Mo1428 Prospective Evaluation of the Karnofsky Score As a Guide to Placing a Plastic Versus Metal...
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precut sphincterotomy, trans-papillary balloon dilatation or multiple pancreatic duct injections; the remainers were classified as low-risk. The incidence of post-ERCP pancreatitis was analyzed. Results: The overall incidence of acute pancreatitis was 7.4% (44/595). There was a significant difference in the incidence of PEP with or without nafamostat mesylate (13.0% vs 4.0% and 5.1%, respectively, p 0.0001). There was no significant difference between group B and group C (4.0% vs 5.1%, , p 0.622). Subgroup analysis showed that, in low-risk patients, the rate of PEP was significantly different with nafamost (11.9% vs 2.7% and 4.0%, respectively, p0.007). In high-risk patients, the rate of PEP was not significantly different among treatment groups (14.6% vs 5.9% vs 6.9%, respectively; p 0.108). Conclusions: Nafamostat mesylate prophylaxis (20mg or 50mg) is effective in preventing post-ERCP pancreatitis. However, preventive effect of high dose nafamostat mesylate (50mg) is not significant in high risk patients. Incidence of post-ERCP pancreatitis and post-ERCP hyperamylasemia in three groups Group A (N200) Group B (N198) Group C (N197) P value (A vs B) P value (A vs C) P value (B vs C) Total Post-ERCP hyperamylasemia, n (%) 19 (9.5) 27 (13.6) 28 (14.2) .197 .146 .868 74 (12.4) Post-ERCP pancreatitis, n (%) 26 (13.0 8 (4.0) 10 (5.1) .001 .006 .622 44 (7.4) Mild, n (%) 20 (10.0) 8 (4.0) 10 (5.1) Moderate, n (%) 6 (3.0) 0 0 Severe, n (%) 0 0 0 High-risk patients N82 N85 N72 N239 Post-ERCP hyperamylasemia, n (%) 9 (11.0) 14 (16.5) 11 (15.3) .303 .428 .839 34 (14.2) Post-ERCP pancreatitis, n (%) 12 (14.6) 5 (5.9) 5 (6.9) .062 .129 .789 22 (9.2) Mild, n (%) 8 (9.8) 5 (5.9) 5 (6.9) Moderate, n (%) 4 (4.9) 0 0 Severe, n (%) 0 0 0 Low-risk patients N118 N113 N125 N356 Post-ERCP hyperamylasemia, n (%) 10 (8.5) 13 (11.5) 17 (13.6) .442 .204 .627 40 (11.2) Post-ERCP pancreatitis, n (%) 14 (11.9) 3 (2.7) 5 (4.0) .007 .022 .565 22 (6.2) Mild, n (%) 12 (10.2) 3 (2.7) 5 (4.0) Moderate, n (%) 2 (1.7) 0 0 Severe, n (%) 0 0 0 Mo1428 Prospective Evaluation of the Karnofsky Score As a Guide to Placing a Plastic Versus Metal Stent for Pancreaticobiliary Malignancy Charles Wilcox, Milind A. Phadnis, Toni Seay, Shyam Varadarajulu University of Alabama at Birmingham, Birmingham, AL Background: Metal stents continue to be promoted as the ideal choice for biliary decompression of symptomatic patients with pancreaticobiliary malignancy. While there is no question as to their superiority over plastic stents for time to occlusion, the overall expense suggests that a more tailored selection of candidates for such stents should be employed. Plastic stents have been recommended for those with an expected survival of 3-6 months, although there is little data to guide us regarding the best prognostic factors in this setting. Methods Over a 26 month period, all patients with suspected / confirmed symptomatic pancreaticobiliary malignancy referred for ERCP were prospectively identified. At the time of evaluation, the criteria used to determine stent type were: planned surgery, presence of liver metastases and Karnofsky score. For those patients with liver metastases by CT, Karnofsky score of 70 or less, or those in whom surgery was anticipated, a 10 French plastic stent placement was deployed whereas those with a Karnofsky score 70 underwent 10 French metallic stent placement. Patients were then followed long-term to determine the need for repeat ERCP for presumed stent occlusion and survival. Patients referred initially for stent exchange were excluded. Results 100 consecutive patients underwent initial biliary stent placement for pancreaticobiliary malignancy during the 26 month study period. Plastic stents were placed in 62 patients and metallic stents in 38. Overall, during follow-up, 27 patients (27%) required endoscopic reintervention (21 (34%) plastic stents, 6 (16%) metal stents, p 0.024). When reintervention was not required, the median survival time was 7.4 months (interquartile range 1.8- 19.2 months) and patients who received a metal stent without surgical resection had a longer survival than those receiving a plastic stent (10.4 mo vs 3.9 mo; p0.0256). Survival was associated with liver metastases (p 0.002) and Karnofsky score (p 0.018) while not associated with type of malignancy and the patient’s age. Median time to restent for the 27 patients undergoing stent exchange was 1.5 months (range 3 days to 8.7 months). Conclusions The overall restenting rate was relatively low compared to other studies. The use of the Karnofsky score and liver metastases appears to be a useful predictor for survival and for the type of stent to deploy. These results have important financial implications for endoscopic units. Mo1429 Intraductal Aspiration: A Promising New Tissue Sampling Technique for Diagnosis of Suspected Malignant Pancreatobiliary Strictures Gabriele Curcio, Mario Traina, Filippo Mocciaro, Raffaella Gentile, Rosa Liotta, Ilaria Tarantino, Luca Barresi, Bruno G. Gridelli ISMETT, Palermo, Italy INTRODUCTION: Cytologic and tissue acquisition in suspected malignant pancreatobiliary strictures are frequently non-conclusive. Brushing is the standard sampling method at endoscopic retrograde cholangiopancretography (ERCP), but lacks sensitivity for cancer detection (18% to 60%). We assessed a novel tissue- sampling method for cancer detection at ERCP in a pilot study. AIMS AND METHODS: Thirty-five consecutive patients with suspected malignant pancreatobiliary strictures were prospectively studied through tissue sampling at ERCP. All patients signed an informed consent. For each patient, we performed standard brushing of the stricture. After that, we modified a second catheter by removing the brush, and moved the tip back and forth within the stricture at least 10 times, aspirating fluid through a specimen trap connected to a suction line. We called this novel manipulation of the stricture IntraDuctal Aspiration (IDA). Intraductally aspirated fluids were evaluated by two experienced cytopathologists. For each patient a definitive diagnosis was obtained at the end of the follow-up. Our aims were to compare feasibility, sample adequacy, accuracy, sensitivity and specificity, positive and negative predictive value (PPV, NPV), and the safety of IDA versus standard brushing. RESULTS: Twenty-two male and thirteen female patients, mean age 6120, underwent ERCP for suspected malignant pancreatobiliary stricture. Thirty-two patients had biliary stricture, and three had pancreatic stricure. Both techniques were successfully applied to each stricture. Our cytopathologists judged IDA sample adequacy significantly superior to brushing sample adequacy (p0.001, Fig.). Diagnostic accuracy was 97% and 88% for IDA and brushing, respectively. The sensitivity and specificity for cancer detection were 92% (95% CI 60-100%) and 100% (95% CI 80-100%), respectively, for IDA and 67% (95% CI 12-98%) and 100% (95%CI 42-100%), respectively, for brushing. PPV and NPV were 100% (95%CI 68-100%) and 95% (95%CI 74-100%), respectively, for IDA, and 100% (95%CI 20-100%) and 83% (95%CI 36-99%), respectively, for brushing. There were no adverse events. CONCLUSIONS: We found this novel tissue sampling technique (IDA) to be feasible and safe. IDA sample adequacy for cytodiagnosis was superior to standard brushing, with a higher rate of accuracy, sensitivity and NPV. These preliminary data appear to suggest that IDA may represent a new gold-standard for cytodiagnosis at ERCP. Further studies of larger numbers of patients will be necessary to confirm these findings. Abstracts AB342 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011 www.giejournal.org
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Transcript of Mo1428 Prospective Evaluation of the Karnofsky Score As a Guide to Placing a Plastic Versus Metal...
