Management of the Charcot Foot and Ankle: Nonreconstructive Surgery.

Diabetic neuroarthropathy is a complication of diabetes mellitus that results in instability of the foot, structural deformity, and soft-tissue breakdown. Commonly, midfoot collapse of the medial, lateral, or both longitudinal arches may result in increased plantar pressures and subsequent midfoot ulceration. Many of these wounds can be successfully managed with local wound care and off-loading; however, surgical intervention becomes necessary in cases of osteomyelitis or when the wound fails to heal despite conservative efforts. In cases where surgical reconstruction may not be indicated, nonreconstructive surgical efforts have shown effectiveness in resolving wounds and allowing patients to return to ambulatory lifestyles. This article serves as an update to current treatment recommendations for the nonreconstructive surgical management of Charcot neuroarthropathy.

Safety of Tibial Half Pins With Circular External Fixation for Foot and Ankle Reconstruction in Patients With Peripheral Neuropathy.

The primary aim of the study was to evaluate the rate of tibial fracture with half pin placement in conjunction with tensioned wires in Ilizarov static external fixator in patients with peripheral neuropathy. Concentric visualization through a rancho cube and careful identification of anterior, posterior, medial, and lateral borders of the tibia, the "perfect circle" technique was used to ensure avoidance of cortical breach. Bivariate analysis was performed comparing the rates of tibia fractures in those who did and did not employ the "perfect circle" technique for placement of tibial half pins; evaluating for demographics, rationale for external fixation use, and postoperative amputation and complication rates. Tibial stress fractures, and early removal of pin/wires from external fixator secondary to breakage both occurred at statistically significant higher rates in patients in which the "perfect circle" technique was not employed (p < .001 and p = .03 respectively). The overall rate of tibia stress fractures was 2.08% (2/96), 0% (0/85) when "perfect circle" technique was used, compared to 18.18% (2/11) when it was not used. This study demonstrates a substantially low rate of tibia stress fractures with half pin use, in contrast to prior literature and should provide foot and ankle surgeons confidence, particularly when appropriate placement is observed in this high-risk population.

Image once, print thrice? Three-dimensional printing of replacement parts.

OBJECTIVE: The last 20 years has seen an exponential increase in 3D printing as it pertains to the medical industry and more specifically surgery. Previous reviews in this domain have chosen to focus on applications within a specific field. To our knowledge, none have evaluated the broad applications of patient-specific or digital imaging and communications in medicine (DICOM) derived applications of this technology. METHODS: We searched PUBMED and CINAHL from April 2012 to April 2017. RESULTS: 261 studies fulfilled the inclusion criteria. Proportions of articles reviewed: DICOM (5%), CT (38%), MRI (20%), Ultrasonography (28%), and Bio-printing (9%). CONCLUSION: There is level IV evidence to support the use of 3D printing for education, pre-operative planning, simulation and implantation. In order to make this technology widely applicable, it will require automation of DICOM to standard tessellation language to implant. Advances in knowledge: Recent lapses in intellectual property and greater familiarity with rapid prototyping in medicine has set the stage for the next generation of custom implants, simulators and autografts. Radiologists may be able to help establish reimbursable procedural terminology.

Illustration of Cost Saving Implications of Lower Extremity Nerve Decompression to Prevent Recurrence of Diabetic Foot Ulceration.

