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Tu1787 Randomized Clinical Trial of Duct-to-Mucosa Pancreaticogastrostomy of Pancreatic Stump Versus Hand-Sewn Closure After Distal Pancreatectomy
factors with significant impact elucidated in the single test that the application of hemostat device onto the hepatic resection area resulted unexpectedly rather in an increase than a decrease of the drainage volume but 4.) under accompanying more pronounced increase of the white blood cell count (leucocytosis). 5.) General and specific complications such as postoperative bleeding, biliary fistula and subhepatic abscess were not further lowered in a significant manner using hemostat device. Conclusion: Adequate surgery in the operative management of hepatic resection area cannot further be improved or optimized using hemostat device. In this context, drainage volume may not be considered a sufficient rather an orienting parameter. However, there is an inflammatory response detectable most likely indicated by a(n un-)specific effusion and increase of white blood cell count, which can be interpreted as reactive inflammation to foreign material.
Table 1. Adjusted Odds Ratios Associated with Race for 30- and 90-Day Readmission after Complex Alimentary Tract Cancer Surgery, California Inpatient Database 2004-2011.
Tu1785 Trends in Acute Cholecystitis With and Without Choledocholithiasis Roman Grinberg, John Afthinos, Karen E. Gibbs Introduction: Acute cholecystitis with concomitant choledocholithiasis is an uncommon presentation of biliary tract disease. Traditional sources have placed the incidence at under 12%. We sought to evaluate the incidence of this disease entity in the setting of a large national database and to identify trends in management. Methods: The NIS database was queried from 2005 to 2010 for all patients presenting with acute cholecystitis (AC) and acute cholecystitis with choledocholithiasis (AC/CH). Age, gender, comorbid conditions were quantified. Rates of cholecystectomy, intraoperative cholangiogram and ERCP were evaluated. Post-procedural complications were also quantified. Multivariate logistic regression analyses were performed to evaluate for risk factors for independent risk factors predicting presentation of AC with choledocholithiasis. Results: We identified 321,802 patients diagnosed with AC and AC/CH, of which 73,648 (23%) had AC/CH. Female patients comprised 61% of the total population. Mortality was 0.73% in the AC group and 0.74% in the AC/ CH group (p=NS). In the AC group 7% of patients underwent ERCP, while in the AC/CH group 63% underwent ERCP (p < 0.001). Laparoscopic cholecystectomy was undertaken in 72% of all patients with AC; it was performed for 70% of the patients with AC/CH (p= NS). Within the AC group, 25% had an intraoperative cholangiogram as compared to 45.5% in AC/CH group (p<0.05). CBD exploration occurred in 0.7% of the AC patients and 9.5% of AC/CH patients (p < 0.01). Length of stay for the AC group was 4.27 + 4.8 days, compared to 5.6 + 4.8 days for the AC/CH group. Female gender (OR 1.2, p < 0.001) and severe liver disease (OR 1.3, p < 0.001) are independent risk factors for presentation of AC/CH. Conclusion: The incidence of acute cholecystitis with concomitant choledocholithiasis was 23%. The increased length of stay for these patients is most likely related to additional consultations/procedures (i.e. ERCP). Female gender and severe liver disease are independent predictors of AC/CH. Our data suggests that, in the appropriate clinical setting, surgeons should have a higher degree of suspicion for concomitant choledocholithiasis in patients presenting with acute cholecystitis.
(a)Adjusted for year of admission, age at admission, sex, patient residence (rural/urban), region, procedure type. (b)Adjusted for all covariates in Model 1, plus comorbidity, inhospital complication, insurance type and hospital volume. (c)Reference group: non-Hispanic Whites. Tu1786 The Safety of Stapler Versus Non-Stapler Closure of the Pancreatic Remnant After Distal Pancreatectomy: A Multicenter Randomized Controlled Trial Kazuaki Shimada, Masaru Konishi, Akio Saiura, Tsuyoshi Sano, Masashi Hashimoto, Katsuhiko Uesaka, Yoshihiro Sakamoto, Takeharu Yamanaka Objective: The objective of this study was to assess whether stapler closure after distal pancreatectomy has equivalent safety in the incidence of clinical pancreatic fistula to nonstapler closure, because a stapler technique may be more convenient and faster to perform. Stapler closure has been widely applied along with the recent introduction of laparoscopic distal pancreatectomy. However, stapler closure of the pancreatic remnant has not always reduced the incidence of pancreatic fistula compared with non-stapler closure. Methods: A multicenter, randomized, controlled, non-inferiority trial was conducted at five hospitals. Patients undergoing distal pancreatectomy were assigned by central randomization after laparotomy to either stapler or non-stapler closure of the pancreatic remnant. The primary endpoint was the incidence of Grade B or C pancreatic fistula. The final analysis was performed per-protocol in all patients undergoing distal pancreatectomy. This trial was registered with University hospital Medical Information Network (UMIN) Center (registration ID: UMIN000004838). Results: From January 18, 2011 to August 30, 2013, 141 patients were enrolled and randomly assigned to stapler closure (n=73) or non-stapler closure (n= 68). One hundred and thirty-four patients, consisting of 68 with stapler closure and 66 with non-stapler closure, were analyzed. Grade B or C pancreatic fistulas occurred in 34 patients (50%) in the stapler closure group and 27 (41%) in the non-stapler group (absolute risk reduction, -0.09; 95%CI, -0.25 to 0.08; P=0.38) The rate of severe adverse complications were similar for both closure techniques. Conclusion: As stapler closure did not result in a non-inferior rate of clinical pancreatic fistula, non-stapler closure might be considered as a standard procedure.
