加贝酯预防ERCP术后胰腺炎的临床研究

目的探讨加贝酯预防ERCP术后胰腺炎、胰性腹痛和高淀粉酶血症的疗效和安全性.方法按随机双盲法将拟行ERCP术的患者分为加贝酯组和对照组.加贝酯组患者在ERCP术前0.5 h起开始静脉滴注加贝酯(300 mg加入林格氏液500 ml),维持4.5 h.对照组则仅静脉滴注林格氏液500 ml,也维持4.5 h.结果共有94例患者完成研究,其中加贝酯组48例,对照组46例.加贝酯组有3例(6.3%)、对照组有9例(19.6%)患者发生了胰腺炎(P = 0.040);高淀粉酶血症的发生率两组分别为12例(25.0%)和21例(45.7%)(P = 0.036);胰性腹痛的发生率两组分别为5例(10.4%)和14例(30.4%)(P = 0.016).结论以加贝酯总量300 mg持续4.5 h静脉滴注(术前0.5 h起给药)较安慰剂能有效减少ERCP术后胰腺炎发生率,减少高淀粉酶血症及胰性腹痛的发生.     

国产加贝酯预防ERCP术后胰腺炎的临床研究

目的探讨国产加贝酯预防ERCP术后胰腺炎、高淀粉酶血症和腹痛的疗效和安全性。方法按随机双盲法将拟行ERCP术的患者分为加贝酯组和对照组。加贝酯组患者在ERCP术前30～90min起开始静脉滴注加贝酯至术后12h为止，总剂量为1000mg。对照组仅静脉常规补液。结果共有77例患者完成研究，其中加贝酯组39例，对照组38例。加贝酯组有2例（5％）、对照组有8例（21％）患者发生了胰腺炎（P=0．038）；高淀粉酶血症的发生率两组分别为9例（23％）和18例（47％）（P=0．013）；腹痛的发生率两组分别为9例（23％）和13例（34％）（P=0．280）。结论加贝酯持续静脉滴注能有效减少ERCP术后胰腺炎发生率，减少高淀粉酶血症的发生。     

小剂量加贝酯预防ERCP术后胰腺炎及高淀粉酶血症的临床研究

目的 探讨小荆量加贝酯术前应用对内镜逆行胰胆管造影（ERCP）术后胰腺炎、高淀粉酶血症及其它并发症的预防作用。方法2005-03／2005-09我科进行ERCP术的63例病人，随机分为加贝酯组和安慰剂组，比较两组术后急性胰腺炎、高淀粉酶血症及其它并发症发生率的差异。结果 加贝酯组和安慰剂组胰腺炎发生率分别为7．41％和2．78％；术后高淀粉酶血症的发生率，矿别为55．56％和41．67％；两组间无显著差异；其它并发症如腹痛、腹胀、恶心、呕吐、出血等在两组间的发生率亦无显著差异。结论 ERCP术前应用小剂量加贝酯不能减轻术后高淀粉酶血症，也不能预防术后胰腺炎及其它并发症的发生。     

加贝酯在ERCP诊治术后的临床应用评价

目的观察加贝酯在预防ERCP术后引起的高淀粉酶血症和急性胰腺炎的有效性。方法两组行ERCP的病人,试验组应用加贝酯。观察试验组和对照组患者术后血清淀粉酶的变化。结果试验组术后高淀粉酶血症及急性胰腺炎发生率明显低于对照组(P<0.05)。结论加贝酯能有效预防ERCP术后高淀粉酶血症及急性胰腺炎的发生。     

静脉滴注丹参注射液预防ERCP术后高淀粉酶血症及急性胰腺炎的临床研究

目的探讨丹参注射液预防内镜逆行胰胆管造影(ERCP)术后高淀粉酶血症及胰腺炎的临床疗效。方法将100例胆总管结石需行ERCP术患者,随机分为观察组50例和对照组50例,两组患者ERCP术后给予常规鼻胆引流、抗感染、抑制胰酶分泌等治疗,观察组于ERCP术前及术后1 d,给予丹参注射液250 mL,2次/d,静脉滴注。分别于术前、术后3 h、24 h检测两组患者的血淀粉酶、脂肪酶水平、术后24 h CRP。统计术后高淀粉酶血症、胰腺炎发生率。结果两组患者术后3 h、24 h血淀粉酶明显高于术前,但观察组术后3 h、24 h血淀粉酶低于对照组同期水平(P0.05);观察组患者高淀粉酶血症发生率为42%(21/50),术后胰腺炎发生率为0%(0/50),对照组高淀粉酶血症发生率为80%(40/50),术后胰腺炎发生率为8%(4/50)。结论丹参注射液对ERCP术后高淀粉酶血症、胰腺炎有一定的预防作用。     

