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【medical-news】正常胆管造影亦需括约肌切开？

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Cutting the sphincter in the presence of a normal cholangiogram
Patrick R. Pfau, MD

Abbreviations: CBD, common bile duct, ERC, endoscopic retrograde cholangiogram, ES, endoscopic sphincterotomy
Article Outline
• Disclosure

• References

• Copyright

Performing an empiric sphincterotomy just because you feel the patient probably has or had a stone, though commonly practiced, still does not have much or even any clinical data to back it up.

Perhaps there is nothing more satisfying in the world of GI endoscopy than performing an ERCP with sphincterotomy and stone extraction. The patient presents with pain and fever and is visibly jaundiced, a filling defect is seen on cholangiogram, a large sphincterotomy is made, and then a stone and possibly even some pus is pulled from the bile duct. The patient immediately feels better and the endoscopist can emphatically state, “Yes, I have accomplished something today.”

However, biliary endoscopy, like life, is not always so straightforward. Sometimes the patient looks and smells just like a common duct stone but no filling defect or stone is seen in the biliary tree on cholangiogram. What to do in this situation? Cut the sphincter and sweep and explore the duct or trust your cholangiogram and not cut the sphincter?

This is the topic that Lee et al1 addressed in a study that examined whether endoscopic sphincterotomy (ES) reduces subsequent biliary symptoms, particularly future episodes of cholangitis, in patients who have a high pretest probability and a clinical suspicion of choledocholithiasis before the ERCP is performed but when no actual stones are seen on fluoroscopy at the time of the endoscopic retrograde cholangiogram (ERC).

Lee et al1 retrospectively examined 117 patients who had cholangitis, defined as fever, abdominal pain, and jaundice, and a high probability of a common duct stone defined as 2 or more of the following: (1) bilirubin greater than or equal to 2 mg/dL or alkaline phosphatase greater than or equal to twice the normal value, (2) a common bile duct (CBD) dilated to 8 mm or larger, (3) the presence of high-density material in the duct on other imaging but no stone seen on cholangiogram at the time of ERCP. They then followed the patients to see if they had further bouts of cholangitis and examined whether the variables of age, sex, dilated CBD; the presence of a periampullary diverticulum; the presence of a gallbladder; the presence of gallbladder stones; or the performance of a sphincterotomy predicted future recurrent episodes of cholangitis.

On univariate analysis, a dilated duct >12 mm, the presence of gallbladder stones, and whether a sphincterotomy was performed all were predictors of recurring cholangitis. On multivariate analysis, only the performance of a sphincterotomy was shown to affect recurring cholangitis, with lower rates of cholangitis found in the sphincterotomy group at 1 and 3 years, and a cholangitis recurrence rate of 9.2% if a sphincterotomy was performed versus 52.1% if a sphincterotomy was not performed after 5 years of follow-up. The investigators thus concluded that ES reduced cholangitis in patients, with 1 documented attack of cholangitis and a high risk of stones even when no stones were seen on cholangiogram. This leads to the suggestion that, even in the absence of a stone, a sphincterotomy should be performed in select patients.

Empiric sphincterotomy when a stone is suspected but not seen in the duct is already likely highly practiced in the real world. But should we be ignoring our cholangiograms and relying just on clinical suspicion when making the decision to cut a sphincterotomy in patients with possible stone disease? Are there data to support performing sphincterotomy with normal cholangiograms? Does the present study by Lee et al1 support this practice?

The main reason to perform a sphincterotomy for a suspected stone but with a normal cholangiogram is the fact that you do not trust your cholangiogram and believe that a small stone or even sludge is present in the duct despite imaging. We consider a cholangiography the criterion standard, but a cholangiogram at the time of ERC is not a perfect study, and every practitioner has dragged a stone out of the duct that was not seen on a cholangiography. The best evidence suggests that ERC for choledocholithiasis is not perfect and has sensitivities that range from 90% to 100%.2 In comparison, a choledochoscopy, which allows direct visualization inside the ducts, has shown that stones can be missed on a cholangiography.3 Another example of how frequently cholangiograms might miss common duct stones is evident through the use of intraductal US, which may find as many as 38% of patients who have small stones (<5 mm) or sludge that was not seen on cholangiography.4 EUS has also been shown to be able to detect tiny stones that could be masked by contrast medium during the time of ERCP.5 When knowing that stones can be missed on ERC, perhaps the investigators are correct and a sphincterotomy with exploration of the duct with a basket or a balloon should be performed, even with a normal cholangiogram when there is a suspicion of a stone.

