Rectal NSAIDs Research Articles

Development and validation of a machine learning–based, point-of-care risk calculator for post-ERCP pancreatitis and prophylaxis selection

A robust model of post-ERCP pancreatitis (PEP) risk is not currently available. We aimed to develop a machine learning-based tool for PEP risk prediction to aid in clinical decision making related to periprocedural prophylaxis selection and postprocedural monitoring. Feature selection, model training, and validation were performed using patient-level data from 12 randomized controlled trials. A gradient-boosted machine (GBM) model was trained to estimate PEP risk, and the performance of the resulting model was evaluated using the area under the receiver operating curve (AUC) with 5-fold cross-validation. A web-based clinical decision-making tool was created, and a prospective pilot study was performed using data from ERCPs performed at the Johns Hopkins Hospital over a 1-month period. A total of 7389 patients were included in the GBM with an 8.6% rate of PEP. The model was trained on 20 PEP risk factors and 5 prophylactic interventions (rectal nonsteroidal anti-inflammatory drugs [NSAIDs], aggressive hydration, combined rectal NSAIDs and aggressive hydration, pancreatic duct stenting, and combined rectal NSAIDs and pancreatic duct stenting). The resulting GBM model had an AUC of 0.70 (65% specificity, 65% sensitivity, 95% negative predictive value, and 15% positive predictive value). A total of 135 patients were included in the prospective pilot study, resulting in an AUC of 0.74. This study demonstrates the feasibility and utility of a novel machine learning-based PEP risk estimation tool with high negative predictive value to aid in prophylaxis selection and identify patients at low risk who may not require extended postprocedure monitoring.

Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial

ObjectiveHemin, a heme oxygenase 1 activator has shown efficacy in the prevention and treatment of acute pancreatitis in mouse models. We conducted a randomized controlled trial (RCT) to assess the protective effect of Hemin administration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients at risk. MethodsIn this multicenter, multinational, placebo-controlled, double-blind RCT, we assigned patients at risk for PEP to receive a single intravenous dose of Hemin (4 mg/kg) or placebo immediately after ERCP. Patients were considered to be at risk on the basis of validated patient- and/or procedure-related risk factors. Neither rectal NSAIDs nor pancreatic stent insertion were allowed in randomized patients. The primary outcome was the incidence of PEP. Secondary outcomes included lipase elevation, mortality, safety, and length of stay. ResultsA total of 282 of the 294 randomized patients had complete follow-up. Groups were similar in terms of clinical, laboratory, and technical risk factors for PEP. PEP occurred in 16 of 142 patients (11.3%) in the Hemin group and in 20 of 140 patients (14.3%) in the placebo group (p = 0.48). Incidence of severe PEP reached 0.7% and 4.3% in the Hemin and placebo groups, respectively (p = 0.07). Significant lipase elevation after ERCP did not differ between groups. Length of hospital stay, mortality and severe adverse events rates were similar between groups. ConclusionWe failed to detect large improvements in PEP rate among participants at risk for PEP who received IV hemin immediately after the procedure compared to placebo. Trial registration numberClinicalTrials.gov number, NCT01855841).

S1033 Rectal NSAIDs to Prevent Post ERCP Pancreatitis: All Comers or High Risk Only?

