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

It is unclear which is the best strategy for difficult biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP). We compared the different techniques, through a network meta-analysis combining direct and indirect comparisons. We identified 12 randomized controlled trials (1605 patients) comparing different techniques for difficult biliary cannulation (early and late needle knife techniques, pancreatic guidewire- and stent-assisted techniques, transpancreatic sphincterotomy, and endoscopic ultrasound rendez-vous [EUS-RV]) either with each other or with persistence with the standard cannulation techniques. The success rate of biliary cannulation and the incidence of post-ERCP pancreatitis (PEP) were the primary outcomes. Only transpancreatic sphincterotomy significantly outperformed pancreatic stent assisted cannulation (risk ratio [RR] 1.33, 1.00-1.55), whereas no difference was observed among the other techniques in terms of cannulation success. SUCRA ranking suggested EUS-RV and early needle knife techniques as the best performing approaches (SUCRA 0.78 and 0.68, respectively). In terms of PEP rate, only EUS-RV significantly outperformed pancreatic guidewire-assisted techniques (RR 0.21, 0.04-0.98). Based on low quality of evidence, the several techniques for difficult biliary cannulation show similar results although a trend in favour of needle knife techniques and EUS-RV was observed. EUS-RV seems to decrease the risk of PEP.

Background:A retrospective analysis was conducted on consecutive patients who underwent endoscopic retrograde cholangiopancreatography (ERCP). This study aimed to evaluate the efficacy and safety of different techniques in difficult biliary cannulation cases after unintentional pancreatic duct access.Methods:The patients were divided into 4 groups according to the cannulation method: the double guidewire (DGW) group, the transpancreatic sphincterotomy (TPS) group, the transpancreatic sphincterotomy combined with a pancreatic duct stent (TPS-PDS) group, and the precut over a pancreatic duct stent (PPDS) group. The baseline characteristics, biliary cannulation success rate, and postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) incidence were compared and analyzed among these groups.Results:A total of 228 cases were enrolled, and there were no significant statistical differences among the groups in terms of the type of baseline characteristic. The final success rates for biliary cannulation ranged from 88.60% to 97.10%, and the incidence of PEP ranged from 0% to 27.50% among the 4 groups (P=0.147 and 0.005, respectively). The incidence of severe PEP was significantly higher in the TPS group compared with the other groups (P<0.001). Among the 156 cases that received pancreatic duct stent placement, the stents spontaneously migrated in 109 cases within 3 months. Furthermore, stents with trimmed wings had significantly higher migration rates when compared with stents without trimmed wings (88.50% vs. 22.70%, P<0.001).Conclusions:For cases with difficult biliary cannulation after unintentional pancreatic duct access, TPS-PDS and PPDS are superior to DGW and TPS. Pancreatic duct stents with a trimmed front side wing would spontaneously migrate at a significantly higher rate.

Needle Knife Sphincterotomy Does Not Increase the Risk of Pancreatitis in Patients With Difficult Biliary Cannulation

Introduction: In 6-10% of endoscopic retrograde cholangiopancreatographies (ERCPs), biliary cannulation (BC) is unsuccessful. In these cases with difficult BC, other cannulation techniques, such as the double guidewire technique (DGT), may be required. In the DGT, a guidewire is placed deep into the pancreatic duct, then alongside this guidewire a sphincterotome loaded with another guidewire is used for BC. The aim of the present study was to evaluate the usefulness of DGT for difficult biliary cannulation after unsuccessful biliary cannulation, using a cannula/sphincterotome under guidance of injected contrast with P-GW. Methods: A total of 652 ERCP were studied at three centers in Guayaquil, Ecuador from October 2013 to May 2017. In total, 143 patients with difficult biliary cannulation who underwent SGT were included in this retrospective study. DGT was carried out if SGT was unsuccessful. Pancreatic duct (PD) stenting was attempted to prevent post-ERCP pancreatitis (PEP) in all patients. The success rate of cannulation and the risk factors for PEP were investigated. Results: Biliary cannulation with SGT was achieved in 70%. DGT was carried out in 143 patients with unsuccessful SGT, biliary cannulation being successful in 72 %( 103 patients). Of the 11 patients who underwent precut sphincterotomy, biliary cannulation was achieved in 52%. The incidence of PEP in patients who had undergone SGT, DGT, and precut sphincterotomy was 8% (12: mild, 8; moderate, 3; severe, 1), 4% (mild, 1), and 0%, respectively. PD stenting was successfully carried out in 86%. Multivariate analysis revealed unsuccessful PD stenting to be the only risk factor for PEP (OR 8.3, 95% CI 2.3-30). Conclusion: The DGT can be used as an alternative to other cannulation techniques in difficult BC with similar success rates. However, the higher risk of PEP with the DGT may prohibit its widespread use. Further studies on whether this higher risk is due to the technique itself or other factors such as a pancreatic duct stent are required.

