Eric J. Silberfein

A Randomized Prospective Multicenter Trial of Pancreaticoduodenectomy With and Without Routine Intraperitoneal Drainage

Objective:To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications. Background:Some surgeons have abandoned the use of drains placed during pancreas resection. Methods:We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups. Results:There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage. Conclusions:This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.

Pancreatic resection without routine intraperitoneal drainage

BACKGROUND Most surgeons routinely place intraperitoneal drains at the time of pancreatic resection but this practice has recently been challenged. OBJECTIVE Evaluate the outcome when pancreatic resection is performed without operatively placed intraperitoneal drains. METHODS In all, 226 consecutive patients underwent pancreatic resection. In 179 patients drains were routinely placed at the time of surgery and in 47 no drains were placed. Outcomes for these two cohorts were recorded in a prospective database and compared using the χ(2) - /Fishers exact test for categorical variables, and Wilcoxons test for continuous variables. RESULTS Demographic, surgical and pathological details were similar between the two cohorts. Elimination of routine intraperitoneal drainage did not increase the frequency or severity of serious complications. However, when all grades of complications were considered, the number of patients that experienced any complication (65% vs. 47%, P= 0.020) and the median complication severity grade (1 vs. 0, P= 0.027) were increased in the group that had drains placed at the time of surgery. Eliminating intra-operative drains was associated with decreased delayed gastric emptying (24% vs. 9%, P= 0.020) and a trend towards decreased wound infection (12% vs. 2%, P= 0.054). The readmission rate (9% vs. 17% P= 0.007) and number of patients requiring post-operative percutaneous drains (2% vs. 11%, P= 0.001) was higher in patients who did not have operatively placed drains but there was no difference in the re-operation rate (4% vs. 0%, P= 0.210). CONCLUSION Abandoning the practice of routine intraperitoneal drainage after pancreatic resection may not increase the incidence or severity of severe post-operative complications.

An assessment of the necessity of transfusion during pancreatoduodenectomy

INTRODUCTION Perioperative transfusion of packed red blood cells (PRBC) has been associated with negative side effects. We hypothesized that a majority of transfusions in our series of patients who underwent pancreaticoduodenectomy (PD) were unnecessary. A retrospective analysis was performed to determine whether transfusions were indicated based on pre-determined criteria, and the impact of perioperative transfusions on postoperative outcomes was assessed. METHODS Our prospectively maintained database was queried for patients who underwent PD between 2004 and 2011. 200 patients were divided into Cohort 1 (no transfusion) and Cohort 2 (transfusion). Rates of various graded 90-day postoperative complications were compared. Categorical values were compared according to the Common Terminology Criteria for Adverse Events. All cases involving intraoperative blood transfusion were reviewed for associated blood loss, intraoperative vital signs, urine output, hemoglobin values, and presence or absence of EKG changes to determine whether the transfusion was indicated based on these criteria. RESULTS There were 164 patients (82%) in Cohort 1 (no transfusion) and 36 patients (18%) in Cohort 2 (transfused). Both groups had similar demographics. Patients in Cohort 2 had lesser median preoperative values of hemoglobin (12.3 vs 13.1, P = .002), a greater incidence of vein resection (33% vs. 16%, P = .021), longer operative times (518 vs 440 minutes, P < .0001), a greater estimated blood loss (850 vs. 300 mL, P < .001), and greater intraoperative fluid resuscitation (6,550 vs. 5,300 mL, P = .002). Ninety-day mortality was similar between the 2 groups (3% vs 1%, P = .328). Patients in Cohort 2 (transfused) had increased rates of delayed gastric emptying (36% vs. 20%, P = .031), wound infection (28% vs. 7%, P = .031), pulmonary complications (6% vs. 0%, P = .032), and urinary retention (6% vs. 0%, P = .032). A greater incidence of any complication of grade II severity (67% vs. 35%, P = .0005) or grade III severity (36% vs. 17%, P = .010) was also noted in Cohort 2. Of the 33 intraoperative transfusions, 15 (46%) did not meet any of the predetermined criteria: intraoperative hypotension (<90/60 mmHg), tachycardia (>110 beats per minute), low urine output (<10 mL/hour), decreased oxygen saturation (<95%), excessive blood loss (>1,000 mL), EKG changes, and low hemoglobin (<7.0 g/dL). CONCLUSION Perioperative transfusions among patients with PD were associated with increased rates of various postoperative complications. A substantive portion (∼46%) of perioperative transfusions in this patient population did not meet predetermined criteria, indicating a potential opportunity for improved blood product use. Further prospective studies are required to determine whether the implementation of these criteria may a positive impact on perioperative outcomes.

