PDF(Pubmed)
Abstract：
The sphincter of Oddi comprises a muscular complex encircling the distal part of the common bile duct and the pancreatic duct regulating the outflow from these ducts. Sphincter of Oddi dysfunction refers to the abnormal opening and closing of the muscular valve, which impairs the circulation of bile and pancreatic juices.
To evaluate the benefits and harms of any type of endoscopic sphincterotomy compared with a placebo drug, sham operation, or any pharmaceutical treatment, administered orally or endoscopically, alone or in combination, or a different type of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.
We used extensive Cochrane search methods. The latest search date was 16 May 2023.
We included randomised clinical trials assessing any type of endoscopic sphincterotomy versus placebo drug, sham operation, or any pharmaceutical treatment, alone or in combination, or a different type of endoscopic sphincterotomy in adults diagnosed with sphincter of Oddi dysfunction, irrespective of year, language of publication, format, or outcomes reported.
We used standard Cochrane methods and Review Manager to prepare the review. Our primary outcomes were: proportion of participants without successful treatment; proportion of participants with one or more serious adverse events; and health-related quality of life. Our secondary outcomes were: all-cause mortality; proportion of participants with one or more non-serious adverse events; length of hospital stay; and proportion of participants without improvement in liver function tests. We used the outcome data at the longest follow-up and the random-effects model for our primary analyses. We assessed the risk of bias of the included trials using RoB 2 and the certainty of evidence using GRADE. We planned to present the results of time-to-event outcomes as hazard ratios (HR). We presented dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean difference (MD) with their 95% confidence intervals (CI).
We included four randomised clinical trials, including 433 participants. Trials were published between 1989 and 2015. The trial participants had sphincter of Oddi dysfunction. Two trials were conducted in the USA, one in Australia, and one in Japan. One was a multicentre trial conducted in seven US centres, and the remaining three were single-centre trials. One trial used a two-stage randomisation, resulting in two comparisons. The number of participants in the four trials ranged from 47 to 214 (median 86), with a median age of 45 years, and the mean proportion of males was 49%. The follow-up duration ranged from one year to four years after the end of treatment. All trials assessed one or more outcomes of interest to our review. The trials provided data for the comparisons and outcomes below, in conformity with our review protocol. The certainty of evidence for all the outcomes was very low. Endoscopic sphincterotomy versus sham Endoscopic sphincterotomy versus sham may have little to no effect on treatment success (RR 1.05, 95% CI 0.66 to 1.66; 3 trials, 340 participants; follow-up range 1 to 4 years); serious adverse events (RR 0.71, 95% CI 0.34 to 1.46; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Physical scale) (MD -1.00, 95% CI -3.84 to 1.84; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Mental scale) (MD -1.00, 95% CI -4.16 to 2.16; 1 trial, 214 participants; follow-up 1 year), and no improvement in liver function test (RR 0.89, 95% CI 0.35 to 2.26; 1 trial, 47 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus endoscopic papillary balloon dilation Endoscopic sphincterotomy versus endoscopic papillary balloon dilationmay have little to no effect on serious adverse events (RR 0.34, 95% CI 0.04 to 3.15; 1 trial, 91 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus dual endoscopic sphincterotomy Endoscopic sphincterotomy versus dual endoscopic sphincterotomy may have little to no effect on treatment success (RR 0.65, 95% CI 0.32 to 1.31; 1 trial, 99 participants; follow-up 1 year), but the evidence is very uncertain. Funding One trial did not provide any information on sponsorship; one trial was funded by a foundation (the National Institutes of Diabetes and Digestive and Kidney Diseases, NIDDK), and two trials seemed to be funded by the local health institutes or universities where the investigators worked. We did not identify any ongoing randomised clinical trials.
Based on very low-certainty evidence from the trials included in this review, we do not know if endoscopic sphincterotomy versus sham or versus dual endoscopic sphincterotomy increases, reduces, or makes no difference to the number of people with treatment success; if endoscopic sphincterotomy versus sham or versus endoscopic papillary balloon dilation increases, reduces, or makes no difference to serious adverse events; or if endoscopic sphincterotomy versus sham improves, worsens, or makes no difference to health-related quality of life and liver function tests in adults with biliary sphincter of Oddi dysfunction. Evidence on the effect of endoscopic sphincterotomy compared with sham, endoscopic papillary balloon dilation,or dual endoscopic sphincterotomyon all-cause mortality, non-serious adverse events, and length of hospital stay is lacking. We found no trials comparing endoscopic sphincterotomy versus a placebo drug or versus any other pharmaceutical treatment, alone or in combination. All four trials were underpowered and lacked trial data on clinically important outcomes. We lack randomised clinical trials assessing clinically and patient-relevant outcomes to demonstrate the effects of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.
