Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China.
Gastric Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
Choosing an optimal reconstruction method is pivotal for patients with gastric cancer undergoing distal gastrectomy. The uncut Roux-en-Y reconstruction, a variant of the conventional Roux-en-Y approach (or variant of the Billroth II reconstruction), employs uncut devices to occlude the afferent loop of the jejunum. This modification is designed to mitigate postgastrectomy syndrome and enhance long-term functional outcomes. However, the comparative benefits and potential harms of this approach compared to other reconstruction techniques remain a topic of debate.
To assess the benefits and harms of uncut Roux-en-Y reconstruction after distal gastrectomy in patients with gastric cancer.
We searched CENTRAL, PubMed, Embase, WanFang Data, China National Knowledge Infrastructure, and clinical trial registries for published and unpublished trials up to November 2023. We also manually reviewed references from relevant systematic reviews identified by our search. We did not impose any language restrictions.
We included randomised controlled trials (RCTs) and quasi-RCTs comparing uncut Roux-en-Y reconstruction versus other reconstructions after distal gastrectomy for gastric cancer. The comparison groups encompassed other reconstructions such as Billroth I, Billroth II (with or without Braun anastomosis), and Roux-en-Y reconstruction.
We used standard Cochrane methodological procedures. The critical outcomes included health-related quality of life at least six months after surgery, major postoperative complications within 30 days after surgery according to the Clavien-Dindo Classification (grades III to V), anastomotic leakage within 30 days, changes in body weight (kg) at least six months after surgery, and incidence of bile reflux, remnant gastritis, and oesophagitis at least six months after surgery. We used the GRADE approach to evaluate the certainty of the evidence.
We identified eight trials, including 1167 participants, which contributed data to our meta-analyses. These trials were exclusively conducted in East Asian countries, predominantly in China. The studies varied in the types of uncut devices used, ranging from 2- to 6-row linear staplers to suture lines. The follow-up periods for long-term outcomes spanned from 3 months to 42 months, with most studies focusing on a 6- to 12-month range. We rated the certainty of evidence from low to very low. Uncut Roux-en-Y reconstruction versus Billroth II reconstruction In the realm of surgical complications, very low-certainty evidence suggests that uncut Roux-en-Y reconstruction compared with Billroth II reconstruction may make little to no difference to major postoperative complications (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.24 to 4.05; I² = 0%; risk difference (RD) 0.00, 95% CI -0.04 to 0.04; I² = 0%; 2 studies, 282 participants; very low-certainty evidence) and incidence of anastomotic leakage (RR 0.64, 95% CI 0.29 