Introduction: One of the most common complications of ERCP is post-ERCP pancreatitis. Prior randomized control trials have shown a protective effect with the use of prophylactic rectal NSAIDs. The goal of our systematic review and meta-analysis was to evaluate the types of patients in which rectal NSAIDs have the most impact. Methods: In collaboration with a health sciences librarian, a systematic search of Ovid Medline, Embase, the Cochrane Library, Web of Science, Clinical Trials.gov, and Google Scholar was performed. Studies were reviewed and screened using the Covidence system by two independent reviewers. Only randomized controlled studies including patients receiving rectal NSAIDs vs no rectal NSAIDs were included. A subgroup of interest were studies which restricted enrollment to those at high risk of developing post-ERCP pancreatitis. Patients were deemed to be high-risk using validated patient and procedure-related risk factors. The primary outcome was development of post-ERCP pancreatitis and severity of pancreatitis scored using Cotton’s criteria. The random effects model was used for quantitative harmonization. Results: Among 270 abstracts and manuscripts which were critically reviewed, we identified 11 RCTs evaluating rectal NSAIDs in high risk patients and 31 studies overall (high and indeterminate risk). Among high-risk patients, there was a reduction in the rates of post-ERCP pancreatitis associated with rectal NSAID use compared to placebo (OR 0.607, 95% CI 0.351-1.050) and a reduction of moderate to severe pancreatitis (OR 0.534, 95% CI 0.237-1.199) though these findings narrowly missed statistical significance (Table 1). For the overall group of studies which included both high risk and unselected patients there was a reduction of post-ERCP pancreatitis associated with rectal NSAID use compared to placebo (OR 0.595, 95% CI 0.466-0.760) as well as reduction of moderate to severe pancreatitis (OR 0.498, 95% CI 0.359-0.691). Conclusion: In patients undergoing ERCP, the use of rectal NSAIDs reduces the risk of post-ERCP pancreatitis and moderate to severe pancreatitis. Systematic review of all randomized trials and the subgroup restricted to high risk patients suggests that its effect is not dominated by studies in the latter category. Its use should be considered in all patients.Table 1.: Main Outcomes for Studies Including High Risk versus All Patients.

S1018 Rectal NSAIDs Decrease Post-ERCP Pancreatitis (PEP) in Unselected Patients - Comprehensive Meta-Analysis of Randomized Controlled Trials

Introduction: Endoscopic retrograde cholangiopancreatography (ERCP) is fundamental for treatment of pancreatico-biliary diseases, but results in PEP in up to 15% of patients. Phospholipase A2 (PLA2) is an important factor in the pancreatitis inflammatory cascade and NSAIDs, which inhibit PLA2 activity, prevent PEP in high-risk patients. We endeavored to identify and quantitatively synthesize the existing high-quality data to date on rectal NSAID use for the prevention of post ERCP pancreatitis in unselected patients without specific risk factors for PEP. Methods: In collaboration with a librarian, we searched the following databases: Ovid Medline (coverage 1946 – Present), Embase and Embase Classic (coverage 1947 – Present), Cochrane Library (coverage 1898-present), Web of Science (coverage 1900-present), Clinicaltrials.gov, and Google Scholar through April 2021. Using the Covidence system, two independent reviewers identified randomized controlled studies assessing rectal NSAIDs for PEP prevention in unselected patients. Our primary outcome was odds of developing PEP and our secondary outcome was odds of developing moderately severe or severe PEP. Pooled odds ratios were estimated using the random effects model. Results: After review of 504 abstracts and 234 full text documents, we identified 25 randomized controlled trials evaluating rectal NSAIDs for the prevention of PEP in unselected patients; 4071 patients received rectal NSAIDs and 4005 patients received a placebo. The most frequent NSAID used was diclofenac in 56% of studies, followed by indomethacin in 36%, ketoprofen in 4%, and naproxen in 4%. Unselected patients receiving rectal NSAIDs were less likely to develop PEP (OR 0.59, 95% CI 0.45-0.78) (Figure 1) as well as moderately severe and severe pancreatitis (OR 0.50, 95% CI 0.33-0.75). Conclusion: In unselected patients undergoing ERCP, rectal NSAID administration decreases the risk of post-ERCP pancreatitis and development of moderately severe or severe PEP. They should be considered for unselected patients undergoing ERCP, not simply those high risk for PEP.Figure 1.: Baseline characteristics and clinical outcomes in patients who has ERCP with glucagon (ERCP w glucagon, group 1) compared to individuals ERCP without glucagon (ERCP wo glucagon, group 2) Note: SD-Standard Deviation; € A 1:1 propensity score matching was done based on the following variables: age, gender, race, hypertension, diabetes mellitus, obesity, chronic kidney disease (CKD), Ischemic heart diseases (IHD), chronic obstructive pulmonary disease, indomethacin use, sphincter of Oddi dysfunction (SOD).

