SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Assessing the Implementation of American College of Surgeons Quality Indicators for Pancreatic Cancer Across an Integrated Health System.

PURPOSE: The American College of Surgeons (ACS) recently published quality assurance (QA) indicators for pancreatic cancer care. Implementing quality indicators in a newly formed health system may lead to better patient selection and standardized cancer care. METHODS: Select ACS and internal quality indicators were implemented system wide in 2014. We compared compliance with these measures before and after their implementation at the main hospital and two new affiliate institutions. RESULTS: A total of 506 patients with pancreatic cancer were included. At the main hospital in the pre-QA period, 11 (12.6%) of 87 patients were discussed at our institutional multidisciplinary tumor board meeting; this number rose to 89 (49.7%) of 179 patients (P < .001) after the implementation. Clinical TNM stage was documented in the electronic medical record in 75 patients (86.2%) in the pre-QA group; this number rose to 170 (94.9%; P = .026) in the post-QA era. External imaging of patients undergoing resection was uploaded in 10 (66.7%) of 15 patient cases in the pre-QA period; this number rose to 33 (93.4%) of 35 (P = .020). Rates of time from diagnosis to treatment initiation shorter than 60 days were similar between eras (n = 26, 96.3% v n = 57, 95%). Implementation of QA measures at the affiliate institutions did not result in measurable differences. There were no differences in margin-negative resection rate, lymph node yield, or perioperative mortality after QA implementation at any site. CONCLUSION: The implementation of ACS quality indicators at our main hospital was feasible and effective for several measures, without delaying treatment. Instituting these indicators at lower-volume affiliates was more challenging.

Outcomes of octogenarians undergoing gastrectomy performed for malignancy.

BACKGROUND: Studies on perioperative outcomes of octogenarians with gastric cancer are limited by small sample size. Our aim was to determine the outcomes of gastrectomy and the variation of treatments associated with advanced age (≥80 y). METHODS: The National Surgical Quality Improvement Program database was queried from 2005 to 2011. Patients who underwent gastrectomy for malignancy were identified using International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes. RESULTS: Of 2591 cases, 487 patients were octogenarians (≥80) and 2104 were nonoctogenarians (<80). Overall, 4.9% of patients had disseminated cancer. Octogenarians had higher 30-d mortality (7.2% versus 2.5%, P < 0.01) and more major complications (31.4% versus 25.5%, P < 0.01), though fewer octogenarians underwent total gastrectomy (24.0% versus 43.2%, P < 0.01) and extended lymphadenectomy (10.1% versus 17.4%, P < 0.01) than the nonoctogenarian cohort. On multivariate analysis, age ≥80 y was associated with major complications (OR, 1.3; 95% CI, 1.03-1.6; P = 0.03) and increased mortality (OR, 3.0; 95% CI, 1.9-4.9; P < 0.01). CONCLUSIONS: Advanced age (≥80 y) was associated with worse outcomes in patients undergoing gastrectomy for malignancy. Therefore, careful staging is necessary to reduce unnecessary operations in this population. Furthermore, surgeons must place greater attention on optimizing the octogenarian population before surgery.

The effects of neoadjuvant chemoradiation on pancreaticoduodenectomy­the American College of Surgeon's National Surgical Quality Improvement Program analysis.

BACKGROUND: The purpose of this study was to investigate the effects of preoperative chemoradiation therapy on postoperative outcomes of pancreaticoduodenectomy (PD). MATERIALS AND METHODS: The American College of Surgeon's National Surgical Quality Improvement Program Participant User File from 2005-2011 was used to analyze the outcomes of patients who underwent chemoradiation therapy before PD. Their outcomes were compared with those who underwent PD without neoadjuvant therapy. RESULTS: We identified 110 patients who received preoperative chemoradiation therapy before undergoing PD for pancreatic malignancies and compared them with 4915 patients who did not. The two groups were similar in their preoperative comorbidities and demographics. The neoadjuvant group experienced a significantly longer operative time with a higher rate of vascular reconstruction, transfusion requirement, and superficial wound infection compared with those who did not receive neoadjuvant therapy. However, mortality and the rate of major complications between the two groups were similar. CONCLUSIONS: Preoperative chemoradiation therapy is associated with an increase in transfusion requirement and superficial surgical site infection. However, it is not associated with an increase in 30-d mortality or major complications.

Primary lymph node gastrinoma. A diagnosis of exclusion. A case for duodenotomy in the setting of a negative imaging for primary tumor: A case report and review of the literature.

INTRODUCTION: Zollinger-Ellison syndrome (ZES) is caused by uninhibited secretion of gastrin from a gastrinoma. Gastrinomas most commonly arise within the wall of the duodenum followed by the pancreas. Primary lymph node gastrinomas have also been reported in the literature. This is a case of ZES where preoperative localization revealed a gastrinoma in a solitary portacaval lymph node, presumed to be a primary lymph node gastrinoma. PRESENTATION OF CASE: The patient is a 57 year old female diagnosed with ZES, suspected of having a primary lymph node gastrinoma. The patient underwent an exploratory laparotomy and excision of a portacaval lymph node with a frozen section which was positive for gastrinoma. Intraoperative sonography of the pancreas, upper endoscopy with transillumination of the duodenum, and a duodenotomy with bimanual examination of the duodenal wall were also performed. The patient was found to have a 4mm duodenal mass near the pylorus, which was excised. DISCUSSION: Pathology showed that the duodenal mass was primary gastrinoma. Serum gastrin levels taken four months postoperatively were normal and the repeat octreotide scan did not show any evidence of recurrence. CONCLUSION: Primary lymph node gastrinoma is a diagnosis of exclusion. The duodenum and pancreas must be fully explored to rule out a primary gastrinoma that may be occult.