precut sphincterotomy, trans-papillary balloon dilatation or multiplepancreatic duct injections; the remainers were classified as low-risk. Theincidence of post-ERCP pancreatitis was analyzed. Results: The overallincidence of acute pancreatitis was 7.4% (44/595). There was a significantdifference in the incidence of PEP with or without nafamostat mesylate(13.0% vs 4.0% and 5.1%, respectively, p � 0.0001). There was no significantdifference between group B and group C (4.0% vs 5.1%, , p � 0.622).Subgroup analysis showed that, in low-risk patients, the rate of PEP wassignificantly different with nafamost (11.9% vs 2.7% and 4.0%, respectively,p�0.007). In high-risk patients, the rate of PEP was not significantly differentamong treatment groups (14.6% vs 5.9% vs 6.9%, respectively; p � 0.108).Conclusions: Nafamostat mesylate prophylaxis (20mg or 50mg) is effective inpreventing post-ERCP pancreatitis. However, preventive effect of high dosenafamostat mesylate (50mg) is not significant in high risk patients.
Incidence of post-ERCP pancreatitis and post-ERCP hyperamylasemia in threegroups
Group A(N�200)
Group B(N�198)
Group C(N�197)
Pvalue(A vs
B)
Pvalue(A vs
C)
Pvalue(B vs
C) Total
Post-ERCPhyperamylasemia,n (%)
19 (9.5) 27 (13.6) 28 (14.2) .197 .146 .868 74 (12.4)
Post-ERCPpancreatitis, n(%)
26 (13.0 8 (4.0) 10 (5.1) .001 .006 .622 44 (7.4)
Mild, n (%) 20 (10.0) 8 (4.0) 10 (5.1)Moderate, n (%) 6 (3.0) 0 0Severe, n (%) 0 0 0High-risk patients N�82 N�85 N�72 N�239Post-ERCP
hyperamylasemia,n (%)
9 (11.0) 14 (16.5) 11 (15.3) .303 .428 .839 34 (14.2)
Post-ERCPpancreatitis, n(%)
12 (14.6) 5 (5.9) 5 (6.9) .062 .129 .789 22 (9.2)
Mild, n (%) 8 (9.8) 5 (5.9) 5 (6.9)Moderate, n (%) 4 (4.9) 0 0Severe, n (%) 0 0 0Low-risk patients N�118 N�113 N�125 N�356Post-ERCP
hyperamylasemia,n (%)
10 (8.5) 13 (11.5) 17 (13.6) .442 .204 .627 40 (11.2)
Post-ERCPpancreatitis, n(%)
14 (11.9) 3 (2.7) 5 (4.0) .007 .022 .565 22 (6.2)
Mild, n (%) 12 (10.2) 3 (2.7) 5 (4.0)Moderate, n (%) 2 (1.7) 0 0Severe, n (%) 0 0 0
Mo1428Prospective Evaluation of the Karnofsky Score As a Guide toPlacing a Plastic Versus Metal Stent for PancreaticobiliaryMalignancyCharles Wilcox, Milind A. Phadnis, Toni Seay, Shyam VaradarajuluUniversity of Alabama at Birmingham, Birmingham, ALBackground: Metal stents continue to be promoted as the ideal choice for biliarydecompression of symptomatic patients with pancreaticobiliary malignancy.While there is no question as to their superiority over plastic stents for time toocclusion, the overall expense suggests that a more tailored selection ofcandidates for such stents should be employed. Plastic stents have beenrecommended for those with an expected survival of 3-6 months, although thereis little data to guide us regarding the best prognostic factors in this setting.Methods Over a 26 month period, all patients with suspected / confirmedsymptomatic pancreaticobiliary malignancy referred for ERCP were prospectivelyidentified. At the time of evaluation, the criteria used to determine stent typewere: planned surgery, presence of liver metastases and Karnofsky score. Forthose patients with liver metastases by CT, Karnofsky score of 70 or less, orthose in whom surgery was anticipated, a 10 French plastic stent placement wasdeployed whereas those with a Karnofsky score �70 underwent 10 Frenchmetallic stent placement. Patients were then followed long-term to determine theneed for repeat ERCP for presumed stent occlusion and survival. Patientsreferred initially for stent exchange were excluded. Results 100 consecutivepatients underwent initial biliary stent placement for pancreaticobiliarymalignancy during the 26 month study period. Plastic stents were placed in 62patients and metallic stents in 38. Overall, during follow-up, 27 patients (27%)required endoscopic reintervention (21 (34%) plastic stents, 6 (16%) metal stents,p � 0.024). When reintervention was not required, the median survival time was
7.4 months (interquartile range 1.8- 19.2 months) and patients who received ametal stent without surgical resection had a longer survival than those receivinga plastic stent (10.4 mo vs 3.9 mo; p�0.0256). Survival was associated with livermetastases (p � 0.002) and Karnofsky score (p � 0.018) while not associatedwith type of malignancy and the patient’s age. Median time to restent for the 27patients undergoing stent exchange was 1.5 months (range 3 days to 8.7months). Conclusions The overall restenting rate was relatively low compared toother studies. The use of the Karnofsky score and liver metastases appears to bea useful predictor for survival and for the type of stent to deploy. These resultshave important financial implications for endoscopic units.