Even in experienced hands, a common problem with endoscopic retrograde cholangiopancreatography (ERCP) is difficulty reaching a deep biliary cannulation. The most recent alternative method for difficult biliary cannulation is the double-guidewire technique. The current prospective study aimed to clarify the feasibility and safety of the double-guidewire-assisted biliary cannulation at the authors' institution. All consecutive patients (n=284) admitted for biliary ERCP during 2009 who had unhindered access to a native papilla were included in the study. The application and success rates of the double-guidewire method for deep biliary cannulation and the complications of ERCP procedures using the double-guidewire technique were determined. The overall success rate for biliary cannulation in these cases also was determined, and the times from the first touch to the papilla to deep biliary cannulation and for the entire ERCP procedure were recorded. The double-guidewire-assisted cannulation technique was applied in 18% (50/284) of ERCPs with a success rate of 66% (33/50). In these 50 cases, the overall success rate for biliary cannulation was 98% (49/50). The median cannulation time was 8 min, and the median duration of the entire ERCP procedure was 20 min. The rate of post-ERCP pancreatitis was 2% (1/50). The double-guidewire technique is a feasible and safe method for difficult biliary cannulation with low rate of post-ERCP pancreatitis. However, it seems important to proceed to alternative cannulation techniques if the double-guidewire technique appears troublesome.

Difficult biliary cannulation is a key challenge in endoscopic retrograde cholangiopancreatography and a major risk factor for post-ERCP pancreatitis. When the pancreatic duct is unintentionally accessed, double guidewire (DGW) is the primary rescue strategy, while transpancreatic sphincterotomy (TPS) is an alternative. Previous evidence suggests that TPS may achieve higher cannulation success and lower PEP rates compared to DGW, though direct comparative data remain limited. This review and meta-analysis assess the clinical outcomes of TPS and DGW in the setting of difficult biliary cannulation. This review involved searching Medline, Embase, Lilacs, Central Cochrane, and Google Scholar. Outcomes assessed included PEP, successful biliary cannulation, mean cannulation time, and other adverse events (bleeding, cholangitis, perforation). A total of 463 patients from five randomized controlled trials were included. The DGW group showed a higher risk of PEP pancreatitis and other adverse events (p = 0.009; RR = 1.81 [1.16, 2.83]; I2 = 34%) and (p = 0.03; RR = 2.20 [1.10, 4.39]; I2 = 0%), respectively. A significant difference favoring TPS was found for successful cannulation and mild pancreatitis (p = 0.001; RR = 1.79 [1.26, 2.54]; I2 = 40%) and (p = 0.01; RR = 2.26 [1.20, 4.28]; I2 = 35%), respectively. No significant difference was observed for mean cannulation time or moderate to severe PEP (p = 0.18; SMD = -0.37 [-0.91, 0.17]; I2 = 79%) and (p = 0.32; RR = 1.50 [0.67, 3.36]; I2 = 0%), respectively. A restricted analysis excluding two studies affected by external factors inflating the pancreatitis rate did not reveal a significant difference (p = 0.61; RR = 1.16 [0.66, 2.04]; I2 = 0%). Prior studies comparing TPS and DGW yield different results. This may occur because there are technical variables that are difficult to control. Overall, TPS demonstrated superior cannulation success, may have lower PEP rates, and fewer other complications, although more homogeneous studies are needed to validate these findings.

Comparison of rectal indomethacin and diclofenac for post ERCP pancreatitis prophylaxis: A single center study.

Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials

Endoscopic retrograde cholangiopancreatography (ERCP) is indispensable for the management of biliary and pancreatic diseases but carries a high risk of post-ERCP pancreatitis (PEP). This study aimed to clarify the current status and temporal trends of ERCP and PEP in Japan, including preventive measures. We conducted a retrospective, population-based cohort study using the Diagnosis Procedure Combination database from April 1, 2016, to March 31, 2023. Trend analyses were performed for ERCP, PEP, nonsteroidal anti-inflammatory drugs (NSAIDs), and protease inhibitors. Additionally, factors associated with PEP and severe PEP were evaluated. Among the 1,073,513 ERCP cases, PEP and severe PEP incidences were 85,212 (7.9%) and 4841 cases (0.5%), respectively. The mortality rate was 0.5% for severe PEP and 0.2% for non-severe cases. The number of ERCP procedures and the proportion of therapeutic ERCP increased over time. The incidence of PEP declined from 9.1% in the fiscal year 2016-2017 to 6.4% in the fiscal year 2022, while the incidence of severe PEP decreased from 0.5 to 0.33% over the same period. The usage rate of rectal NSAIDs increased from 16.4 to 27.6%, whereas that of protease inhibitors decreased from 70.5 to 53.5%. The administration of rectal NSAIDs at doses of 20-25mg and 50mg was associated with a reduced risk of severe PEP. The number of ERCP procedures and the proportion of therapeutic ERCP have increased, whereas the incidences of PEP and severe PEP have decreased. Rectal NSAIDs may prevent the progression of PEP to severe disease.

