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Risk factors for post-ERCP pancreatitis: A prospective multicenter study
ERCP-PANCREAS "561
1"563
DOES PROPHYLACTIC ORAL STEROID ADMINISTRATION REDUCE THE FREQUENCY AND SEVERITY OF FOST-ERCP PANCREATITIS?: R A N D O I V n ~ PROSPECTIVE MULTICENTER STUDY. S. Sherman. G. Lehnmn, D. Earle, J. Watkins, J. Barnett, J. Johansoa, M. Freanan, J. Geenen, M. Ryan, H. Parker, E. Lazaridis, E. Fogel, J. Flueckiger, W. Silvcramn, FL Dua, G. Aliperti, P. Yaksbe, M. Uzcr, W. Jones, J. Goff, Indiana University Medical Center, Indianapolis, IN and the Midwest Panoreafinobiliary Group. Although ERCP provides a unique opportunity to administer prophylactic therapy to limit the incidence and severity of post-procedure poncrenfitis, no agent thus far studied has been effective in this regard. By elevating the fiatctional C-I -estemse inhibitor levels and inhibiting many of the events in the cascade of autodigestion, systemic corticosternids may reduce the incidence of post-ERCP panaresfitis. The aim of this randomized, double blind, controlled trial was to determine whether prophylactic enrticostemide will reduce the fiequency and severity of post-ERCP pancreatitis. METHODS: Patients were randomized to receive either oral prednisone (40 rag) or placebo 15 hours and 3 hours prior to ERCP. A 160 variable database was prospectively collected by a defined prutonol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancrenticobiliaty Group. Standardized criteria were used to diagnose and grade the severity of post-prosedum p ~ t i s (GI Endosc 1991;37:383). This is the interim anulysis of nearly 50% of plaoned enrollment. RESULTS: pANCREATITIS SEVERITY Total with Therapy N Mild Moderate Severe pancreatitis Prednisone 464 49 (10.6%) 21 (4.5%) 3 (.6%) 73 (15.7%) Placebo 471 44 (9.3%) 17 0.6%) 5 (1%) 66 (14.0%) p = .43
ROLE OF MICROLrrHIASIS IN IDIOPATHIC ACUTE PANCREATITIS. S. Sherman. K. Gottlieb, D. Earle, P. Bnote, M. Kern, E. Fogel, L. Bucks~ P. Fay, 0. Lehman. Indiana University Medical Center, Indianapolis, IN. In 10% to 30% of patients with acute pancrentitis (AP), a cause will not be identified after a careful history, physical examination, laboratory testing, and radiologienl evuluation. These patients are classified as having idiopathic acute ~ t i s (IAP). Two recent studies (Gastroenterology 1991;101:1701; NFJM 1992;326:589) suggested that 67-75% of patients had microlithiasis as tbe caose for their lAP. The aim of this stody was to determine the flequency of cholesterol crystals (CC) and calcium bilirubinate granules (CBG) (markers for sludge and microlithiasis) in bile in a cohort of patients (with the gallbladder in site) referredfor ERCP evaluation of IAP. METHODS: During the past 5 years, 37 patients with IAP, a normal ERCP, serum hepatic chemistries <2 times upper limits of normal on presentation, and the gallbladder in situ underwent evaluation of their bile for crystsls. Minimal criteria for the diagnosis of AP included acute upper abdominal pain (without another identified cause) and serum amylase/lipase >3 times the upper limits of normal usually associated with pancreatitis changes on CT scan and/or ultrasound. Gallstones or sludge were not seen on ultrasound and/or CT scan. Sphincter of Oddi manomeWy(SOM) was performed in 33 patients (successful in 31) in the standard retrograde fashion using the aspirating catheter. Sphincter of Oddi dysfunction (SOD) was diagnosed when the basal sphincter pressure was >40 nuni-lg. Bile was collected directly from the gallbladder (n=6) after cystic duet eannulation with aid ofa glidewire or from the common bile duct (nffi3I) following intravenous Kinevac (3 ug) infusion. Fresh bile was evaluated by light and polarizing microscopy after centrifogation at 3000g for 10 minutes. RESULTS: This table shows the number of patients with CC or CBG of the total number of patients with a given SOM result. SOM $OM Normal Abnormal Failed Not Done 1/17 0/14 0/2 0/4
The groups were similar with regards to age, sex, body mass index (BMI), fiequency of prior paocreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulafion, frequen~ of pnumt sphincteretomy, pancreatic sphincterotomy, sphincter of Oddi (SO) dysfunction, SO mahomet,, pancreatic acinariz~en, ckronic pancreatitis, number of pancreatic duct injections, and common bile duct dimnoter. CONCLUSIONS: 1) In this interim analysis, prophylactic oral cortieasteroids was not shown to reduce the frequency or severity of post-ERCP pencreatitis. 2) The study is engoing with planned enrollment of 1,000 patiants into each intervention arm.