Efficacy of Per Rectal Non-Steroidal Anti-inflammatory Drugs to Prevent Post Endoscopic Retrograde Cholangiopancrea-tography Pancreatitis: A Comparative Study

Background and aims: Acute pancreatitis is the most common major post-ERCP complication ranging as high as 10% to 40%. Rectal NSAIDS (Indomethacin or Diclofenac) seem to be the most promising drugs to prevent post ERCP pancreatitis. We performed a trial to investigate the efficacy of indomethacin or diclofenac.
 Methods: A prospective randomized comparative trial was performed at Dhaka from January 2013 to June 2019. Patients undergoing ERCP were randomly selected to group-A and group-B. Diclofenac 50mg suppository was given to group-A patients and Indomethacin 100mg suppository was given to group-B patients during or just after ERCP. The primary outcome was acute pancreatitis following the procedure which was defined by new upper abdominal pain, elevation of pancreatic lipase to at least 3 times the upper limit of normal level 24 hours after ERCP and hospitalization for 02 nights. Retrospective analysis of data of 122 patients who had undergone ERCP in 2012 but had no history of rectal NSAIDS (group C) was done.
 Results: Total 613 patients were included in this study and followed up. Post ERCP pancreatitis developed in 21(8.5%) patients of group-A (n=247), in 19(7.78%) patients of group-B (n=244) and in 20(17.85%) patients of group-C (n=122)(p=0.02). Moderate to severe pancreatitis was found in 08(3.23%) patients of group-A, in 06(2.45%) patients of group-B and in 12(9.83%) patients of group-C(p= 0.01). Administration of these NSAIDS showed clear benefit to reduce occurrence of Post ERCP pancreatitis when compared with no drug group (P=0.01). The efficacy of indomethacin compared with diclofenac was similar (P=0.874).
 Conclusions: Prophylactic use of rectal indomethacin or diclofenac during or just after ERCP significantly reduces the incidence of post ERCP pancreatitis. These NSAIDs are inexpensive, safe and should be used routinely in each patient undergoing ERCP.
 Bangladesh J Medicine July 2021; 32(2) : 99-106

Rectal NSAIDs and selective pancreatic stenting significantly reduces acute pancreatitis in normal risk ERCP

Rectal NSAIDs and selective pancreatic stenting significantly reduces acute pancreatitis in normal risk ERCP

Emerging Therapies to Prevent Post-ERCP Pancreatitis

The aim of this review is to evaluate emerging, novel therapies for the prevention of post-ERCP pancreatitis. Rectal indomethacin reduces the risk of pancreatitis in low- and average-risk patients, who comprise the majority of patients undergoing ERCP. An 8-h protocol of aggressive lactated Ringer's reduces the risk of pancreatitis in average-risk patients. Sublingual nitrate may provide additional benefit to rectal NSAIDs in preventing PEP. A tacrolimus trough > 2.5ng/mL was recently shown to be associated with a lower risk of PEP in liver transplant patients undergoing ERCP. Routine usage of rectal indomethacin in all patients undergoing ERCP reduces the risk of PEP. Pancreatic-duct stents reduce the risk of PEP in high-risk patients. There is emerging data that aggressive hydration with lactated Ringer's and nitrates may further reduce PEP. Tacrolimus is a promising potential agent to prevent PEP but needs further clinical study.

S0006 Efficacy of Combining Aggressive Hydration With Rectal Indomethacin in Preventing Post-ERCP Pancreatitis: A Systemic Review and Network Meta-Analysis