SSAT Abstracts
Tu1785a Cancer Surgery Readmission Among Vulnerable Populations: Insights Into the Medicare Hospital Readmission Reduction Program Russell C. Langan, Chaoyi Zheng, Yewande Alimi, Erin C. Hall, Chukwuemeka Ihemelandu, Nawar Shara, Lynt B. Johnson, Waddah Al-Refaie Background: Concerns have arisen about the applicability of the Medicare Hospital Readmission Reduction Program (HRRP) to surgical readmission including its lack of risk adjustment for vulnerable populations who are typically at risk for poorer operative outcomes. Such knowledge is particularly relevant to minority-serving US hospitals. In this study, we sought to assess the extent to which race/ethnicity, among other factors, affect unplanned readmissions (including to non-indexed hospitals) within a large and racially diverse cohort of gastrointestinal (GI) cancer surgery patients. Methods: We identified 49,755 adults who underwent 1 of 6 major GI cancer surgeries (esophagectomy, distal gastrectomy, total gastrectomy, pancreatectomy, hepatectomy, proctectomy) between 2004 and 2011 from the California State Inpatient Database. Multivariable logistic regression analyses were conducted to examine the effect of race/ethnicity on all-cause 30- and 90-day readmission after GI cancer surgery while controlling for relevant patient-, procedure-, complication-, hospital-, and regionrelated factors. Results: Our sample had 16.6% Hispanics, 13.2% Asian/Pacific Islanders and 5.3% Blacks. Overall 30- and 90-day readmission rates to index-hospitals were 12.4% and 22.3%, respectively and 10.2% and 17.7% to non-index hospitals. Black race predicted 22% and 18% higher odds of 30- and 90-day readmission to index hospitals than whites, respectively (Table 1 Model 1). Additionally, Hispanic ethnicity predicted 10% higher odds of 90-day readmission to index hospitals than NHW. These risks remained elevated even after adjusting for comorbidity, in-hospital complication, insurance type and hospital volume (Table 1 Model 2). Conclusion: In this large and racially diverse population-based study, Black and Hispanic race predicted higher readmission rates. Our findings reinforce previous concerns about HRRP lacking adjustment for patient characteristics, and thus placing hospitals serving vulnerable populations at risk for higher penalties.
SSAT Abstracts
Tu1787 Randomized Clinical Trial of Duct-to-Mucosa Pancreaticogastrostomy of Pancreatic Stump Versus Hand-Sewn Closure After Distal Pancreatectomy Kenichiro Uemura, Sohei Satoi, Fuyuhiko Motoi, Yasushi Hashimoto, Hiroaki Yanagimoto, Koji Fukase, Naru Kondo, Tomohisa yamamoto, Yu Katayose, A-Hon Kwon, Michiaki Unno, Yoshiaki Murakami Background: Postoperative pancreatic fistula (POPF) remains the main morbidity after distal pancreatectomy (DP). The aim of this study was to investigate whether duct-to-mucosa pancreaticogastrostomy (PG) of pancreatic stump would decrease clinical POPF compared with a hand-sewn closure (HSC) after DP. Methods: This multicenter, randomized, control trial was done between April 2012 and June 2014. Patients with pancreatic diseases undergoing DP were randomly assigned by central randomization before surgery to either PG or HSC. Primary endpoint was the incidence of clinical POPF. Secondary endpoints were rate of other complications and hospital stay. Results: In total of 73 patients were included in the final analysis, 36 patients in the PG and 37 patients in the HSC group. Duration of operation was significantly longer in the PG group than in the HSC group (268 versus 197 min; P<0.001). The incidence of clinical POPF did not differ between PG and HSC (19 versus 19 per cent; p=1.000). Rate of intra-abdominal fluid collection was significantly lower in the PG group than in the HSC group (17 versus 54 per cent; P=0.001).There were no significant difference in the rate of other complication or hospital stay between the groups. Conclusions: This study demonstrated that PG does not reduce the incidence of clinical POPF compared with HSC. Clinical Study Registration number UMIN000007426 (http:// www.umin.ac.jp)
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Table 1. Adjusted Odds Ratios Associated with Race for 30- and 90-Day Readmission after Complex Alimentary Tract Cancer Surgery, California Inpatient Database 2004-2011.
