Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial.

BACKGROUND AND STUDY AIM: Precut sphincterotomy is a technique usually employed for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of bile duct disease. It is a validated risk factor for post-ERCP pancreatitis (PEP), but it is not clear whether the risk is related to the technique itself or to the repeated biliary cannulation attempts preceding it. The primary aim of the study was to assess the incidence of PEP in early precut compared with the standard technique in patients with difficult biliary cannulation. Secondary aims were to compare complications and cannulation success. PATIENTS AND METHODS: In this prospective, multicenter, randomized, clinical trial, patients who were referred for therapeutic biliary ERCP and difficult biliary cannulation were randomized to early precut (Group A) or repeated papillary cannulation attempts followed, in cases of failure, by late precut (Group B). PEP was defined as the onset of upper abdominal pain associated with an elevation in serum pancreatic enzymes of at least three times the normal level at more than 24 hours after the procedure. No rectal indomethacin or diclofenac was used for prevention of PEP. RESULTS: A total of 375 patients were enrolled. PEP developed in 10 of the 185 patients (5.4 %) in Group A and 23 of the 190 (12.1 %) in Group B (odds ratio [OR] 0.35; 95 % confidence interval [CI] 0.16 - 0.78). The incidence of PEP was significantly lower in the early precut group (10/185, 5.4 %) than in the delayed precut subgroup (19/135 [14.1 %]; OR 0.42, 95 %CI 0.17 - 1.07). There were no differences in biliary cannulation success rates, bleeding, perforation, and cholangitis. CONCLUSIONS: In patients with difficult biliary cannulation, early precut is an effective technique and can significantly reduce the incidence of PEP. Repeated biliary cannulation attempts are a real risk factor for this complication.

Outcome of endotherapy for pancreas divisum in patients with acute recurrent pancreatitis.

AIM: To assess the rate of relapses of acute pancreatitis (AP), recurrent AP (RAP) and the evolution of endosonographic signs of chronic pancreatitis (CP) in patients with pancreas divisum (PDiv) and RAP. METHODS: Over a five-year period, patients with PDiv and RAP prospectively enrolled were divided into two groups: (1) those with relapses of AP in the year before enrollment were assigned to have endoscopic therapy (recent RAP group); and (2) those free of recurrences were conservatively managed, unless they relapsed during follow-up (previous RAP group). All patients in both groups entered a follow-up protocol that included clinical and biochemical evaluation, pancreatic endoscopic ultrasonography (EUS) every year and after every recurrence of AP, at the same time as endoscopic retrograde cholangiopancreatography (ERCP). RESULTS: Twenty-two were treated by ERCP and 14 were conservatively managed during a mean follow-up of 4.5 ± 1.2 years. In the recent RAP group in whom dorsal duct drainage was achieved, AP still recurred in 11 (57.9%) after the first ERCP, in 6 after the second ERCP (31.6%) and in 5 after the third ERCP (26.3%). Overall, endotherapy was successful 73.7%. There were no cases of recurrences in the previous RAP group. EUS signs of CP developed in 57.9% of treated and 64.3% of untreated patients. EUS signs of CP occurred in 42.8% of patients whose ERCPs were successful and in all those in whom it was unsuccessful (P = 0.04). There were no significant differences in the rate of AP recurrences after endotherapy and in the prevalence of EUS signs suggesting CP when comparing patients with dilated and non-dilated dorsal pancreatic ducts within each group. CONCLUSION: Patients with PDiv and recent episodes of AP can benefit from endoscopic therapy. Effective endotherapy may reduce the risk of developing EUS signs of CP at a rate similar to that seen in patients of previous RAP group, managed conservatively. However, in a subset of patients, endotherapy, although successful, did not prevent the evolution of endosonographic signs of CP.

Guidewire biliary cannulation does not reduce post-ERCP pancreatitis compared with the contrast injection technique in low-risk and high-risk patients.