The US diabetic foot ulcer (DFU) incidence is 3-4% of 22.3 million diagnosed diabetes cases plus 6.3 million undiagnosed, 858 000 cases total. Risk of recurrence after healing is 30% annually. Lower extremity multiple nerve decompression (ND) surgery reduces neuropathic DFU (nDFU) recurrence risk by >80%. Cost effectiveness of hypothetical ND implementation to minimize nDFU recurrence is compared to the current $6.171 billion annual nDFU expense. A literature review identified best estimates of annual incidence, recurrence risk, medical management expense, and noneconomic costs for DFU. Illustrative cost/benefit calculations were performed assuming widespread application of bilateral ND after wound healing to the nDFU problem, using Center for Medicare Services mean expense data of $1143/case for unilateral lower extremity ND. Calculations use conservative, evidence-based cost figures, which are contemporary (2012) or adjusted for inflation. Widespread adoption of ND after nDFU healing could reduce annual DFU occurrences by at least 21% in the third year and 24% by year 5, representing calculated cost savings of $1.296 billion (year 3) to $1.481 billion (year 5). This scenario proffers significant expense reduction and societal benefit, and represents a minimum 1.9× return on the investment cost for surgical treatment. Further large cost savings would require reductions in initial DFU incidence, which ND might achieve by selective application to advanced diabetic sensorimotor polyneuropathy (DSPN). By minimizing the contribution of recurrences to yearly nDFU incidence, ND has potential to reduce by nearly $1 billion the annual cost of DFU treatment in the United States.

A passing glance? Differences in eye tracking and gaze patterns between trainees and experts reading plain film bunion radiographs.

Eye tracking and gaze pattern studies have been used to evaluate human behavior for decades. This is because of its ability to reveal conscious and subconscious behaviors when subjects are tasked with observation, decision making, and surgical performance. Many have popularized the use of this technology for radiographic assessment while evaluating radiologist behaviors, but little has been described for surgeon behavior patterns when evaluating preoperative deformities by radiograph. Because the radiographic assessment strongly influences surgical selection, the present study was designed to evaluate the differences between groups of novice and experienced surgeons' gaze patterns when tasked to describe hallux valgus deformities. The subjects were asked to rate the deformity as "none," "mild," "moderate," or "severe." Using an externally mounted eye tracking system, our study assessed saccades, fixations, overall time spent per radiograph, and the subjects' chosen bunion rating. Both the novice and advanced groups of foot and ankle surgeons were tasked to evaluate 25 total anteroposterior radiographs from patients who presented with a primary complaint of bunion pain. These patients were chosen at random, such that all participating surgeons had no previous patient familiarization. Statistically significant differences were observed with regard to the activity and rating of the moderate bunion films. The experience of surgeons does appear to modify gaze behavior with respect to time and attention, such that less overall time spent per image is needed by the advanced group, with improved efficiency. Future academic curriculum and training techniques could be developed to reflect these potential technical differences in search behavior, diagnostic technique, and surgical selection strategy.

Identification of a cytotoxic form of dimeric interleukin-2 in murine tissues.

Interleukin-2 (IL-2) is a multi-faceted cytokine, known for promoting proliferation, survival, and cell death depending on the cell type and state. For example, IL-2 facilitates cell death only in activated T cells when antigen and IL-2 are abundant. The availability of IL-2 clearly impacts this process. Our laboratory recently demonstrated that IL-2 is retained in blood vessels by heparan sulfate, and that biologically active IL-2 is released from vessel tissue by heparanase. We now demonstrate that heparanase digestion also releases a dimeric form of IL-2 that is highly cytotoxic to cells expressing the IL-2 receptor. These cells include "traditional" IL-2 receptor-bearing cells such as lymphocytes, as well as those less well known for IL-2 receptor expression, such as epithelial and smooth muscle cells. The morphologic changes and rapid cell death induced by dimeric IL-2 imply that cell death is mediated by disruption of membrane permeability and subsequent necrosis. These findings suggest that IL-2 has a direct and unexpectedly broad influence on cellular homeostatic mechanisms in both immune and non-immune systems.

Long-term survival analysis of the Canadian Lung Volume Reduction Surgery trial.