However, before it can be recommended to cut the sphincter of every patient with a suspected stone, the downside or negative aspects of performing empiric and sometimes unnecessary sphincterotomies need to be considered. ES, although a safe procedure in experienced hands, is not without complications. Bleeding from a sphincterotomy may range from 0.7% to 2.0% of cases, with mortality related to bleeding in the range of 0.08% to 0.1%.6, 7, 8 The majority of bleeding related to sphincterotomy is mild and can be managed conservatively, with or without additional endoscopic therapy. Perforation related to sphincterotomy in earlier studies9, 10 occurred in 0.8% of cases but was found to be less common and closer to 0.35% in more recent studies.11 Again, although the majority of sphincterotomy-related perforations can be managed with conservative measures, it is very rare that a perforation secondary to cutting the biliary sphincter will lead to disastrous consequences, including death. Controversy continues to exist on how much the thermal injury of a sphincterotomy leads to pancreatitis. Most recent data suggest that a biliary sphincterotomy does not lead directly to pancreatitis.6, 12, 13 The presence of a common duct stone, in fact, does appear to be protective in preventing pancreatitis. The greatest risks of post-ERCP pancreatitis are patient related, with patients who have suspected sphincter of Oddi dysfunction or the indication for the ERCP being abdominal pain, which carries the highest risk for pancreatitis. ERCP and empiric sphincterotomy in patients who do not have stones on cholangiogram nor are they at high risk for stones are thus likely at greater risk of pancreatitis. Thus, overall, sphincterotomy is relatively safe, but complications do occur, and, if a complication occurs in a patient with a normal (no stone seen) duct, then the complications are harder to defend.

In addition to immediate complications, there has been a concern about the long-term effect of the ablation of the sphincter after a sphincterotomy. Whereas, the investigators suggest that sphincterotomy can reduce future episodes of cholangitis, other studies that examined the long-term impact of sphincterotomy, particularly in young people, noted that sphincterotomy can lead to recurrent biliary symptoms and, in particular, recurrent choledocholithiasis, in as many as 10% of patients.14, 15 Although 10% is an acceptably low number in patients who have had documented common duct stones that needed to be removed, it may be considered a relatively high long-term complication rate for a sphincterotomy that was performed without a stone even seen in the duct on cholangiogram and for a sphincterotomy that may have had little clinical benefit for the patient.

Three previous studies examined the issue of an ES with an inconclusive cholangiogram before the present study by Lee et al1 and found mixed results. Johnston et al16 found that, in 20 patients, sphincterotomy performed for a suspected stone but no stone seen on cholangiogram did not reduce future biliary problems but instead increased procedure-related patient morbidity. Siddique et al17 studied 78 patients who had a sphincterotomy despite a normal cholangiogram and found 25% to have small stones not seen on cholangiogram. However, even though more stones were seen and removed by performing the sphincterotomy, biliary symptoms were not decreased compared with a control group, and the sphincterotomy group had more procedure-related complications, which suggests that removing the small stones not seen on cholangiography might not make a clinical difference except for increasing the complication risk to the patient. Finally, in the one existing study that supported an empiric sphincterotomy, Brand et al18 found biliary-related pain to be reduced after a sphincterotomy in patients with a normal cholangiogram but suspected stones but did not address the impact of sphincterotomy on subsequent development of cholangitis in these patients.

The present article by Lee et al1 further supports the idea that an ES may be beneficial in certain situations, even with a normal cholangiogram. However, the practice should still be recommended with caution and only in a select group of patients. One issue with the data presented by Lee et al1 in their article is whether it is applicable to a Western population. In Western populations, approximately 95% of patients with common duct stones have stones in the gallbladder as well.19, 20, 21 Only 20% of patients in the study by Lee et al1 had a cholecystectomy after an ES, and only 25% had gallbladder stones at the time that there was a suspicion of a common duct stone. Thus, choledocholithiasis in the West, where the majority of common duct stones migrate from the gallbladder, is likely not the same thing as choledocholithiasis in Asia, where most common duct stones are primarily intraductal. With significantly less de novo common duct stones forming in Western populations, it may be that an empiric sphincterotomy for suspected stones but a normal cholangiogram may be of less benefit, particularly if there is the concomitant presence of cholelithiasis and the gallbladder is subsequently removed.

Of more importance in judging the clinical relevancy of the study by Lee et al1 is to closely examine the patient selection in the study. Patients included were not patients at moderate clinical risk for having a stone or even just a high-risk group for choledocholithiasis22, 23 but rather could be classified as extremely high-risk patients for having common duct stones. All the patients had clinical cholangitis and elevated bilirubin or alkaline phosphatase, CBD dilatation, or a possible stone seen on another imaging study. The patients who had a sphincterotomy had a mean bilirubin of 4.0 mg/dL (reference range 0.0-1.4 mg/dL), a mean alkaline phosphatase of 250 U/L (35-130 U/L), and a mean ductal dilatation of almost 12 mm. These patients are not the patients with mildly elevated transaminases, intermittent abdominal pain, and stones seen in the gallbladder that, in the United States, comprise a large number of patients who may be referred for consideration of an ERCP before cholecystectomy. The patients in the study by Lee et al1 are the patients you are almost sure have a stone before doing an ERCP. They had a very high pretest probability of having choledocholithiasis and presented with cholangitis, clinically making the cutting of a sphincterotomy without cholangiography evidence of a stone perhaps more justifiable.