Tu1785 Trends in Acute Cholecystitis With and Without Choledocholithiasis Roman Grinberg, John Afthinos, Karen E. Gibbs Introduction: Acute cholecystitis with concomitant choledocholithiasis is an uncommon presentation of biliary tract disease. Traditional sources have placed the incidence at under 12%. We sought to evaluate the incidence of this disease entity in the setting of a large national database and to identify trends in management. Methods: The NIS database was queried from 2005 to 2010 for all patients presenting with acute cholecystitis (AC) and acute cholecystitis with choledocholithiasis (AC/CH). Age, gender, comorbid conditions were quantified. Rates of cholecystectomy, intraoperative cholangiogram and ERCP were evaluated. Post-procedural complications were also quantified. Multivariate logistic regression analyses were performed to evaluate for risk factors for independent risk factors predicting presentation of AC with choledocholithiasis. Results: We identified 321,802 patients diagnosed with AC and AC/CH, of which 73,648 (23%) had AC/CH. Female patients comprised 61% of the total population. Mortality was 0.73% in the AC group and 0.74% in the AC/ CH group (p=NS). In the AC group 7% of patients underwent ERCP, while in the AC/CH group 63% underwent ERCP (p < 0.001). Laparoscopic cholecystectomy was undertaken in 72% of all patients with AC; it was performed for 70% of the patients with AC/CH (p= NS). Within the AC group, 25% had an intraoperative cholangiogram as compared to 45.5% in AC/CH group (p<0.05). CBD exploration occurred in 0.7% of the AC patients and 9.5% of AC/CH patients (p < 0.01). Length of stay for the AC group was 4.27 + 4.8 days, compared to 5.6 + 4.8 days for the AC/CH group. Female gender (OR 1.2, p < 0.001) and severe liver disease (OR 1.3, p < 0.001) are independent risk factors for presentation of AC/CH. Conclusion: The incidence of acute cholecystitis with concomitant choledocholithiasis was 23%. The increased length of stay for these patients is most likely related to additional consultations/procedures (i.e. ERCP). Female gender and severe liver disease are independent predictors of AC/CH. Our data suggests that, in the appropriate clinical setting, surgeons should have a higher degree of suspicion for concomitant choledocholithiasis in patients presenting with acute cholecystitis.
(a)Adjusted for year of admission, age at admission, sex, patient residence (rural/urban), region, procedure type. (b)Adjusted for all covariates in Model 1, plus comorbidity, inhospital complication, insurance type and hospital volume. (c)Reference group: non-Hispanic Whites. Tu1786 The Safety of Stapler Versus Non-Stapler Closure of the Pancreatic Remnant After Distal Pancreatectomy: A Multicenter Randomized Controlled Trial Kazuaki Shimada, Masaru Konishi, Akio Saiura, Tsuyoshi Sano, Masashi Hashimoto, Katsuhiko Uesaka, Yoshihiro Sakamoto, Takeharu Yamanaka Objective: The objective of this study was to assess whether stapler closure after distal pancreatectomy has equivalent safety in the incidence of clinical pancreatic fistula to nonstapler closure, because a stapler technique may be more convenient and faster to perform. Stapler closure has been widely applied along with the recent introduction of laparoscopic distal pancreatectomy. However, stapler closure of the pancreatic remnant has not always reduced the incidence of pancreatic fistula compared with non-stapler closure. Methods: A multicenter, randomized, controlled, non-inferiority trial was conducted at five hospitals. Patients undergoing distal pancreatectomy were assigned by central randomization after laparotomy to either stapler or non-stapler closure of the pancreatic remnant. The primary endpoint was the incidence of Grade B or C pancreatic fistula. The final analysis was performed per-protocol in all patients undergoing distal pancreatectomy. This trial was registered with University hospital Medical Information Network (UMIN) Center (registration ID: UMIN000004838). Results: From January 18, 2011 to August 30, 2013, 141 patients were enrolled and randomly assigned to stapler closure (n=73) or non-stapler closure (n= 68). One hundred and thirty-four patients, consisting of 68 with stapler closure and 66 with non-stapler closure, were analyzed. Grade B or C pancreatic fistulas occurred in 34 patients (50%) in the stapler closure group and 27 (41%) in the non-stapler group (absolute risk reduction, -0.09; 95%CI, -0.25 to 0.08; P=0.38) The rate of severe adverse complications were similar for both closure techniques. Conclusion: As stapler closure did not result in a non-inferior rate of clinical pancreatic fistula, non-stapler closure might be considered as a standard procedure.