BACKGROUND: The Canadian Lung Volume Reduction Surgery (CLVRS) trial was a multicentered randomized controlled trial that concluded that lung volume reduction surgery improves functional status and health-related quality of life (for at least 2 years) in selected patients with advanced emphysema. METHODS: This retrospective observational study assessed the long-term survival of patients enrolled in the CLVRS at 8 to 10 years after randomization. Vital statistics were gathered through telephone contact, physician records, and municipal obituaries. Survival analysis was undertaken using Kaplan-Meier and the Cox proportional hazards models. RESULTS: Fifty-two patients (84% of the initial 62 patients randomized) had a median survival time of 4.11 years. A 16-month survival advantage and a 20% reduction in mortality was observed in the LVRS group as compared with the best medical care group. Although clinically meaningful, these differences were not statistically significant. CONCLUSIONS: These findings echo those of other published reports and demonstrate the potential long-term benefit of LVRS in the treatment of end-stage emphysema.

Positron emission tomography in staging early lung cancer: a randomized trial.

BACKGROUND: Among patients with early-stage non-small cell lung cancer (NSCLC), preoperative imaging tests are important in defining surgical candidates. OBJECTIVE: To assess whether whole-body positron emission tomography and computed tomography (PET-CT) plus cranial imaging correctly upstages cancer in more patients with NSCLC than does conventional staging plus cranial imaging. DESIGN: Randomized clinical trial with recruitment from June 2004 to August 2007. The centralized, computer-generated, variable block size randomization scheme was stratified by treatment center and cancer stage. Participants, health care providers, and outcome assessors were not blinded to imaging modality assignment. SETTING: 8 hospitals and 5 PET-CT centers in academic institutions. PATIENTS: Eligible patients were older than 18 years; had histologic or cytologic proof of stage I, II, or IIIA NSCLC on the basis of chest radiography and thoracic CT; and had a tumor considered to be resectable. INTERVENTION: PET-CT or conventional staging (abdominal CT and bone scan). All patients also had cranial imaging using CT or magnetic resonance imaging. MEASUREMENTS: The primary outcome was correct upstaging, thereby avoiding stage-inappropriate surgery. Secondary outcomes were incorrect upstaging and incorrect understaging. RESULTS: 170 patients were assigned to PET-CT and 167 to conventional staging. Eight patients (3 who had PET-CT and 5 who had conventional staging) did not have planned surgery. Disease was correctly upstaged in 23 of 167 PET-CT recipients and 11 of 162 conventional staging recipients (13.8% vs. 6.8%; difference, 7.0 percentage points [95% CI, 0.3 to 13.7 percentage points]), thereby sparing these patients from surgery. Disease was incorrectly upstaged in 8 PET-CT recipients and 1 conventional staging recipient (4.8% vs. 0.6%; difference, 4.2 percentage points [CI, 0.5 to 8.6 percentage points]), and it was incorrectly understaged in 25 and 48 patients, respectively (14.9% vs. 29.6%; difference, 14.7 percentage points [CI, 5.7 to 23.4 percentage points]). At 3 years, 52 patients who had PET-CT and 57 patients who had conventional staging had died. LIMITATION: The relatively small sample and the fact that some patients did not have planned surgery limited the ability to determine precise differences in clinical outcomes that were attributable to testing strategies. CONCLUSION: Preoperative staging with PET-CT and cranial imaging identifies more patients with mediastinal and extrathoracic disease than conventional staging, thereby sparing more patients from stage-inappropriate surgery, but the strategy also incorrectly upstaged disease in more patients.

Differentiation and transplantation of human embryonic stem cell-derived hepatocytes.