Does the present article by Lee et al1 then alter practice and make it permissible or at least defensible to perform an ES in stone cases solely based on clinical suspicion, despite negative ERC imaging? What the study by Lee et al1 does do is give the first clinical evidence that performing a sphincterotomy without stones seen on cholangiogram can provide a clinical benefit in a very select group of patients. What the study does not do is justify cutting a sphincterotomy when the clinical suspicion for a stone is only low or moderate. Performing an empiric sphincterotomy just because you feel the patient probably has or had a stone, though commonly practiced, still does not have much or even any clinical data to back it up. Continue to use and trust your cholangiogram as the primary guide in the decision to cut a sphincterotomy, because this remains a highly accurate test for choledocholithiasis, with sensitivities well over 90% and approaching 100%. ERCP should not automatically equal a sphincterotomy in all suspected stone cases. A sphincterotomy should obviously be performed when a filling defect is seen, and now there is some evidence it may be acceptable when a patient presents with cholangitis and, in addition, when, by biochemical measures, ductal dilatation, and noninvasive imaging, there is a very high chance of having a common duct stone even when a stone is not detected by ERCP.

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• 【规培笔记128】—工作报告偶遇，颅脑MR，您能看出几处异常？据说工作中很罕见！

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本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。

2008-01-09 19:21

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• 新型冠状病毒肺炎疫情下的基层医疗卫生发展策略

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Cutting the sphincter in the presence of a normal cholangiogram
正常胆管造影亦需括约肌切开术？
Patrick R. Pfau, MD

Abbreviations: CBD, common bile duct, ERC, endoscopic retrograde cholangiogram, ES, endoscopic sphincterotomy
Article Outline
• Disclosure

• References

• Copyright

Performing an empiric sphincterotomy just because you feel the patient probably has or had a stone, though commonly practiced, still does not have much or even any clinical data to back it up.对疑有结石的患者行经验性的括约肌切开术，虽然普遍都这么做，但目前尚没有临床数据支持。

Perhaps there is nothing more satisfying in the world of GI endoscopy than performing an ERCP with sphincterotomy and stone extraction. The patient presents with pain and fever and is visibly jaundiced, a filling defect is seen on cholangiogram, a large sphincterotomy is made, and then a stone and possibly even some pus is pulled from the bile duct. The patient immediately feels better and the endoscopist can emphatically state, “Yes, I have accomplished something today.”或许在胃肠内镜的世界里，没有什么比行ERCP并括约肌切开及取石术更让人满意了。当患者出现腹痛，发热以及黄疸时，而行胆管造影结果却是阴性时，随后行括约肌切开术通常能从胆管中取出一个或者多个结石。患者症状马上缓解同时内镜医师会自豪的说“是的，今天我做的很好”。

However, biliary endoscopy, like life, is not always so straightforward. Sometimes the patient looks and smells just like a common duct stone but no filling defect or stone is seen in the biliary tree on cholangiogram. What to do in this situation? Cut the sphincter and sweep and explore the duct or trust your cholangiogram and not cut the sphincter?然而，正如生命一样，胆道内镜检查并非总是一帆风顺的。有时，患者症状象总胆管结石，但是胆管造影在胆管分支未见充盈缺损。在这种情况下我们该怎么办？切开括约肌清除胆管还是坚持胆管造影的结果不进行括约肌切开。

This is the topic that Lee et al1 addressed in a study that examined whether endoscopic sphincterotomy (ES) reduces subsequent biliary symptoms, particularly future episodes of cholangitis, in patients who have a high pretest probability and a clinical suspicion of choledocholithiasis before the ERCP is performed but when no actual stones are seen on fluoroscopy at the time of the endoscopic retrograde cholangiogram (ERC).这些正是李等人的研究主题：即判断内镜下括约肌切开术是否能降低随后的胆道症状，尤其是对于在行ERCP之前行ERC未发现明确的结石而伴发生胆石症的高风险因素并临床上高度怀疑胆管炎的患者，是否降低胆管炎复发率。

Lee et al1 retrospectively examined 117 patients who had cholangitis, defined as fever, abdominal pain, and jaundice, and a high probability of a common duct stone defined as 2 or more of the following: (1) bilirubin greater than or equal to 2 mg/dL or alkaline phosphatase greater than or equal to twice the normal value, (2) a common bile duct (CBD) dilated to 8 mm or larger, (3) the presence of high-density material in the duct on other imaging but no stone seen on cholangiogram at the time of ERCP. They then followed the patients to see if they had further bouts of cholangitis and examined whether the variables of age, sex, dilated CBD; the presence of a periampullary diverticulum; the presence of a gallbladder; the presence of gallbladder stones; or the performance of a sphincterotomy predicted future recurrent episodes of cholangitis.李等人回顾了117个胆管炎患者，判断指标有发热，腹痛，黄疸，有至少2个发生胆总管结石的高风险因素，（1）胆红素>=2mg\dL或者碱性磷酸酶》=2倍正常（2）总胆管直径>=8mm（3）在ERCP中胆管造影未发现结石，但是在其他影像检查中发现高密度影。他们对这些患者进行随访以判断是否发展成胆管炎以及调查其年龄性别的变异以及总胆管是否扩张；是否存在壶腹周围栖室；胆囊是否存在；是否有胆囊结石或者是否为了预防再发胆管炎而行括约肌切开术。
On univariate analysis, a dilated duct >12 mm, the presence of gallbladder stones, and whether a sphincterotomy was performed all were predictors of recurring cholangitis. On multivariate analysis, only the performance of a sphincterotomy was shown to affect recurring cholangitis, with lower rates of cholangitis found in the sphincterotomy group at 1 and 3 years, and a cholangitis recurrence rate of 9.2% if a sphincterotomy was performed versus 52.1% if a sphincterotomy was not performed after 5 years of follow-up. The investigators thus concluded that ES reduced cholangitis in patients, with 1 documented attack of cholangitis and a high risk of stones even when no stones were seen on cholangiogram. This leads to the suggestion that, even in the absence of a stone, a sphincterotomy should be performed in select patients.用单变量分析，胆道直径>12mm，胆囊结石以及是否行括约肌切开术是再发胆管炎的预测指标。在多变量分析中，研究显示仅括约肌切开术对再发胆管炎有影响。研究数据显示：在行括约肌切开术组中在其后的1和3年随访中胆管炎的发生率较低，在其后的5年随访中，行括约肌切开术组中胆管炎的复发率是9.2%，而未行括约肌切开术组中是52.1%。研究者下结论为：ES能降低患者的胆管炎复发率，这样的患者包括有一次胆管炎发作史以及行胆管造影未发现结石而有发生结石的高危因素。因此，即便没有发现结石也应该有选择的行括约肌切开术。

