Development and assessment of Memorial Sloan Kettering Cancer Center's Surgical Secondary Events grading system.

BACKGROUND: Studying surgical secondary events is an evolving effort with no current established system for database design, standard reporting, or definitions. Using the Clavien-Dindo classification as a guide, in 2001 we developed a Surgical Secondary Events database based on grade of event and required intervention to begin prospectively recording and analyzing all surgical secondary events (SSE). METHODS: Events are prospectively entered into the database by attending surgeons, house staff, and research staff. In 2008 we performed a blinded external audit of 1,498 operations that were randomly selected to examine the quality and reliability of the data. RESULTS: Of 4,284 operations, 1,498 were audited during the third quarter of 2008. Of these operations, 79 % (N = 1,180) did not have a secondary event while 21 % (N = 318) had an identified event; 91 % of operations (1,365) were correctly entered into the SSE database. Also 97 % (129 of 133) of missed secondary events were grades I and II. There were 3 grade III (2 %) and 1 grade IV (1 %) secondary event that were missed. There were no missed grade 5 secondary events. CONCLUSIONS: Grade III-IV events are more accurately collected than grade I-II events. Robust and accurate secondary events data can be collected by clinicians and research staff, and these data can safely be used for quality improvement projects and research.

Cost variation in a laparoscopic cholecystectomy and the association with outcomes across a single health system: implications for standardization and improved resource utilization.

BACKGROUND: Payers and regulatory bodies are increasingly placing emphasis on cost containment, quality/outcome measurement and transparent reporting. Significant cost variation occurs in many operative procedures without a clear relationship with outcomes. Clear cost-benefit associations will be necessary to justify expenditures in the era of bundled payment structures. METHODS: All laparoscopic cholecystectomies (LCCKs) performed within a single health system over a 1-year period were analysed for operating room (OR) supply cost. The cost was correlated with American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) outcomes. RESULTS: From July 2013 to June 2014, 2178 LCCKs were performed by 55 surgeons at seven hospitals. The median case OR supply cost was $513 ± 156. There was variation in cost between individual surgeons and within an individual surgeon's practice. There was no correlation between cost and ACS NSQIP outcomes. The majority of cost variation was explained by selection of trocar and clip applier constructs. CONCLUSIONS: Significant case OR cost variation is present in LCCK across a single health system, and there is no clear association between increased cost and NSQIP outcomes. Placed within the larger context of overall cost, the opportunity exists for improved resource utilization with no obvious risk for a reduction in the quality of care.

A prospective outcomes analysis of palliative procedures performed for malignant intestinal obstruction due to recurrent ovarian cancer.

OBJECTIVE: To obtain prospective outcomes data on patients (pts) undergoing palliative operative or endoscopic procedures for malignant bowel obstruction due to recurrent ovarian cancer. METHODS: An institutional study was conducted from July 2002 to July 2003 to prospectively identify pts who underwent an operative or endoscopic procedure to palliate the symptoms of advanced cancer. This report focuses on pts with malignant bowel obstruction due to recurrent ovarian cancer. Procedures performed with an upper or lower gastrointestinal (GI) endoscope were considered "endoscopic." All other cases were classified as "operative." Following the procedure, the presence or absence of symptoms was determined and followed over time. All pts were followed until death. RESULTS: Palliative interventions were performed on 74 gynecologic oncology pts during the study period, of which 26 (35%) were for malignant GI obstruction due to recurrent ovarian cancer. The site of obstruction was small bowel in 14 (54%) cases and large bowel in 12 (46%) cases. Palliative procedures were operative in 14 (54%) pts and endoscopic in the other 12 (46%). Overall, symptomatic improvement or resolution within 30 days was achieved in 23 (88%) of 26 patients, with 1 (4%) postprocedure mortality. At 60 days, 10 (71%) of 14 pts who underwent operative procedures and 6 (50%) of 12 pts who had endoscopic procedures had symptom control. Median survival from the time of the palliative procedure was 191 days (range, 33-902) for those undergoing an operative procedure and 78 days (range, 18-284) for those undergoing an endoscopic procedure. CONCLUSION: Patients with malignant bowel obstructions due to recurrent ovarian cancer have a high likelihood of experiencing relief of symptoms with palliative procedures. Although recurrence of symptoms is common, durable palliation and extended survival are possible, especially in those patients selected for operative intervention.