Mo1429Intraductal Aspiration: A Promising New Tissue SamplingTechnique for Diagnosis of Suspected MalignantPancreatobiliary StricturesGabriele Curcio, Mario Traina, Filippo Mocciaro, Raffaella Gentile,Rosa Liotta, Ilaria Tarantino, Luca Barresi, Bruno G. GridelliISMETT, Palermo, ItalyINTRODUCTION: Cytologic and tissue acquisition in suspected malignantpancreatobiliary strictures are frequently non-conclusive. Brushing is the standardsampling method at endoscopic retrograde cholangiopancretography (ERCP), butlacks sensitivity for cancer detection (18% to 60%). We assessed a novel tissue-sampling method for cancer detection at ERCP in a pilot study. AIMS ANDMETHODS: Thirty-five consecutive patients with suspected malignantpancreatobiliary strictures were prospectively studied through tissue sampling atERCP. All patients signed an informed consent. For each patient, we performedstandard brushing of the stricture. After that, we modified a second catheter byremoving the brush, and moved the tip back and forth within the stricture atleast 10 times, aspirating fluid through a specimen trap connected to a suctionline. We called this novel manipulation of the stricture IntraDuctal Aspiration(IDA). Intraductally aspirated fluids were evaluated by two experiencedcytopathologists. For each patient a definitive diagnosis was obtained at the endof the follow-up. Our aims were to compare feasibility, sample adequacy,accuracy, sensitivity and specificity, positive and negative predictive value (PPV,NPV), and the safety of IDA versus standard brushing. RESULTS: Twenty-twomale and thirteen female patients, mean age 61�20, underwent ERCP forsuspected malignant pancreatobiliary stricture. Thirty-two patients had biliarystricture, and three had pancreatic stricure. Both techniques were successfullyapplied to each stricture. Our cytopathologists judged IDA sample adequacysignificantly superior to brushing sample adequacy (p�0.001, Fig.). Diagnosticaccuracy was 97% and 88% for IDA and brushing, respectively. The sensitivityand specificity for cancer detection were 92% (95% CI 60-100%) and 100% (95%CI 80-100%), respectively, for IDA and 67% (95% CI 12-98%) and 100% (95%CI42-100%), respectively, for brushing. PPV and NPV were 100% (95%CI 68-100%)and 95% (95%CI 74-100%), respectively, for IDA, and 100% (95%CI 20-100%) and83% (95%CI 36-99%), respectively, for brushing. There were no adverse events.CONCLUSIONS: We found this novel tissue sampling technique (IDA) to befeasible and safe. IDA sample adequacy for cytodiagnosis was superior tostandard brushing, with a higher rate of accuracy, sensitivity and NPV. Thesepreliminary data appear to suggest that IDA may represent a new gold-standardfor cytodiagnosis at ERCP. Further studies of larger numbers of patients will benecessary to confirm these findings.
Abstracts
AB342 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011 www.giejournal.org
