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【文摘发布】急性胆源性胰腺炎与胆胰梗阻的早期内镜干预或保守治疗的RCT研究

Title: Early endoscopic intervention versus early conservative management in patients with acute gallstone pancreatitis and biliopancreatic obstruction: a randomized clinical trial.

Author:Oria A, Cimmino D, Ocampo C, Silva W, Kohan G, Zandalazini H, Szelagowski C, Chiappetta L.

Resource: Ann Surg. 2007 Jan;245(1):10-7

Abstract: OBJECTIVE: To test the hypothesis that early endoscopic intervention, performed on patients with acute gallstone pancreatitis and biliopancreatic obstruction, reduces systemic and local inflammation. SUMMARY BACKGROUND DATA: The role of early endoscopic intervention, in the treatment of acute gallstone pancreatitis, remains controversial. Previous randomized trials have not focused on the subgroup of patients with clinical evidence of biliopancreatic obstruction. METHODS: This single-center randomized clinical trial was performed between May 2000 and September 2005. Of 238 patients, admitted within 48 hours after the onset of acute gallstone pancreatitis, 103 with a distal bile duct measuring > or =8 mm combined with a total serum bilirubin > or =1.20 mg/dL, were randomized to receive either endoscopic retrograde cholangiopancreatography followed by endoscopic papillotomy for bile duct stones (EEI, n = 51) or early conservative management (ECM, n = 52). Patients with clinical evidence of coexisting acute cholangitis were excluded. Outcome measures included changes in organ failure score and computed tomography (CT) severity index during the first week after admission, incidence of local complications, and overall morbidity and mortality. RESULTS: The incidence of bile duct stones at EEI was 72% and 40% of patients in the ECM group had persisting bile duct stones at elective biliary surgery. No significant differences were found between the EEI and ECM groups regarding changes in mean organ failure score (P = 0.87), mean CT severity index (P = 0.88), incidence of local complications (6% vs. 6%, P = 0.99), overall morbidity (21% vs. 18%, P = 0.80), and mortality (6% vs. 2%, P = 1). CONCLUSIONS: The present study failed to provide evidence that early endoscopic intervention reduces systemic and local inflammation in patients with acute gallstone pancreatitis and biliopancreatic obstruction. If acute cholangitis can be safely excluded, early endoscopic intervention is not mandatory and should not be considered a standard indication.

PMID:17197959
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Title: Early endoscopic intervention versus early conservative management in patients with acute gallstone pancreatitis and biliopancreatic obstruction: a randomized clinical trial.
题目:急性胆源性胰腺炎与胆胰梗阻的早期内镜干预或保守治疗的RCT研究

Author:Oria A, Cimmino D, Ocampo C, Silva W, Kohan G, Zandalazini H, Szelagowski C, Chiappetta L.
作者:Oria A, Cimmino D, Ocampo C, Silva W, Kohan G, Zandalazini H, Szelagowski C, Chiappetta L.
Resource: Ann Surg. 2007 Jan;245(1):10-7
来源:Ann Surg. 2007 Jan;245(1):10-7

Abstract: OBJECTIVE: To test the hypothesis that early endoscopic intervention, performed on patients with acute gallstone pancreatitis and biliopancreatic obstruction, reduces systemic and local inflammation.
摘要:目的:为了探讨急性胆源性胰腺炎与胆道梗阻患者的早期内镜干预治疗。

SUMMARY BACKGROUND DATA: The role of early endoscopic intervention, in the treatment of acute gallstone pancreatitis, remains controversial. Previous randomized trials have not focused on the subgroup of patients with clinical evidence of biliopancreatic obstruction.
主要的背景数据:急性胆源性胰腺炎的早期内镜干预治疗仍有争论。以前的随机试验并没有集中在具有临床依据的胆道梗阻患者。