Surgical palliation: getting back to our roots.

This article provides an overview of the approach to patients who may benefit from palliative care. While the article's details lend themselves to the treatment of complications secondary to advanced malignancies, the data herein can also be extrapolated to other chronic, terminal diseases. Guidelines for patient selection are discussed, using currently available outcomes data as a platform for the critical decision making process. Suggestions for a multidisciplinary team approach are offered, using the palliative triangle as the ideal model of communication and cooperation. Finally, methods for measuring success are detailed, along with proposals for how to better equip the surgeons of tomorrow with the knowledge and experience needed to tackle these difficult and intimate problems.

Methods of detection of first recurrence in patients with stage I/II primary cutaneous melanoma after sentinel lymph node biopsy.

BACKGROUND: An understanding of the methods of detection of recurrent melanoma after sentinel lymph node biopsy (SLNB) is essential for the coordination of a rational plan of follow-up. METHODS: Clinical stage I/II melanoma patients who underwent SLNB from 1991 to 2004 were identified from a prospectively maintained single-institution database. Detection of recurrence by self (awareness of symptoms or abnormal physical findings) or physician (discovered on routine physical or scheduled test) and timing of clinic visit were recorded. Postoperative follow-up included physical exam every 3-4 months for the first year, every 3-6 months for the second year, and every 6-12 months thereafter. Serum lactate dehydrogenase (LDH) and chest X-ray (CXR) were obtained annually. Computed tomography (CT) and positron emission tomography (PET) were performed selectively. RESULTS: Of 1062 patients who underwent SLNB, 203 (19%) experienced 230 initial sites of recurrence; 198 patients were evaluable for follow-up. Median follow-up after first recurrence was 17 months. Symptoms and self-detected physical findings were present in 109 patients (55%); 85 patients (78%) were seen earlier than their scheduled visit. Self-detected physical findings identified in-transit (n = 26; 24%) and nodal (n = 25; 23%) disease. Physician detection occurred in 89 patients (45%), nearly half by a scheduled radiographic test (CXR, 16%; CT, 29%; PET, 1%). The method of detection significantly predicted post-recurrence survival (p < 0.05). CONCLUSION: More than half of melanoma recurrences are self-detected; these patients have the most favorable post-recurrence survival rates because of the type of recurrence detected. The mode of detection is a significant predictor of post-recurrence survival. This supports an aggressive program of patient education in self-examination after SLNB for melanoma.

Surgeon Variation in Intraoperative Supply Cost for Pancreaticoduodenectomy: Is Intraoperative Supply Cost Associated with Outcomes?

BACKGROUND: With increased scrutiny on the quality and cost of health care, surgeons must be mindful of their outcomes and resource use. We evaluated surgeon-specific intraoperative supply cost (ISC) for pancreaticoduodenectomy and examined whether ISC was associated with patient outcomes. STUDY DESIGN: Patients undergoing open pancreaticoduodenectomy between January 2012 and March 2015 were included. Outcomes were tracked prospectively through postoperative day 90, and ISC was defined as the facility cost of single-use surgical items and instruments, plus facility charges for multiuse equipment. Multivariate logistic regression was used to test associations between ISC and patient outcomes using repeated measures at the surgeon level. RESULTS: There were 249 patients who met inclusion criteria. Median ISC was $1,882 (interquartile range [IQR] $1,497 to $2,281). Case volume for 6 surgeons ranged from 18 to 66. Median surgeon-specific ISC ranged from $1,496 to $2,371. Greater case volume was associated with decreased ISC (p < 0.001). Overall, ISC was not predictive of postoperative complications (p = 0.702) or total hospitalization expenditures (p = 0.195). At the surgeon level, surgeon-specific ISC was not associated with the surgeon-specific incidence of severe complication or any wound infection (p > 0.227 for both), but was associated with delayed gastric emptying (p = 0.004) and postoperative pancreatic fistula (p < 0.001). CONCLUSIONS: In a single-institution cohort of 249 pancreaticoduodenectomies, high-volume surgeons tended to be low-cost surgeons. Across the cohort, ISC was not associated with outcomes. At the surgeon level, associations were noted between ISC and complications, but these may be attributable to unmeasured differences in the postoperative management of patients. These findings suggest that quality improvement efforts to restructure resource use toward more cost-effective practice may not affect patient outcomes, although prospective monitoring of safety and effectiveness must be of the utmost concern.