ABSTRACTNumerous endoscopic retrograde cholangiopancreatography (ERCP) techniques have been reported to achieve selective biliary cannulation success. For standard biliary cannulation procedures, the wire-guided cannulation technique has been reported to reduce the rate of post-ERCP pancreatitis (PEP) and increase the biliary cannulation success rate, although conflicting reports exist. The pancreatic or double-guidewire technique and several precut techniques have been reported as useful techniques in difficult biliary cannulation cases. Although ERCP is a useful endoscopic procedure, the risk of adverse events, particularly post-ERCP pancreatitis, is inevitable. Previous studies and analyses have revealed the risk factors for PEP. The efficacy of prophylactic pancreatic duct stent placement and the administration of rectal nonsteroidal anti-inflammatory drugs for preventing PEP has also been reported. Herein, we reviewed reports in the literature regarding the current status of selective biliary cannulation techniques and PEP prevention.

Background and study aims Difficult cannulation is a risk factor for pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP). The double-guidewire technique (DGT) may improve cannulation success and reduce the risk of post-ERCP pancreatitis (PEP) in patients with difficult cannulation. This systematic review compared the DGT with persistent conventional cannulation or other advanced techniques in patients with difficult cannulation. Patients and Methods CENTRAL, MEDLINE, EMBASE, and CINAHL databases and DDW and UEGW abstracts up to March 2016 were searched for randomized controlled trials (RCTs) comparing DGT with persistent conventional cannulation or other advanced techniques (precut, pancreatic duct [PD] stenting). The primary outcome was PEP. Secondary outcomes included severity of PEP, successful cannulation of the common bile duct (CBD) with the randomized technique, overall CBD cannulation success, and ERCP-related complications. Results 7 RCTs (577 patients) were included. Use of the DGT significantly increased PEP compared to other endoscopic techniques (risk ratio [RR] 1.98, 95 % confidence interval [95 %CI] 1.14 - 3.42). There was no significant difference in CBD cannulation success with the randomized technique (RR 1.04, 95 %CI 0.87 - 1.24) or in overall cannulation success (RR 1.04, 95 %CI 0.91 - 1.18) between DGT and other techniques. There was also no significant difference in the risk of other ERCP-related complications (bleeding, perforation, cholangitis, and mortality). The results were robust in sensitivity analyses. Conclusions In patients with difficult cannulation, sole use of the DGT appears to increase the risk of PEP without any superiority in achieving biliary cannulation compared to other techniques. PD stenting may reduce the risk of PEP when the DGT is used. The influence of co-intervention in the form of per-procedural nonsteroidal anti-inflammatory drug (NSAID) administration is unclear.

Double-guidewire technique (DWT) has been successfully performed by experts in difficult biliary cannulation as an advanced technique. This study aimed to define the learning curve and safety of DWT by trainees during hands-on endoscopic retrograde cholangiopancreatography (ERCP) training. Patients were eligible for inclusion in the study if the biliary cannulation was difficult and the pancreatic duct was inadvertently cannulated. DWT was performed by two trainees randomly under trainers' guidance. The primary outcome was the success rate of DWT biliary cannulation of trainees. Cumulative sum analysis was used to generate visual learning curves. A total of 60 patients with difficult cannulation were enrolled. The main indications for ERCP were common bile duct stones (65%) and biliary stricture (31.7%). The learning curve analysis showed that to achieve a 70% rate of successful DWT, 12 procedures were needed for trainee A and 15 for trainee B. Higher targeted success rate of DWT could be achieved if the number of DWT procedures increased. Compared with the early stage of learning DWT (case 1 to 15 for each trainee), trainees had significantly higher DWT success rate in the late stage (36.7% [11/30] vs 80% [24/30], P=0.001). The final success rate of cannulation was 98.3% (59/60). The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60), respectively. Double-guidewire technique was safely performed by two novel trainees during hands-on ERCP training. Fifteen procedures may be enough for trainees to achieve the competency of performing DWT. (Clinicaltrials.gov number: NCT03707613).