To evaluate the benefits and harms of any type of endoscopic sphincterotomy compared with a placebo drug, sham operation, or any pharmaceutical treatment, administered orally or endoscopically, alone or in combination, or a different type of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.
We used extensive Cochrane search methods. The latest search date was 16 May 2023.
We included randomised clinical trials assessing any type of endoscopic sphincterotomy versus placebo drug, sham operation, or any pharmaceutical treatment, alone or in combination, or a different type of endoscopic sphincterotomy in adults diagnosed with sphincter of Oddi dysfunction, irrespective of year, language of publication, format, or outcomes reported.
We used standard Cochrane methods and Review Manager to prepare the review. Our primary outcomes were: proportion of participants without successful treatment; proportion of participants with one or more serious adverse events; and health-related quality of life. Our secondary outcomes were: all-cause mortality; proportion of participants with one or more non-serious adverse events; length of hospital stay; and proportion of participants without improvement in liver function tests. We used the outcome data at the longest follow-up and the random-effects model for our primary analyses. We assessed the risk of bias of the included trials using RoB 2 and the certainty of evidence using GRADE. We planned to present the results of time-to-event outcomes as hazard ratios (HR). We presented dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean difference (MD) with their 95% confidence intervals (CI).
We included four randomised clinical trials, including 433 participants. Trials were published between 1989 and 2015. The trial participants had sphincter of Oddi dysfunction. Two trials were conducted in the USA, one in Australia, and one in Japan. One was a multicentre trial conducted in seven US centres, and the remaining three were single-centre trials. One trial used a two-stage randomisation, resulting in two comparisons. The number of participants in the four trials ranged from 47 to 214 (median 86), with a median age of 45 years, and the mean proportion of males was 49%. The follow-up duration ranged from one year to four years after the end of treatment. All trials assessed one or more outcomes of interest to our review. The trials provided data for the comparisons and outcomes below, in conformity with our review protocol. The certainty of evidence for all the outcomes was very low. Endoscopic sphincterotomy versus sham Endoscopic sphincterotomy versus sham may have little to no effect on treatment success (RR 1.05, 95% CI 0.66 to 1.66; 3 trials, 340 participants; follow-up range 1 to 4 years); serious adverse events (RR 0.71, 95% CI 0.34 to 1.46; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Physical scale) (MD -1.00, 95% CI -3.84 to 1.84; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Mental scale) (MD -1.00, 95% CI -4.16 to 2.16; 1 trial, 214 participants; follow-up 1 year), and no improvement in liver function test (RR 0.89, 95% CI 0.35 to 2.26; 1 trial, 47 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus endoscopic papillary balloon dilation Endoscopic sphincterotomy versus endoscopic papillary balloon dilationmay have little to no effect on serious adverse events (RR 0.34, 95% CI 0.04 to 3.15; 1 trial, 91 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus dual endoscopic sphincterotomy Endoscopic sphincterotomy versus dual endoscopic sphincterotomy may have little to no effect on treatment success (RR 0.65, 95% CI 0.32 to 1.31; 1 trial, 99 participants; follow-up 1 year), but the evidence is very uncertain. Funding One trial did not provide any information on sponsorship; one trial was funded by a foundation (the National Institutes of Diabetes and Digestive and Kidney Diseases, NIDDK), and two trials seemed to be funded by the local health institutes or universities where the investigators worked. We did not identify any ongoing randomised clinical trials.
Based on very low-certainty evidence from the trials included in this review, we do not know if endoscopic sphincterotomy versus sham or versus dual endoscopic sphincterotomy increases, reduces, or makes no difference to the number of people with treatment success; if endoscopic sphincterotomy versus sham or versus endoscopic papillary balloon dilation increases, reduces, or makes no difference to serious adverse events; or if endoscopic sphincterotomy versus sham improves, worsens, or makes no difference to health-related quality of life and liver function tests in adults with biliary sphincter of Oddi dysfunction. Evidence on the effect of endoscopic sphincterotomy compared with sham, endoscopic papillary balloon dilation,or dual endoscopic sphincterotomyon all-cause mortality, non-serious adverse events, and length of hospital stay is lacking. We found no trials comparing endoscopic sphincterotomy versus a placebo drug or versus any other pharmaceutical treatment, alone or in combination. All four trials were underpowered and lacked trial data on clinically important outcomes. We lack randomised clinical trials assessing clinically and patient-relevant outcomes to demonstrate the effects of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.