Defining morbidity after pancreaticoduodenectomy: use of a prospective complication grading system.

BACKGROUND: Improving surgical quality of care requires accurate reporting of postoperative complications. STUDY DESIGN: Accuracy of a prospective surgical complication grading database was assessed by performing a retrospective review of 204 pancreaticoduodenectomies (PDs) entered into the database from January 1, 2001, to December 31, 2003. This updated database was then used to characterize 30-day morbidity and mortality after PD. RESULTS: On review, 13% of patients had a complication not identified in the prospective complication database, 8% of patients had a complication reclassified, and 4% of patients had a complication removed. At least 1 postoperative complication was experienced by 47% of patients. After PD, 45 different complications occurred. Postoperative mortality at 30 days was 1%, and 30-day readmission rate was 11%. The 30-day reoperation rate was 9%, and 14% of patients required a percutaneous drainage procedure. Pancreatic anastomotic leak (12%), wound infection (11%), and delayed gastric emptying (7%) were the 3 most common postoperative complications, and all were associated with an increased length of stay. CONCLUSIONS: Our prospective surgical complication database accurately characterized outcomes after PD and facilitated information gathering and analysis. The accuracy, efficiency, and reproducibility of a prospective surgical complication database favor its widespread use in postoperative complication reporting.

Merkel cell carcinoma: prognosis and treatment of patients from a single institution.

PURPOSE: Merkel cell carcinoma (MCC) is an uncommon cutaneous malignancy. Most reports consist of single-institution experiences of fewer than 30 patients. The natural history of MCC is poorly defined. PATIENTS AND METHODS: A review was performed of Memorial Sloan-Kettering Cancer Center's MCC database, identifying 251 patients who had been treated between 1970 and 2002. Patient, tumor, and treatment-related factors were analyzed for their association with recurrence and survival. RESULTS: The average follow-up for all patients was 40 months and 46 months for patients alive at last follow-up. The 5-year disease-specific survival rate was 64%. Disease stage was the only independent predictor of survival (stage I, 81%; stage II, 67%; stage III, 52%; stage IV, 11%; P = .001). Pathologic staging of the draining nodal basin was performed in 71 (40%) of 177 patients who presented with clinically negative nodes, and 16 of these patients (23%) were found to have node-positive disease. Pathologic nodal staging was associated with improved stage-specific survival probabilities (clinical node-negative, 75% v pathologic node-negative disease, 97%; P = .009) and decreased nodal recurrence (44% v 11%, P < .001). The median time to recurrence was 9 months, and 102 patients (43%) recurred. Local recurrence developed in 8% of patients after margin-negative excision. CONCLUSION: These data demonstrate that the natural history of MCC is variable and dependent on the stage of disease at presentation. Pathologic nodal staging identifies a group of patients with excellent long-term survival. After margin-negative excision and pathologic nodal staging, local and nodal recurrence rates are low.

Operative Site Drainage after Hepatectomy: A Propensity Score Matched Analysis Using the American College of Surgeons NSQIP Targeted Hepatectomy Database.