INTRODUCTION: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is a major adverse event after endoscopic retrograde cholangiopancreatography. No RCT has compared the efficacy of all American Society of Gastrointestinal Endoscopy (ASGE)- and European Society of Gastrointestinal Endoscopy (ESGE)-recommended interventions for PEP prevention. We assessed the effectiveness of these interventions and their combinations amongst each other using network meta-analysis approach. METHODS: We conducted a literature search of PubMed, EMBASE, and Cochrane databases from inception to January 14, 2020, to identify RCTs comparing ASGE-and ESGE-recommended interventions -including rectal NSAIDs, pancreatic stent (PS), aggressive hydration (AH), sublingual nitrate or combinations of those - with each other or with the control group for PEP prevention (primary outcome). RCTs defining PEP only as per cotton's criteria or consensus criteria were included. Odds ratios (ORs) with 95% credible intervals (CrIs) were reported for network comparisons. We also did a subgroup network meta-analysis for high-risk patients. We used the surface under the cumulative ranking curve to rank interventions in terms of PEP prevention. Model consistency was assessed with the node splitting method. RESULTS: We identified a total of 38 RCTs with ten different interventions (Figure 1Figure 1.: Network Plots Showing Direct Comparisons Available Among Interventions. A) All interventions. B) Interventions for high-risk patients. The thickness of the line connecting two interventions are proportional to available RCTs comparing them.). Each intervention was protective against PEP on network meta-analysis compared to controls as shown in Figure 2Figure 2.: League table showing results of all possible comparison of all interventions. Odds ratio with 95% CrI in a particular cell represents a comparison of column defining treatment to raw defining treatment. All statistically significant comparisons are highlighted in green colour. AH: Aggressive hydration; I: Indomethacin; D: Diclofenac; N: Nitrate; S: Stent. “+” represents a combination of intervention.. Except AH+diclofenac and NSAIDs + sublingual nitrate, AH+indomethacin was associated with a significant reduction in risk of PEP compared to PS (OR: 0.09; CrI: 0.003–0.71), indomethcin+PS (OR: 0.09; CrI: 0.003–0.85), diclofenac (OR: 0.09; CrI: 0.003–0.65), AH (OR: 0.09; CrI: 0.003–0.65), sublingual nitrate (OR: 0.07; CrI: 0.002–0.63), and indomethacin (OR: 0.06; 0.002–0.43). AH with either rectal NSAIDs or sublingual nitrate had similar efficacy as shown in Figure 2. AH+indomethacin was the best intervention for preventing PEP with 95.3% probability of being ranked first (Figure 3AFigure 3.: SUCRA Based on Cumulative Probabilities. A) All interventions. B) Interventions for high-risk patients. AH indicates aggressive hydration; D, rectal diclofenac; I, rectal indomethacin; N, sublingual nitrate; S, pancreatic stent; SUCRA, surface under the cumulative.). For high-risk patients, although the efficacy of PS and indomethacin were comparable, PS had an 80.8% probability of being ranked first (Figure 3B). Node splitting with P-value < 0.05 for direct and indirect comparison confirmed model consistency. CONCLUSION: Combination of rectal indomethacin with aggressive hydration seems the best intervention for preventing PEP. For high-risk patients, pancreatic stent seems the most effective strategy.

77 Post-ERCP Pancreatitis Rates and NSAID Use in a Community Hospital

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) has been consistently used for more than 50 years as a diagnostic and therapeutic procedure in pancreaticobiliary diseases. However, its use is associated with several adverse effects including bleeding, cholangitis, pancreatitis, intestinal perforation, and death. Of these, post-ERCP pancreatitis (PEP) is the leading cause of morbidity and mortality with an estimated incidence of 1.6–15%. Endoscopic techniques, patient characteristics, and the hospital setting have been noted to put patients at higher risk of developing PEP. Williams et al. reported a significantly increased risk of PEP in community hospitals compared to university hospitals. Rectal NSAIDs, including diclofenac and indomethacin, have shown promising results in several high-quality clinical trials and meta-analysis, especially in high-risk patients. More recent trials failed to show a significant reduction of PEP after NSAID use. There is scant data on the efficacy of rectal NSAIDs in higher risk patients in community hospitals. The aim of this study is to determine if there is an increased risk of PEP in a community hospital and if the use of rectal NSAIDs for high-risk patients is beneficial within a community hospital. METHODS: After obtaining IRB approval, the charts of every adult patient admitted to a Wichita, KS community hospital for ERCP in a 2-year time period were reviewed. Primary endpoint was percentage of patients developing PEP. Secondary endpoints included NSAID use in high-risk individuals (Table 1) and the change in incidence of PEP in this group with the use of rectal NSAID. RESULTS: 422 patients underwent ERCP during the study period. Of these, about 212 (50.2%) were noted to have at least 1 high risk factor to develop PEP. 24 (5.6%) of the patients received rectal NSAIDs, of which 10 patients were noted to be high-risk for PEP. 9 patients (2.1%) developed PEP during the study time period. Of the nine patients, 3 patients were high risk and did not receive any NSAIDs. The use of NSAIDs did not cause a significant reduction in PEP in the high-risk group (p-value 0.7) or overall (P-value 0.66). CONCLUSION: PEP rates in a community hospital setting have not been well established. Our study reports an incidence of 2.1%, comparable to the PEP incidence described in academic trials. Despite the unstandardized use of rectal NSAIDs noted in the study population, there appears to be no significant benefit in their use overall or in the high-risk population.