Empiric sphincterotomy when a stone is suspected but not seen in the duct is already likely highly practiced in the real world. But should we be ignoring our cholangiograms and relying just on clinical suspicion when making the decision to cut a sphincterotomy in patients with possible stone disease? Are there data to support performing sphincterotomy with normal cholangiograms? Does the present study by Lee et al1 support this practice?事实上，对疑有结石而在胆道未发现结石的患者行经验性的括约肌切开术已经实施已久了。但是我们是否应该忽略胆管造影结果而仅仅依赖疑诊而对结石症患者行括约肌切开术呢？对正常胆管造影的患者行括约肌切开术有证据支持么？由李等人所做的这项研究支持这种做法么？

The main reason to perform a sphincterotomy for a suspected stone but with a normal cholangiogram is the fact that you do not trust your cholangiogram and believe that a small stone or even sludge is present in the duct despite imaging. 对疑有结石而胆管造影正常的患者行括约肌切开术的主要原因是你不相信胆管造影结果而相信胆道有小的结石或者胆泥。We consider a cholangiography the criterion standard, but a cholangiogram at the time of ERC is not a perfect study, and every practitioner has dragged a stone out of the duct that was not seen on a cholangiography. The best evidence suggests that ERC for choledocholithiasis is not perfect and has sensitivities that range from 90% to 100%.2 In comparison, a choledochoscopy, which allows direct visualization inside the ducts, has shown that stones can be missed on a cholangiography.3 Another example of how frequently cholangiograms might miss common duct stones is evident through the use of intraductal US, which may find as many as 38% of patients who have small stones (<5 mm) or sludge that was not seen on cholangiography.4 EUS has also been shown to be able to detect tiny stones that could be masked by contrast medium during the time of ERCP.5 When knowing that stones can be missed on ERC, perhaps the investigators are correct and a sphincterotomy with exploration of the duct with a basket or a balloon should be performed, even with a normal cholangiogram when there is a suspicion of a stone.考虑到胆管造影的诊断标准，胆道造影并非是一个完美的诊断，因为术者可以从胆管造影阴性的患者的胆道中取出结石。最好的证据表明：对胆总管炎患者行ERC并非完美，敏感性是90%--100%。与之对比，胆管镜能够直接观察到胆道，它能看到胆管造影阴性的结石。另外胆管内超声会发现<5mm结石的38%患者或者胆管造影阴性的胆泥，这样就能知道胆管造影错过多少胆道内结石。在ERCP期间超声内镜也能发现被对比媒介掩盖的微小结石。因为知道ERC能够错过结石，操作者行括约肌切开术是正确的，他们用网篮或者球囊来清理胆道，即便是正常的胆道造影而疑有胆石的患者。