BACKGROUND: Operative site drainage (OSD) after elective hepatectomy remains widely used despite data suggesting limited benefit. Multi-institutional, quality-driven databases and analytic techniques offer a unique source from which the utility of OSD can be assessed. STUDY DESIGN: Elective hepatectomies from the 2014 American College of Surgeons (ACS) NSQIP Targeted Hepatectomy Database were propensity score matched on the use of OSD using preoperative and intraoperative variables. The influence of OSD on the diagnosis of postoperative bile leaks, rates of subsequent intervention, and other outcomes within 30 days were assessed using paired testing. RESULTS: Operative site drainage was used in 42.2% of 2,583 eligible hepatectomies. There were 1,868 cases matched, with 7.2% experiencing a post-hepatectomy bile leak. The incidence of bile leak initially requiring intervention was no different between the OSD and no OSD groups (n = 32 vs n = 24, p = 0.278), and OSD was associated with a greater number of drainage procedures to manage post-hepatectomy bile leak (n = 27 in the OSD group, n = 13 in the no OSD group, p = 0.034, relative risk [RR] 2.1 [95% CI 1.1 to 4.0]). The OSD group had a greater mean length of stay (+0.8 days, p = 0.004) and more 30-day readmissions (p < 0.001, RR 1.6 [95% CI 1.2 to 2.1]). On multivariate analysis, post-hepatectomy bile leak and receipt of additional drainage procedures were stronger predictors of increased length of stay and readmissions than OSD. CONCLUSIONS: In a propensity score matched cohort, OSD did not improve the rate of diagnosis of major bile leaks and was associated with increased interventions, greater length of stay, and more 30-day readmissions. These data suggest that routine OSD after elective hepatectomy may not be helpful in capturing clinically relevant bile leaks and has additional consequences.

Primary adult soft tissue sarcoma: time-dependent influence of prognostic variables.

PURPOSE: To define prognostic factors for postrelapse survival and their time-dependent influence for adult soft tissue sarcoma (STS). PATIENTS AND METHODS: We analyzed 2,123 patients with completely resected localized primary STS treated from 1982 to 1999. Variables studied included tumor site, size, depth, grade, and resection margin but not treatment other than resection. Landmark time frames were used to assess the influence of disease-free interval (DFI) on disease-specific survival (DSS). DSS was estimated with the Kaplan-Meier method. Univariate and multivariate analyses were performed using log-rank test and the Cox proportional hazards regression model. Time-dependent stepwise regression analysis evaluated the time-dependent influence of each variable. RESULTS: Two thirds of recurrences developed within 2 years of initial resection. Tumor size (P <.001), grade (P <.001), and microscopic resection margin (P <.001) independently predicted DSS for all STS. Size and grade independently predicted early (DFI 3 years) DSS. Risk of tumor-related death was the same across all sites 3 years postresection and decreased significantly for extremity/trunk STS when DFI exceeded 3 years (P <.001). Influence of initial high-risk factors for tumor-related mortality in extremity/trunk STS decreased by 40% 3 years postresection, but their influence over DSS for non-extremity/trunk sites remained constant over time. Likelihood of complete resection after recurrence (all sites) increased with DFI (9% and 33% for DFI < 6 and > 36 months, respectively). CONCLUSION: Tumor size, grade, and resection margin predict outcome for completely resected STS, and their influence for DSS is time- and site-dependent. The influence of prognostic factors changes over the natural history of extremity/trunk STS. Time to recurrence exerts significant influence over complete resection rates for recurrent disease.

Adrenocortical carcinoma: clinical, morphologic, and molecular characterization.