CC (n=l) and CBG (n=0) were found in I of 37 IAP patients (2.7%). Bilimy ~ s were found in no patients with SOD and one patient (5.9%) with a normal SOM. CONCLUSIONS: In this cohort of IAP patients referred for ERCP evaluation, micxolithiasis was an infrequent (potential) etiology of the AP. These fiadings suggest that patients who have normal (or near normal) serum hepatic chemistries at the time of their episode of AP have a very low likelihood of harhoring microlithiusis.
1"562
1"564
RISK FACTORS FOR POST-ERCP PANCREATITIS: A PROSPECTIVE MULTICENTER STUDY. S. Sherman. O. Lehman, D. Earle, J. Watldm, J. Bamctt, J. Johamen, M. Freanno, J. Gemen, M. Rysa, H. Parker, E. I J-a~dis, J. Flueckiger, W. Silvemmn, K. Dua, O. Aliperti, P. Yskshe, M. Uzef, W. Joins, J. Goff, Indiana Univmity Medical Centar, I n d i ~ , IN and the Midwest PMcrmtinddliasy Grou.p Panaeetitis is the moat cenmaon nm~r complicaticm of diagnmfic and thempentic ERCP. "Pnis stedy examined the ontosmm real infl;,e~- of muRiple p o t m ~ risk facton for acute pamuditis (AP) erom diagnoatk end therapeutic ERCP. METHODS: A 160 vemble database was prospectively enIIected by a defmed protnoul on patiems nodergoiNl diasnosticor therapeutic ERCP and pa~cipatin8 in a rmdemized ~molled study ~ a l , , , ~ prophylactic cxatiu~eroide will reduce the incidenee of pmt..prooedme penc~afitis. Data were col!~,~ ~'~__~at thc time of the procedure, prior to and aft" disabm~e. Smnderdized cdtsria were used to diasnme end 8redo the severity of pmt-pmceduse pmsaeetitis (GI FJut~c 1991;37:383). RESULTS: Of 935 patients ~ ERCP, 139 (14.9%) developed ~ t i s . By univariats analysis, the incidence of AP was significantly higher with the following risk factors: age <60 yo [1111625 (17.8%) vs 28/310 (9.0%); p<.001], suspected sphincter of Oddi dysfunction (SOD) [76/309 (24.6%) vs 631626 (10.1%); p<.001), diffimdty of cannulation [36/393 (9.2%) vs 103/542 (19.0%); p<.O01, eesy vs moderate/difl~enlq, pancreatic ephinctemtomy [43/157 (27.4%) vs 96f/78 (12.3%); p<.001]. The incidence of AP incsensed incrementslly with each eddifioml pancreatic duct (PD) injection (p=.003). incidenee of AP was not significantly higher with the following: prior ~tis, placebo (ve prednisoae), body mass index, use of precut sphincterotomy, acinarizatioa, CBD diameter, and the absence of d m ~ c panc~afitis. In the multivariate risk model, the risk factors for AP were penaentie sphincteretomy [Odds Ratio (O.IL), 2.31), number of PD injections (O.R. for each additimud injection, 1.15), suspected SOD (O.P,. 1.99). There was a significant association between the difficulty of monulation and the number of pancreatic duct injections (p<.001). The mean number of PD injectinns for the essy cannulatinn gronp was 1.7 nod for the modemte/difficoit group, 2.68. In patients >60 yo, pancreatic (O.R. 10.12; pffi.003) and bilimy sphimerotmny (02,. 4.44; pffi.05) increased the risk of panc~atitis compmed to diagnostic only procedures; this pattern was not observed in yoonqgerage groups. Patients >60 yo undersulng a diagnostic only procedure (O.R. 0.13; p=.008) or bilinry sphincteretomy (O.R. 0.3;pffi.004)were at lower risk for AP than patients <40 yo. CONCLUSIONS: The rate of post-ERCP pancreatitis is related to patient (age and SOD) and tedmical (number of PD injections, difficulty of cnonulatinn, and pancreatic sphincterotomy) factors. For diasnostin only and biliary sphinctemtomy procedures, older age played a protective role.
ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) IN ISLET CELL TUMORS OF THE PANCREAS R.SHUDO, T.OBARA, S.TANNO, T.FUJ II, N.NISHINO, HMAGUCHI. H.URA, Y.KOHGO Third Department of Internal Medicine, Asahikawa Medical College, Asahikawa, Japan BACKGROUND/AlMS: Although the diagnosis of islet cell tumor of the pancreas are highly accurate with imaging modalities such as endoscopic ultrasonography(EUS), it is difficult to differentiate preoperatively between malignant and benign variants of the islet cell tumor unless metasitases are present. It is known that endoscopic retrograde pancreatograpby (ERP) mainly shows normal or compression and displacement finding in the main duct on the islet cell tumor. We studied ERP to elucidate whether ERP findings are useful predictors of malignant variants of the islet cell tumor with a review of the literatures. PATIENTS AND METHODS: Seven patients with islet cell tumor of the pancreas consisted of 5 men and 2 women with a median age of 60 years( range: 41-76 ). All 7 patients underwent ERP, EUS,compoted tomography(CT) and angiography. RESULTS: Islet cell tumors were located in the pancreatic head (n= 2) and in the body (n=5). EUS demonstrated a hypoechoic mass in all 7 cases, and all 7 tumors were visualized as a high density area on CT with contrast enhancement. Angiography disclosed a hypervascular mass in all cases. ERP findings are summarized in the Table. All cases had a pathologic confirmation of the islet cell tumor( 3 cases of benign glucagonoma and 4 of malignant nonfuoctionning tumor) on the surgically resacted specimens(n=6) and on the needle biopsy specimens(n=l). Case Aoe/Sex Location Size ERPfindin2s Patholo2ical dia2no$is I 74/1: Pb 9ram n.p. glucagonoma benign 2 76/F Ph I Imm stenosis nonfunctioning malig. 3 63/F Pb 12ram stenosis glucagonoma benign 4 41/M Pb 19mm obstruction nonfunctioning malig. 5 55/M Pb 2 0 m m stenosis glucagonoma benign 6 65/M Ph 42mm stenosis nonfunctioning malig. 7 46/M Pb 45mm obstruction nonfunctionin~ mall2. On ERP, 4 malignant islet cell tumors showed stenosis(n=2) and obstruction(n=2) of the main duct, and of 3 benign tumors, 2 showed stenosis. Six cases in which obstruction of the main duct was noted on ERP have been reported in the literatures to be all malignant variant of islet cell tumor. Thus, obstruction of the main duct on ERP, if present, may be a ERP finding to indicate a malignant variant of islet cell tumor of the pancreas. CONCLUSIONS: The presence of obstruction of the main pancreatic duct on ERP is strongly suggestive of a malignant variant of the islet cell tumor of the pancreas.
