Somala Mohammed

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 cancer: Advances in treatment

Pancreatic cancer is a leading cause of cancer mortality and the incidence of this disease is expected to continue increasing. While patients with pancreatic cancer have traditionally faced a dismal prognosis, over the past several years various advances in diagnosis and treatment have begun to positively impact this disease. Identification of effective combinations of existing chemotherapeutic agents, such as the FOLFIRINOX and the gemcitabine + nab-paclitaxel regimen, has improved survival for selected patients although concerns regarding their toxicity profiles remain. A better understanding of pancreatic carcinogenesis has identified several pre-malignant precursor lesions, such as pancreatic intraepithelial neoplasias, intraductal papillary mucinous neoplasms, and cystic neoplasms. Imaging technology has also evolved dramatically so as to allow early detection of these lesions and thereby facilitate earlier management. Surgery remains a cornerstone of treatment for patients with resectable pancreatic tumors, and advances in surgical technique have allowed patients to undergo resection with decreasing perioperative morbidity and mortality. Surgery has also become feasible in selected patients with borderline resectable tumors as a result of neoadjuvant therapy. Furthermore, pancreatectomy involving vascular reconstruction and pancreatectomy with minimally invasive techniques have demonstrated safety without significantly compromising oncologic outcomes. Lastly, a deeper understanding of molecular aberrations contributing to the development of pancreatic cancer shows promise for future development of more targeted and safe therapeutic agents.

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.

Impact of intraoperative administration of local vancomycin on inguinal wound complications

OBJECTIVE Local vancomycin treatment has been shown to decrease sternal wound complication rates. Whether a similar effect can be achieved at other surgical sites is unknown. This study investigates the effect of local vancomycin on inguinal wound complication rates after vascular procedures. METHODS Retrospective analysis was performed on 454 patients who underwent open aortofemoral or infrainguinal vascular procedures between 2006 and 2011. Patients received preoperative systemic antibiotics either alone (group A) or in conjunction with intraoperative wound application of vancomycin powder and irrigation (group B). Inguinal wound infection and dehiscence over a 30-day period were recorded. Fisher exact test and multivariate regression analyses were performed. RESULTS There were 211 patients in group A and 243 patients in group B. Both groups had similar demographics and operative characteristics. There was a small but statistically significant decrease in the 30-day incidence of overall wound infections (25.1% vs 17.2%; P = .049) for group B patients. This was primarily due to a decreased rate in superficial infections (18.9% vs 11.5%; P = .033). No significant difference in the incidence of deep wound infections (6.1% vs 5.7%; P = .692) or overall dehiscence rates (22.2% vs 17.7%; P = .239) was detected. On multivariate analysis, history of chronic obstructive pulmonary disease and increased body mass index significantly increased risk of both infection and dehiscence. Medically optimized coronary artery disease was associated with less risk for dehiscence. CONCLUSIONS Addition of intraoperative local vancomycin did not improve the rates of inguinal wound dehiscence or deep infections but had a positive impact on superficial wound infections.

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.

Endovascular therapy in patients with genetically triggered thoracic aortic disease: applications and short- and mid-term outcomes

OBJECTIVES For patients with genetically triggered thoracic aortic disease, the morbidity and mortality associated with reoperation are high, making endovascular treatment an appealing option. We evaluated the short- and mid-term outcomes of different applications of endovascular intervention in such patients. METHODS Between January 2003 and April 2013, 60 patients received endovascular or hybrid treatment for genetically triggered thoracic aortic disease. The inclusion criteria were based on those devised by the National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions. We included patients with thoracic aneurysm or dissection not due to trauma in a patient aged ≤50 years (n = 30), bicuspid aortic valve (BAV) and coarctation (n = 11), Marfan syndrome (n = 10), BAV with thoracic aneurysm (n = 4), Loeys-Dietz syndrome (n = 3), familial thoracic aneurysm or dissection (n = 3) and genetic mutations (n = 2). Some patients met more than one inclusion criterion. Forty-one (68.3%) patients were treated with only endovascular stent grafting. Nineteen (31.7%) patients underwent a hybrid procedure with open proximal or total arch replacement and concomitant endovascular stenting of the aortic arch or the descending thoracic aorta. Twenty-nine (48.3%) had previous cardiovascular operations (mean ± SD, 1.9 ± 1.4) before undergoing hybrid or endovascular therapy. The median follow-up was 2.3 years (interquartile interval 25-75%, 1.4-4.6 years). RESULTS The technical success rate was 100%. In-hospital mortality was 3.3% (n = 2) and neurological events occurred in 2 patients; 1 (1.6%) had a stroke and 1 (1.6%) suffered paraparesis with partial recovery. Fifteen repeat open or endovascular interventions were required in 10 surviving patients (17.2%). Overall survival during follow-up was 94.8% (55/58). CONCLUSIONS Endovascular technology can be helpful in treating selected young patients with genetically triggered thoracic aortic disease. Long-term studies and further evolution of endovascular technology will be necessary for it to be incorporated into the armamentarium of surgical options for this challenging patient population.