联合应用质子泵抑制剂、生长抑素和加贝酯预防ERCP术后胰腺炎和高淀粉酶血症的临床研究

背景：急性胰腺炎和高淀粉酶血症是内镜逆行胰胆管造影术（ERCP）的主要并发症,术前用药对预防和减轻并发症的作用尚存争议。目的：探讨联合应用质子泵抑制剂、生长抑素和加贝酯对ERCP术后胰腺炎（PEP）和高淀粉酶血症的预防作用。方法：共纳入510例行ERCP的患者,随机分为加贝酯组、生长抑素组、联合治疗组（质子泵抑制剂＋生长抑素＋加贝酯）和安慰剂组。观察术后2h、12h和24h血清淀粉酶水平,评估PEP和高淀粉酶血症的发生率．并分析PEP和高淀粉酶血症的危险因素。结果：ERCP术后2h、12h、24h,联合治疗组、生长抑素组和加贝酯组血清淀粉酶水平显著低于安慰剂组（P〈0．05或P〈0．01）,联合治疗组血清淀粉酶水平亦显著低于生长抑素组或加贝酯组（P〈0．05）。ERCP胰管显影者的PEP和高淀粉酶血症发生率显著高于胆管显影者（P〈0．05）。单变量分析显示ERCP操作过程中胰管多次显影、导丝多次插入胰管、导丝辅助、反复插管以及操作中发生上腹疼痛为PEP和高淀粉酶血症的技术相关性高危因素。结论：ERCP术前后联合应用质子泵抑制剂、生长抑素和加贝酯可改善PEP和高淀粉酶血症的发生。     

奥曲肽预防ERCP术后胰腺炎及高淀粉酶血症的多中心随机对照临床研究

目的 探讨奥曲肽预防ERCP术后胰腺炎和高淀粉酶血症的临床疗效和安全性。方法 研究在国内12个中心同时进行,拟行ERCP诊断和治疗的患者进入研究,并随机分为2组。奥曲肽组:0.3 mg奥曲肽加入500 ml生理盐水中,于ERCP术前1 h开始静脉滴注并持续6 h,输注停止后6 h和12 h再分别给予奥曲肽0.1 mg皮下注射各1次。对照组则给予安慰剂(生理盐水)行静脉滴注,但不进行皮下注射。结果 共有961例ERCP患者入选,其中129例患者不符合要求而被剔除,最后832例患者纳入统计,其中奥曲肽组414例,对照组418例。急性胰腺炎总的发生率为3.85％,其中奥曲肽组为2.42％(10/414),对照组为5.26％(22/418)(P=0.026)。高淀粉酶血症总发生率为14.9％,奥曲肽组为12.32％(51/414),对照组为17.46％(73/418)(P=0.041);两组基础数据如年龄、操作过程(诊断和治疗)、造影剂的使用量、胰胆管显影次数等基本相似(P>0.05),未发生与奥曲肽相关的不良反应。结论 奥曲肽对ERCP术后胰腺炎和高淀粉酶血症均有预防作用。     

吲哚美辛预防经内镜逆行胰胆管造影术后胰腺炎和高淀粉酶血症的临床研究

目的 探讨吲哚美辛对ERCP术后胰腺炎和高淀粉酶血症的预防作用.方法 将拟施行ERCP手术的600例患者随机表法分为吲哚美辛组、奥曲肽组和安慰剂对照组,每组200例,观察其术前、术后24 h血清淀粉酶水平,并评估ERCP术后胰腺炎和高淀粉酶血症发生率及预后.结果 3组患者ERCP术前血清淀粉酶均为正常值.ERCP术后24h血清淀粉酶水平,吲哚美辛组[(101.3±77.7)U/L]低于奥曲肽组[(176.6±138.3)U/L]及对照组[(227.2±264.9) U/L],差异均有统计学意义(P=0.040,P=0.048);奥曲肽组低于对照组,但差异没有显著意义(P＞0.05).ERCP术后胰腺炎发生率,吲哚美辛组(2.5％)低于对照组(9.5％),差异有显著性意义(P=0.003);奥曲肽组(4.5％)低于对照组,但无统计学差异(P=0.05).ERCP术后高淀粉酶血症发生率,吲哚美辛组(5.5％)低于对照组(13.5％),差异有显著性意义(P=0.006);奥曲肽组(10.0％)低于对照组,但差异没有统计学意义(P＞0.05).结论 ERCP术前应用吲哚美辛可有效降低胰腺炎和高淀粉酶血症的发生率.     