VOLUME 45, NO. 4, 1997
GASTROINTESTINAL ENDOSCOPY AB165
1"563
DOES PROPHYLACTIC ORAL STEROID ADMINISTRATION REDUCE THE FREQUENCY AND SEVERITY OF FOST-ERCP PANCREATITIS?: R A N D O I V n ~ PROSPECTIVE MULTICENTER STUDY. S. Sherman. G. Lehnmn, D. Earle, J. Watkins, J. Barnett, J. Johansoa, M. Freanan, J. Geenen, M. Ryan, H. Parker, E. Lazaridis, E. Fogel, J. Flueckiger, W. Silvcramn, FL Dua, G. Aliperti, P. Yaksbe, M. Uzcr, W. Jones, J. Goff, Indiana University Medical Center, Indianapolis, IN and the Midwest Panoreafinobiliary Group. Although ERCP provides a unique opportunity to administer prophylactic therapy to limit the incidence and severity of post-procedure poncrenfitis, no agent thus far studied has been effective in this regard. By elevating the fiatctional C-I -estemse inhibitor levels and inhibiting many of the events in the cascade of autodigestion, systemic corticosternids may reduce the incidence of post-ERCP panaresfitis. The aim of this randomized, double blind, controlled trial was to determine whether prophylactic enrticostemide will reduce the fiequency and severity of post-ERCP pancreatitis. METHODS: Patients were randomized to receive either oral prednisone (40 rag) or placebo 15 hours and 3 hours prior to ERCP. A 160 variable database was prospectively collected by a defined prutonol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancrenticobiliaty Group. Standardized criteria were used to diagnose and grade the severity of post-prosedum p ~ t i s (GI Endosc 1991;37:383). This is the interim anulysis of nearly 50% of plaoned enrollment. RESULTS: pANCREATITIS SEVERITY Total with Therapy N Mild Moderate Severe pancreatitis Prednisone 464 49 (10.6%) 21 (4.5%) 3 (.6%) 73 (15.7%) Placebo 471 44 (9.3%) 17 0.6%) 5 (1%) 66 (14.0%) p = .43
ROLE OF MICROLrrHIASIS IN IDIOPATHIC ACUTE PANCREATITIS. S. Sherman. K. Gottlieb, D. Earle, P. Bnote, M. Kern, E. Fogel, L. Bucks~ P. Fay, 0. Lehman. Indiana University Medical Center, Indianapolis, IN. In 10% to 30% of patients with acute pancrentitis (AP), a cause will not be identified after a careful history, physical examination, laboratory testing, and radiologienl evuluation. These patients are classified as having idiopathic acute ~ t i s (IAP). Two recent studies (Gastroenterology 1991;101:1701; NFJM 1992;326:589) suggested that 67-75% of patients had microlithiasis as tbe caose for their lAP. The aim of this stody was to determine the flequency of cholesterol crystals (CC) and calcium bilirubinate granules (CBG) (markers for sludge and microlithiasis) in bile in a cohort of patients (with the gallbladder in site) referredfor ERCP evaluation of IAP. METHODS: During the past 5 years, 37 patients with IAP, a normal ERCP, serum hepatic chemistries <2 times upper limits of normal on presentation, and the gallbladder in situ underwent evaluation of their bile for crystsls. Minimal criteria for the diagnosis of AP included acute upper abdominal pain (without another identified cause) and serum amylase/lipase >3 times the upper limits of normal usually associated with pancreatitis changes on CT scan and/or ultrasound. Gallstones or sludge were not seen on ultrasound and/or CT scan. Sphincter of Oddi manomeWy(SOM) was performed in 33 patients (successful in 31) in the standard retrograde fashion using the aspirating catheter. Sphincter of Oddi dysfunction (SOD) was diagnosed when the basal sphincter pressure was >40 nuni-lg. Bile was collected directly from the gallbladder (n=6) after cystic duet eannulation with aid ofa glidewire or from the common bile duct (nffi3I) following intravenous Kinevac (3 ug) infusion. Fresh bile was evaluated by light and polarizing microscopy after centrifogation at 3000g for 10 minutes. RESULTS: This table shows the number of patients with CC or CBG of the total number of patients with a given SOM result. SOM $OM Normal Abnormal Failed Not Done 1/17 0/14 0/2 0/4
The groups were similar with regards to age, sex, body mass index (BMI), fiequency of prior paocreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulafion, frequen~ of pnumt sphincteretomy, pancreatic sphincterotomy, sphincter of Oddi (SO) dysfunction, SO mahomet,, pancreatic acinariz~en, ckronic pancreatitis, number of pancreatic duct injections, and common bile duct dimnoter. CONCLUSIONS: 1) In this interim analysis, prophylactic oral cortieasteroids was not shown to reduce the frequency or severity of post-ERCP pencreatitis. 2) The study is engoing with planned enrollment of 1,000 patiants into each intervention arm.