摘要：
背景：Oddi括约肌包含一个肌肉复合体，包围着胆总管和胰管的远端部分，调节这些管的流出。Oddi括约肌功能障碍是指肌肉瓣膜的异常打开和关闭，会损害胆汁和胰液的循环。
目的：为了评估与安慰剂药物相比，任何类型的内镜括约肌切开术的益处和危害，假手术,或任何药物治疗，口服或内窥镜给药，单独或组合，或不同类型的内镜括约肌切开术在成人胆道括约肌Oddi功能障碍。
方法：我们使用了广泛的Cochrane搜索方法。最近的搜索日期是2023年5月16日。
方法：我们纳入了随机临床试验，评估任何类型的内镜括约肌切开术与安慰剂药物，假手术,或任何药物治疗，单独或组合，或在诊断为Oddi括约肌功能障碍的成人中进行不同类型的内窥镜括约肌切开术，不论年份,出版语言,格式,或报告的结果。
方法：我们使用标准的Cochrane方法和ReviewManager来准备审查。我们的主要结果是：没有成功治疗的参与者比例；有一个或多个严重不良事件的参与者比例；和健康相关的生活质量。我们的次要结果是：全因死亡率；有一个或多个非严重不良事件的参与者比例；住院时间；以及肝功能测试未改善的参与者比例。我们使用最长随访的结果数据和随机效应模型进行主要分析。我们使用RoB2评估纳入试验的偏倚风险，并使用GRADE评估证据的确定性。我们计划将事件发生时间结果的结果作为风险比（HR）。我们将二分结果表示为风险比（RR），将连续结果表示为平均差（MD）及其95％置信区间（CI）。
结果：我们纳入了四项随机临床试验，其中包括433人。试验在1989年至2015年之间发布。试验参与者有Oddi括约肌功能障碍。两项试验在美国进行，一个在澳大利亚,一个在日本。一个是在美国七个中心进行的多中心试验，其余三项是单中心试验。一项试验采用两阶段随机分组,导致两个比较。四项试验的参与者人数从47到214不等（中位数86），平均年龄为45岁，男性的平均比例为49%。治疗结束后随访时间为1年至4年。所有试验都评估了我们审查感兴趣的一个或多个结果。试验提供了以下比较和结果的数据，符合我们的审查协议。所有结果的证据确定性非常低。内镜括约肌切开术与假内镜括约肌切开术与假内镜括约肌切开术可能对治疗成功几乎没有影响(RR1.05,95%CI0.66to1.66;3项试验,340名参与者；随访范围1至4年）；严重不良事件（RR0.71，95％CI0.34至1.46；1项试验，214名参与者；随访1年)，健康相关生活质量（物理量表）（MD-1.00，95%CI-3.84至1.84；1项试验，214名参与者；随访1年)，健康相关生活质量（心理量表）（MD-1.00，95％CI-4.16至2.16；1项试验，214名参与者；随访1年)，肝功能检查无改善（RR0.89，95%CI0.35至2.26；1项试验，47名参与者；随访1年)，但是证据非常不确定。内镜下括约肌切开术与内镜下乳头球囊扩张术与内镜下乳头球囊扩张术可能对严重不良事件几乎没有影响(RR0.34，95%CI0.04至3.15；1项试验，91名参与者；随访1年)，但是证据非常不确定。内镜括约肌切开术与双内镜括约肌切开术相比，内镜括约肌切开术与双内镜括约肌切开术可能对治疗成功几乎没有影响(RR0.65，95%CI0.32至1.31；1项试验，99名参与者；随访1年)，但是证据非常不确定。资助一项试验未提供任何赞助信息；一项试验由一个基金会资助（美国国立糖尿病与消化和肾脏疾病研究所，NIDDK),两项试验似乎是由调查人员所在的当地卫生机构或大学资助的。我们没有发现任何正在进行的随机临床试验。
结论：基于本综述中包含的试验的极低确定性证据，我们不知道内镜括约肌切开术与假手术或双内镜括约肌切开术是否增加，减少,或对治疗成功的人数没有影响；如果内窥镜括约肌切开术与假手术或内窥镜乳头球囊扩张增加，减少,或对严重不良事件没有影响；或者如果内窥镜括约肌切开术与假手术改善，恶化，或对患有Oddi括约肌功能障碍的成年人的健康相关生活质量和肝功能检查没有影响。内镜括约肌切开术与假手术相比效果的证据，内镜下乳头球囊扩张术,或双重内镜括约肌全因死亡率，非严重不良事件，缺乏住院时间。我们没有发现比较内窥镜括约肌切开术与安慰剂药物或任何其他药物治疗的试验，单独或组合。所有四项试验的功效均不足，缺乏有关临床重要结局的试验数据。我们缺乏评估临床和患者相关结局的随机临床试验，以证明内镜下括约肌切开术对成人胆道括约肌Oddi功能障碍的影响。