Routine nasogastric suction may be unnecessary after a pancreatic resection

BACKGROUND Most surgeons routinely place a nasogastric tube at the time of a pancreatic resection. The goal of the present study was to evaluate the outcome when a pancreatic resection is performed without routine post-operative nasogastric suction. METHODS One hundred consecutive patients underwent a pancreatic resection (64 a pancreaticoduodenectomy, 98% pylorus sparing and 36 a distal pancreatectomy). In the first cohort (50 patients), a nasogastric tube was routinely placed at the time of surgery and in the second cohort (50 patients) the nasogastric was removed in the operating room. Outcomes for these two cohorts were recorded in a prospective database and compared using the χ(2) or Fishers exact test and Wilcoxons rank-sum test. RESULTS Demographical, surgical and pathological details were similar between the two cohorts. A post-operative complication occurred in 22 (44%) in each group (P= 1.000). There were no statistically significant differences in the frequency or severity of complications, or length of stay between groups. The spectrum of complications experienced by the two cohorts was similar including complications that could potentially be related to the use of nasogastric suction such as delayed gastric emptying, anastomotic leak, wound dehiscence and pneumonia. There was no difference between the two groups in the number of patients who required post-operative nasogastric tube placement (or replacement) [2 (4%) vs. 4 (8%), P= 0.678]. CONCLUSION It may be safe to place a nasogastric tube post-operatively in a minority of patients after a pancreatic resection and spare the majority the discomfort associated with routine post-operative nasogastric suction.

Obesity Does Not Increase Complications Following Pancreatic Surgery

BACKGROUND Recent evidence suggests that the quantity of intra-abdominal fat may be a more important predictor of postoperative complications than body mass index (BMI). We hypothesized that increased intra-abdominal fat would be associated with longer operations, increased blood loss, more complications, and prolonged length of stay after pancreatic resection. METHODS Retrospective cohort study. Intra-abdominal fat was quantified using CT imaging, and patients were divided into three groups (low, moderate, high). Unconditional multiple logistic regression was used to evaluate the relationship between obesity measures and complications. RESULTS Between 2002 and 2010, 255 patients underwent pancreaticoduodenectomy or distal pancreatectomy, and 201 had preoperative CT imaging available for review. Operative time was significantly prolonged in patients with high quantities of intra-abdominal fat compared with those with low fat quantity (median 438 versus 354 min, P < 0.05), while BMI was not associated with changes in duration of surgery. Neither obesity defined by BMI (OR 0.90, 95% CI 0.36-2.21) nor visceral fat (OR 1.20, 95% CI 0.46-3.16) significantly predicted risk of complications. Median length of stay was similar in patients who were obese by BMI (7 versus 7.5 d) or amount of intra-abdominal fat (7 d). CONCLUSIONS Intra-abdominal fat was a better predictor than BMI for determining length of procedure. However, in contrast to previous studies evaluating abdominal surgery, neither BMI nor intra-abdominal fat significantly predicted risk of complication or length of hospital stay. Further research is needed to determine the best measure to assist in risk prediction of obese patients undergoing pancreatic surgery.

