后淋巴结切除术可获得生存益处。
Objective To evaluate, in a prospective, randomized single-institution trial, the end points of operative morbidity, operative mortality, and survival in patients undergoing standard versus radical (extended) pancreaticoduodenectomy.Summary Background Data Numerous retrospective reports and a few prospective randomized trials have suggested that the performance of an extended lymphadenectomy in association with a pancreaticoduodenal resection may improve survival for patients with pancreatic and other periampullary adenocarcinomas.Methods Between April 1996 and June 2001, 299 patients with periampullary adenocarcinoma were enrolled in a prospective, randomized single-institution trial. After intraoperative verification (by frozen section) of margin-negative resected periampullary adenocarcinoma, patients were randomized to either a standard pancreaticoduodenectomy (removing only the peripancreatic lymph nodes en bloc with the specimen) or a radical (extended) pancreaticoduodenectomy (standard resection plus distal gastrectomy and retroperitoneal lymphadenectomy). All pathology specimens were reviewed, fully categorized, and staged. The postoperative morbidity, mortality, and survival data were analyzed.Results Of the 299 patients randomized, 5 (1.7%) were subsequently excluded because their final pathology failed to reveal periampullary adenocarcinoma, leaving 294 patients for analysis (146 standard vs. 148 radical). The two groups were statistically similar with regard to age (median 67 years) and gender (54% male). All the patients in the radical group underwent distal gastric resection, while 86% of the patients in the standard group underwent pylorus preservation (P < .0001). The mean operative time in the radical group was 6.4 hours, compared to 5.9 hours in the standard group (P = .002). There were no significant differences between the two groups with respect to intraoperative blood loss, transfusion requirements (median zero units), location of primary tumor (57% pancreatic, 22% ampullary, 17% distal bile duct, 3% duodenal), mean tumor size (2.6 cm), positive lymph node status (74%), or positive margin status on final permanent section (10%). The mean total number of lymph nodes resected was significantly higher in the radical group. Of the 148 patients in the radical group, only 15% (n = 22) had metastatic adenocarcinoma in the resected retroperitoneal lymph nodes, and none had retroperitoneal nodes as the only site of lymph node involvement. One patient in the radical group with negative pancreaticoduodenectomy specimen lymph nodes had a micrometastasis to one perigastric lymph node. There were six perioperative deaths (4%) in the standard group versus three perioperative deaths (2%) in the radical group (P = NS). The overall complication rates were 29% for the standard group versus 43% for the radical group (P = .01), with patients in the radical group having significantly higher rates of early delayed gastric emptying and pancreatic fistula and a significantly longer mean postoperative stay. With a mean patient follow-up of 24 months, there were no significant differences in 1-, 3-, or 5-year and median survival when comparing the standard and radical groups.Conclusions Radical (extended) pancreaticoduodenectomy can be performed with similar mortality but some increased morbidity compared to standard pancreaticoduodenectomy. The data to date fail to indicate that a survival benefit is derived from the addition of a distal gastrectomy and retroperitoneal lymphadenectomy to a pylorus-preserving pancreaticoduodenectomy.