However, before it can be recommended to cut the sphincter of every patient with a suspected stone, the downside or negative aspects of performing empiric and sometimes unnecessary sphincterotomies need to be considered. ES, although a safe procedure in experienced hands, is not without complications. Bleeding from a sphincterotomy may range from 0.7% to 2.0% of cases, with mortality related to bleeding in the range of 0.08% to 0.1%.6, 7, 8 The majority of bleeding related to sphincterotomy is mild and can be managed conservatively, with or without additional endoscopic therapy. Perforation related to sphincterotomy in earlier studies9, 10 occurred in 0.8% of cases but was found to be less common and closer to 0.35% in more recent studies.11 Again, although the majority of sphincterotomy-related perforations can be managed with conservative measures, it is very rare that a perforation secondary to cutting the biliary sphincter will lead to disastrous consequences, including death. Controversy continues to exist on how much the thermal injury of a sphincterotomy leads to pancreatitis. Most recent data suggest that a biliary sphincterotomy does not lead directly to pancreatitis.6, 12, 13 The presence of a common duct stone, in fact, does appear to be protective in preventing pancreatitis. The greatest risks of post-ERCP pancreatitis are patient related, with patients who have suspected sphincter of Oddi dysfunction or the indication for the ERCP being abdominal pain, which carries the highest risk for pancreatitis. ERCP and empiric sphincterotomy in patients who do not have stones on cholangiogram nor are they at high risk for stones are thus likely at greater risk of pancreatitis. Thus, overall, sphincterotomy is relatively safe, but complications do occur, and, if a complication occurs in a patient with a normal (no stone seen) duct, then the complications are harder to defend.然而，在推荐对每一个怀疑结石的患者行括约肌切开术之前，应该考虑到行经验性或者没必要的括约肌切开术的负面。对于有经验的内镜医师来说，ES是安全的，但是它并非没有并发症的。括约肌切开术出血的发生率为0.7%--2.0%，出血相关死亡率是0.008%--0.1%。多数括约肌切开术出血的是轻度的，并能够做适当的处理，用或者不用内镜处置。早期研究中穿孔占0.8%但穿孔并发症罕见，在近期的研究中是0.35%。尽管括约肌切开相关的穿孔可以内科保守治疗，但是继发于胆道括约肌切开的穿孔会导致严重的后果，甚至会死亡，虽然这种并发症极为罕见。在括约肌切开术热损害所导致的胰腺炎问题上仍存争议。最近研究数据表明括约肌切开并不能直接导致胰腺炎。事实上，胆总管结石也能导致导致胰腺炎。ERCP后胰腺炎的最危险因素是患者相关的，即怀疑有Oddis括约肌失调或者有行ERCP的适应症的腹痛患者有较大风险发生胰腺炎。对胆管造影阴性而有高风险发生胆石症因素的患者行ERCP和括约肌切开术很可能发生胰腺炎。所以，括约肌切开术还是比较安全的但是也存在并发症。如果在胆道正常的患者发生了并发症，那么并发症是很难处置的。

In addition to immediate complications, there has been a concern about the long-term effect of the ablation of the sphincter after a sphincterotomy. Whereas, the investigators suggest that sphincterotomy can reduce future episodes of cholangitis, other studies that examined the long-term impact of sphincterotomy, particularly in young people, noted that sphincterotomy can lead to recurrent biliary symptoms and, in particular, recurrent choledocholithiasis, in as many as 10% of patients.14, 15 Although 10% is an acceptably low number in patients who have had documented common duct stones that needed to be removed, it may be considered a relatively high long-term complication rate for a sphincterotomy that was performed without a stone even seen in the duct on cholangiogram and for a sphincterotomy that may have had little clinical benefit for the patient.除了急性并发症，我们还应该关注括约肌切开术后的括约肌消融的远期影响。然而，研究者认为括约肌切开术能够降低胆管炎的复发。旨在评估括约肌切开术的后期影响（尤其在年轻人）的研究表明括约肌切开术可以导致胆道症状的复发，尤其是胆管炎的复发（约占10%）。虽然10%对于需要取石的患者来说是个可以接受的数字，但是对于胆管造影发现结石而行括约肌切开术未发现结石的患者以及括约肌切开术有很小的临床益处的患者来说，10%仍是一个相对高的远期并发症发生率。

Three previous studies examined the issue of an ES with an inconclusive cholangiogram before the present study by Lee et al1 and found mixed results. Johnston et al16 found that, in 20 patients, sphincterotomy performed for a suspected stone but no stone seen on cholangiogram did not reduce future biliary problems but instead increased procedure-related patient morbidity. Siddique et al17 studied 78 patients who had a sphincterotomy despite a normal cholangiogram and found 25% to have small stones not seen on cholangiogram. However, even though more stones were seen and removed by performing the sphincterotomy, biliary symptoms were not decreased compared with a control group, and the sphincterotomy group had more procedure-related complications, which suggests that removing the small stones not seen on cholangiography might not make a clinical difference except for increasing the complication risk to the patient. Finally, in the one existing study that supported an empiric sphincterotomy, Brand et al18 found biliary-related pain to be reduced after a sphincterotomy in patients with a normal cholangiogram but suspected stones but did not address the impact of sphincterotomy on subsequent development of cholangitis in these patients.在李等人所做的研究之前，旨在评估对不确定的胆管造影结果行ES的三个研究发现了混合的结果。Johnston等人研究发现：在被纳入研究的20个患者中，对疑有胆结石而胆管造影阴性的患者行括约肌切开术并不能降低远期胆道疾病的发生而是增加了操作相关的疾病发生率。Siddique等人研究了78名胆管造影阴性的行括约肌切开术患者，他们发现其中25%患者有小结石。然而，尽管行括约肌切开术能够看到结石并能取出，但是与对照组相比，胆道并发症并未增加并且括约肌切开术组有更多的操作相关的并发症。这些表明取出胆管造影未见的小结石除了增加临床并发症之外并未使患者受益。最后， Brand 等人所做的研究支持经验性的括约肌切除术，他们发现对疑有胆石症的但有正常的胆道造影患者在行括约肌切除术后胆道相关的腹痛减轻了，但是他们并没有指出括约肌切开术对患者随后的胆管炎的影响。