Quality Metrics in Pancreatic Surgery

As the practice of pancreatic surgery evolves to encompass a wider array of clinical indications, incorporate increasingly complex technologies, and provide care to an aging population with many comorbid conditions, systematic assessment of quality and outcomes in an effort to improve the quality of care is imperative. This article discusses the volume-outcomes relationship that exists in pancreatic surgery, trends in centralization of practice within the field, common outcomes measures, and the complexity of assessing quality metrics. It also highlights surgical outcomes from several high-volume institutions and recent developments in quality metrics within pancreatic surgery.

A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage

Objective: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. Background: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. Methods: Patients undergoing DP for all causes at 14 high-volume pancreas centers were preoperatively randomized to placement of a drain or no drain. Complications and their severity were tracked for 60 days and mortality for 90 days. The study was powered to detect a 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. Results: A total of 344 patients underwent DP with (N = 174) and without (N = 170) the use of intraperitoneal drainage. There were no differences between cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique. There was no difference in the rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, percutaneous drain placement, reoperation, readmission, or quality of life scores. Conclusions: This prospective randomized multicenter trial provides evidence that clinical outcomes are comparable in DP with or without intraperitoneal drainage.

Evidence-Based Management of Drains Following Pancreatic Resection: A Systematic Review

Abstract Many pancreatic surgeons continue to use intraperitoneal drains, but others have limited or avoided their use, believing this improves outcomes. We conducted a systematic review and meta-analysis of the literature assessing outcomes in pancreatectomy without drains, selective drainage, and early drain removal. We searched PubMed, Embase, and the Cochrane Library databases and conducted a systematic review of randomized and nonrandomized studies comparing routine intra-abdominal drainage versus no drainage, selective drain use, and early versus late drain removal after pancreatectomy, with major complications as the primary outcome. A meta-analysis of the literature assessing routine use of drains was conducted using the random-effects model. A total of 461 articles met search criteria from PubMed (168 articles), Embase (263 articles), and the Cochrane Library (30 articles). After case reports and articles without primary data on complications were excluded, 14 studies were identified for systematic review. Definitive evidence-based recommendations cannot be made regarding the management of drains following pancreatectomy because of limitations in the available literature. Based on available evidence, the most conservative approach, pending further data, is routine placement of a drain and early removal unless the patients clinical course or drain fluid amylase concentration suggests a developing fistula.

Delayed gastric emptying following pancreaticoduodenectomy: Incidence, risk factors, and healthcare utilization

AIM To characterize incidence and risk factors for delayed gastric emptying (DGE) following pancreaticoduodenectomy and examine its implications on healthcare utilization. METHODS A prospectively-maintained database was reviewed. DGE was classified using International Study Group of Pancreatic Surgery criteria. Patients who developed DGE and those who did not were compared. RESULTS Two hundred and seventy-six patients underwent pancreaticoduodenectomy (PD) (> 80% pylorus-preserving, antecolic-reconstruction). DGE developed in 49 patients (17.8%): 5.1% grade B, 3.6% grade C. Demographic, clinical, and operative variables were similar between patients with DGE and those without. DGE patients were more likely to present multiple complications (32.6% vs 4.4%, ≥ 3 complications, P < 0.001), including postoperative pancreatic fistula (POPF) (42.9% vs 18.9%, P = 0.001) and intra-abdominal abscess (IAA) (16.3% vs 4.0%, P = 0.012). Patients with DGE had longer hospital stay (median, 12 d vs 7 d, P < 0.001) and were more likely to require transitional care upon discharge (24.5% vs 6.6%, P < 0.001). On multivariate analysis, predictors for DGE included POPF [OR = 3.39 (1.35-8.52), P = 0.009] and IAA [OR = 1.51 (1.03-2.22), P = 0.035]. CONCLUSION Although DGE occurred in < 20% of patients after PD, it was associated with increased healthcare utilization. Patients with POPF and IAA were at risk for DGE. Anticipating DGE can help individualize care and allocate resources to high-risk patients.