Dataset Information

Rectal NSAIDs-based combination modalities are superior to single modalities for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a network meta-analysis.

ABSTRACT:

Background/aims

Different modalities have been employed to reduce the risk and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, there has been a paucity of studies comparing the efficacy of various prophylactic modalities for preventing PEP. This network meta-analysis (NMA) aimed to determine the relative efficacy of pancreatic duct stents and pharmacological modalities for preventing PEP.

Methods

We performed a systematic and comprehensive search to identify and analyze all randomized controlled studies published until June 2020 that examined the effectiveness of pancreatic duct stents, rectal non-steroidal anti-inflammatory drugs (NSAIDs) based regimens, hydration, and their combinations for the prevention of PEP. The primary outcome was the frequency of PEP. An NMA was performed to combine direct and indirect comparisons of different prophylactic modalities.

Results

The NMA included 46 studies evaluating 18 regimens in 16,241 patients. Based on integral analysis of predictive interval plots, and expected mean ranking and surface under the cumulative ranking curve values, combination prophylaxis with indomethacin + lactated Ringer's solution (LR), followed by diclofenac + nitrate and indomethacin + normal saline, was found to be the most efficacious modality for the overall prevention of PEP. Indomethacin + LR, followed by diclofenac and pancreatic duct stents, was the most efficacious modality for high-risk groups.

Conclusion

Rectal NSAIDs-based combination regimens with aggressive hydration or nitrate are superior to single modalities for the prevention of PEP.

SUBMITTER: Park TY

PROVIDER: S-EPMC8925947 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Rectal NSAIDs-based combination modalities are superior to single modalities for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a network meta-analysis.

Park Tae Young TY Kang Hyun H Choi Geun Joo GJ Oh Hyoung-Chul HC

The Korean journal of internal medicine 20220216 2

<h4>Background/aims</h4>Different modalities have been employed to reduce the risk and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, there has been a paucity of studies comparing the efficacy of various prophylactic modalities for preventing PEP. This network meta-analysis (NMA) aimed to determine the relative efficacy of pancreatic duct stents and pharmacological modalities for preventing PEP.<h4>Methods</h4>We performed a systematic and com ...[more]

PMID: 35168302

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Project description:BackgroundAlthough rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients.MethodsIn this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete.FindingsBetween July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up.InterpretationDose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.FundingAmerican College of Gastroenterology.

Project description:BackgroundPancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP) which can be severe and cause death in approximately 10% of cases. Up to now, six randomized controlled trials (RCTs) have been found relevant to the effect of allopurinol on prevention of Post-ERCP pancreatitis (PEP). However, these results remained controversial.ObjectiveTo conduct a meta-analysis with RCTs published in full text to determine the effectiveness of prophylactic allopurinol of different dosages and administration time in the incidence and severity of PEP.MethodsLiterature search was performed in PubMed, Embase, Web of Science and Cochrane Library from databases inception to May 2014. RCTs comparing the effect of allopurinol with placebo on prevention of PEP were included. Statistical heterogeneity was quantitatively evaluated by?2 test with the significance set P<0.10 or I2>50%.ResultsSix RCTs consisting of 1974 participants were eventually included. The incidences of PEP in allopurinol group and placebo group were 8.4%(83/986) and 9.9%(98/988) respectively. Meta-analysis showed no evident prevention effect of allopurinol on the incidence of PEP (RR 0.75, 95%CI 0.39-1.42) with significant heterogeneity (I2?=?70.4%, P?=?0.005). When studies were stratified according to the dosages and administration time of allopurinol they applied, there was still no evident prevention effect of allopurinol on mild, moderate or severe PEP. However, statistically substantial heterogeneity was presented in the subgroup of moderate PEP when the effect of high dose of allopurinol was analyzed (Imoderate2?=?82.3%, Pmoderate?=?0.018). Statistically significant heterogeneity was also observed in subgroup of mild PEP, when the effect of long adminstration time of allopurinol was investigated (Imild2?=?62.8%, Pmild?=?0.068).ConclusionThe prophylactic use of allopurinol in different dosages and administration time had no effect in preventing incidence and severity of PEP.

Project description:Acute pancreatitis is the most common major complication after endoscopic retrograde cholangiopancreatography (ERCP). Many drugs have been evaluated for prophylaxis, including nonsteroidal anti-inflammatory drugs (NSAIDs), which are potent inhibitors of phospholipase A2 and play a role in the pathogenesis of acute pancreatitis. Rectal NSAIDs have been shown in prospective studies to decrease the incidence of this complication, but the indication is not generalized in clinical practice. The aim of this study was to evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of post-ERCP pancreatitis in high-risk patients.This was a controlled clinical trial where patients with an elevated risk of developing post-ERCP pancreatitis were assigned to receive 100 mg of rectal indomethacin or a 2.6 g suppository of glycerin immediately after ERCP, without placement of a pancreatic stent. The patients were determined to be at high risk based on validated patient- and procedure-related risk factors. Post-ERCP pancreatitis was defined as the presence of new upper abdominal pain, hyperamylasemia/hyperlipasemia (at least three times the upper limit) 2 hours after the procedure and hospitalization at least 48 hours because of the complication. Pancreatitis severity was defined according to Cotton's criteria.One hundred sixty-six patients were included; 82 in the study group and 84 in the placebo group. Patients had at least one major and/or two minor risk factors for developing post-ERCP pancreatitis. The incidence of the complication was 4.87% (4/82) in the study group and 20.23% (17/84) in the placebo group; this difference was significant (P?=?0.01). According to Cotton's criteria, 17 patients (80.9%) developed mild pancreatitis and 4 (19.1%) had moderate pancreatitis; 3 of these 4 patients belonged to the placebo group (P?=?0.60). Based on these results, an absolute risk reduction of 0.15 (15%), a relative risk reduction of 0.75 (75%) and a number needed to treat of 6.5 patients were calculated to prevent an episode of post-ERCP pancreatitis. There was no mortality.Rectal indomethacin reduced the incidence of post-ERCP pancreatitis among patients at high risk of developing this complication.National Clinical Trials NCT02110810. Date April 7, 2014.

Dataset Information

Rectal NSAIDs-based combination modalities are superior to single modalities for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a network meta-analysis.

Background/aims

Methods

Results

Conclusion

Publications

Rectal NSAIDs-based combination modalities are superior to single modalities for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a network meta-analysis.

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