Treatment of bacteriobilia decreases wound infection rates after pancreaticoduodenectomy

BACKGROUND Although mortality following pancreaticoduodenectomy is decreasing, postoperative morbidity remains high. It was hypothesized that culture-directed treatment of bacteriobilia would decrease the incidence of infectious complications following pancreaticoduodenectomy. METHODS In a retrospective study of 197 pancreaticoduodenectomy patients, those in the control group (n = 128, 2005-2009) were given perioperative prophylactic antibiotics, whereas those in the treatment group (n = 69, 2009-2011) were continued on antibiotics until intraoperative bile culture results became available. Patients with bacteriobilia received 10 days of antibiotic treatment, which was otherwise discontinued in patients without bacteriobilia. Various complication rates were compared using Fishers exact test for categorical variables, Wilcoxon rank sum test for ordinal variables, and a two-sample t-test for continuous variables. RESULTS Demographics, comorbidities, baseline clinical characteristics, and intraoperative and postoperative variables were similar between the two groups. There were higher incidences of elevated creatinine (19% versus 4%; P = 0.004) and preoperative hyperglycaemia (18% versus 7%; P = 0.053) in the control group. Fewer patients in the control group underwent preoperative biliary stenting (48% versus 67%; P = 0.017) and intraperitoneal drains were placed at the time of resection more frequently in the control group (85% versus 38%; P < 0.001). Bacteriobilia was found in 59% of patients. Treatment of bacteriobilia was associated with a decrease in the rate of postoperative wound infections (12% in the control group versus 3% in the treatment group; P = 0.036) and overall complication severity score (1 in the control group versus 0 in the treatment group; P = 0.027). CONCLUSIONS Prolonged antibiotic therapy for bacteriobilia may decrease postoperative wound infection rates after pancreaticoduodenectomy. A randomized prospective trial is warranted to provide evidence to further support this practice.

Factors associated with phyllodes tumor of the breast after core needle biopsy identifies fibroepithelial neoplasm

BACKGROUND Phyllodes tumors represent less than 1% of all breast neoplasms and can mimic fibroadenoma on core needle biopsy (CNB). The treatment of fibroepithelial (FE) neoplasms identified on CNB is controversial. We sought to identify factors that were associated with phyllodes tumors after CNB suggested FE neoplasm. MATERIALS AND METHODS A retrospective database was queried for all patients diagnosed with FE neoplasm on CNB at Ben Taub General Hospital over a 10-y period. One hundred twenty-three patients were identified and demographic, clinical, and outcome data were analyzed. RESULTS Of the 123 patients, 46 (37%) were found to have fibroadenomatous features and 59 (48%) were found to have FE features. All went on to have surgical excision. Forty (38%) contained phyllodes tumors, and 65 (62%) found no phyllodes tumor on final pathology. There were significant differences in the median size of the masses (4 cm versus 2.4 cm P < 0.002) and density of the masses (P < 0.001) between the group that contained phyllodes tumors and the group that did not on preoperative imaging. Further evaluation did not show any significant differences on preoperative imaging between benign and borderline/malignant phyllodes tumors. Hispanic ethnicity correlated with a higher chance of phyllodes tumor after CNB (P < 0.001). CONCLUSIONS Women commonly present to clinics for evaluation of palpable breast masses. Based on the results of CNB, clinical decisions can be made to help direct treatment. If CNB identifies phyllodes tumor, surgical excision remains the standard of care; however, patients with suspicious FE neoplasms represent a treatment dilemma as many will prove to be benign. Preoperative size and the density of the mass on imaging and ethnicity were associated with phyllodes tumors on final pathology.

