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内镜和手术囊胃造口术治疗胰腺假性囊肿引流的随机试验等效。

Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial.

机构信息

University of Alabama at Birmingham, Birmingham, AL, USA.

出版信息

Gastroenterology. 2013 Sep;145(3):583-90.e1. doi: 10.1053/j.gastro.2013.05.046. Epub 2013 May 31.

Abstract

BACKGROUND & AIMS: Although surgery is the standard technique for drainage of pancreatic pseudocysts, use of endoscopic methods is increasing. We performed a single-center, open-label, randomized trial to compare endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage.

METHODS

Patients with pancreatic pseudocysts underwent endoscopic (n = 20) or surgical cystogastrostomy (n = 20). The primary end point was pseudocyst recurrence after a 24-month follow-up period. Secondary end points were treatment success or failure, complications, re-interventions, length of hospital stay, physical and mental health scores, and total costs.

RESULTS

At the end of the follow-up period, none of the patients who received endoscopic therapy had a pseudocyst recurrence, compared with 1 patient treated surgically. There were no differences in treatment successes, complications, or re-interventions between the groups. However, the length of hospital stay was shorter for patients who underwent endoscopic cystogastrostomy (median, 2 days, vs 6 days in the surgery group; P < .001). Although there were no differences in physical component scores and mental health component scores (MCS) between groups at baseline on the Medical Outcomes Study 36-Item Short-Form General Survey questionnaire, longitudinal analysis showed significantly better physical component scores (P = .019) and mental health component scores (P = .025) for the endoscopy treatment group. The total mean cost was lower for patients managed by endoscopy than surgery ($7011 vs $15,052; P = .003).

CONCLUSIONS

In a randomized trial comparing endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage, none of the patients in the endoscopy group had pseudocyst recurrence during the follow-up period, therefore there is no evidence that surgical cystogastrostomy is superior. However, endoscopic treatment was associated with shorter hospital stays, better physical and mental health of patients, and lower cost.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00826501.

摘要

背景与目的

尽管手术是引流胰腺假性囊肿的标准技术,但内镜方法的应用正在增加。我们进行了一项单中心、开放标签、随机试验,比较内镜和手术囊肿胃吻合术治疗胰腺假性囊肿引流的效果。

方法

接受胰腺假性囊肿治疗的患者接受内镜(n=20)或手术囊肿胃吻合术(n=20)。主要终点是在 24 个月的随访期间假性囊肿复发。次要终点是治疗成功或失败、并发症、再干预、住院时间、身体和心理健康评分以及总费用。

结果

在随访结束时,接受内镜治疗的患者无一例假性囊肿复发,而接受手术治疗的患者中有 1 例。两组之间的治疗成功率、并发症或再干预没有差异。然而,接受内镜囊肿胃吻合术的患者住院时间更短(中位数为 2 天,手术组为 6 天;P<.001)。尽管在基线时,医疗结局研究 36 项简短形式一般调查问卷的身体成分评分和心理健康成分评分(MCS)在两组之间没有差异,但纵向分析显示,内镜治疗组的身体成分评分(P=.019)和心理健康成分评分(P=.025)明显更好。接受内镜治疗的患者总平均费用低于手术治疗(7011 美元与 15052 美元;P=.003)。

结论

在比较内镜和手术囊肿胃吻合术治疗胰腺假性囊肿引流的随机试验中,内镜组在随访期间无一例假性囊肿复发,因此没有证据表明手术囊肿胃吻合术更优越。然而,内镜治疗与较短的住院时间、患者更好的身体和心理健康以及更低的成本相关。

试验注册

ClinicalTrials.gov:NCT00826501。

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