The present article by Lee et al1 further supports the idea that an ES may be beneficial in certain situations, even with a normal cholangiogram. However, the practice should still be recommended with caution and only in a select group of patients. One issue with the data presented by Lee et al1 in their article is whether it is applicable to a Western population. In Western populations, approximately 95% of patients with common duct stones have stones in the gallbladder as well.19, 20, 21 Only 20% of patients in the study by Lee et al1 had a cholecystectomy after an ES, and only 25% had gallbladder stones at the time that there was a suspicion of a common duct stone. Thus, choledocholithiasis in the West, where the majority of common duct stones migrate from the gallbladder, is likely not the same thing as choledocholithiasis in Asia, where most common duct stones are primarily intraductal. With significantly less de novo common duct stones forming in Western populations, it may be that an empiric sphincterotomy for suspected stones but a normal cholangiogram may be of less benefit, particularly if there is the concomitant presence of cholelithiasis and the gallbladder is subsequently removed.由李等人撰写的论文支持这样的观点，即ES即便在正常胆管造影患者中在某些情况下也是有益的。然而，指南还应谨慎推出并且仅仅适用于某些患者。另外由李等人所做的论文数据是否也应用于西方人口。在西方总胆管结石患者中95%同时伴有胆囊结石。在李等人的研究中，仅20%患者在ES后行胆管造影，发现25%患者同时伴有胆囊结石。这样，西方的胆管炎与亚洲的胆管炎不太一样，因为西方的患者同时伴有胆囊结石而亚洲患者主要是总胆管结石。因为在西方人中有很明显的总胆管结石形成，所以经验性的括约肌切开术可能会使正常胆管造影而疑诊胆石症的患者受益较小。尤其是伴有胆管炎以及胆囊切除的患者。
Of more importance in judging the clinical relevancy of the study by Lee et al1 is to closely examine the patient selection in the study. Patients included were not patients at moderate clinical risk for having a stone or even just a high-risk group for choledocholithiasis22, 23 but rather could be classified as extremely high-risk patients for having common duct stones. All the patients had clinical cholangitis and elevated bilirubin or alkaline phosphatase, CBD dilatation, or a possible stone seen on another imaging study. The patients who had a sphincterotomy had a mean bilirubin of 4.0 mg/dL (reference range 0.0-1.4 mg/dL), a mean alkaline phosphatase of 250 U/L (35-130 U/L), and a mean ductal dilatation of almost 12 mm.在判断李等人所做研究的临床相关性上，最重要的是经过仔细的检查选择合适的患者。这些患者并不包括有中等患有胆石症风险因素的和高等患有胆管炎因素的患者，而是有极高患有总胆管结石风险因素的患者。这些患者必须有临床胆管炎，升高的胆红素和碱性磷酸酶，CBD扩张和在其他的的影像学检查可以看到可能的结石。这些患者其平均胆红素4.0mg\dl（正常值是0.0--1.4）平均碱性磷酸酶是250U\L（35--130），平均胆管直径为12mm.These patients are not the patients with mildly elevated transaminases, intermittent abdominal pain, and stones seen in the gallbladder that, in the United States, comprise a large number of patients who may be referred for consideration of an ERCP before cholecystectomy. 这些患者并非是轻度的转氨酶升高，间歇性的腹痛并胆囊内可见结石，在美国，这样的患者占了一大部分，因此对其行括约肌切除术之前应行ERCP.The patients in the study by Lee et al1 are the patients you are almost sure have a stone before doing an ERCP. They had a very high pretest probability of having choledocholithiasis and presented with cholangitis, clinically making the cutting of a sphincterotomy without cholangiography evidence of a stone perhaps more justifiable.由李等人所做的研究所纳入的患者是在行ERCP之前几乎可以肯定有结石。这些患者有很大的可能性患有胆总管炎以及胆管炎，这使得胆管造影阴性而行括约肌切开术可能更加合理。
Does the present article by Lee et al1 then alter practice and make it permissible or at least defensible to perform an ES in stone cases solely based on clinical suspicion, despite negative ERC imaging? What the study by Lee et al1 does do is give the first clinical evidence that performing a sphincterotomy without stones seen on cholangiogram can provide a clinical benefit in a very select group of patients. What the study does not do is justify cutting a sphincterotomy when the clinical suspicion for a stone is only low or moderate. Performing an empiric sphincterotomy just because you feel the patient probably has or had a stone, though commonly practiced, still does not have much or even any clinical data to back it up. Continue to use and trust your cholangiogram as the primary guide in the decision to cut a sphincterotomy, because this remains a highly accurate test for choledocholithiasis, with sensitivities well over 90% and approaching 100%. ERCP should not automatically equal a sphincterotomy in all suspected stone cases. A sphincterotomy should obviously be performed when a filling defect is seen, and now there is some evidence it may be acceptable when a patient presents with cholangitis and, in addition, when, by biochemical measures, ductal dilatation, and noninvasive imaging, there is a very high chance of having a common duct stone even when a stone is not detected by ERCP. 由李等人所做的研究是否能改变指南或者在ERC造影阴性临床疑诊胆石症的患者行预防性的ES呢？由李等人所做的研究用第一手的临床资料来证明：在胆管造影阴性的合适的患者中行括约肌切开术是有益的。但是研究没有证明：有低到中度的胆管结石危险因素的患者中行括约肌切开术是否有益。对疑诊胆石症患者中行经验性的括约肌切开术，虽然普遍都这么做，但是临床证据仍不足。在决定切开括约肌时候应应用并相信胆道造影结果，因为胆道造影对胆石症仍有很高的特异性，敏感度〉90%接近100%。在疑诊胆石症的患者中，ERCP不能等同于括约肌切开术。造影有明显的充盈缺损是行括约肌切开术较强的指证，对于生化指标，胆道扩张以及非侵入性影像检查提示胆管炎并ERCP阴性但是有高风险患总胆管结石因素的患者中也可以行括约肌切开术。