PURPOSE: To define multimolecular phenotypes of adrenocortical carcinoma (ACC) and to correlate outcome with morphologic and molecular parameters. PATIENTS AND METHODS: Clinical data were analyzed for 124 patients, histopathologic slides for 67 primary tumors, and tissue specimens for 74 patients (38 primary and 36 metastatic tumors) with ACC and for 38 normal adrenal tissue samples. Molecular expression profiles were investigated by immunohistochemistry. The prognostic significance of 12 gross and histologic parameters in 67 primary ACCs was evaluated. Morphologic and protein expression patterns were correlated with disease-specific survival (DSS). Univariate influence of prognostic factors on DSS was analyzed by log-rank test and multivariate analysis by Cox regression. RESULTS: The median follow-up period was 4.7 years. Significant predictors of DSS included distant metastasis at time of initial presentation; venous, capsular, and adjacent organ invasion; tumor necrosis, mitotic rate, atypical mitosis, and mdm-2 overexpression. Five-year DSS by number (one to six) of adverse histologic parameters was as follows: one to two, 84%; three to four, 37%; more than four, 9% (P =.005). The phenotype Ki-67(-)p53(-)mdm-2(+)cyclinD1(-)Bcl-2(-)p21(-)p27(+) was observed in 83% of normal and 3% of malignant adrenal tissue (P =.01). Molecular phenotypic expression was more heterogeneous in malignant than in normal (10 v five phenotypes) adrenal tissue. CONCLUSION: Meticulous morphologic evaluation, mitotic count, and tumor stage are essential in determining prognosis for patients with ACC. Multimolecular phenotyping demonstrates that the molecular complexity and heterogeneity of these neoplasms are such that targeted therapy needs to be patient specific.

Is detection of asymptomatic recurrence after curative resection associated with improved survival in patients with gastric cancer?

BACKGROUND: It is not clear if more intense surveillance is associated with improved survival after curative resection for cancer. In the context of a followup program after curative gastrectomy, recurrence and survival were investigated for patients presenting with either symptomatic or asymptomatic recurrence. STUDY DESIGN: A prospectively maintained gastric cancer database was used to identify all patients who underwent a curative (R0) gastrectomy from July 1985 to June 2000. Survival curves were generated for patients with either symptomatic or asymptomatic recurrence, and the prognostic variables associated with outcomes were identified. RESULTS: Of 1,172 patients who underwent a curative (R0) gastrectomy, 561 patients (48%) had documented recurrence and 382 patients had complete data about symptoms. Median time to recurrence was 10.8months for asymptomatic patients and 12.4months for symptomatic patients (p = NS). Median postrecurrence survival was 13.5months for asymptomatic patients and 4.8months for symptomatic patients (p < 0.01). Median disease-specific survival was 29.4months for asymptomatic patients and 21.6months for symptomatic patients (p < 0.05). Variables predictive of poor postrecurrence survival included symptomatic recurrence, advanced stage (III/IV), poor differentiation, short disease-free interval (<12months), and multiple sites of recurrence. CONCLUSIONS: Followup did not identify asymptomatic recurrence earlier than symptomatic recurrence. Patients with symptomatic recurrence have more aggressive disease with a shorter postrecurrence survival. The impact of detecting asymptomatic recurrence in the course of followup after curative gastrectomy could not be distinguished from the effects of four powerful biologic variables that also interact to govern outcomes.

Predictors of intensive care unit admission and related outcome for patients after pancreaticoduodenectomy.

High-volume centers have low morbidity and mortality after pancreaticoduodenectomy (PD). Less is known about treatment pathways and their influence on intensive care unit (ICU) utilization. Patients who underwent PD at a tertiary cancer center during the five-year period between January 1998 and December 2003 were identified from a prospective database. Preoperative and intraoperative factors relating to ICU admission and outcome were analyzed. Five hundred ninety-one pancreaticoduodenectomies were performed during the study period. Of these, 536 patients had complete records for analysis. Of the 536 patients, 51 (10%) were admitted to the ICU after surgery. Admission to the ICU was associated with decreased overall survival (P < .0001). Of the preoperative predictors of ICU admission, serum creatinine, albumin, and increased body mass index (BMI) were associated with ICU admission (P = .02, .05, and .002, respectively). Age, blood glucose, diagnosis of diabetes mellitus, and chronic obstructive pulmonary disease were not predictive of ICU admission on univariate analysis. Of the intraoperative factors, longer operative time and estimated blood loss (EBL) correlated with ICU admission (P = .003 and .0001, respectively). On multivariate analysis, only preoperative BMI and intraoperative EBL were independent predictors of ICU admission (P = .03 and .003, respectively). Patients with a preoperative BMI greater than 30 had a substantially higher risk of ICU admission (relative risk 2.4). The majority of patients who undergo PD do not require admission to the ICU. Factors most associated with ICU admission after PD are increased preoperative BMI and intraoperative blood loss.