Aggressive Hydration for the Prevention of Post-ERCP Pancreatitis: Effective When Combined With Rectal NSAIDs?

Aggressive Hydration for the Prevention of Post-ERCP Pancreatitis: Effective When Combined With Rectal NSAIDs?

Update on the Prevention of Post-ERCP Pancreatitis.

Endoscopic retrograde cholangiopancreatography (ERCP) is a commonly performed procedure to manage pancreaticobiliary disease. Post-ERCP pancreatitis (PEP) is the most common adverse event of ERCP with a significant burden of morbidity and cost. Appropriate indication and counseling is mandatory especially for patients at increased risk for PEP such as those with suspected sphincter of Oddi dysfunction, pancreatic indications, and a prior history of PEP. Guidewire-facilitated deep cannulation is favored over contrast injection. High-quality trials support the use of rectal administered non-steroidal anti-inflammatory agents and pancreatic duct stent placement for high-risk patients. There is emerging evidence favoring the use of rectal NSAIDs and aggressive hydration in average-risk patients though further studies are required. There is also growing interest in the use of combination therapies as well such as pancreatic stents in combination with NSAIDs. The initial step towards PEP prevention involves careful patient selection and informed decision-making. Endoscopists should use several approaches to mitigate the risk of PEP, including guidewire-assisted cannulation, pancreatic stent placement, and rectal NSAIDs use for high-risk patients. The exact role of aggressive hydration and combination therapies needs to be further investigated.

WEO Newsletter.

WEO Newsletter.

Risk factors of pancreatitis after endoscopic sphincterotomy. Review of literature and practical remarks based on approximately 10,000 ERCPs.

Post-endoscopic pancreatitis (PEP) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Depending on the presence of risk factors, PEP can occur in 4,1% to about 43% of patients. According to the European Society of Gastrointestinal Endoscopy (ESGE) guidelines, only three to patient-associated risk factors have been identified: suspected sphincter of Oddi dysfunction (SOD) (OR 4.09), female gender (OR 2.23), and previous pancreatitis (OR 2.46). Another three procedure-associated factors include cannulation attempt duration &gt; 10 minutes (OR 1.76), more than one pancreatic guidewire passage (OR 2.77, CI: 1.79 - 4.30), and pancreatic injection (OR 2.2, CI: 1.60 - 3.01). Importantly, analyses of cumulative risk due to coexistence of several factors emphasize the importance of female sex, difficult cannulation, CBD diameter &lt;5 mm, young age, and many other factors. Unfortunately, studies performed to date have included only small numbers of patients with several co-existing risk factors. Therefore, further analysis of other risk factors and the cumulative risk related to their co-occurrence is necessary. Based on current evidence, special care must be given to patients with several risk factors. Also, care should be given to proper qualification of patients, use of guidewires, early pre-cut incision, protective Wirsung's duct stenting, and rectal NSAID administration.