2008-01-10 09:57

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• 恒生医院处理压疮最新方式:白天康复，晚上纱布负压引流，效果也是杠杠滴

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正常胆管造影亦需括约肌切开术？
Patrick R. Pfau, MD

对疑有结石的患者行经验性的括约肌切开术，虽然普遍都这么做，但目前尚没有临床数据支持。

或许在胃肠内镜的世界里，没有什么比行ERCP并括约肌切开及取石术更让人满意了。当患者出现腹痛，发热以及黄疸时，而行胆管造影结果却是阴性时，随后行括约肌切开术通常能从胆管中取出一个或者多个结石。患者症状马上缓解同时内镜医师会自豪的说“是的，今天我做的很好”。

然而，正如生命一样，胆道内镜检查并非总是一帆风顺的。有时，患者症状象总胆管结石，但是胆管造影在胆管分支未见充盈缺损。在这种情况下我们该怎么办？切开括约肌清除胆管还是坚持胆管造影的结果不进行括约肌切开。

这些正是李等人的研究主题：即判断内镜下括约肌切开术是否能降低随后的胆道症状，尤其是对于在行ERCP之前行ERC未发现明确的结石而伴发生胆石症的高风险因素并临床上高度怀疑胆管炎的患者，是否降低胆管炎复发率。

李等人回顾了117个胆管炎患者，判断指标有发热，腹痛，黄疸，有至少2个发生胆总管结石的高风险因素，（1）胆红素>=2mg\dL或者碱性磷酸酶》=2倍正常（2）总胆管直径>=8mm（3）在ERCP中胆管造影未发现结石，但是在其他影像检查中发现高密度影。他们对这些患者进行随访以判断是否发展成胆管炎以及调查其年龄性别的变异以及总胆管是否扩张；是否存在壶腹周围栖室；胆囊是否存在；是否有胆囊结石或者是否为了预防再发胆管炎而行括约肌切开术。
用单变量分析，胆道直径>12mm，胆囊结石以及是否行括约肌切开术是再发胆管炎的预测指标。在多变量分析中，研究显示仅括约肌切开术对再发胆管炎有影响。研究数据显示：在行括约肌切开术组中在其后的1和3年随访中胆管炎的发生率较低，在其后的5年随访中，行括约肌切开术组中胆管炎的复发率是9.2%，而未行括约肌切开术组中是52.1%。研究者下结论为：ES能降低患者的胆管炎复发率，这样的患者包括有一次胆管炎发作史以及行胆管造影未发现结石而有发生结石的高危因素。因此，即便没有发现结石也应该有选择的行括约肌切开术。

事实上，对疑有结石而在胆道未发现结石的患者行经验性的括约肌切开术已经实施已久了。但是我们是否应该忽略胆管造影结果而仅仅依赖疑诊而对结石症患者行括约肌切开术呢？对正常胆管造影的患者行括约肌切开术有证据支持么？由李等人所做的这项研究支持这种做法么？

对疑有结石而胆管造影正常的患者行括约肌切开术的主要原因是你不相信胆管造影结果而相信胆道有小的结石或者胆泥。.考虑到胆管造影的诊断标准，胆道造影并非是一个完美的诊断，因为术者可以从胆管造影阴性的患者的胆道中取出结石。最好的证据表明：对胆总管炎患者行ERC并非完美，敏感性是90%--100%。与之对比，胆管镜能够直接观察到胆道，它能看到胆管造影阴性的结石。另外胆管内超声会发现<5mm结石的38%患者或者胆管造影阴性的胆泥，这样就能知道胆管造影错过多少胆道内结石。在ERCP期间超声内镜也能发现被对比媒介掩盖的微小结石。因为知道ERC能够错过结石，操作者行括约肌切开术是正确的，他们用网篮或者球囊来清理胆道，即便是正常的胆道造影而疑有胆石的患者。

然而，在推荐对每一个怀疑结石的患者行括约肌切开术之前，应该考虑到行经验性或者没必要的括约肌切开术的负面。对于有经验的内镜医师来说，ES是安全的，但是它并非没有并发症的。括约肌切开术出血的发生率为0.7%--2.0%，出血相关死亡率是0.008%--0.1%。多数括约肌切开术出血的是轻度的，并能够做适当的处理，用或者不用内镜处置。早期研究中穿孔占0.8%但穿孔并发症罕见，在近期的研究中是0.35%。尽管括约肌切开相关的穿孔可以内科保守治疗，但是继发于胆道括约肌切开的穿孔会导致严重的后果，甚至会死亡，虽然这种并发症极为罕见。在括约肌切开术热损害所导致的胰腺炎问题上仍存争议。最近研究数据表明括约肌切开并不能直接导致胰腺炎。事实上，胆总管结石也能导致导致胰腺炎。ERCP后胰腺炎的最危险因素是患者相关的，即怀疑有Oddis括约肌失调或者有行ERCP的适应症的腹痛患者有较大风险发生胰腺炎。对胆管造影阴性而有高风险发生胆石症因素的患者行ERCP和括约肌切开术很可能发生胰腺炎。所以，括约肌切开术还是比较安全的但是也存在并发症。如果在胆道正常的患者发生了并发症，那么并发症是很难处置的。