加贝酯预防内镜逆行胰胆管造影术后胰腺炎的实验研究

背景：急性胰腺炎是内镜逆行胰胆管造影术（ERCP）的常见并发症，加贝酯对ERCP术后胰腺炎的预防作用仍存在争议。目的：探讨加贝酯对大鼠ERCP术后胰腺炎的预防作用。方法：通过血压计传导50mmHg（1mmHg=0.133kPa）的恒定压力，向胰胆管内注入30％泛影葡胺，以制备SD大鼠ERCP术后胰腺炎模型。检测各组血清淀粉酶水平，并行胰腺组织病理学检查。结果：加贝酯治疗组的血清淀粉酶水平和胰腺组织炎症评分均显著低于胰腺炎对照组（P〈0.05）。结论：加贝酯静脉滴注对预防ERCP术后胰腺炎有效。     

ERBD预防ERCP术后高淀粉酶血症及胰腺炎临床分析

目的探讨内镜鼻胆管引流术（ENBD）预防内镜逆行胰胆管造影（ERCP）术后高淀粉酶血症及胰腺炎的临床疗效。方法胆石症行ERCP术患者160例,随机分为观察组85例和对照组65例,观察组术后置鼻胆管引流,对照组术后静脉滴注5％GS500ml＋法莫替丁20mg／d。分别于术前、术后3h、24h抽血,检测血淀粉酶（AMY）水平。结果两组术后3、24h血AMY明显高于术前;观察组术后3、24h血AMY明显低于对照组（P均〈0．05）;观察组发生高淀粉酶血症（AMY〉420U／L）2例,无胰腺炎发生,对照组发生高淀粉酶血症9例,急性胰腺炎5例。结论ERBD对ERCP术后预防高淀粉酶及胰腺炎有一定的临床价值。     

Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate.

BACKGROUND & AIMS: It still is debated whether post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be prevented by administering either somatostatin or gabexate mesylate. The aim of the study is to assess the efficacy of a 6.5-hour infusion of somatostatin or gabexate mesylate in preventing ERCP-related complications. METHODS: In a double-blind multicenter trial, 1127 patients undergoing ERCP were randomly assigned to intravenous administration of somatostatin (750 microg; n = 351), gabexate mesylate (500 mg; n = 381), or placebo (saline; n = 395). The drug infusion started 30 minutes before and continued for 6 hours after endoscopy. Patients were evaluated clinically, and serum amylase levels were determined at 4, 24, and 48 hours after endoscopy. RESULTS: No significant differences in incidences of pancreatitis, hyperamylasemia, or abdominal pain were observed among the placebo (4.8%, 32.6%, and 5.3%, respectively), somatostatin (6.3%, 26.8%, and 5.1%, respectively), and gabexate mesylate groups (5.8%, 31.5%, and 6.3%, respectively). Univariate analysis of patient characteristics and endoscopic maneuvers showed that a Freeman score >1 (P < 0.0001), >/=3 pancreatic injections (P < 0.00001), and precut sphincterotomy (P = 0.01) were significantly associated with post-ERCP pancreatitis. At multiple logistic regression analysis, >/=3 pancreatic injections (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.45-2.63) and a Freeman score >1 (OR, 1.47; 95% CI, 1.11-1.94) retained their predictive power. CONCLUSIONS: Long-term (6.5-hr) administration of either somatostatin or gabexate mesylate is ineffective for the prevention of post-ERCP pancreatitis. Pancreatic injury seems to be related to difficulty in common bile duct access.     

Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter,placebo-controlled,randomized clinical trial

BACKGROUND: ERCP is frequently complicated by pancreatitis. The aims of this study were to assess the efficacy of somatostatin and gabexate for prevention of post-ERCP pancreatitis in high-risk patients and to determine predisposing factors for post-ERCP pancreatitis. A meta-analysis was conducted of all published studies on the use of somatostatin or gabexate for prevention of post-ERCP pancreatitis. METHODS: A double blind, multicenter, placebo-controlled trial was conducted in patients at high risk for post-ERCP pancreatitis. Patients were randomized to receive an intravenous infusion of somatostatin (750 mg), gabexate (500 mg), or placebo that was started 30 minutes before endoscopy and continued for 2 hours afterward. Patients were evaluated clinically and serum amylase levels determined at 4 and 24 hours after endoscopy. RESULTS: No significant difference in the occurrence of pancreatitis, hyperamylasemia, or abdominal pain was observed among placebo-, gabexate-, and somatostatin-treated patients. A sphincterotomy longer than 2 cm (p = 0.0001), more than 3 pancreatic injections (p = 0.0001), and unsuccessful cannulation (p = 0.008) were predictive of post-ERCP pancreatitis. Hyperamylasemia was predicted by more than 3 pancreatic injections (p = 0.0001) and sphincterotomy (p = 0.02). The meta-analysis of trials of short-term infusion of gabexate or somatostatin did not show efficacy for either drug. CONCLUSIONS: Short-term administration of gabexate or somatostatin in patients at high risk for pancreatitis is ineffective for prevention of ERCP-induced pancreatitis. Pancreatic injury is related to maneuvers used to obtain biliary access rather than to any patient characteristic or endoscopist experience.     

Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis

BACKGROUND: The identification of therapeutic agents that can prevent the pancreatic injury after endoscopic retrograde cholangiopancreatography (ERCP) is of considerable importance. METHODS: We performed a meta-analysis including 28 clinical trials on the use of somatostatin (12 studies), octreotide (10 studies), and gabexate mesilate (6 studies) after ERCP. Outcome measures evaluated were the incidence of acute pancreatitis, hyperamylasemia, and pancreatic pain. Three analyses were run separately: for all available studies, for randomized trials only, and for only those studies published as complete reports. RESULTS: When all available studies were analyzed, somatostatin and gabexate mesilate were significantly associated with improvements in all three outcomes. Odds ratios (OR) for gabexate mesilate were 0.27 (95% CI [0.13, 0. 57], p = 0.001) for acute pancreatitis, 0.66 (95% CI [0.48, -0.89], p = 0.007) for hyperamylasemia, and 0.33 (95% CI [0.18, 0.58], p = 0. 0005) for post-procedural pain. Somatostatin reduced acute pancreatitis (OR 0.38: 95% CI [0.22, 0.65], p < 0.001), pain (OR 0. 24: 95% CI [0.14, 0.42], p < 0.001), and hyperamylasemia (OR 0.65: 95% CI [0.48, 0.90], p = 0.008). Octreotide was associated only with a reduced risk of post-ERCP hyperamylasemia (OR 0.51: 95% CI [0.31, 0.83], p = 0.007) but had no effect on acute pancreatitis and pain. The statistical significance of data did not change after analyzing randomized trials only or studies published as complete reports. For each considered outcome, the publication bias assessment and the number of patients that need to be treated to prevent one adverse effect were, respectively, higher and lower for somatostatin than for gabexate mesilate. CONCLUSIONS: The pancreatic injury after ERCP can be prevented with the administration of either somatostatin or gabexate mesilate, but the former agent is more cost-effective. Additional studies comparing the efficacy of short-term infusion of somatostatin versus gabexate mesilate in patients at high risk for post-ERCP complications seem warranted.     

Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study

BACKGROUND AND OBJECTIVE: Gabexate mesylate reduces the incidence of post-ERCP pancreatitis. Patient-related risk factors associated with pancreatitis can be identified before ERCP, but the procedure-related factors are recognized only at the end of the procedure. This study's aim was to evaluate whether gabexate mesylate administered after ERCP reduces the incidence of pancreatitis. DESIGN: Randomized, prospective, double-blind, multicenter trial. SETTING: Tertiary care centers. PATIENTS AND INTERVENTION: A total of 608 patients undergoing ERCP were treated with gabexate mesylate 500 mg within 1 hour before ERCP (group A, 203 patients) or within 1 hour after ERCP (group B, 203), or with saline solution (group C, 202). MAIN OUTCOME MEASUREMENTS: The incidence and severity of pancreatitis and hyperamylasemia, as well as factors associated with the development of pancreatitis. RESULTS: The groups were similar for demographic characteristics, indications to ERCP, risk factors for pancreatitis, and therapeutic procedures. The incidence of pancreatitis was 3.9% in group A, 3.4% in group B, and 9.4% in group C (P<.01). Two patients (in groups A and C) developed necrotizing pancreatitis, and 1 died. Hyperamylasemia occurred in 23.6% in groups A and B, and in 24.7% in group C. Levels of amylase, the incidence of abdominal pain, and other complications occurred similarly. Female sex (odds ratios [OR] 2.7, 95% CI 1.2-5.9) and difficult cannulation (OR 5.6, 95% CI 2.6-12.3) were independently associated with pancreatitis. CONCLUSIONS: The administration of gabexate mesylate after ERCP protects against the development of pancreatitis similarly to the preprocedure administration. Factors associated with pancreatitis were mainly recognized after ERCP. We suggest administering gabexate mesylate after ERCP only in those patients recognized to be at risk of developing pancreatitis.     

Ulinastatin shows preventive effect on post-endoscopic retrograde cholangiopancreatography pancreatitis in a multicenter prospective randomized study

BACKGROUND AND AIM: Endoscopic retrograde cholangiopancreatography (ERCP) is a useful diagnostic and therapeutic procedure; however, ERCP occasionally causes post-ERCP pancreatitis. The administration of gabexate mesilate has been reported to be effective for the prevention for post-ERCP pancreatitis when given during and after the procedure. The aim of the present study was to investigate the preventive effect of the novel protease inhibitor ulinastatin on post-ERCP pancreatitis. METHODS: One hundred and thirty-nine patients who underwent the ERCP procedure were studied. These patients were randomly divided into three groups based on the agent and dose given during and following the ERCP procedure: gabexate mesilate (900 mg), high-dose ulinastatin (450 000 units) and low-dose ulinastatin (150 000 units). Serum amylase, interleukin (IL)-6 and IL-8 levels and plasma polymorphonuclear leukocyte elastase (PMN-E) activity were measured after ERCP. In addition, post-ERCP hyperamylasemia and post-ERCP pancreatitis were recorded. RESULTS: There were no significant differences in serum amylase, IL-6 and IL-8 levels and PMN-E activity after ERCP procedure between the three groups. Post-ERCP pancreatitis was observed in two (4.3%), three (6.5%) and four (8.5%) cases in the gabexate mesilate, high-dose ulinastatin and low-dose ulinastatin groups, respectively. Multiple logistic regression analysis showed that the addition of endoscopic sphincterotomy during the ERCP procedure was the only significant risk factor for the development of post-ERCP hyperamylasemia and post-ERCP pancreatitis (P = 0.03 and P = 0.04, respectively), but there was no significant difference in the occurrence of post-ERCP hyperamylasemia and post-ERCP pancreatitis between the three groups receiving different preventative treatments. CONCLUSION: The administration of low- and high-dose ulinastatin has similar effects to high-dose gabexate in the prevention of post-ERCP pancreatitis.     

Comparison between ulinastatin and gabexate mesylate for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a prospective,randomized trial

Background It has been reported that the administration of ulinastatin, gabexate mesylate, or somatostatin may be effective in the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, few randomized trials of ulinastatin and gabexate mesylate for the prevention of post-ERCP pancreatitis have been reported. The aim of this study was to compare the efficacy of ulinastatin and gabexate mesylate for the prevention of post-ERCP pancreatitis. Methods Sixty-eight patients who underwent diagnostic ERCP at our hospital were divided at random by computer-generated randomization into an ulinastatin group (n = 34) and a gabexate group (n = 34). Each patient received a continuous intravenous infusion of ulinastatin (150 000 units) or gabexate mesylate (600 mg), beginning 60–90 min before the ERCP and continuing until 22 h after the ERCP. The primary endpoint was the incidence of post-ERCP pancreatitis, and the secondary endpoints were the incidences of hyperenzymemia and pain. Results The overall incidence of post-ERCP pancreatitis was 2.9% (two patients), comprising one patient in the ulinastatin group and one patient in the gabexate group (2.9% vs 2.9%, respectively). Neither of these two patients developed severe pancreatitis. There were no significant differences in the serum levels of pancreatic enzymes or in the levels of pain between the two groups. Conclusions There was no clinical difference between the effect of preventive administration of ulinastatin and that of gabexate mesylate on the incidence of post-ERCP pancreatitis. Ulinastatin may be equivalent in efficacy to gabexate for reducing the incidence of post-ERCP pancreatitis.     

