Prior to publication of the Clavien-Dindo classification in 2004, there were no grading definitions for surgical complications in either clinical practice or surgical trials. This report establishes supplementary criteria for this classification to standardize the evaluation of postoperative complications in clinical trials.The Japan Clinical Oncology Group (JCOG) commissioned a committee. Members from nine surgical study groups (gastric, esophageal, colorectal, lung, breast, gynecologic, urologic, bone and soft tissue, and brain) specified postoperative complications experienced commonly in their fields and defined more detailed grading criteria for each complication in accordance with the general grading rules of the Clavien-Dindo classification.We listed 72 surgical complications experienced commonly in surgical trials, focusing on 17 gastroenterologic complications, 13 infectious complications, six thoracic complications, and several other complications. The grading criteria were defined simply and were optimized for surgical complications.The JCOG postoperative complications criteria (JCOG PC criteria) aim to standardize the terms used to define adverse events (AEs) and provide detailed grading guidelines based on the Clavien-Dindo classification. We believe that the JCOG PC criteria will allow for more precise comparisons of the frequency of postoperative complications among trials across many different surgical fields.
Dilated cardiomyopathy (DCM) is a heart muscle disease characterized by progressive heart failure, and is a leading cause of mortality and morbidity. Recently, cellular therapy for end-stage heart failure has been emerging. We herein report a 56-year-old male who received a transplant of autologous myoblast sheets manufactured in temperature-responsive culture dishes. His clinical condition improved markedly, leaving him without any arrhythmia and able to discontinue using a left ventricular assist system and avoid cardiac transplantation. These findings suggest that cellular therapy using myoblast sheets is a promising new strategy for treating patients with end-stage DCM. This method might be an effective alternative to heart transplantation in the near future.
Preoperative assessments regarding a patient’s immunological and nutritional condition are required to predict the outcomes of patients with malignant tumors. The aim of the current study was to clarify the significance of Onodera’s prognostic nutritional index (OPNI), which can simply account for the immunological and nutritional conditions, in patients with colorectal carcinoma.The correlations of the preoperative OPNI value with clinicopathological features were examined in 219 patients with colorectal carcinoma who had been surgically treated.Not only the tumor stage (P = 0.028) and venous invasion (P = 0.002), but also an OPNI of less than 40 (P = 0.002) were found to be independently correlated with a worse prognosis of patients with colorectal carcinoma.The preoperative OPNI can be used as a simple prognostic indicator in colorectal carcinoma.
The National Clinical Database (NCD) of Japan was established in April, 2010 with ten surgical subspecialty societies on the platform of the Japan Surgical Society. Registrations began in 2011 and over 4,000,000 cases from more than 4100 facilities were registered over a 3-year period. The gastroenterological section of the NCD collaborates with the American College of Surgeons’ National Surgical Quality Improvement Program, which shares a similar goal of developing a standardized surgical database for surgical quality improvement, with similar variables for risk adjustment. Risk models of mortality for eight procedures; namely, esophagectomy, partial/total gastrectomy, right hemicolectomy, low anterior resection, hepatectomy, pancreaticoduodenectomy, and surgery for acute diffuse peritonitis, have been established, and feedback reports to participants will be implemented. The outcome measures of this study were 30-day mortality and operative mortality. In this review, we examine the eight risk models, compare the procedural outcomes, outline the feedback reporting, and discuss the future evolution of the NCD.
The therapeutic strategy for borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) has remained unestablished because the preoperative prognostic factors have not been determined.One hundred eighty-four consecutive PDAC patients who underwent upfront surgery with a curative resection between January 2000 and June 2013 at Kobe University Hospital were retrospectively studied. The PDAC patients were stratified into resectable (R)-PDAC (n = 147) and BR-PDAC patients (n = 37). We evaluated the independent prognostic significance of the neutrophil-lymphocyte ratio (NLR) and the platelet-lymphocyte ratio (PLR) in the BR-PDAC patients.BR-PDAC patient survival was significantly worse than R-PDAC patient survival (median survival time: 22.1 months vs. 24.3 months; 5-year survival rate 6 vs. 21 %; P = 0.042). The median survival in BR-PDAC patients with a preoperative NLR of >3 (n = 12) was 10.2 months, while that in patients with preoperative NLR of ≤3 (n = 25) was 24.9 months (P = 0.002). Moreover, the median survival in BR-PDAC patients with a preoperative PLR of >225 (n = 8) was 10.2 months, while that in patients with a preoperative PLR of ≤225 (n = 29) was 24.7 months (P = 0.003). Preoperative NLR >3 (HR = 2.980, 95 % CI 1.251–6.920; P = 0.015) and PLR >225 (HR = 3.050, 95 % CI 1.169–7.468; P = 0.024) were independent prognostic factors in BR-PDAC patients.Higher preoperative NLR and PLR can be independent predictive risk factors in BR-PDAC patients following curative resection.