CC (n=l) and CBG (n=0) were found in I of 37 IAP patients (2.7%). Bilimy ~ s were found in no patients with SOD and one patient (5.9%) with a normal SOM. CONCLUSIONS: In this cohort of IAP patients referred for ERCP evaluation, micxolithiasis was an infrequent (potential) etiology of the AP. These fiadings suggest that patients who have normal (or near normal) serum hepatic chemistries at the time of their episode of AP have a very low likelihood of harhoring microlithiusis.
1"562
1"564
RISK FACTORS FOR POST-ERCP PANCREATITIS: A PROSPECTIVE MULTICENTER STUDY. S. Sherman. O. Lehman, D. Earle, J. Watldm, J. Bamctt, J. Johamen, M. Freanno, J. Gemen, M. Rysa, H. Parker, E. I J-a~dis, J. Flueckiger, W. Silvemmn, K. Dua, O. Aliperti, P. Yskshe, M. Uzef, W. Joins, J. Goff, Indiana Univmity Medical Centar, I n d i ~ , IN and the Midwest PMcrmtinddliasy Grou.p Panaeetitis is the moat cenmaon nm~r complicaticm of diagnmfic and thempentic ERCP. "Pnis stedy examined the ontosmm real infl;,e~- of muRiple p o t m ~ risk facton for acute pamuditis (AP) erom diagnoatk end therapeutic ERCP. METHODS: A 160 vemble database was prospectively enIIected by a defmed protnoul on patiems nodergoiNl diasnosticor therapeutic ERCP and pa~cipatin8 in a rmdemized ~molled study ~ a l , , , ~ prophylactic cxatiu~eroide will reduce the incidenee of pmt..prooedme penc~afitis. Data were col!~,~ ~'~__~at thc time of the procedure, prior to and aft" disabm~e. Smnderdized cdtsria were used to diasnme end 8redo the severity of pmt-pmceduse pmsaeetitis (GI FJut~c 1991;37:383). RESULTS: Of 935 patients ~ ERCP, 139 (14.9%) developed ~ t i s . By univariats analysis, the incidence of AP was significantly higher with the following risk factors: age <60 yo [1111625 (17.8%) vs 28/310 (9.0%); p<.001], suspected sphincter of Oddi dysfunction (SOD) [76/309 (24.6%) vs 631626 (10.1%); p<.001), diffimdty of cannulation [36/393 (9.2%) vs 103/542 (19.0%); p<.O01, eesy vs moderate/difl~enlq, pancreatic ephinctemtomy [43/157 (27.4%) vs 96f/78 (12.3%); p<.001]. The incidence of AP incsensed incrementslly with each eddifioml pancreatic duct (PD) injection (p=.003). incidenee of AP was not significantly higher with the following: prior ~tis, placebo (ve prednisoae), body mass index, use of precut sphincterotomy, acinarizatioa, CBD diameter, and the absence of d m ~ c panc~afitis. In the multivariate risk model, the risk factors for AP were penaentie sphincteretomy [Odds Ratio (O.IL), 2.31), number of PD injections (O.R. for each additimud injection, 1.15), suspected SOD (O.P,. 1.99). There was a significant association between the difficulty of monulation and the number of pancreatic duct injections (p<.001). The mean number of PD injectinns for the essy cannulatinn gronp was 1.7 nod for the modemte/difficoit group, 2.68. In patients >60 yo, pancreatic (O.R. 10.12; pffi.003) and bilimy sphimerotmny (02,. 4.44; pffi.05) increased the risk of panc~atitis compmed to diagnostic only procedures; this pattern was not observed in yoonqgerage groups. Patients >60 yo undersulng a diagnostic only procedure (O.R. 0.13; p=.008) or bilinry sphincteretomy (O.R. 0.3;pffi.004)were at lower risk for AP than patients <40 yo. CONCLUSIONS: The rate of post-ERCP pancreatitis is related to patient (age and SOD) and tedmical (number of PD injections, difficulty of cnonulatinn, and pancreatic sphincterotomy) factors. For diasnostin only and biliary sphinctemtomy procedures, older age played a protective role.
ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) IN ISLET CELL TUMORS OF THE PANCREAS R.SHUDO, T.OBARA, S.TANNO, T.FUJ II, N.NISHINO, HMAGUCHI. H.URA, Y.KOHGO Third Department of Internal Medicine, Asahikawa Medical College, Asahikawa, Japan BACKGROUND/AlMS: Although the diagnosis of islet cell tumor of the pancreas are highly accurate with imaging modalities such as endoscopic ultrasonography(EUS), it is difficult to differentiate preoperatively between malignant and benign variants of the islet cell tumor unless metasitases are present. It is known that endoscopic retrograde pancreatograpby (ERP) mainly shows normal or compression and displacement finding in the main duct on the islet cell tumor. We studied ERP to elucidate whether ERP findings are useful predictors of malignant variants of the islet cell tumor with a review of the literatures. PATIENTS AND METHODS: Seven patients with islet cell tumor of the pancreas consisted of 5 men and 2 women with a median age of 60 years( range: 41-76 ). All 7 patients underwent ERP, EUS,compoted tomography(CT) and angiography. RESULTS: Islet cell tumors were located in the pancreatic head (n= 2) and in the body (n=5). EUS demonstrated a hypoechoic mass in all 7 cases, and all 7 tumors were visualized as a high density area on CT with contrast enhancement. Angiography disclosed a hypervascular mass in all cases. ERP findings are summarized in the Table. All cases had a pathologic confirmation of the islet cell tumor( 3 cases of benign glucagonoma and 4 of malignant nonfuoctionning tumor) on the surgically resacted specimens(n=6) and on the needle biopsy specimens(n=l). Case Aoe/Sex Location Size ERPfindin2s Patholo2ical dia2no$is I 74/1: Pb 9ram n.p. glucagonoma benign 2 76/F Ph I Imm stenosis nonfunctioning malig. 3 63/F Pb 12ram stenosis glucagonoma benign 4 41/M Pb 19mm obstruction nonfunctioning malig. 5 55/M Pb 2 0 m m stenosis glucagonoma benign 6 65/M Ph 42mm stenosis nonfunctioning malig. 7 46/M Pb 45mm obstruction nonfunctionin~ mall2. On ERP, 4 malignant islet cell tumors showed stenosis(n=2) and obstruction(n=2) of the main duct, and of 3 benign tumors, 2 showed stenosis. Six cases in which obstruction of the main duct was noted on ERP have been reported in the literatures to be all malignant variant of islet cell tumor. Thus, obstruction of the main duct on ERP, if present, may be a ERP finding to indicate a malignant variant of islet cell tumor of the pancreas. CONCLUSIONS: The presence of obstruction of the main pancreatic duct on ERP is strongly suggestive of a malignant variant of the islet cell tumor of the pancreas.
VOLUME 45, NO. 4, 1997
GASTROINTESTINAL ENDOSCOPY AB165