Aggressive intravenous fluid hydration, by administering 3500mL of lactated Ringer's solution (LRS) in 9h with a peri-procedural bolus, reduces post-ERCP pancreatitis (PEP) incidence. A concern of this strategy is adverse events related to volume overload; however, the impact of fluid hydration over an extended period without a bolus on PEP is unknown. To assess the effect of continuous infusion of high-volume fluid at a constant rate over 24h on PEP incidence and severity. Two-hundred patients were randomly assigned (1:1) to receive either 3600mL of LRS in 24h starting 2h before the ERCP (high-volume group) or maintenance fluid hydration calculated by the Holliday-Segar method (control group). The mean age of the patients was 50.6 ± 11.6years. The predominant indications were choledocholithiasis (48%) and malignancies (32%). Patient demographics and PEP risk factors were similar in both groups. Patients in the high-volume group received significantly more fluid than the control group (3600 vs. 2413ml, P < 0.001). PEP incidence was not different between the high-volume and the control group (14% vs. 15%; relative risk 0.93: 95% CI 0.48-1.83, P = 0.84). There were no differences in moderate to severe PEP (3% vs. 4%; relative risk 0.75: 95% CI, 0.17-3.27, P = 1.00). Subgroup analysis did not show a benefit in high-risk patients. Only one patient in the control group developed peripheral edema. An infusion of high-volume hydration over 24h is not sufficient to provide optimal hydration for PEP prevention. No. NCT02821546.

Background: Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) ranges between 15 and 20% among patients at high risk of developing PEP. The efficacy of indomethacin administration in the prevention of PEP is rather debatable. In the present randomized trial study, we evaluated whether or not the combination of indomethacin and epinephrine in comparison to the single administration of indomethacin differs in the pathogenesis and prevention of post-ERCP pancreatitis. Patients and Methods: One hundred and ninety-two patients were randomized in a double-blinded manner into 3 groups: the epinephrine group (group A), the indomethacin group (group B), and the combined epinephrine and indomethacin group (group C). After the procedure, patients were evaluated for the PEP development. Results: During the procedure, 66 patients were randomized to the epinephrine group (group A), 68 cases to the indomethacin group (group B), and 58 individuals to the indomethacin-epinephrine group (group C). The mean age of patients in the epinephrine group was 59.59 ± 15.680 years, in the indomethacin group it was 58.06 ± 17.125 years, and in the combination group it was 59.62 ± 15.369 years. In the present study, we did not observe a significant difference between the 3 groups in sex, age, pre-ERCP amylase, lipase, and patient and procedure risk factors including pancreatic duct (PD) dilation (p = 0.404), PD cannulation (p = 0.329), and difficult cannulation (p = 0.076) among others. PEP developed in 7 of the 192 individuals (3.6%), 6 PEP cases occurred in the indomethacin group and 1 in the epinephrine group (p = 0.016). Univariate analysis of risk factors for PEP in patients with and without pancreatitis revealed no significant difference between the pancreatitis group and the non-pancreatitis group. Conclusion: In comparison to the administration of indomethacin alone, a single application of epinephrine and the combination of epinephrine and indomethacin seem to be effective in reducing the cases of PEP. A further randomized clinical trial with a larger sample size is required to confirm the efficacy of our medication in the prevention of pancreatitis after ERCP.

BackgroundVarious endoscopic techniques are employed to achieve biliary cannulation when confronted with difficult biliary access. Every procedure carries its own risk in terms of bleeding, infection, pancreatitis, and cholangitis. Our meta-analysis aimed to compare pre-cut papillotomy and endoscopic ultrasound (EUS)-rendezvous in terms of technical success rates, and post-procedure pancreatitis and bleeding.MethodsWe conducted a systematic review and meta-analysis of studies that compared pre-cut papillotomy and EUS-rendezvous. The primary outcome was technical success by achieving biliary cannulation. Secondary outcomes were postoperative pancreatitis and bleeding. A random-effects model was used to calculate the risk ratios (RRs) and confidence intervals (CIs). A P value < 0.05 was considered statistically significant.ResultsOur meta-analysis included four studies comparing pre-cut papillotomy and EUS-rendezvous. The studies included 13,659 total endoscopic retrograde cholangiopancreatography (ERCP) procedures, of whom 1,004 patients underwent alternate biliary cannulation procedures due to difficult biliary cannulation. The mean age of the study population was noted to be 49.5 years and males represented 53.3% of the total participants. Both procedures were similar in terms of technical success (RR: 0.95, 95% CI (0.88, 1.02)). No difference was found between rates of post procedure pancreatitis (RR: 1.82, 95% CI (0.80, 4.15)) and post procedure bleeding (RR: 2.80, 95% CI (0.67, 11.66)).ConclusionsThere was no difference in technical success of procedure or post-procedure complications such as pancreatitis and bleeding between pre-cut papillotomy and EUS-rendezvous technique. More randomized controlled trials (RCTs) are needed to compare both procedural techniques and complications rates. However, currently, both procedures are equally effective and safe during difficult biliary cannulation in the hands of experienced endoscopists.