to 1.44; I² not applicable; RD -0.00, 95% CI -0.03 to 0.02; I² = 32%; 3 studies, 615 participants; very low-certainty evidence). We are very uncertain about these results. Focusing on long-term outcomes, low- to very low-certainty evidence suggests that uncut Roux-en-Y reconstruction compared with Billroth II reconstruction may make little to no difference to changes in body weight (mean difference (MD) 0.04 kg, 95% CI -0.84 to 0.92 kg; I² = 0%; 2 studies, 233 participants; low-certainty evidence), may reduce the incidence of bile reflux into the remnant stomach (RR 0.67, 95% CI 0.55 to 0.83; RD -0.29, 95% CI -0.43 to -0.16; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 3 to 7; 1 study, 141 participants; low-certainty evidence), and may have little or no effect on the incidence of remnant gastritis (RR 0.27, 95% CI 0.01 to 5.06; I = 78%; RD -0.15, 95% CI -0.23 to -0.07; I = 0%; NNTB 7, 95% CI 5 to 15; 2 studies, 265 participants; very low-certainty evidence). No studies reported on quality of life or the incidence of oesophagitis. Uncut Roux-en-Y reconstruction versus Roux-en-Y reconstruction In the realm of surgical complications, very low-certainty evidence suggests that uncut Roux-en-Y reconstruction compared with Roux-en-Y reconstruction may make little to no difference to major postoperative complications (RR 4.74, 95% CI 0.23 to 97.08; I² not applicable; RD 0.01, 95% CI -0.02 to 0.04; I² = 0%; 2 studies, 256 participants; very low-certainty evidence) and incidence of anastomotic leakage (RR 0.34, 95% CI 0.05 to 2.08; I² = 0%; RD -0.02, 95% CI -0.06 to 0.02; I² = 0%; 2 studies, 213 participants; very low-certainty evidence). We are very uncertain about these results. Focusing on long-term outcomes, very low-certainty evidence suggests that uncut Roux-en-Y reconstruction compared with Roux-en-Y reconstruction may increase the incidence of bile reflux into the remnant stomach (RR 10.74, 95% CI 3.52 to 32.76; RD 0.57, 95% CI 0.43 to 0.71; NNT for an additional harmful outcome (NNTH) 2, 95% CI 2 to 3; 1 study, 108 participants; very low-certainty evidence) and may make little to no difference to the incidence of remnant gastritis (RR 1.18, 95% CI 0.69 to 2.01; I² = 60%; RD 0.03, 95% CI -0.03 to 0.08; I² = 0%; 3 studies, 361 participants; very low-certainty evidence) and incidence of oesophagitis (RR 0.82, 95% CI 0.53 to 1.26; I² = 0%; RD -0.02, 95% CI -0.07 to 0.03; I² = 0%; 3 studies, 361 participants; very low-certainty evidence). We are very uncertain about these results. Data were insufficient to assess the impact on quality of life and changes in body weight.