41 Rectal nsaids and selective pancreatic stenting significantly reduces acute pancreatitis in normal risk ercp

Background In high-risk cases a combination of non-steroidal anti-inflammatory drugs (NSAIDs) and selective pancreatic stenting may reduce the risk of post ERCP pancreatitis (PEP). However, studies on whether this practice reduces PEP in normal risk ERCPs have shown conflicting results. Aim To compare the rate of PEP for normal risk ERCP, where patients are administered rectal NSAIDs immediately following the procedure with selective pancreatic stenting (N/S), against the previous practice, which did not incorporate N/S. Method Consecutive ERCPs from 2009–2016 were analysed pre and post N/S. In the post N/S group rectal NSAIDS were administered immediately following the procedure. Pancreatic stents were used if the pancreatic duct was cannulated more than three times during the procedure. PEP was defined as post ERCP abdominal pain and a rise in amylase to at least twice the upper limit of normal. Statistical analysis was by paired t and McNemars tests. Results 574 ERCP procedures were performed, of which 509 were successful (89%). 335 (58%) were female, with an average age of 67.7 (range16–94 years). 488 were therapeutic (96%). There were no statistically significant differences in the demographics of each group. 23 of 375 (6.1%) in the Pre N/S group developed PEP compared with 4 of 199 (2%) in the Post N/S group, p=0.02. Conclusions This study shows a further significant reduction of PEP in normal risk ERCP in a cohort of patients with a historically low PEP rate following the introduction of rectal NSAIDs and selective pancreatic stenting.

Preventing Post-ERCP Pancreatitis: Update 2016.

Post-ERCP remains a major challenge, although significant progress has been made in predicting risk and methods of prevention. Facets of post-ERCP pancreatitis can be divided into the four "P's": they are patient-related factors, procedure-related factors, pancreatic stents, and pharmacoprophylaxis. New information about risk factors includes a description of IPMN as a patient-related risk, with smoking and chronic liver disease as protective factors. Procedure-related factors include one or more deep passages of a guidewire into the pancreatic duct as a salient risk, perhaps outweighing difficult cannulation or contrast injection, but one that can be mitigated by placement of a pancreatic stent. In addition, placement of transpapillary metallic stents has emerged as an independent risk for post-ERCP pancreatitis (PEP). Although there has been a rising wave of enthusiasm for rectal NSAIDs as a kind of panacea for prevention of post-ERCP pancreatitis, the newest data question their efficacy in unselected cohorts. Pancreatic stent placement remains the most proven and reliable method of preventing post-ERCP pancreatitis in both mixed- and high-risk ERCP. Success at placement of protective pancreatic stents is a paramount for safety and efficacy, and technical expertise at placing pancreatic stents widely among centers. The use of specialized techniques including very small caliber guidewires and stents is necessary to approach 100% success.

PWE-161 Preventing Post-ERCP Pancreatitis (PEP): The Role of Prophylactic Pancreatic Duct Stenting In The Rectal NSAID era

Introduction Post ERCP pancreatitis (PEP) is an important complication. Rectal NSAIDs at ERCP is the standard of care to reduce the risk. Pancreatic duct (PD) stenting also reduces the risk of PEP in high risk patients, but placement can be technically challenging. Failed PD stenting carries reported PEP rates of at least 35%. We aimed to assess whether prophylactic pancreatic stenting is still justified in the current rectal NSAID era. Methods Between January 2013 and June 2015, we retrospectively evaluated the use of PD stents in a UK tertiary referral centre. Rectal NSAIDs were used universally for all cases post-ERCP, except in those contraindicated to NSAIDs. Prophylactic PD stenting (unflanged 5Fr 5–7 cm single pigtail stents, Cook Medical) was attempted in predicted high risk PEP cases. Indications for therapeutic PD stents included patients with chronic pancreatitis. Data was collected from our prospective database, completed following each ERCP. Follow-up information was reviewed through electronic records and telephone enquiry. Results 1633 ERCPs were performed during the study period. Pancreatic stenting was attempted in 324 cases (20%); successful placement was achieved in 307 cases (95%). Prophylactic PD stenting failed in 12 cases, one case developed PEP (1/12 = 8%). This patient had sphincter of Oddi dysfunction (SOD) and a contraindication to NSAIDs. 65% (201/307), of successfully placed pancreatic stents were inserted prophylactically, in whom 9% (18/201) developed PEP. PEP occurred in 1.4% (18/1309) of cases who did not undergo attempted PD stenting. The relative risk of PEP was 8.4 (p = 0.04) in the stented group. Conclusion PEP rates in failed PD stenting were low (8%) compared to past studies, and comparable to PEP rates in successful prophylactic PD stenting. This suggests a protective role of rectal NSAIDs, as previously shown by Choksi et al.1 The higher rate of PEP in the PD stenting/attempted stenting group, compared to the unstented group, likely reflects the higher perceived risk of PEP in the PD stenting group. The low rate of recorded PEP in the unstented group may, in part, be due to under-reporting. Our data suggests that increased rates of PEP continue to be seen in perceived high risk cases, even in a universal NSAID use setting. The overall risk appears lower than in the pre-NSAID era, and in our series a lack of difference in the PEP rate between successful and failed PD stenting suggests there is less need for prophylactic PD stenting in the NSAID era. Reference 1 Choksi, et al. The risk of post-ERCP pancreatitis and the protective effect of rectal indomethacin in cases of attempted but unsuccessful prophylactic pancreatic stent placement Gastrointest Endosc 2015;81(1):150–155. Disclosure of Interest None Declared