BACKGROUND & AIMS: The ability to obtain unlimited numbers of human hepatocytes would improve the development of cell-based therapies for liver diseases, facilitate the study of liver biology, and improve the early stages of drug discovery. Embryonic stem cells are pluripotent, potentially can differentiate into any cell type, and therefore could be developed as a source of human hepatocytes. METHODS: To generate human hepatocytes, human embryonic stem cells were differentiated by sequential culture in fibroblast growth factor 2 and human activin-A, hepatocyte growth factor, and dexamethasone. Functional hepatocytes were isolated by sorting for surface asialoglycoprotein-receptor expression. Characterization was performed by real-time polymerase chain reaction, immunohistochemistry, immunoblot, functional assays, and transplantation. RESULTS: Embryonic stem cell-derived hepatocytes expressed liver-specific genes, but not genes representing other lineages, secreted functional human liver-specific proteins similar to those of primary human hepatocytes, and showed human hepatocyte cytochrome P450 metabolic activity. Serum from rodents given injections of embryonic stem cell-derived hepatocytes contained significant amounts of human albumin and alpha1-antitrypsin. Colonies of cytokeratin-18 and human albumin-expressing cells were present in the livers of recipient animals. CONCLUSIONS: Human embryonic stem cells can be differentiated into cells with many characteristics of primary human hepatocytes. Hepatocyte-like cells can be enriched and recovered based on asialoglycoprotein-receptor expression and potentially could be used in drug discovery research and developed as therapeutics.

Maternal microchimerism leads to the presence of interleukin-2 in interleukin-2 knock out mice: implications for the role of interleukin-2 in thymic function.

The role of interleukin-2 (IL-2) in thymic development is uncertain. Not surprisingly, IL-2 knockout (KO) mice have been used to address this question. However, as we report here, such mice are chimeric, containing both IL-2 KO cells and IL-2-expressing cells transferred in utero from their heterozygous mothers. These cells produce IL-2 in amounts detectable by conventional means, and their presence in lymphoid tissues confounds efforts to define the true IL-2 KO phenotype. To minimize the amount of IL-2 available to the thymus, we subjected recombinase activating gene-1 KO mice to bone marrow transplantation using IL-2 KO donors, and then followed the reconstitution of the thymus. The thymuses of these mice became increasingly aberrant over time, including abnormalities in both stromal cells and thymocytes. These results demonstrate that IL-2 is critical to several aspects of thymic function, a finding previously obscured by the presence of IL-2 in IL-2 KO mice.

Asthma control during the year after bronchial thermoplasty.

BACKGROUND: Bronchial thermoplasty is a bronchoscopic procedure to reduce the mass of airway smooth muscle and attenuate bronchoconstriction. We examined the effect of bronchial thermoplasty on the control of moderate or severe persistent asthma. METHODS: We randomly assigned 112 subjects who had been treated with inhaled corticosteroids and long-acting beta2-adrenergic agonists (LABA) and in whom asthma control was impaired when the LABA were withdrawn to either bronchial thermoplasty or a control group. The primary outcome was the frequency of mild exacerbations, calculated during three scheduled 2-week periods of abstinence from LABA at 3, 6, and 12 months. Airflow, airway responsiveness, asthma symptoms, the number of symptom-free days, use of rescue medication, and scores on the Asthma Quality of Life Questionnaire (AQLQ) and the Asthma Control Questionnaire (ACQ) were also assessed. RESULTS: The mean rate of mild exacerbations, as compared with baseline, was reduced in the bronchial-thermoplasty group but was unchanged in the control group (change in frequency per subject per week, -0.16+/-0.37 vs. 0.04+/-0.29; P=0.005). At 12 months, there were significantly greater improvements in the bronchial-thermoplasty group than in the control group in the morning peak expiratory flow (39.3+/-48.7 vs. 8.5+/-44.2 liters per minute), scores on the AQLQ (1.3+/-1.0 vs. 0.6+/-1.1) and ACQ (reduction, 1.2+/-1.0 vs. 0.5+/-1.0), the percentage of symptom-free days (40.6+/-39.7 vs. 17.0+/-37.9), and symptom scores (reduction, 1.9+/-2.1 vs. 0.7+/-2.5) while fewer puffs of rescue medication were required. Values for airway responsiveness and forced expiratory volume in 1 second did not differ significantly between the two groups. Adverse events immediately after treatment were more common in the bronchial-thermoplasty group than in the control group but were similar during the period from 6 weeks to 12 months after treatment. CONCLUSIONS: Bronchial thermoplasty in subjects with moderate or severe asthma results in an improvement in asthma control. (ClinicalTrials.gov number, NCT00214526 [ClinicalTrials.gov].).