Outcomes of pancreaticoduodenectomy for pancreatic malignancy in octogenarians: an American College of Surgeons National Surgical Quality Improvement Program analysis.

BACKGROUND: Most series analyzing outcomes of pancreaticoduodenectomy in octogenarians are limited by a small sample size. The investigators used the American College of Surgeons National Surgical Quality Improvement Program database for an analysis of the impact of advanced age on outcomes after pancreatic cancer surgery. METHODS: The National Surgical Quality Improvement Program database from 2005 to 2010 was accessed to study the outcomes of 475 pancreaticoduodenectomies performed in patients ≥80 years of age compared with 4,102 patients <80 years of age using chi-square and Student's t tests. A multivariate logistic regression was used to analyze factors associated with 30-day mortality and the occurrence of major complications. RESULTS: Octogenarians had significantly more preoperative comorbidities compared with patients <80 years of age. On multivariate analysis, age ≥80 years was associated with an increased likelihood of experiencing 30-day mortality and major complications compared with patients <80 years of age. On subgroup analysis, septuagenarians had a similar odds ratio of experiencing mortality or complications compared with octogenarians, whereas patients <70 years of age were at lower risk. CONCLUSIONS: Although octogenarians have an increased risk for mortality and major complications compared with patients <80 years of age, on subgroup analysis, they do not differ from septuagenarians.

Mixed adenoneuroendocrine carcinoma (MANEC) of the gallbladder: a possible stem cell tumor?

A 48 year-old African American woman presented to her physician complaining of a rapidly evolving epigastric and right upper quadrant abdominal pain. A PET-CT of the abdomen and pelvis demonstrated hypermetabolic, polypoid masses within the gallbladder and several tumors in the left lobe of the liver for which she underwent diagnostic laparoscopy. The gallbladder revealed a 3.5 × 3.3 × 2.4 tan-brown exophytic mass located at the fundus and growing into the lumen with multiple contiguous papillary projections arising from the mucosal surface. A concurrent large cell neuroendocrine carcinoma and papillary adenocarcinoma of the gallbladder was revealed histologically. There was shared reactivity to antibodies directed against the distinct antigens for each morphological component with transitional tumor cells (of both histological components) located at the areas where the two tumor types merged, revealing common immunoreactivity for carcinoembryonic antigen, cancer antigen 19-9, keratin 19, c-kit (cluster of differentiation protein 117 (CD117)) and epithelial cell adhesion molecule. Ultrastructurally, individual cells were demonstrated to have overlapping features of neuroendocrine and glandular differentiation. The aforementioned histological, ultrastructural and immunohistochemical profile is strongly suggestive of a biphenotypic stem/progenitor cell tumor of the gallbladder.

Morbidity and mortality after hepatic and pancreatic resections: results from one surgeon at a low-volume urban hospital over thirty years.

BACKGROUND: Recent reviews of state and national databases suggest that hospital volume is inversely proportional to morbidity after hepatic and pancreatic resection. Volume may be a surrogate marker for factors such as coordination of care and surgeon training. The authors hypothesized that low-volume centers can obtain acceptable outcomes if these requirements are satisfied. METHODS: A retrospective review was performed of all hepatic and pancreatic resections performed from 1978 to 2008 by 1 surgeon at 1 low-volume institution. The etiology of disease, type of resection, and 30-day morbidity and mortality were assessed. RESULTS: One hundred sixty-eight hepatic resections were performed for malignant (76%) or benign (24%) etiologies. Major resections included extended lobectomy (n = 19), lobectomy (n = 58), and segmentectomy (n = 62); minor resections consisted of wedge resections (n = 29). Overall 30-day mortality was 1.8%, and major morbidity was 17.9%; for major hepatic resections, mortality and morbidity were 1.4% and 20.1%, respectively. One hundred fourteen pancreatic resections were performed for malignant (76.3%) or benign (23.7%) etiologies. Major resections included pancreaticoduodenectomy (n = 91), central pancreatectomy (n = 1), and total pancreatectomy (n = 4); minor resections consisted of distal pancreatectomy (n = 18). Overall 30-day mortality was 2.6%, and major morbidity was 27.2%; for major pancreatic resections, mortality and morbidity were 3.1% and 31.3%, respectively. CONCLUSIONS: Hepatic and pancreatic resections can be performed safely at a low-volume hospital with adequate surgeon training and perioperative systems of care.

Primary carcinoid tumors of the liver.

BACKGROUND: Primary carcinoid tumors of the liver are uncommon and rarely symptomatic. The diagnosis of primary hepatic etiology requires rigorous workup and continued surveillance to exclude a missed primary. CASE PRESENTATION: We present a case of a 62-year-old female with a primary hepatic carcinoid tumor successfully resected, now with three years of disease-free follow-up. We present a review of the current literature regarding the diagnosis, pathology, management, and natural history of this disease entity. CONCLUSION: Primary carcinoid tumors of the liver are rare, therefore classifying their nature as primary hepatic in nature requires extensive workup and prolonged follow-up. All neuroendocrine tumors have an inherent malignant potential that must be recognized. Management remains surgical resection, with several alternative options available for non-resectable tumors and severe symptoms. The risk of recurrence of primary hepatic carcinoid tumors after resection remains unknown.