PTH-019 Does Rectal Diclofenac Reduce Post ERCP Pancreatitis in The UK?

Introduction Post ERCP pancreatitis(PEP) occurs in up to 10% of unselected cases and carries significant morbidity. PEP is significantly higher in certain patient groups, for example females, young age, Sphincter of Oddi dysfunction, previous pancreatitis and following pancreatic duct cannulation. There is a growing body of evidence that NSAIDS should be used in PEP prophylaxis but use is still uncommon in the UK. The 2010 European Society for Gastrointestinal Endoscopy Guidelines on PEP recommends routine use of rectal NSAIDs in all patients. There is only one published RCT from the UK demonstrating the efficacy of NSAIDS in reducing PEP. Rectal diclofenac was introduced into ERCP practice at the RUH in two phases. Firstly, a selective use in patients determined to be at high risk as determined by criteria above. Secondly diclofenac was used routinely in all patients without contraindication. Methods A retrospective analysis of 5 years ERCP data was performed using readmission data, blood results, radiology reports and discharge summaries to identify patients with PEP from August 2010 – December 2015. The administration of rectal diclofenac post procedure was recorded from the endoscopy reporting system. Fisher’s exact test was used to statistically analyse categorical data. Results 1318 ERCPs were performed by 4 endoscopists during the study period with 66 (5.0%) cases of pancreatitis. 445 ERCPs were performed prior to the introduction of NSAID use during which time there were 35 (7.9%) episodes of PEP. During the selective period of NSAID use (only used if patient deemed high risk by endoscopist) 539 ERCPs were performed and 72 (13.4%) patients received NSAIDS. 17 (3.2%) developed PEP. 334 ERCPs were performed when NSAIDS were given to all patients without contraindication. 289 (86.5%) of patients received rectal diclofenac and 13 (3.9%) developed pancreatitis. There is a statistically significant decrease in PEP comparing the groups of patients receiving NSAIDS selectively (p = 0.0009) or routinely (p = 0.0172) when compared with none. There is no difference between the selective and routine group (p = 0.571). Conclusion The use of rectal diclofenac post ERCP decreases the rate of PEP when used in a selective or routine protocol. Despite a growing body of evidence for NSAIDS use routine administration is used by the minority of endoscopists in the UK. The evidence for use of NSAIDS in PEP is heterogeneous a number of factors including diagnostic criteria for pancreatitis, type and route of NSAID and selective high risk or routine use. We believe that this heterogeneity and lack of UK evidence accounts for the slow uptake of NSAIDS for PEP. Our data demonstrates that the introduction of a selective or routine use of NSAIDS for PEP in a DGH significantly decreases the risk of pancreatitis (RR 43.7%). Disclosure of Interest None Declared

PWE-034 The impact of indomethacin prophylaxis on the rate of pancreatitis following endoscopic retrograde cholangiopancreatography (ercp) – a single operator experience: Abstract PWE-034 Table 1