Bronchial thermoplasty for asthma.

RATIONALE: Bronchial thermoplasty (BT) reduces the potential for smooth muscle-mediated bronchoconstriction by reducing the mass of smooth muscle in the walls of conducting airways. OBJECTIVES: This study was conducted to examine the safety and impact on lung function and airway responsiveness of BT over 2 yr. METHODS: The safety of BT was studied in 16 subjects with mild to moderate asthma. Baseline and 12-wk post-treatment measurements included spirometry, methacholine challenge, daily diary recordings of peak flow, symptoms, and medication usage. Subjects completed follow-up evaluations at 12 wk, 1 yr, and 2 yr. MEASUREMENTS AND MAIN RESULTS: The procedure was well tolerated; side effects were transient and typical of what is commonly observed after bronchoscopy. All subjects demonstrated improvement in airway responsiveness. The mean PC(20) increased by 2.37 +/- 1.72 (p < 0.001), 2.77 +/- 1.53 (p = 0.007), and 2.64 +/- 1.52 doublings (p < 0.001), at 12 wk, 1 yr, and 2 yr post-procedure, respectively. Data from daily diaries collected for 12 wk indicated significant improvements over baseline in symptom-free days (p = 0.015), morning peak flow (p = 0.01), and evening peak flow (p < or = 0.007). Spirometry measurements remained stable throughout the study period. CONCLUSIONS: BT is well tolerated in patients with asthma and results in decreased airway hyperresponsiveness that persists for at least 2 yr.

A randomized clinical trial of lung volume reduction surgery versus best medical care for patients with advanced emphysema: a two-year study from Canada.

BACKGROUND: We present a summary report evaluating the efficacy of lung volume reduction surgery (LVRS) in patients with advanced emphysema in the Canadian setting. METHODS: Quality of Life measures assessed the efficacy of adding LVRS to best medical care including rehabilitation in this blinded randomized multicentered controlled trial with 2 years of follow-up. Health utility and quality-adjusted life years (QALY) were outcomes central to our economic assessment. RESULTS: None of the 32 patients randomized to the LVRS arm or 30 patients in the best medical care (BMC) arm crossed-over and no patients were lost to follow-up. Overall surgical mortality was 16% at 2 years while the overall medical mortality was 13% (p = 0.914). There were no 30-day postoperative deaths but 2 deaths (6%) occurred within 90 days of randomization. Surgery reduced the residual volume measured at 6 months by 23% (5,385 mL to 4,322 mL, p = 0.007). There was an increase in forced expiratory volume in 1 second (FEV1) of 30% (265 mL, p = 0.013) from baseline, an improvement in the six minute walk test (6MWT) of 78 meters (p = 0.045), and an increase in Health Utility Index 3 (HUI3) which peaked at 6 months with a difference of 0.16 (p = 0.129). There was a gain in QALYs of 0.21 (p = 0.19) in the LVRS-arm over the BMC-arm. The LVRS costs an additional 28,119 Canadian dollars (CAD) compared with BMC or 133,900 CAD/QALY gained. CONCLUSIONS: The addition of LVRS to best medical care including pulmonary rehabilitation improves pulmonary function, exercise activity, and quality of life in selected patients with advanced emphysema. Cost is high but in keeping with other treatment modalities currently available.

A prospective feasibility study of bronchial thermoplasty in the human airway.