AUTHORS' CONCLUSIONS: Given the predominance of low- to very low-certainty evidence, this Cochrane review faces challenges in providing definitive clinical guidance. We found the majority of critical outcomes may be comparable between the uncut Roux-en-Y reconstruction and other methods, but we are very uncertain about most of these results. Nevertheless, it indicates that uncut Roux-en-Y reconstruction may reduce the incidence of bile reflux compared to Billroth-II reconstruction, albeit with low certainty. In contrast, compared to Roux-en-Y reconstruction, uncut Roux-en-Y may increase bile reflux incidence, based on very low-certainty evidence. To strengthen the evidence base, further rigorous and long-term trials are needed. Additionally, these studies should explore variations in surgical procedures, particularly regarding uncut devices and methods to prevent recanalisation. Future research may potentially alter the conclusions of this review.
选择最佳的重建方法对于接受远端胃癌胃切除术的患者至关重要。未切割 Roux-en-Y 重建是传统 Roux-en-Y 方法(或 Billroth II 重建的变体)的一种变体,它使用未切割装置来闭塞空肠的输入襻。这种改良设计旨在减轻术后胃综合征并改善长期功能结果。然而,与其他重建技术相比,这种方法的比较益处和潜在危害仍然是一个争论的话题。
评估胃癌患者远端胃切除术后未切割 Roux-en-Y 重建的益处和危害。
我们检索了 CENTRAL、PubMed、Embase、万方数据、中国国家知识基础设施和临床试验注册中心,截至 2023 年 11 月,检索了已发表和未发表的试验。我们还手动审查了我们搜索中确定的相关系统评价的参考文献。我们没有对语言施加任何限制。
我们纳入了比较远端胃癌胃切除术后未切割 Roux-en-Y 重建与其他重建的随机对照试验(RCT)和准随机对照试验。比较组包括其他重建,如 Billroth I、Billroth II(有或没有 Braun 吻合术)和 Roux-en-Y 重建。
我们使用了标准的 Cochrane 方法学程序。关键结局包括手术后至少 6 个月的健康相关生活质量、根据 Clavien-Dindo 分类(等级 III 至 V)在手术后 30 天内的主要术后并发症、手术后 30 天内的吻合口漏、手术后至少 6 个月的体重变化(kg)以及胆汁反流、残胃炎和食管炎的发生率。我们使用 GRADE 方法评估证据的确定性。
我们确定了八项试验,包括 1167 名参与者,这些试验提供了我们的荟萃分析数据。这些试验仅在东亚国家进行,主要在中国。所使用的未切割装置类型各不相同,范围从 2 至 6 排线性吻合器到缝线。长期结果的随访期从 3 个月到 42 个月不等,大多数研究集中在 6 至 12 个月的范围内。我们将证据的确定性评级从低到极低。未切割 Roux-en-Y 重建与 Billroth II 重建:在手术并发症方面,极低确定性证据表明,与 Billroth II 重建相比,未切割 Roux-en-Y 重建可能对主要术后并发症(风险比(RR)0.98,95%置信区间(CI)0.24 至 4.05;I²=0%;差异风险(RD)0.00,95%CI -0.04 至 0.04;I²=0%;2 项研究,282 名参与者;极低确定性证据)和吻合口漏的发生率(RR 0.64,95%CI 0.29 至 1.44;I²不适用于;RD -0.00,95%CI -0.03 至 0.02;I²=32%;3 项研究,615 名参与者;极低确定性证据)没有显著影响。对于长期结果,低至极低确定性证据表明,与 Billroth II 重建相比,未切割 Roux-en-Y 重建可能对体重变化(平均差值(MD)0.04kg,95%CI -0.84 至 0.92kg;I²=0%;2 项研究,233 名参与者;低确定性证据)、胆汁反流到残胃的发生率(RR 0.67,95%CI 0.55 至 0.83;RD -0.29,95%CI -0.43 至 -0.16;需要治疗的额外获益人数(NNTB)4,95%CI 3 至 7;1 项研究,141 名参与者;低确定性证据)和残胃炎的发生率(RR 0.27,95%CI 0.01 至 5.06;I=78%;RD -0.15,95%CI -0.23 至 -0.07;I=0%;NNTB 7,95%CI 5 至 15;2 项研究,265 名参与者;极低确定性证据)没有显著影响。没有研究报告生活质量或食管炎的发生率。未切割 Roux-en-Y 重建与 Roux-en-Y 重建:在手术并发症方面,极低确定性证据表明,与 Roux-en-Y 重建相比,未切割 Roux-en-Y 重建可能对主要术后并发症(RR 4.74,95%CI 0.23 至 97.08;I²不适用于;RD 0.01,95%CI -0.02 至 0.04;I²=0%;2 项研究,256 名参与者;极低确定性证据)和吻合口漏的发生率(RR 0.34,95%CI 0.05 至 2.08;I²=0%;RD -0.02,95%CI -0.06 至 0.02;I²=0%;2 项研究,213 名参与者;极低确定性证据)没有显著影响。对于这些结果,我们也不确定。对于长期结果,极低确定性证据表明,与 Roux-en-Y 重建相比,未切割 Roux-en-Y 重建可能会增加胆汁反流到残胃的发生率(RR 10.74,95%CI 3.52 至 32.76;RD 0.57,95%CI 0.43 至 0.71;需要治疗的额外获益人数(NNTH)2,95%CI 2 至 3;1 项研究,108 名参与者;极低确定性证据),并且可能对残胃炎的发生率(RR 1.18,95%CI 0.69 至 2.01;I²=60%;RD 0.03,95%CI -0.03 至 0.08;I²=0%;3 项研究,361 名参与者;极低确定性证据)和食管炎的发生率(RR 0.82,95%CI 0.53 至 1.26;I²=0%;RD -0.02,95%CI -0.07 至 0.03;I²=0%;3 项研究,361 名参与者;极低确定性证据)没有显著影响。对于这些结果,我们也不确定。数据不足以评估生活质量和体重变化的影响。
由于低至极低确定性证据的存在,本 Cochrane 综述在提供明确的临床指导方面面临挑战。我们发现大多数关键结局可能在未切割 Roux-en-Y 重建和其他方法之间相似,但我们对大多数结果也非常不确定。尽管如此,它表明与 Billroth-II 重建相比,未切割 Roux-en-Y 重建可能会降低胆汁反流的发生率,尽管确定性较低。相比之下,与 Roux-en-Y 重建相比,未切割 Roux-en-Y 重建可能会增加胆汁反流的发生率,这是基于极低确定性证据。为了加强证据基础,需要进一步进行严格和长期的试验。此外,这些研究应探讨手术程序的变化,特别是未切割装置和预防再通的方法。未来的研究可能会改变本综述的结论。