A Multi-institutional Study of Pancreatic Cancer in Harris County, Texas: Race Predicts Treatment and Survival

BackgroundRacial disparities exist for patients with pancreatic cancer. This observation has primarily been noted in the Surveillance, Epidemiology, and End Results database and has focused primarily on whites and African Americans. We sought to determine if these disparities exist in a local, racially diverse patient population.MethodsRetrospective review of a pancreatic cancer tumor registry from two hospital systems from 1998 to 2010. Clinicopathologic parameters were recorded. Statistical analysis was performed by analysis of variance, Chi square test, Kaplan–Meier survival analysis, log rank test, and regression models.ResultsA total of 1039 patients were identified for this study. Hispanic and African American patients presented at an earlier age when compared to whites. There was no difference in gender or stage at presentation between racial groups. Adjusted for stage, race was predictive of chemotherapy administration. Independent predictors of increased mortality included male gender, African American race, stage at diagnosis, and older age.ConclusionsDespite adjusting for covariates, survival remains lowest for African American patients. Further investigation is needed to understand the effect of race and how it mediates treatment and survival in those with pancreatic cancer.

Relationship between documentation status and survival for medically underserved Hispanic breast cancer patients

BACKGROUND Undocumented immigrants have been shown to be predisposed to worse clinical outcomes than the general population. This study examines survival in socioeconomically disadvantaged Hispanic documented and undocumented breast cancer patients. METHODS Analysis of a prospective breast cancer database of patients treated in a safety-net hospital system. Overall survival was the primary outcome, and advanced stage at diagnosis (regional and metastatic) was a secondary outcome. Survival analysis and multivariate regression modeling were performed. RESULTS Seven hundred fifty-one breast cancer patients were identified. Undocumented patients presented at an earlier age and were likely to present with advanced stage. After adjusting for covariates, undocumented status was not associated with increased mortality. The diagnosis-to-treatment interval was significantly longer in undocumented patients. CONCLUSIONS Despite undocumented patients presenting at a younger age, they have similar mortality compared with documented patients. This finding is partly explained by the local treatment afforded by undocumented patients, further studies are necessary to detail the reasons for these differences in presentation and outcome.

Postoperative mortality and need for transitional care following liver resection for metastatic disease in elderly patients: a population‐level analysis of 4026 patients

OBJECTIVES The goal of this study was to characterize the association of age with postoperative mortality and need for transitional care following hepatectomy for liver metastases. METHODS A retrospective cohort study using the Nationwide Inpatient Sample (2005-2008) was performed. Patients undergoing hepatectomy for liver metastases were categorized by age as: Young (aged <65 years); Old (aged 65-74 years), and Oldest (aged ≥75 years). Multivariate logistic regression analyses were performed to identify predictors of in-hospital mortality and need for transitional care (non-home discharge). RESULTS A total of 4026 patients were identified; 36.6% (n = 1475) were elderly (aged ≥65 years). Rates of in-hospital mortality and non-home discharge increased with advancing age group [1.3% vs. 2.2% vs. 3.3% (P = 0.005) and 2.1% vs. 6.1% vs. 18.3% (P < 0.001), respectively]. Independent predictors of in-hospital mortality were age within the Oldest category [odds ratio (OR) 2.21, 95% confidence interval (CI) 1.19-4.12] and a Deyo Comorbidity Index score of ≥3 (OR 6.95, 95% CI 3.55-13.60). Independent predictors for need for transitional care were age within the Old group (OR 2.44, 95% CI 1.66-3.58), age within the Oldest group (OR 8.48, 95% CI 5.87-12.24), a Deyo score of 1 (OR 2.00, 95% CI 1.40-2.85), a Deyo score of 2 (OR 4.70, 95% CI 2.93-7.56), a Deyo score of ≥3 (OR 6.41, 95% CI 3.67-11.20), and female gender (OR 1.56, 95% CI 1.15-2.11). CONCLUSIONS Although increasing age was associated with higher risk for in-hospital mortality, the absolute risk was low and within accepted ranges, and comorbidity was the primary driver of mortality. Conversely, need for transitional care was significantly more common in elderly patients. Therefore, liver resection for metastases is safe in well-selected elderly patients, although consideration should be made for potential transitional care needs.