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胃分隔术与胃空肠吻合术治疗不可切除胃癌所致胃出口梗阻的随机临床试验

Gastric partitioning versus gastrojejunostomy for gastric outlet obstruction due to unresectable gastric cancer: randomized clinical trial.

作者信息

Ramos Marcus Fernando Kodama Pertille, Pereira Marina Alessandra, Dias André Roncon, Yagi Osmar Kenji, Zilberstein Bruno, Ribeiro-Junior Ulysses

机构信息

Department of Gastroenterology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil.

出版信息

BJS Open. 2024 Dec 30;9(1). doi: 10.1093/bjsopen/zrae152.

DOI:10.1093/bjsopen/zrae152
PMID:39835447
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11747725/
Abstract

BACKGROUND

Gastric outlet obstruction due to unresectable tumours is usually managed with a gastrojejunostomy. Unfortunately, the unsatisfactory outcomes of this procedure have led to the search for alternatives, including gastric partitioning.

METHODS

Monocentric, randomized, parallel, open-label trial that included patients with obstructive, unresectable distal gastric tumours. The objective was to compare gastric partitioning to gastrojejunostomy, considering the gastric outlet obstruction scoring system scale as the main outcome. Randomization was performed using computer-generated software available online and after the application of the informed consent term, the allocation group was revealed to the surgeon before the surgical procedure.

RESULTS

Over 7 years, 90 patients were initially randomized. After applying the inclusion and exclusion criteria, 25 patients were included in the gastrojejunostomy group and 27 in the partitioning group. Both groups were similar regarding initial clinical characteristics including sex, age, weight, clinical performance, and the acceptance of oral diet. Surgery duration, length of hospital stay, postoperative complications, and 30- and 90-day mortality rates were similar between groups. Acceptance of normal diet was more frequently reached by patients in the partitioning group (96% versus 72%; P = 0.022). During outpatient follow-up, maintenance of oral intake and weight was similar between groups. Patients in the partitioning group received more frequent red blood cell transfusions (81% versus 52%; P = 0.024). There was no difference regarding the administration of palliative chemotherapy lines and survival. In the multivariable analysis, the inability to eat a full diet (P = 0.035) and the absence of palliative chemotherapy after the procedure (P = 0.001) were associated with worse survival.

CONCLUSIONS

Gastric partitioning provided a better return of the ability to accept food orally. There was no difference regarding postoperative complications and long-term survival.

TRIAL REGISTRATION

NCT02065803, clinicaltrials.gov.

摘要

背景

因无法切除的肿瘤导致的胃出口梗阻通常采用胃空肠吻合术进行治疗。不幸的是,该手术效果不尽人意,促使人们寻求替代方法,包括胃分隔术。

方法

一项单中心、随机、平行、开放标签试验,纳入患有梗阻性、无法切除的远端胃肿瘤患者。目的是比较胃分隔术与胃空肠吻合术,将胃出口梗阻评分系统量表作为主要结局指标。使用在线计算机生成软件进行随机分组,在应用知情同意条款后,手术前向外科医生透露分配组。

结果

在7年多的时间里,最初有90名患者被随机分组。应用纳入和排除标准后,胃空肠吻合术组纳入25例患者,分隔术组纳入27例患者。两组在初始临床特征方面相似,包括性别、年龄、体重、临床表现和口服饮食接受情况。两组之间的手术持续时间、住院时间、术后并发症以及30天和90天死亡率相似。分隔术组患者更频繁地恢复正常饮食(96%对72%;P = 0.022)。在门诊随访期间,两组之间的口服摄入量和体重维持情况相似。分隔术组患者接受红细胞输血的频率更高(81%对52%;P = 0.024)。在姑息化疗疗程和生存率方面没有差异。在多变量分析中,无法进食全量饮食(P = 0.035)和术后未进行姑息化疗(P = 0.001)与较差的生存率相关。

结论

胃分隔术在口服食物接受能力恢复方面表现更好。术后并发症和长期生存率方面没有差异。

试验注册

NCT02065803,clinicaltrials.gov。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31be/11747725/bd48721276ae/zrae152f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31be/11747725/d70678377482/zrae152f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31be/11747725/8de6f4d1f2f4/zrae152f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31be/11747725/bd48721276ae/zrae152f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31be/11747725/d70678377482/zrae152f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31be/11747725/8de6f4d1f2f4/zrae152f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31be/11747725/bd48721276ae/zrae152f3.jpg

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Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).日本胃癌治疗指南 2021(第 6 版)。
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SURGICAL TREATMENT IN CLINICAL STAGE IV GASTRIC CANCER: A COMPARISON OF DIFFERENT PROCEDURES AND SURVIVAL OUTCOMES.临床 IV 期胃癌的外科治疗:不同手术方式与生存结局的比较。
Arq Bras Cir Dig. 2022 Jun 17;35:e1648. doi: 10.1590/0102-672020210002e1648. eCollection 2022.
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Partial stomach-partitioning gastrojejunostomy for gastric outlet obstruction: A cohort study based on consecutive case series from a single center.
部分胃分隔式胃空肠吻合术治疗胃出口梗阻:一项基于单中心连续病例系列的队列研究。
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