An evidence-based approach to the surgical management of resectable pancreatic adenocarcinoma.

BACKGROUND: Randomized prospective trials have addressed various treatment approaches to pancreatic adenocarcinoma in order to improve on the dismal prognosis associated with this disease. We conducted a comprehensive review of prospective randomized clinical trials and summarized the contemporary treatment of resectable pancreatic carcinoma. STUDY DESIGN: A literature search strategy identified prospective randomized clinical trials for pancreatic carcinoma using standard medical subject heading terms. The articles were critically reviewed and ranked according to a standardized three-tiered system (Ia, Ib, Ic) by a panel of experts. RESULTS: Surgical studies have demonstrated that morbidity and mortality are similar for pylorus-preserving and classic pancreaticoduodenectomy. Extended retroperitoneal lymphadenectomy can be performed with similar mortality but increased morbidity compared with standard pancreaticoduodenectomy but does not prolong survival. Pancreaticogastrostomy and pancreaticojejunostomy appear to be comparable techniques for pancreatic duct reconstruction. Pancreatic-enteric anastomosis is associated with lower rates of pancreatic fistula and endocrine insufficiency than duct occlusion without anastomosis. Intraperitoneal drainage after pancreatic resection is unwarranted and may contribute to intraabdominal complications. Routine use of prophylactic octreotide does not lower the rate of pancreatic fistula; it should be considered for reoperative pancreatic resection or for a soft gland. Early trials found that adjuvant chemoradiation therapy prolongs survival. But in more recent studies chemoradiation after resection has failed to show a survival advantage over surgery alone. CONCLUSIONS: Surgical resection remains the only potentially curative therapy for adenocarcinoma of the pancreas. There is no clear indication as to a single preferable resection approach.

Defining palliative surgery in patients receiving noncurative resections for gastric cancer.

BACKGROUND: Effective palliation rather than cure is often the most appropriate goal in the management of patients with advanced gastric cancer. The literature to date is limited by the imprecise use of the term palliative and subsequent variable designation of patients into evaluable groups. STUDY DESIGN: Between July 1985 and July 2001, 1,595 patients were entered into a prospective database after undergoing a resection for gastric adenocarcinoma. Patients who received a noncurative (R1/R2) resection were identified. A procedure was defined as palliative if it was performed explicitly to palliate symptoms or improve quality of life. RESULTS: Three hundred seven patients received a noncurative gastric resection. The operation was palliative in 48% (147/307) and nonpalliative in 52% (160/307). Palliative operations included an esophageal anastomosis less frequently (46% versus 69%, p < 0.001) and had a less extensive lymphadenectomy performed compared with nonpalliative operations. Surgical intent did not alter operative morbidity (54%) or mortality (6%) significantly. The overall median survival after a noncurative gastric resection was 10.6 months and was independently associated with operations performed with explicit palliative indications (8.3 months [palliative] versus 13.5 months [nonpalliative], p < 0.001) and patient age > 65 years. CONCLUSIONS: There are important differences among patients undergoing noncurative operations for gastric cancer. Studies designed to measure palliative interventions would benefit from precise designations of palliative intent in patients receiving noncurative operations.

Achieving RO resection for locally advanced gastric cancer: is it worth the risk of multiorgan resection?

