Pancreatic Stents Are They Now State of the Art Care? To Help Limit Post ERCP Pancreatitis Glen A. Lehman, M.D. Professor of Medicine and Radiology Division of Gastroenterology/Hepatology Indiana University Medical Center Indianapolis, Indiana, USA If an endoscopist performs ERCP and does not offer prophylactic pancreatic stents she/he is providing appropriate or inappropriate care? 2 1
Rationale for Prophylactic Pancreas Stents Placement of a prophylactic stent across the pancreatic sphincter can decrease the intraductal pressure and decrease post- ERCP pancreatitis i frequency and severity. Patient Risk Category for Prophylactic Pancreatic Stents Low risk of post-ercp pancreatitis ( <5-7%) such as most bile duct stones and pancreas Ca; Little stent data no stent indicated High risk patients for post-ercp pancreatitis (> 8-10%) yes stent indicated 2
Stent choice Technique - Type: Polyethylene/Standard; Softer Plastic - Diameter: 3, 4, 5 Fr - Length: 2-12 cm - Internal barbs generally no Plastic Stents Cook Endoscopy Soft Plastic Hobbs Sof-flex Cook; 5 Fr only 3
Prophylactic Pancreatic Stents Prevent Post-ERCP Pancreatitis Meta-analysis analysis of 5 Prospective Controlled Trials (n=481) in High Risk Patients Stent No Stent O.R.(C.I.) OR(CI) Pancreatitis 5.8% 15.5% 3.2 (1.6-6.4)* 6.4)* Mild/Mod 5.8% 13.1% 3.0 (1.4-6.2)* Severe 0/0.4%ª 2.5% 2.9 (0.6-13)** NNT to prevent 1 episode of AP = 10; *p=0.001; **p=0.15 Singh. GIE 2004;60:544 ª IUMC data (0.4%) Patients at Higher Risk for PEP Pre During Suspected SOD Pancreas Divisum Prior Acute/Recurrent Pancreatitis / PEP No Chronic Pancreatitis Young, Female w/o biliary stones Precut Sphincterotomy Endoscopic Ampullectomy Balloon Dilation of Intact Sphincter Difficult Cannulation Pancreatic Duct Injection (any, multiple, to tail) 4
High versus Low Risk? Young to middle-aged woman Recurrent RUQ biliary type pain (like pre-ccx done for gallbladder sludge) Normal LFTs except Alk Phos mildly elevated Normal CT scan findings except mild fatty liver and 8mm diameter CBD ERCP being considered d to evaluate for stones Diagnostic ERCP.high or low risk? Empiric biliary sphincterotomy.high or low risk? 10 5
11 Patients at Higher Risk for PEP Pre During Suspected SOD Pancreas Divisum Prior Acute/Recurrent Pancreatitis / PEP No Chronic Pancreatitis Young, Female w/o biliary stones Precut Sphincterotomy Endoscopic Ampullectomy Balloon Dilation of Intact Sphincter Difficult Cannulation Pancreatic Duct Injection (any, multiple, to tail) 6
Cannulation Attempts vs PEP in 451 Intact Papilla Patients 25 Post-ER RCP pancreatitis (%) 20 15 10 5 0 1 2 3 4 5 6 7 8 9 10 Swan et al, GIE 71:AB111, 2010 PEP Rate (%) 13 Survey of 676 USA ERCP Endoscopists Low <50/yr Medium 51-200/yr High >200/yr Cote et al. GIE 2011;74:65-73 14 7
Survey of 676 USA Endoscopists Cote, et al. GIE 2011;74:65-73 15 Patients at Higher Risk for PEP Pre During Suspected SOD Pancreas Divisum Prior Acute/Recurrent Pancreatitis / PEP No Chronic Pancreatitis Young, Female w/o biliary stones Precut Sphincterotomy Endoscopic Ampullectomy Balloon Dilation of Intact Sphincter Difficult Cannulation Pancreatic Duct Injection (any, multiple, to tail) 8
Post-ERCP pancreatitis rates according to extent of pancreatic duct opacification is (%) Post-ERCP pancreatit 10 9 8 7 6 5 4 3 2 1 0 Overall post-ercp pancreatitis rate : 4.0% 53/6731 0.8% No p < 0.001 30/815 3.6% Head 93/2061 4.5% Body 404/4886 Tail 8.6% Cheon et al., GI Endosc 2007;65:385-93 Plastic prophylactic pancreatic stents (Negative aspects) - Less than 100% effective - 10-15% difficult to place (genu) - 5-8% have failed placement (increases risk more) - Migration In/Out - Perforation (GW / Stent) - Stent induced scar (if left too long in situ) - Follow up to removal 9
Guide wire Perforation Post-ERCP Pancreatitis.Mild PD Stent Outside Pancreatic Duct 10
PD Stent-Induced Ductal Changes Plastic prophylactic pancreatic stents (Negative aspects) - Less than 100% effective - 10-15% difficult to place (genu) -5-8% have failed placement (increases risk more) - Migration In/Out - Perforation (GW / Stent) - Stent induced scar (if left too long in situ) - Follow up to removal 11
Other means to decrease post ERCP Pancreatitis?.. And avoids stents? 23 Possibly/probably effective Ineffective don t work Secretin Non-ionic Glyceryl contrast trinitrate Octreotide Protease Inhibitors* NSAID Somatostatin* *12 hr. *not available in USA PAF inhibitors Steroids Allopurinol Heparin Ca 2+ ch blockers Lidocaine Interleukin-10 12
Rectal NSAIDs in the prevention of post- ERCP pancreatitis: meta-analysisanalysis favors NSAIDs favors no NSAIDs Elmunzer et al. Gut 2008;57;1262-1267. Post-ERCP Pancreatitis in 602 High Risk Patients - All Sites Patients (%) 18 Placebo 16 16.9 Indomethacin 14 12 10 8 6 4 2 0 p = 0.005 9.2 8.8 4.4 All PEP Moderate or Severe PEP (100 mg rectal suppository) p = 0.03 N EJM 2012;366:15 13
Post-ERCP Pancreatitis in 602 High Risk Patients Other Sites vs IU 30 25 26.9 Placebo Indomethacin Patients (%) 20 15 10 12. 12.6 100 mg rectal suppository 5 7.2 0 Other sites IU NEJM 2012;366:15 Rectal NSAIDS for high risk ERCP Patients Now Standard of Care 14
Can NSAIDS or Other Drugs Replace Pancreatic Stents for Prevention of Post ERCP Pancreatitis? No direct comparative studies. Needed Studies for PEP Prophylaxis Drugs (NSAIDS) vs Stents vs Both Optimal dose of NSAIDS Combination NSAIDS + Nitroglycerin + Others Optimal Stent 15
Recognize prophylactic pancreatic stent benefit - Attorneys - A few colleagues have published opinions and given court testimony. Pancreatic Stents Are They Now State of the Art Care to Help Limit Post-ERCP Pancreatitis? Low risk patients no High risk patients yes Low risk patients who convert to high risk (difficult cannulation; suspected ductal stones but none found) usually need protection of prophylactic pancreatic stents (or at least indomethacin). 16
Thank you. Indianapolis, IN glehman@iu.edu 33 17