除了急性并发症，我们还应该关注括约肌切开术后的括约肌消融的远期影响。然而，研究者认为括约肌切开术能够降低胆管炎的复发。旨在评估括约肌切开术的后期影响（尤其在年轻人）的研究表明括约肌切开术可以导致胆道症状的复发，尤其是胆管炎的复发（约占10%）。虽然10%对于需要取石的患者来说是个可以接受的数字，但是对于胆管造影发现结石而行括约肌切开术未发现结石的患者以及括约肌切开术有很小的临床益处的患者来说，10%仍是一个相对高的远期并发症发生率。

在李等人所做的研究之前，旨在评估对不确定的胆管造影结果行ES的三个研究发现了混合的结果。Johnston等人研究发现：在被纳入研究的20个患者中，对疑有胆结石而胆管造影阴性的患者行括约肌切开术并不能降低远期胆道疾病的发生而是增加了操作相关的疾病发生率。Siddique等人研究了78名胆管造影阴性的行括约肌切开术患者，他们发现其中25%患者有小结石。然而，尽管行括约肌切开术能够看到结石并能取出，但是与对照组相比，胆道并发症并未增加并且括约肌切开术组有更多的操作相关的并发症。这些表明取出胆管造影未见的小结石除了增加临床并发症之外并未使患者受益。最后， Brand 等人所做的研究支持经验性的括约肌切除术，他们发现对疑有胆石症的但有正常的胆道造影患者在行括约肌切除术后胆道相关的腹痛减轻了，但是他们并没有指出括约肌切开术对患者随后的胆管炎的影响。

由李等人撰写的论文支持这样的观点，即ES即便在正常胆管造影患者中在某些情况下也是有益的。然而，指南还应谨慎推出并且仅仅适用于某些患者。另外由李等人所做的论文数据是否也应用于西方人口。在西方总胆管结石患者中95%同时伴有胆囊结石。在李等人的研究中，仅20%患者在ES后行胆管造影，发现25%患者同时伴有胆囊结石。这样，西方的胆管炎与亚洲的胆管炎不太一样，因为西方的患者同时伴有胆囊结石而亚洲患者主要是总胆管结石。因为在西方人中有很明显的总胆管结石形成，所以经验性的括约肌切开术可能会使正常胆管造影而疑诊胆石症的患者受益较小。尤其是伴有胆管炎以及胆囊切除的患者。
在判断李等人所做研究的临床相关性上，最重要的是经过仔细的检查选择合适的患者。这些患者并不包括有中等患有胆石症风险因素的和高等患有胆管炎因素的患者，而是有极高患有总胆管结石风险因素的患者。这些患者必须有临床胆管炎，升高的胆红素和碱性磷酸酶，CBD扩张和在其他的的影像学检查可以看到可能的结石。这些患者其平均胆红素4.0mg\dl（正常值是0.0--1.4）平均碱性磷酸酶是250U\L（35--130），平均胆管直径为12mm.这些患者并非是轻度的转氨酶升高，间歇性的腹痛并胆囊内可见结石，在美国，这样的患者占了一大部分，因此对其行括约肌切除术之前应行ERCP.由李等人所做的研究所纳入的患者是在行ERCP之前几乎可以肯定有结石。这些患者有很大的可能性患有胆总管炎以及胆管炎，这使得胆管造影阴性而行括约肌切开术可能更加合理。
由李等人所做的研究是否能改变指南或者在ERC造影阴性临床疑诊胆石症的患者行预防性的ES呢？由李等人所做的研究用第一手的临床资料来证明：在胆管造影阴性的合适的患者中行括约肌切开术是有益的。但是研究没有证明：有低到中度的胆管结石危险因素的患者中行括约肌切开术是否有益。对疑诊胆石症患者中行经验性的括约肌切开术，虽然普遍都这么做，但是临床证据仍不足。在决定切开括约肌时候应应用并相信胆道造影结果，因为胆道造影对胆石症仍有很高的特异性，敏感度〉90%接近100%。在疑诊胆石症的患者中，ERCP不能等同于括约肌切开术。造影有明显的充盈缺损是行括约肌切开术较强的指证，对于生化指标，胆道扩张以及非侵入性影像检查提示胆管炎并ERCP阴性但是有高风险患总胆管结石因素的患者中也可以行括约肌切开术。
总3107字

2008-01-10 10:01

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sige511 编辑于 2008-01-10 10:05

• 恒生医院处理压疮最新方式:白天康复，晚上纱布负压引流，效果也是杠杠滴

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