BACKGROUND: In gastric adenocarcinoma, only complete resection (R0) translates into survival benefit. Given the potential for increased morbidity and mortality from multiple organ resection we asked the question as to whether extended (multiple organ) resection was justified for advanced gastric cancer. STUDY DESIGN: From July 1985 to July 2000, 1,283 patients underwent gastric resection for adenocarcinoma at Memorial Sloan-Kettering Cancer Center, and were entered and followed in a prospectively recorded database. Four hundred eighteen patients (33%) underwent primary resection and had one or more organs resected in addition to the stomach. Eight hundred twenty-six patients (64%) underwent gastrectomy alone, with 39 patients (3%) not undergoing gastrectomy. Clinicopathologic, operative, and morbidity data were evaluated in this group. Complications were categorized by severity on a scale from 0 to 5, 0 being no complication to 5 being death. Chi-square analysis and the logistic regression method were used to compare and estimate factors significantly associated with having a complication. RESULTS: Three hundred thirty-seven patients had a single additional organ resected, 63 had two organs, and 18 had three organs. Five hundred eighty complications occurred in 33% of patients (404 of 1,283). The perioperative mortality was 4% (48 patients). Logistic regression identified the number of organs resected, two or greater, to be predictive of complications (RR 2.0), as well as age greater than 70 years old (RR 1.57). When excluding minor complications (values 1 and 2), only the number of organs resected (RR 3.8) was a major factor for severe complications (values 3, 4, and 5). CONCLUSIONS: Resection of two or more adjacent organs in advanced gastric adenocarcinoma is associated with a greater risk of developing a complication. The use of a graded surgical complication scale is needed for better reporting and comparison of complications. Achieving an R0 resection should still be considered the goal, even in locally advanced gastric cancer, but resection of additional organs should be performed judiciously.

Cystic lesions of the pancreas: selection criteria for operative and nonoperative management in 209 patients.

Because of the inability to determine benign from malignant, many have recommended that all cystic lesions of the pancreas be resected. Patients evaluated between January 1995 and December 2000 for the ICD-9 diagnosis of pancreatic cyst (577.2) or benign neoplasm of the pancreas (211.6) were reviewed. Patient, cyst, and treatment characteristics were recorded. Comparisons were made between patients who underwent operative and nonoperative management. Over the 5-year period, 209 patients were evaluated. Nonoperative treatment was initially chosen for 144 patients (69%). In this group the average cyst diameter was 2.5 cm (range 0.5 cm to 13.0 cm), and the median change in diameter during follow-up was zero cm (range 1.5 cm to 4.0 cm). In six patients (4%) changes occurred within the cyst that resulted in resection. None of these patients had a malignant diagnosis. Operative treatment was initially chosen for 65 (31%) of the 209 patients. Malignancy was found in six of the operative patients (6 [9%] of 65). Differences in patient and cyst characteristics between groups included the cyst size, septations, a solid component, and the presence of symptoms. Selected patients with cystic lesions of the pancreas may be safely followed radiographically. Selection criteria identified in this study (symptoms, cyst size, solid component, and septations) and the utilization of new imaging techniques allow the creation of treatment plans for these patients that can be prospectively tested.

Does additional surgical training increase participation in randomized controlled trials?

