Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study

doi:10.1067/mge.2003.124

Gastrointestinal Endoscopy

Volume 57, Issue 3, March 2003, Pages 291-294

https://doi.org/10.1067/mge.2003.124 Get rights and content

Abstract

Background: Pancreatitis is the most frequent complication of ERCP. Injury to the papilla during ERCP could obstruct pancreatic duct outflow and initiate pancreatitis. A randomized prospective study was performed to evaluate the effect of pancreatic duct stent placement on the frequency and severity of post-ERCP pancreatitis in a selected group of patients. Methods: The study group consisted of patients over 18 years of age at high risk for post-ERCP pancreatitis because of a difficult cannulation, sphincter of Oddi manometry, and/or the performance of endoscopic sphincterotomy. Patients were prospectively randomized to have a pancreatic duct stent placed or no stent upon completion of the ERCP. The endoprosthesis used was either a 5F nasopancreatic catheter or 5F, 2-cm long pancreatic stent. Study endpoints were the frequency and severity of post-ERCP pancreatitis. Results: Patients undergoing pancreatic duct stent placement had a lower frequency of post-ERCP pancreatitis as compared with those in the control group (28% vs. 5%; p < 0.05). Pancreatitis tended to be less severe in patients who had pancreatic duct drainage. Conclusions: Pancreatic duct stent insertion after ERCP reduces the frequency of post-ERCP pancreatitis in patients at high risk for this complication. (Gastrointest Endosc 2003;57:291-4.)

Section snippets

Patients

The study was conducted at a tertiary pancreaticobiliary referral center over a 6-year period. The study group consisted of patients over 18 years of age at high risk for post-ERCP pancreatitis because of a difficult cannulation, SO manometry, or the performance of endoscopic sphincterotomy. Difficult cannulation was defined as that requiring greater than 30 minutes of manipulation to achieve successful cannulation. Exclusion criteria were clinical evidence of acute or chronic pancreatitis at

Results

Of the 86 patients enrolled, 76 were at high risk for post-ERCP pancreatitis and were randomly allocated to the PD stent (NPC or PD stent) group after ERCP or the no stent group (control group). Ten patients were excluded because cannulation was not difficult and they did not require sphincterotomy or SO manometry (low risk for post-ERCP pancreatitis). Two patients randomized to the PD stent group were excluded because difficulty in obtaining deep cannulation of the PD precluded the possibility

Discussion

This prospective randomized controlled trial demonstrates that a PD stent reduces the frequency of post-ERCP pancreatitis in patients at high risk for this complication. PD stent insertion effectively prevented the more severe forms of post-ERCP pancreatitis. Among the patients who had pancreatic drainage, all cases of post-ERCP pancreatitis were mild in severity. There was no complication resulting from stent placement or NPC in the PD stent group, and the rate of unsuccessful placement was

