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随机对照临床试验比较了远端胃癌切除术后毕 I 式与 Roux-en-Y 重建术的长期生活质量。

Randomized clinical trial comparing long-term quality of life for Billroth I versus Roux-en-Y reconstruction after distal gastrectomy for gastric cancer.

机构信息

Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan.

Department of Surgery, National Hospital Organization Osaka Minami Medical Centre, Osaka, Japan.

出版信息

Br J Surg. 2016 Mar;103(4):337-47. doi: 10.1002/bjs.10060. Epub 2016 Feb 3.

Abstract

BACKGROUND

Patients' quality of life (QoL) deteriorates remarkably after gastrectomy. Billroth I reconstruction following distal gastrectomy has the physiological advantage of allowing food to pass through the duodenum. It was hypothesized that Billroth I reconstruction would be superior to Roux-en-Y reconstruction in terms of long-term QoL after distal gastrectomy. This study compared two reconstructions in a multicentre prospective randomized clinical trial to identify the optimal reconstruction procedure.

METHODS

Between January 2009 and September 2010, patients who underwent gastrectomy for gastric cancer were randomized during surgery to Billroth I or Roux-en-Y reconstruction. The primary endpoint was assessment of QoL using the Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) questionnaire 36 months after surgery.

RESULTS

A total of 122 patients were enrolled in the study, 60 to Billroth I and 62 to Roux-en-Y reconstruction. There were no differences between the two groups in terms of postoperative complications or mortality, and no significant differences in FACT-Ga total score (P = 0·496). Symptom scales such as epigastric fullness (heaviness), diarrhoea and fatigue were significantly better in the Billroth I group at 36 months after gastrectomy (heaviness, P = 0·040; diarrhoea, P = 0·046; fatigue, P = 0·029). The rate of weight loss in the third year was lower for patients in the Billroth I group (P = 0·046).

CONCLUSION

The choice of anastomotic reconstruction after distal gastrectomy resulted in no difference in long-term QoL in patients with gastric cancer.

REGISTRATION NUMBER

NCT01065688 (http://www.clinicaltrials.gov).

摘要

背景

胃切除术后患者的生活质量(QoL)显著恶化。远端胃切除术后的 Billroth I 重建具有使食物通过十二指肠的生理优势。假设 Billroth I 重建在远端胃切除术后的长期 QoL 方面优于 Roux-en-Y 重建。本研究在多中心前瞻性随机临床试验中比较了两种重建方法,以确定最佳的重建程序。

方法

2009 年 1 月至 2010 年 9 月,在手术中对因胃癌而行胃切除术的患者进行随机分组,接受 Billroth I 或 Roux-en-Y 重建。主要终点是在手术后 36 个月使用癌症治疗功能评估-胃(FACT-Ga)问卷评估 QoL。

结果

共有 122 例患者入组本研究,60 例接受 Billroth I 重建,62 例接受 Roux-en-Y 重建。两组术后并发症或死亡率无差异,FACT-Ga 总评分无显著差异(P=0.496)。胃切除术后 36 个月,Billroth I 组在上腹饱胀(沉重感)、腹泻和疲劳等症状量表方面明显更好(沉重感,P=0.040;腹泻,P=0.046;疲劳,P=0.029)。Billroth I 组患者的体重减轻率在第三年较低(P=0.046)。

结论

远端胃切除术后吻合重建方式的选择对胃癌患者的长期 QoL 没有影响。

登记号

NCT01065688(http://www.clinicaltrials.gov)。

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