BACKGROUND: Guidewire (GW) cannulation can reduce the risk of post-ERCP pancreatitis (PEP) by avoiding the opacification of the main pancreatic duct. OBJECTIVE: To compare the effects of conventional contrast ERCP and GW cannulation of the common bile duct on the rate of PEP in low- and high-risk patients. DESIGN: Prospective, comparative-intervention single-center study. SETTING: Tertiary referral center. PATIENTS: Patients with biliary disease with an intact papilla were prospectively examined by ERCP. INTERVENTIONS: Biliary cannulation using a sphincterotome with contrast injection (ConI) or a hydrophilic GW without contrast injection. MAIN OUTCOME MEASUREMENTS: Pancreatitis rate in the GW group and the contrast injection (ConI) group. RESULTS: PEP occurred in 60 of 1249 patients (4.8%), 35 of 678 (5.2%) in the GW group and 25 of 571 (4.4%) in the ConI group (not significant). The overall rate of PEP was significantly higher in high-risk patients (12.2%) than in low-risk patients (3.5%) (P < .001), but was similar for the 2 techniques within each of these 2 groups. In patients with unintended main pancreatic duct (MPD) cannulation or opacification, the rate of PEP was not significantly different with the GW (15.2%) and ConI (8.4%) techniques but was associated with a significantly higher rate of pancreatitis (11.9%) than in patients in whom the contrast medium or GW did not enter the MPD (3.5%) (P < .001). Multivariate analysis indicated that more than 10 papillary cannulation attempts, MPD cannulation or opacification, suspected sphincter of Oddi dysfunction, and precut methods were significant risk factors independently associated with PEP. LIMITATIONS: Lack of randomization. CONCLUSIONS: For selective cannulation of the CBD, the risk of inducing PEP is similar with the ConI and GW techniques in high-risk and low-risk patients. Any manipulation of the MPD must be considered a high-risk factor for PEP, such as multiple attempts on the papilla or use of the precut method.

Precut sphincterotomy, repeated cannulation and post-ERCP pancreatitis in patients with bile duct stone disease.

BACKGROUND: Repeated attempts at cannulating the papilla of Vater and "needle-knife" precut sphincterotomy are independent risk factors for post-ERCP pancreatitis. Whether precut alone or repeated attempts at cannulation is the culprit factor in the development of post-ERCP pancreatitis remains controversial. AIM: To retrospectively assess the role of precutting and multiple cannulation in the occurrence of post-ERCP pancreatitis in a consecutive series of patients with bile stone disease. METHODS: 2004 patients who had undergone endoscopic retrograde cholangio-pancreatography over a 9-year period for bile stones were evaluated. Pancreatitis rate was assessed in relation to the number of cannulation attempts (<10 and ≥10) and precutting. RESULTS: Procedures were successful in 1878 patients (93.7%). Cannulation was done without precutting in 1717 cases and with in 161. Pancreatitis occurred in 2.7% of patients who had undergone biliary cannulation without precutting and in 6.5% with (p=0.006). It was lower with <10 attempts than with ≥10 (p<0.0001), either without (p<0.0001) or with precutting (p<0.01). Pancreatitis rate did not differ without and with precutting when <10 attempts at cannulation were done, whilst it was lower when precut was done before 10 attempts than when 10 or more attempts were made without precutting (p=0.02). CONCLUSIONS: Pancreatitis rate was lower when precut was done with <10 attempts than when ≥10 attempts were made without precutting. In experienced hands precut biliary sphincterotomy does not seem to be an independent risk factor for post-ERCP pancreatitis in patients undergoing endoscopic retrograde cholangio-pancreatography for bile duct stones.

Difficult biliary cannulation during ERCP: how to facilitate biliary access and minimize the risk of post-ERCP pancreatitis.

Endoscopic retrograde cholangio-pancreatography (ERCP) is one of the most technically challenging procedures in therapeutic endoscopy; difficulties in biliary cannulation and post-ERCP pancreatitis are still significant problems. Deep cannulation of Vater's papilla may fail in up to 5% of cases; selective biliary cannulation reportedly fails in 15-35% of cases, even in experienced hands; repeated and prolonged attempts at cannulation increase the risk of post-procedure pancreatitis. Therefore, cannulation technique plays a pivotal role in successful cannulation and occurrence of post-procedure pancreatitis. This review presents and discusses the techniques that can be used for achieving biliary cannulation after an initial failure and for minimizing the risk of pancreatitis, including guide wire assisted technique, needle knife precutting, trans-pancreatic sphincterotomy, and pancreatic stenting.

Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study.