目的：为了评估与安慰剂药物相比，任何类型的内镜括约肌切开术的益处和危害，假手术,或任何药物治疗，口服或内窥镜给药，单独或组合，或不同类型的内镜括约肌切开术在成人胆道括约肌Oddi功能障碍。
方法：我们使用了广泛的Cochrane搜索方法。最近的搜索日期是2023年5月16日。
方法：我们纳入了随机临床试验，评估任何类型的内镜括约肌切开术与安慰剂药物，假手术,或任何药物治疗，单独或组合，或在诊断为Oddi括约肌功能障碍的成人中进行不同类型的内窥镜括约肌切开术，不论年份,出版语言,格式,或报告的结果。
方法：我们使用标准的Cochrane方法和ReviewManager来准备审查。我们的主要结果是：没有成功治疗的参与者比例；有一个或多个严重不良事件的参与者比例；和健康相关的生活质量。我们的次要结果是：全因死亡率；有一个或多个非严重不良事件的参与者比例；住院时间；以及肝功能测试未改善的参与者比例。我们使用最长随访的结果数据和随机效应模型进行主要分析。我们使用RoB2评估纳入试验的偏倚风险，并使用GRADE评估证据的确定性。我们计划将事件发生时间结果的结果作为风险比（HR）。我们将二分结果表示为风险比（RR），将连续结果表示为平均差（MD）及其95％置信区间（CI）。
结果：我们纳入了四项随机临床试验，其中包括433人。试验在1989年至2015年之间发布。试验参与者有Oddi括约肌功能障碍。两项试验在美国进行，一个在澳大利亚,一个在日本。一个是在美国七个中心进行的多中心试验，其余三项是单中心试验。一项试验采用两阶段随机分组,导致两个比较。四项试验的参与者人数从47到214不等（中位数86），平均年龄为45岁，男性的平均比例为49%。治疗结束后随访时间为1年至4年。所有试验都评估了我们审查感兴趣的一个或多个结果。试验提供了以下比较和结果的数据，符合我们的审查协议。所有结果的证据确定性非常低。内镜括约肌切开术与假内镜括约肌切开术与假内镜括约肌切开术可能对治疗成功几乎没有影响(RR1.05,95%CI0.66to1.66;3项试验,340名参与者；随访范围1至4年）；严重不良事件（RR0.71，95％CI0.34至1.46；1项试验，214名参与者；随访1年)，健康相关生活质量（物理量表）（MD-1.00，95%CI-3.84至1.84；1项试验，214名参与者；随访1年)，健康相关生活质量（心理量表）（MD-1.00，95％CI-4.16至2.16；1项试验，214名参与者；随访1年)，肝功能检查无改善（RR0.89，95%CI0.35至2.26；1项试验，47名参与者；随访1年)，但是证据非常不确定。内镜下括约肌切开术与内镜下乳头球囊扩张术与内镜下乳头球囊扩张术可能对严重不良事件几乎没有影响(RR0.34，95%CI0.04至3.15；1项试验，91名参与者；随访1年)，但是证据非常不确定。内镜括约肌切开术与双内镜括约肌切开术相比，内镜括约肌切开术与双内镜括约肌切开术可能对治疗成功几乎没有影响(RR0.65，95%CI0.32至1.31；1项试验，99名参与者；随访1年)，但是证据非常不确定。资助一项试验未提供任何赞助信息；一项试验由一个基金会资助（美国国立糖尿病与消化和肾脏疾病研究所，NIDDK),两项试验似乎是由调查人员所在的当地卫生机构或大学资助的。我们没有发现任何正在进行的随机临床试验。
结论：基于本综述中包含的试验的极低确定性证据，我们不知道内镜括约肌切开术与假手术或双内镜括约肌切开术是否增加，减少,或对治疗成功的人数没有影响；如果内窥镜括约肌切开术与假手术或内窥镜乳头球囊扩张增加，减少,或对严重不良事件没有影响；或者如果内窥镜括约肌切开术与假手术改善，恶化，或对患有Oddi括约肌功能障碍的成年人的健康相关生活质量和肝功能检查没有影响。内镜括约肌切开术与假手术相比效果的证据，内镜下乳头球囊扩张术,或双重内镜括约肌全因死亡率，非严重不良事件，缺乏住院时间。我们没有发现比较内窥镜括约肌切开术与安慰剂药物或任何其他药物治疗的试验，单独或组合。所有四项试验的功效均不足，缺乏有关临床重要结局的试验数据。我们缺乏评估临床和患者相关结局的随机临床试验，以证明内镜下括约肌切开术对成人胆道括约肌Oddi功能障碍的影响。