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The incidence, severity, and mortality of post-ERCP pancreatitis (PEP) largely remain unknown with changing trends in ERCP use, indication, and techniques. We sought to determine the incidence, severity, and mortality of PEP in consecutive and high-risk patients based on a systemic review and meta-analysis of patients in placebo and no-stent arms of randomized control trials (RCTs).
The MEDLINE, Embase, and Cochrane databases were searched from the inception of each database to June 2022 to identify full-text RCTs evaluating PEP prophylaxes. The incidence, severity, and mortality of PEP from the placebo or no-stent arms of RCTs were recorded for consecutive and high-risk patients. A random-effects meta-analysis for a proportions model was used to calculate PEP incidence, severity, and mortality.
One hundred forty-five RCTs were found with 19,038 patients in the placebo or no-stent arms. The overall cumulative incidence of PEP was 10.2% (95% confidence interval [CI], 9.3-11.3), predominantly among the academic centers conducting such RCTs. The cumulative incidences of severe PEP and mortality were .5% (95% CI, .3-.7) and .2% (95% CI, .08-.3), respectively, across 91 RCTs with 14,441 patients. The cumulative incidences of PEP and severe PEP were 14.1% (95% CI, 11.5-17.2) and .8% (95% CI, .4-1.6), respectively, with a mortality rate of .2% (95% CI, 0-.3) across 35 RCTs with 3733 patients at high risk of PEP. The overall trend for the incidence of PEP among patients randomized to placebo or no-stent arms of RCTs has remained unchanged from 1977 to 2022 (P = .48).
The overall incidence of PEP is 10.2% but is 14.1% among high-risk patients based on this systematic review of placebo or no-stent arms of 145 RCTs; this rate has not changed between 1977 and 2022. Severe PEP and mortality from PEP are relatively uncommon.
Optimal indication of endoscopic retrograde pancreatography-based cytology in the preoperative pathological diagnosis of pancreatic ductal adenocarcinoma
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This study included 267 patients with PDAC who underwent preoperative ERP. The diagnostic performance of ERP-based cytology for PDAC was evaluated based on the sample collection method (pancreatic juice cytology [PJC] during ERP, brush cytology, PJC via endoscopic nasopancreatic drainage [ENPD] catheter), lesion site (pancreatic head, body/tail), and lesion size (≤10 mm, 10–20 mm, >20 mm), and compared with the diagnostic performance of EUS-FNA.
The overall sensitivity of ERP-based cytology was 54.9%; sensitivity by the sampling method was 34.7% for PJC during ERP, 65.8% for brush cytology, and 30.8% for PJC via an ENPD catheter. The sensitivity of EUS-FNA was 85.3%. Brush cytology and PJC via an ENPD catheter were performed more often in pancreatic body/tail lesions than in head lesions (P = 0.016 and P < 0.001, respectively), and the overall sensitivity of ERP-based cytology was better for body/tail lesions (63.2% vs. 49.0%, P = 0.025). The sensitivities of ERP-based cytology and EUS-FNA in diagnosing PDAC ≤10 mm were 92.3% and 33.3%, respectively. Post-ERP pancreatitis was observed in 22 patients (8.2%) and significantly less common with ENPD catheters (P = 0.002).
ERP-based cytology may be considered the first choice for pathological diagnosis of PDAC ≤10 mm and in the pancreatic body/tail.
Non-steroidal anti-inflammatory drugs, intravenous fluids, pancreatic stents, or their combinations for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and network meta-analysis
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Non-steroidal anti-inflammatory drugs (NSAIDs), intravenous fluid, pancreatic stents, or combinations of these have been evaluated in randomised controlled trials (RCTs) for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, but the comparative efficacy of these treatments remains unclear. Our aim was to do an exploratory network meta-analysis of previous RCTs to systematically compare the direct and indirect evidence and rank NSAIDs, intravenous fluids, pancreatic stents, or combinations of these to determine the most efficacious method of prophylaxis for post-ERCP pancreatitis.
We searched PubMed, Embase, and the Cochrane Central Register from inception to Nov 15, 2020, for full-text RCTs that evaluated the efficacy of NSAIDs, pancreatic stents, intravenous fluids, or combinations of these for post-ERCP pancreatitis prevention in adult (aged ≥18 years) patients undergoing ERCP. Summary data from intention-to-treat analyses were extracted from published reports. We analysed incidence of post-ERCP pancreatitis across studies using network meta-analysis under the frequentist framework, obtaining pairwise odds ratios (ORs) and 95% CIs. We used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system for the confidence rating. This study is registered with PROSPERO, CRD42020172606.
We identified 1503 studies, of which 55 RCTs evaluating 20 interventions in 17 062 patients were included in the network meta-analysis. The mean incidence of post-ERCP pancreatitis in the placebo or active control group was 12·2% (95% CI 11·4–13·0). Normal saline plus rectal indometacin (OR 0·02, 95% CI 0·00–0·40), intramuscular diclofenac 75 mg (0·24, 0·09–0·69), intravenous high-volume Ringer's lactate plus rectal diclofenac 100 mg (0·30, 0·16–0·55), intravenous high-volume Ringer's lactate (0·31, 0·12–0·78), 5–7 Fr pancreatic stents (0·35, 0·26–0·48), rectal diclofenac 100 mg (0·36, 0·25–0·52), 3 Fr pancreatic stents (0·47, 0·26–0·87), and rectal indometacin 100 mg (0·60, 0·50–0·73) were all more efficacious than placebo for preventing post-ERCP pancreatitis in pairwise comparisons. 5–7 Fr pancreatic stents (0·59, 0·41–0·84), intravenous high-volume Ringer's lactate plus rectal diclofenac 100 mg (0·49, 0·26–0·94), intravenous standard-volume normal saline plus rectal indometacin 100 mg (0·04, 0·00–0·66), and rectal diclofenac 100 mg (0·59, 0·40–0·89) were more efficacious than rectal indometacin 100 mg. The GRADE confidence rating was low to moderate for 98·3% of the pairwise comparisons.
This systematic review and network meta-analysis summarises the available literature on NSAIDs, pancreatic stents, intravenous fluids, or combinations of these for prophylaxis of post-ERCP pancreatitis. Rectal diclofenac 100 mg is the best performing rectal NSAID in this network meta-analysis. Combinations of prophylaxis might be more effective, but there is little evidence. These findings help to establish prophylaxis of post-ERCP pancreatitis for future research and practice, and could reduce costs and increase adoption of prophylaxis.
None.
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Seven NSAID RCTs (2593 patients), and 2 PPS RCTs (265 patients) in the average-risk, while 5 NSAID RCTs (1703 patients), and 8 PPS RCTs (974 patients) in the high-risk group were included in the final analysis. Compared to placebo, only PPS placement reduced the risk of moderate and severe PEP in both patient groups (average-risk: RR = 0.07, 95% CI [0.002–0.58], high-risk: RR = 0.20, 95% CI [0.051–0.56]) significantly. Rectal NSAID also reduced the risk, but this effect was not significant (average-risk: RR = 0.58, 95% CI [0.22–1.3], high-risk: RR = 0.58, 95% CI [0.18–2.3]). Based on SUCRA, PPS placement was ranked as the best preventive method.
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^☆: Reprint requests: Joseph E. Geenen, MD, St. Luke's Medical Center, Milwaukee, WI 53215.

^☆☆: 0016-5107/2003/$30.00 + 0

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Original ArticlesDoes a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study☆,☆☆

Abstract

Section snippets

Patients

Results

Discussion

Gastrointest Endosc

Gastroenterology

Gastrointest Endosc

Gastrointest Endosc

Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography

N Engl J Med

Original Articles
Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study☆,☆☆