BACKGROUND: Bronchial thermoplasty is a novel procedure being developed as a potential treatment for asthma. Experience with animal studies has enabled development of appropriate reliable equipment, definition of therapeutic parameters, and descriptions of tissue effects of treatment. STUDY OBJECTIVES: This study was undertaken to assess the feasibility and general safety of the application of bronchial thermoplasty in the human airway, and to determine if the reduction in airway smooth muscle seen in animal studies could be replicated. DESIGN: A prospective study. SETTING: Academic thoracic surgery center. PARTICIPANTS: Nine patients scheduled to undergo lung resection for suspected or proven lung cancer. INTERVENTIONS: Bronchial thermoplasty was performed during routine preoperative bronchoscopy up to 3 weeks prior to prescheduled lung resection. Treatment was limited to areas of the segmental bronchi within the lobe that was to be removed. Treated airways were inspected via bronchoscopy at the time of thoracotomy, and were examined histologically following surgical resection. RESULTS: There were no adverse clinical effects of the procedure, including no new symptoms and no unscheduled visits for medical care. Treated sites exhibited slight redness and edema of the mucosa within 2 weeks of treatment, and appeared normal at later time points. There was narrowing (visually estimated at 25 to 50%) in four airways in two subjects examined at 5 days and 13 days after treatment, with excess mucus in two of these airways. There was no bronchoscopic evidence of scarring in any of the airways examined. Histologic examination showed a reduction in airway smooth muscle, and the extent of the treatment effect was confined to the airway wall and the immediate peribronchial region. CONCLUSION: Application of bronchial thermoplasty to the human airway appears to be well tolerated. Treatment resulted in significant reduction of smooth muscle mass in the airways. Bronchial thermoplasty may provide therapeutic benefit in disease states such as asthma.

Lung volume reduction surgery vs medical treatment: for patients with advanced emphysema.

OBJECTIVE: To contribute to the knowledge on the therapeutic value of lung volume reduction surgery (LVRS). DESIGN: Two similar, independently conceived and conducted, multicenter, randomized clinical trials. SETTING: The Canadian Lung Volume Reduction (CLVR) study and the Overholt-Blue Cross Emphysema Surgery Trial (OBEST). METHODS: Using a fixed-effects meta-analysis, the 6-month results produced by the addition of LVRS to optimal medical therapy were compared to those obtained from optimal medical therapy alone. Patients were required to have severe emphysema, marked airflow limitation (ie, FEV(1), 15 to 40% predicted), hyperinflation (total lung capacity [TLC], > 120% predicted), CO(2), < 55 mm Hg, and measurable dyspnea (chronic respiratory disease questionnaire [CRDQ] scores /= 1 for the OBEST). Optimal medical therapy included pulmonary rehabilitation in both arms of both studies. RESULTS: The CLVR study randomized 58 patients and the OBEST randomized 35 patients for a total of 93 patients. Of these, 54 patients were randomized to undergo surgery, and 39 patients were randomized to receive medical treatment. The 6-month mortality rate (including operative mortality) in the surgical and medical cohorts was similar (5.6% vs 5.1%, respectively). A comparison of the medical and surgical arms of the combined CLVR study/OBEST population showed that LVRS was associated with a higher FEV(1) (167 mL or 24% predicted; 95% confidence interval [CI], 29 to 304; p = 0.017), lower residual volume (-1,342 mL or 24.5% predicted; 95% CI, -1,844 to -840; p < 0.001), lower TLC (-1,044 mL or 13% predicted; 95% CI, -1483 to -605; p < 0.001), and higher 6-min walk distance (148.8 feet; 95% CI, 24.3 to 273.2; p = 0.019). Each domain of the CRDQ showed statistically significant improvement in the surgical arm of the study, but not in the medical arm. The summary physical component scale of the Medical Outcomes Study 36-item short form (SF-36) was also more favorable in the LVRS cohort (6.9; 95% CI, 2.86 to 10.90; p < 0.001). The summary mental component scale of the SF-36 did not show a statistically significant difference between the two groups. CONCLUSION: Six months after randomization, LVRS produced better palliation than optimal medical therapy in patients with advanced emphysema.

Preoperative and intraoperative factors predictive of length of hospital stay after pulmonary lobectomy.