BACKGROUND: The prospective randomized controlled trial (PRCT) is agreeably the gold standard in reporting data on patient management. This study evaluates the impact of specialty training on the leadership, development, and enrollment in PRCT. METHODS: Questionnaires were sent to surgical oncology as well as general surgery graduates from 1985 to 1999. RESULTS: A total of 67% (201 of 300) of the surgeons responded, with one half of the respondents completing a surgical oncology (SO) fellowship (50%, 100 of 201), 33% (66 of 201) another type of fellowship (OF), and 17% (35 of 201) general surgery (GS) training alone. The utilization of PRCT in the decision making of their clinical practice was reported by a majority of SO graduates (99%) as well as GS graduates (88%) with a smaller number (77%) of OF trained surgeons. The opinions on PRCT were evenly distributed with breast disease, colorectal cancer, and melanoma having the greatest impact on surgeons practicing in these fields. A greater percentage of SO (89%) reported participation in a PRCT than did the GS (42%) or OF (54%). The most frequent reason for the lack of participation in a PRCT by both GS and OF trained graduates was absence of active recruitment (80%) to participate with the second most common being no time available (18%). CONCLUSIONS: PRCT are utilized and continue to change surgeons' decision making for a majority of the surgeons surveyed. There are certain disease sites for which PRCT have failed to influence practice decisions. Unfortunately, few surgeons take a leadership role in PRCT. Emphasizing the existence of PRCT at both meetings, and in journals, with a more aggressive recruitment of participating surgeons with minimal time commitment, should enhance the patients included in prospective randomized controlled trials.

Randomized clinical trials in soft tissue sarcoma.

What has been learned thus far from the very best prospective randomized controlled clinical trials for soft tissue sarcoma that will guide physicians in the quest for evidence-based treatment decision making? Based on the evidence provided in the following articles, we have learned that limb-sparing surgery with adjuvant radiation is equivalent (and therefore preferable) to a radical amputation in controlling local disease. We also learned that adding radiation therapy (both external beam and brachytherapy) to a complete surgical resection of extremity soft tissue sarcoma significantly improves local control over surgery alone. This is true for high-grade lesions and may be true (external beam) for larger low-grade lesions also. Local control, however, does not govern overall survival as most patients who die from this disease do so from systemic (not local) manifestations. Finally, further studies are required to identify the role of adjuvant chemotherapy in the treatment of soft tissue sarcoma as no single study has demonstrated a consistent long-term survival benefit with the use of any chemotherapeutic regimen. Based on a recent large meta-analysis, however, if there is any benefit to adjuvant doxorubicin based chemotherapy, it must be a very small one.

Association of discharge home with home health care and 30-day readmission after pancreatectomy.

BACKGROUND: We sought to determine if discharge home with home health care (HHC) is an independent predictor of increased readmission after pancreatectomy. STUDY DESIGN: We examined 30-day readmissions in patients undergoing pancreatectomy using the Healthcare Cost and Utilization Project State Inpatient Database for California from 2009 to 2011. Readmissions were categorized as severe or nonsevere using the Modified Accordion Severity Grading System. Multivariable logistic regression models were used to examine the association of discharge home with HHC and 30-day readmission using discharge home without HHC as the reference group. Propensity score matching was used as an additional analysis to compare the rate of 30-day readmission between patients discharged home with HHC with patients discharged home without HHC. RESULTS: Of 3,573 patients who underwent pancreatectomy, 752 (21.0%) were readmitted within 30 days of discharge. In a multivariable logistic regression model, discharge home with HHC was an independent predictor of increased 30-day readmission (odds ratio = 1.37; 95% CI, 1.11-1.69; p = 0.004). Using propensity score matching, patients who received HHC had a significantly increased rate of 30-day readmission compared with patients discharged home without HHC (24.3% vs 19.8%; p < 0.001). Patients discharged home with HHC had a significantly increased rate of nonsevere readmission compared with those discharged home without HHC, by univariate comparison (19.2% vs 13.9%; p < 0.001), but not severe readmission (6.4% vs 4.7%; p = 0.08). In multivariable logistic regression models, excluding patients discharged to facilities, discharge home with HHC was an independent predictor of increased nonsevere readmissions (odds ratio = 1.41; 95% CI, 1.11-1.79; p = 0.005), but not severe readmissions (odds ratio = 1.31; 95% CI, 0.88-1.93; p = 0.18). CONCLUSIONS: Discharge home with HHC after pancreatectomy is an independent predictor of increased 30-day readmission; specifically, these services are associated with increased nonsevere readmissions, but not severe readmissions.