Risk for post-ERCP pancreatitis after needle knife precut sphincterotomy following repeated cannulation attempts

GOALS: The aim of this study was to determine the risk and identify the factors associated with post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients who undergo needle knife precut sphincterotomy (NKS). In addition, we evaluated the effect of gabexate for the prevention of post-ERCP pancreatitis. BACKGROUND: NKS, after repeated cannulation attempts during ERCP, is known to increase the risk of post-ERCP pancreatitis. However, the specific risk factors for post-ERCP pancreatitis have not been identified, and the preventive role of protease inhibitors, such as gabexate, has not yet been established. STUDY: The medical records of 200 patients who underwent NKS, after repeated cannulation attempts during ERCP, were reviewed retrospectively. The potential risk factors for post-ERCP pancreatitis were investigated. The effect of gabexate infused after the ERCP procedure was also evaluated. RESULTS: Thirteen (6.5%) patients out of 200 developed post-ERCP pancreatitis. Sex, age, the presence of pancreatitis at procedure, underlying disease, direction of the sphincterotomy, success or failure of cannulation after NKS, diameter of common bile duct, pancreatic duct status, and the presence of acinar filling were not associated with the risk of pancreatitis. Gabexate infusion after ERCP increased the incidence of ERCP-associated pancreatitis. CONCLUSIONS: We could not identify any risk factors associated with the development of post-ERCP pancreatitis in patients who underwent NKS after repeated cannulation attempts during ERCP. However, gabexate administered after the ERCP procedure was found to increase the incidence of pancreatitis.     

Prophylactic effect of glyceryl trinitrate on post-endoscopic retrograde cholangiopancreatography pancreatitis： A randomized placebo-controlled trial

AIM： To examine the prophylactic effect of glyceryl trinitrate on post-endoscopic retrograde cholangiopancreatography （ERCP） pancreatitis and hyperamylasemia. METHODS： Patients scheduled for ERCP were randomly divided into study group and placebo group. Patients in study group and placebo group were treated with 5 mg glyceryl trinitrate and 100 mg vitamin C, respectively, 5 min before endoscopic maneuvers. RESULTS： A total of 74 patients were enrolled in the final analysis. Post-ERCP pancreatitis occurred in 3 patients （7.9%） of the study group and 9 patients （25%） in the placebo group （P = 0.012）. Hyperamylasemia occurred in 8 patients of the study group （21.1%） and 13 patients （36.1%） of the placebo group （P = 0.037）. CONCLUSION： Glyceryl trinitrate before ERCP can effectively prevent post-ERCP and hyperamylasemia.     

Comparison of two dosing regimens of gabexate in the prophylaxis of post-ERCP pancreatitis

OBJECTIVES: A continuous 13-h infusion of gabexate starting 30-90 min before endoscopic cholangiopancreatography (ERCP) can reduce postprocedural pancreatitis, the onset of which is generally observed within the first 6 h after ERCP. This study was designed to verify whether a 6.5-h infusion of gabexate was as effective as a 13-h infusion, at the same concentration, for reducing the incidence of post-ERCP pancreatitis (primary endpoint) and pancreatic hyperenzymemia and pain (secondary endpoints). METHODS: A total of 434 patients (201 male and 233 female; mean age 63.9 yr, range 18-96 yr) scheduled for ERCP were prospectively recruited in 25 Italian centers. Patients were randomized double-blind to two treatment groups. All subjects enrolled were first treated with a 500-mg continuous intravenous infusion of gabexate, starting 30 min before the endoscopic maneuvers and continuing up to 6.5 h after it. Over the next 6.5 h, 214 patients (group I) continued the infusion of gabexate (for a total of 1 g over 13 h) and 220 patients (group II) were given placebo (saline solution). RESULTS: The overall incidence of acute pancreatitis was 1.8% (eight patients), which included 1.4% in group I (three of 214 patients) and 2.2% in group II (five of 220 patients). Serum amylase and lipase values over time, peak levels of the two enzymes, pancreatic pain, and need for analgesics did not significantly differ in the two groups. CONCLUSIONS: These results suggest that a 6.5-h infusion of gabexate (for a total of 500 mg) is not less effective than a 13 h infusion, with evident savings.