BACKGROUND: Length of hospital stay is an important determinant of overall surgical costs. Health care resources are finite, so reductions in length of stay are desirable. We reviewed our experience with pulmonary lobectomy to identify preoperative and intraoperative factors that predicted the length of postoperative hospital stay. By identifying these factors, we hoped to favorably influence future patient management. METHODS: Records of patients undergoing pulmonary lobectomy for benign or malignant disease over a four-year period (1998-2001) were reviewed. Data was collected on age, sex, pulmonary function, pulmonary pathology, cigarette smoking, type of thoracotomy incision, use of surgical sealants, surgeon, and length of hospital stay. RESULTS: Three hundred and sixty patients underwent lobectomy. Forward stepwise regression identified age (p=0.022), FEV1 (forced expiratory volume in one second) (p=0.047), diffusion capacity (p=0.020), and surgeon (p<0.001) as independent factors predictive of hospital length of stay. When these four factors were analyzed in a multiple linear regression model, the surgeon variable emerged as the strongest predictor of length of stay (p<0.001). CONCLUSIONS: Although patient factors were influential, the individual surgeon was the most important determinant of hospital length of stay after pulmonary lobectomy. It may be possible to reduce length of hospital stay by identifying variations in practice within the surgical group, and encouraging widespread adoption of "best practice" surgical techniques.

Pyloric drainage (pyloroplasty) or no drainage in gastric reconstruction after esophagectomy: a meta-analysis of randomized controlled trials.

BACKGROUND/AIM: A gastric conduit is usually used to reconstruct the foregut after esophagectomy for cancer. The gastric emptying may be impaired after this operation, so some esophageal surgeons routinely add a pyloric drainage procedure (pyloroplasty or pyloromyotomy). We performed a meta-analysis of randomized controlled trials (RCTs) to determine the effect of pyloric drainage on patient outcomes. METHODS: Medline and manual searches were done (completed independently and in duplicate) to identify all published RCTs that addressed the issue of pyloric drainage procedures during gastric conduit reconstruction of the esophagus. The selection process was inclusive; no trials were excluded. Trial validity assessment was done, and a trial quality score was assigned. Early outcomes assessed by meta-analysis included operative mortality, esophagogastric anastomotic leaks, pulmonary morbidity, pyloric drainage complications, fatal pulmonary aspiration, and gastric outlet obstruction. A random-effects model was used, and the relative risk was the principal measure of effect. Systematic semiquantitative review was used for late outcomes such as gastric emptying, bile reflux, nutritional status, and obstructive foregut symptoms. RESULTS: Nine RCTs, that included a total of 553 patients, were selected, with quality scores ranging from 1 to 4 (5-point Jadad scale). Selection and validity agreement was strong. The relative risk (95% CI; p value), expressed as pyloric drainage versus no drainage (treatment vs. control), was 0.92 (0.34, 2.44; p = 0.86) for operative mortality, 0.90 (0.47, 1.76; p = 0.77) for esophagogastric anastomotic leaks, 0.69 (0.42, 1.14; p = 0.15) for pulmonary morbidity, 2.55 (0.34, 18.98; p = 0.36) for pyloric drainage complications, 0.25 (0.04, 1.60; p = 0.14) for fatal pulmonary aspiration, and 0.18 (0.03, 0.97; p = 0.046) for gastric outlet obstruction. Systematic semiquantitative review showed a nonsignificant trend favoring pyloric drainage for the late outcomes of gastric emptying, nutritional status, and obstructive foregut symptoms. For the late outcome of bile reflux, there was a nonsignificant trend favoring the no-drainage group. The scintographic gastric emptying time, expressed as a ratio (pyloric drainage/no drainage), was 0.53. CONCLUSIONS: Data synthesized from existing RCTs show that pyloric drainage procedures reduce the occurrence of early postoperative gastric outlet obstruction after esophagectomy with gastric reconstruction, but they have little effect on other early and late patient outcomes.