SSAT Abstracts
Tu1785a Cancer Surgery Readmission Among Vulnerable Populations: Insights Into the Medicare Hospital Readmission Reduction Program Russell C. Langan, Chaoyi Zheng, Yewande Alimi, Erin C. Hall, Chukwuemeka Ihemelandu, Nawar Shara, Lynt B. Johnson, Waddah Al-Refaie Background: Concerns have arisen about the applicability of the Medicare Hospital Readmission Reduction Program (HRRP) to surgical readmission including its lack of risk adjustment for vulnerable populations who are typically at risk for poorer operative outcomes. Such knowledge is particularly relevant to minority-serving US hospitals. In this study, we sought to assess the extent to which race/ethnicity, among other factors, affect unplanned readmissions (including to non-indexed hospitals) within a large and racially diverse cohort of gastrointestinal (GI) cancer surgery patients. Methods: We identified 49,755 adults who underwent 1 of 6 major GI cancer surgeries (esophagectomy, distal gastrectomy, total gastrectomy, pancreatectomy, hepatectomy, proctectomy) between 2004 and 2011 from the California State Inpatient Database. Multivariable logistic regression analyses were conducted to examine the effect of race/ethnicity on all-cause 30- and 90-day readmission after GI cancer surgery while controlling for relevant patient-, procedure-, complication-, hospital-, and regionrelated factors. Results: Our sample had 16.6% Hispanics, 13.2% Asian/Pacific Islanders and 5.3% Blacks. Overall 30- and 90-day readmission rates to index-hospitals were 12.4% and 22.3%, respectively and 10.2% and 17.7% to non-index hospitals. Black race predicted 22% and 18% higher odds of 30- and 90-day readmission to index hospitals than whites, respectively (Table 1 Model 1). Additionally, Hispanic ethnicity predicted 10% higher odds of 90-day readmission to index hospitals than NHW. These risks remained elevated even after adjusting for comorbidity, in-hospital complication, insurance type and hospital volume (Table 1 Model 2). Conclusion: In this large and racially diverse population-based study, Black and Hispanic race predicted higher readmission rates. Our findings reinforce previous concerns about HRRP lacking adjustment for patient characteristics, and thus placing hospitals serving vulnerable populations at risk for higher penalties.
SSAT Abstracts
Tu1787 Randomized Clinical Trial of Duct-to-Mucosa Pancreaticogastrostomy of Pancreatic Stump Versus Hand-Sewn Closure After Distal Pancreatectomy Kenichiro Uemura, Sohei Satoi, Fuyuhiko Motoi, Yasushi Hashimoto, Hiroaki Yanagimoto, Koji Fukase, Naru Kondo, Tomohisa yamamoto, Yu Katayose, A-Hon Kwon, Michiaki Unno, Yoshiaki Murakami Background: Postoperative pancreatic fistula (POPF) remains the main morbidity after distal pancreatectomy (DP). The aim of this study was to investigate whether duct-to-mucosa pancreaticogastrostomy (PG) of pancreatic stump would decrease clinical POPF compared with a hand-sewn closure (HSC) after DP. Methods: This multicenter, randomized, control trial was done between April 2012 and June 2014. Patients with pancreatic diseases undergoing DP were randomly assigned by central randomization before surgery to either PG or HSC. Primary endpoint was the incidence of clinical POPF. Secondary endpoints were rate of other complications and hospital stay. Results: In total of 73 patients were included in the final analysis, 36 patients in the PG and 37 patients in the HSC group. Duration of operation was significantly longer in the PG group than in the HSC group (268 versus 197 min; P<0.001). The incidence of clinical POPF did not differ between PG and HSC (19 versus 19 per cent; p=1.000). Rate of intra-abdominal fluid collection was significantly lower in the PG group than in the HSC group (17 versus 54 per cent; P=0.001).There were no significant difference in the rate of other complication or hospital stay between the groups. Conclusions: This study demonstrated that PG does not reduce the incidence of clinical POPF compared with HSC. Clinical Study Registration number UMIN000007426 (http:// www.umin.ac.jp)
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