METHODS: This single-center randomized clinical trial was performed between May 2000 and September 2005. Of 238 patients, admitted within 48 hours after the onset of acute gallstone pancreatitis, 103 with a distal bile duct measuring > or =8 mm combined with a total serum bilirubin > or =1.20 mg/dL, were randomized to receive either endoscopic retrograde cholangiopancreatography followed by endoscopic papillotomy for bile duct stones (EEI, n = 51) or early conservative management (ECM, n = 52). Patients with clinical evidence of coexisting acute cholangitis were excluded. Outcome measures included changes in organ failure score and computed tomography (CT) severity index during the first week after admission, incidence of local complications, and overall morbidity and mortality.
方法:从2000年5月到2005年9月之间采用单中心随机临床试验。急性胆源性胰腺炎发病后48小时内入院的238例患者中,103例远端胆管直经等于或大于8mm且血清总胆红素等于或大于1.20mg/dL的患者,随机分两组,一组先行内镜逆行胰胆管造影再行内镜下十二指肠乳头切开胆管取石术(EEI, n = 51),另一组行早期保守治疗(ECM, n = 52)。排除有临床证据的急性胆管炎。结果评价包括入院后的第一个星期内器官衰竭病改变评分和CT严重指数,局部并发症的发生率,及全部发病率和死亡率。

RESULTS: The incidence of bile duct stones at EEI was 72% and 40% of patients in the ECM group had persisting bile duct stones at elective biliary surgery. No significant differences were found between the EEI and ECM groups regarding changes in mean organ failure score (P = 0.87), mean CT severity index (P = 0.88), incidence of local complications (6% vs. 6%, P = 0.99), overall morbidity (21% vs. 18%, P = 0.80), and mortality (6% vs. 2%, P = 1).
结果: EEI组中胆管结石的发病率为72%,ECM组中有40%坚持胆管结石选择性手术治疗。关于平均器官衰竭病变评分(P = 0.87),平均CT严重指数(P = 0.88),局部并发症的发生率(6% vs. 6%, P = 0.99),所有的发病率(21% vs. 18%, P = 0.80),死亡率(6% vs. 2%, P = 1),这些都没有明显的差别。

CONCLUSIONS: The present study failed to provide evidence that early endoscopic intervention reduces systemic and local inflammation in patients with acute gallstone pancreatitis and biliopancreatic obstruction. If acute cholangitis can be safely excluded, early endoscopic intervention is not mandatory and should not be considered a standard indication.
结论:目前研究没有提供早期内镜干预是否减少急性胆石性胰腺炎和胆胰梗阻患者的全身和局部炎症的证据。如果能够完全地排除急性胆管炎,早期内镜干预是非强制性的而且也不应该被认为是一种标准适应症。
题目:急性胆源性胰腺炎与胆胰梗阻的早期内镜干预或保守治疗的RCT研究

作者:Oria A, Cimmino D, Ocampo C, Silva W, Kohan G, Zandalazini H, Szelagowski C, Chiappetta L.
来源:Ann Surg. 2007 Jan;245(1):10-7

摘要:目的:为了探讨急性胆源性胰腺炎与胆道梗阻患者的早期内镜干预治疗。

主要的背景数据:急性胆源性胰腺炎的早期内镜干预治疗仍有争论。以前的随机试验并没有集中在具有临床依据的胆道梗阻患者。

方法:从2000年5月到2005年9月之间采用单中心随机临床试验。急性胆源性胰腺炎发病后48小时内入院的238例患者中,103例远端胆管直经等于或大于8mm且血清总胆红素等于或大于1.20mg/dL的患者,随机分两组,一组先行内镜逆行胰胆管造影再行内镜下十二指肠乳头切开胆管取石术(EEI, n = 51),另一组行早期保守治疗(ECM, n = 52)。排除有临床证据的急性胆管炎。结果评价包括入院后的第一个星期内器官衰竭病改变评分和CT严重指数,局部并发症的发生率,及全部发病率和死亡率。

结果: EEI组中胆管结石的发病率为72%,ECM组中有40%坚持胆管结石选择性手术治疗。关于平均器官衰竭病变评分(P = 0.87),平均CT严重指数(P = 0.88),局部并发症的发生率(6% vs. 6%, P = 0.99),所有的发病率(21% vs. 18%, P = 0.80),死亡率(6% vs. 2%, P = 1),这些都没有明显的差别。

结论:目前研究没有提供早期内镜干预是否减少急性胆石性胰腺炎和胆胰梗阻患者的全身和局部炎症的证据。如果能够完全地排除急性胆管炎,早期内镜干预是非强制性的而且也不应该被认为是一种标准适应症。
这是一项非常有意义的研究.
有关急性胰腺炎的治疗,看来国内目前过度强调早期内镜治疗的价值了.
值得我们进一步研究和证实.
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