OBJECTIVES: Prospective studies have identified a number of patient- and procedure-related independent risk factors for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, with different conclusions, so various questions are still open. The endoscopist's expertise, case volume, and case mix can all significantly influence the outcome of ERCP procedures, but have been investigated little to date. METHODS: We identified patient- and procedure-related risk factors for post-ERCP pancreatitis and the impact of the endoscopist's experience and the center's case volume, using univariate and multivariate analysis, in a multicenter, prospective study involving low- and high-volume centers, over a 6-month period. RESULTS: A total of 3,635 ERCP procedures were included; 2,838 (78%) ERCPs were performed in the 11 high-volume centers (median 257 each) and 797 in the 10 low-volume centers (median 45 each). Overall, 3,331 ERCPs were carried out by expert operators and 304 by less-skilled operators. There were significantly more grade 3 difficulty procedures in high-volume centers than in low-volume ones (P<0.0001). Post-ERCP pancreatitis occurred in 137 patients (3.8%); the rates did not differ between high- and low-volume centers (3.9% vs. 3.1%) and expert and non-expert operators (3.8% vs. 5.5%). However, in high-volume centers, there were 25% more patients with patient- and procedure-related risk factors, and the pancreatitis rate was one-third higher among non-expert operators. Univariate analysis found a significant association with pancreatitis for history of acute pancreatitis, either non-ERCP- or ERCP-related and recurrent, young age, absence of bile duct stones, and biliary pain among patient-related risk factors, and >10 attempts to cannulate the Vater's papilla, pancreatic duct cannulation, contrast injection of the pancreatic ductal system, pre-cut technique, and pancreatic sphincterotomy, among procedure-related risk factors. Multivariate analysis also showed that a history of post-ERCP pancreatitis, biliary pain, >10 attempts to cannulate the Vater's papilla, main pancreatic duct cannulation, and pre-cut technique were significantly associated with the complication. CONCLUSIONS: A history of pancreatitis among patient-related factors, and multiple attempts at cannulation among procedure-related factors, were associated with the highest rates of post-ERCP pancreatitis. Pre-cut sphincterotomy, although identified as another significant risk factor, appeared safer when done early (fewer than 10 attempts at cannulating), compared with repeated multiple cannulation. The risk of post-ERCP pancreatitis was not associated with the case volume of either the single endoscopist or the center; however, high-volume centers treated a larger proportion of patients at high risk of pancreatitis and did a significantly greater number of difficult procedures.

ERCP-induced and non-ERCP-induced acute pancreatitis: Two distinct clinical entities with different outcomes in mild and severe form?

BACKGROUND: Acute pancreatitis is a complication of endoscopic retrograde cholangio-pancreatography. Aim of the study was to compare endoscopic retrograde cholangio-pancreatography-related acute pancreatitis with attacks caused by other factors. METHODS: A series of consecutive patients with non-endoscopic retrograde cholangio-pancreatography-related acute pancreatitis referred to our hospital in 2007-2008 were examined retrospectively, and compared with the same number of patients with post-endoscopic retrograde cholangio-pancreatography acute pancreatitis done in the same institution. Both groups comprised 116 patients and were comparable for mean age, sex, and body mass index. Duration of abdominal pain, pancreatic enzyme elevation, hospital stay, and type of analgesia administered were retrieved. RESULTS: There were no differences between the groups as regards the severity of pancreatitis, mortality rate and hospitalisation, although mortality was double in severe post-endoscopic retrograde cholangio-pancreatography acute pancreatitis. In the mild acute pancreatitis cases, serum amylase fell 50% from the peak in a mean of 46.4h (range 24-72) in group 1 and 38.9h (range 24-72) in group 2 (p<0.001). The peak amylase serum level halved within 48h in 73.6% of cases with non-endoscopic retrograde cholangio-pancreatography-related acute pancreatitis, and in 92% of patients with endoscopic retrograde cholangio-pancreatography-related acute pancreatitis (p<0.001). CONCLUSIONS: Non-endoscopic retrograde cholangio-pancreatography- and endoscopic retrograde cholangio-pancreatography-induced pancreatitis did not differ as regards severity, hospital stay or mortality; in mild pancreatitis, serum amylase halved significantly sooner in post-endoscopic retrograde cholangio-pancreatography cases.