<h3>Introduction</h3> ERCP has become a standard therapeutic procedure for the management of biliary and pancreatic pathology. ERCP is associated with complications, especially pancreatitis (3–7%), bleeding (1%) and perforation (1%). Several recent meta-analyses indicate that rectal NSAID may reduce post-ERCP pancreatitis (PEP) by up to 50% vs placebo. <h3>Aim</h3> To assess the impact of the selective use of rectal Indomethacin prophylaxis on PEP. <h3>Method</h3> Single centre study over 3 years: Oct 2011 to Oct 2014. Analysis of 404 consecutive patients undergoing ERCP by single operator. In first 2 years Indomethacin prophylaxis was not used; in 3rd year Indomethacin 100mg per rectum was given post procedure at endoscopist’s discretion if patient considered at high risk of PEP. The endoscopy database and patient electronic records were analysed using Microsoft Excel 2010 and GraphPad Prism v6. <h3>Results</h3> <h3>Conclusion</h3> ERCP is essentially a therapeutic procedure with successful outcome in &gt;95% of cases. The pancreatitis rate has dropped from 4% to 2.32% since the introduction of indomethacin prophylaxis. Although this reduction is not statistically significant it is encouraging and in line with recently published European guidelines (ESGE June 2014) which recommend routine use of rectal NSAID for all ERCP cases. <h3>Disclosure of interest</h3> None Declared.

PTU-036 Endoscopic sphincteroplasty in combination with sphincterotomy; is it worth it?

Introduction Endoscopic balloon sphincteroplasty (EBS) is an adjunct and possible alternative to sphincterotomy to remove biliary stones. EBS alone can be associated with complications like pancreatitis but can be safe and effective when combined with sphincterotomy. Reduced pancreatitis rates with a combined technique may relate to the force of dilatation being directed away from the pancreatic orifice. NSAIDs reduce the risk of post-procedure pancreatitis but there is insufficient data on its use specifically with combined technique. Method A retrospective review of patients undergoing EBS in addition to sphincterotomy for management of stones. Objectives were to assess CBD clearance and complication rates, and review the outcome of rectal NSAID use. We identified 93 eligible cases – 10 were excluded due to insufficient data. Results 30 of 41 index cases had successful clearance with EBS. 8 failed cases underwent further ERCP, 5 had upstaged balloon sphincteroplasty with successful clearance. For 32 of 42 repeat cases, this was the first EBS procedure. 22 of these were successful. Reasons for failed clearance were mainly poor tolerance/prolonged procedure/duodenoscope malfunction. Of a total of 22 failed cases, only 4 were due to large stones/difficult anatomy. The addition of EBS achieved higher clearance rates for stones 2 cm led to more complications and reduced clearance rates. No complications were seen when ‘interval’ sphincteroplasty was performed with balloon >15 mm. 15 cases developed complications, 11 were minor bleeds resolved at ERCP. 1 elderly patient had a significant delayed bleed requiring endoscopic haemostasis but developed fatal re-bleeding triggered by anticoagulation. There were 3 cases of post-ERCP biliary sepsis. A total of 39 of 83 cases received rectal diclofenac based on perceived risk of post procedure pancreatitis and risk of NSAID use. No cases of post-ERCP pancreatitis were seen. Conclusion EBS with sphincterotomy appears safe and potentially prevents additional procedures. Complication rates are greater with balloons >15 mm or stones >2 cm at index procedure and suggests alternative modalities should be considered in such cases. ‘Interval’ sphincteroplasty >15 mm appears safer than use at index. Immediate complications encountered were largely minor except 1 patient who required repeat endoscopic haemostasis but had fatal re-bleed due to anticoagulation. The use of adrenaline to control haemostasis and prevent delayed bleeding appears effective. No cases of pancreatitis were seen in our cohort; this may signify a benefit in using NSAIDs post-ERCP where suitable but requires analysis with a larger patient cohort. Disclosure of interest None Declared.

Su1693 5 Fr Pancreatic Stents Are Superior to Rectal NSAIDs and 3 Fr Pancreatic Stents in Preventing Post-ERCP Pancreatitis in High Risk Patients: a Systematic Review and Network Meta-Analysis

Post-ERCP pancreatitis (PEP) is the most common complication of ERCP. Both pancreatic duct (PD) stent placement and pharmacologic agents have been shown to prevent PEP in high-risk patients; however, there are no randomized controlled trials (RCT) comparing PD stents and pharmacologic agents. The efficacy of multiple competing interventions can be simultaneously compared using network meta-analysis (NMA).