Pulmonary complications after esophagectomy are still common and are a major cause of mortality. The aim of this study was to clarify the risk factors for the occurrence of pulmonary complications after esophagectomy.The clinical courses of 299 patients who underwent elective subtotal esophagectomy with lymph node dissection for esophageal cancer were retrospectively analyzed. Group I included patients who had pulmonary complications (n = 53), and group II included patients who did not (n = 246). The clinicopathological factors, surgical procedures and surgical results were compared between the groups.The frequency of any pulmonary complication was 17.7 %. Pneumonia (n = 26; 8.7 %) and respiratory failure that needed initial ventilatory support for 48 h or reintubation (n = 16; 5.4 %) were the major morbidities. The results of the logistic regression analysis suggested that smoking with a Brinkman index ≥800, salvage esophagectomy after definitive chemoradiotherapy and the amount of blood loss/body weight were independent factors associated with the occurrence of pulmonary complications.Pulmonary complications after esophagectomy remain common despite advances in perioperative management. Cases with a history of heavy smoking, preoperative definitive chemoradiotherapy, and high blood loss during surgery require more careful postoperative pulmonary care.
The education of surgical trainees should be based on an accurate evaluation of their surgical skill levels. In our hospital, the Objective Structured Assessment of Technical Skills (OSATS) is used for this purpose. We conducted this study to demonstrate the validity and accuracy of the OSATS for assessing surgical skills in the operating room (OR) setting.Between January, 2007 and December, 2010, the OSATS global rating scale was used to assess several operations in which surgical trainees participated. We assessed ten surgical trainees who participated as the main surgeon or first assistant, and studied the correlation between their postgraduate year and their OSATS score.The median score of the global rating scale for each trainee improved with each year of experience. The median scores of all trainees in postgraduate years 3, 4, and 5 were significantly different (p < 0.001 for both the main surgeon and first assistant roles; Kruskal–Wallis test).Using the OSATS global rating scale to assess the surgical skills of trainees in the OR was feasible and effective.
Several retrospective studies have demonstrated the safety and technical feasibility of robotic-assisted laparoscopic surgery (RALS). The aim of the present study was to clarify the advantages of RALS for rectal cancer by comparing its short-term outcomes with those of conventional laparoscopic surgery (CLS).Between April, 2010 and April, 2015, a total of 974 patients underwent proctectomy for rectal cancer. After the exclusion of those who underwent open surgery, high anterior resection, lateral lymph node dissection, or multiple resection, 442 patients were enrolled in this study, including 203 who underwent RALS and 239 who underwent CLS. We compared the short-term outcomes of these two groups.There was no case of conversion to open surgery in the RALS group, but 8 (3.3 %) cases in the CLS group (p = 0.009). Operative time was not significantly different, but blood loss was significantly less in the RALS group than in the CLS group (p < 0.001). The postoperative hospital stay was shorter in the RALS group than in the CLS group (p < 0.001). The rate of urinary retention was significantly lower in the RALS group than in the CLS group (p = 0.018).The short-term outcomes in this series provide further evidence that RALS may be superior to CLS for rectal cancer.
Idiopathic pulmonary fibrosis (IPF) is a progressive diffuse lung disease associated with an increased risk of lung cancer. Patients with IPF sometimes develop a life-threatening acute exacerbation of IPF (AE-IPF) after lung cancer surgery. In this retrospective study, pirfenidone, an antifibrotic agent, was perioperatively administered to IPF patients with lung cancer with the aim of preventing postoperative AE-IPF, and the feasibility and clinical outcomes were investigated.Twelve IPF patients with concomitant lung cancer who received perioperative pirfenidone treatment (PPT) for lung cancer surgery were retrospectively investigated. Sixteen IPF patients undergoing lung cancer surgery without PPT were analyzed as historical controls.Compared to the controls, the PPT patients had a more severely impaired preoperative pulmonary function and a larger number of limited pulmonary resections. There was a significant preoperative decrease in the serum KL-6 levels of the PPT patients. No severe pirfenidone-related complications or IPF-related events occurred in the PPT patients, while six control patients developed AE-IPF (P = 0.0167). A quantitative histopathological evaluation of resected lung specimens found that tissue changes associated with IPF were significantly fewer in the PPT patients (P = 0.021).PPT is a feasible perioperative treatment for IPF patients with lung cancer. Its effectiveness in preventing postoperative AE-IPF thus warrants prospective verification.
The prognostic nutritional index (PNI), which is calculated based on the serum albumin concentration and the peripheral blood lymphocyte count, has been used to assess the immunological and nutritional condition of patients with digestive diseases. However, its value as an indicator of aggressiveness in gastric carcinoma has not been fully investigated. Two hundred and forty-eight cases of gastric carcinoma were studied with regard to the relationship between the preoperative PNI value and the clinicopathological characteristics of the patients. A lower preoperative PNI value significantly correlated with greater tumor depth, lymph node metastasis, lymphatic permeation, and venous invasion. Moreover, the PNI value proved to be an independent prognostic indicator in gastric carcinoma. The PNI value can be a useful tool to predict the prognosis of patients with gastric carcinoma.
Preoperative chemoradiotherapy (CRT) is a novel, emerging treatment strategy for pancreatic ductal adenocarcinoma (PDAC), but it remains unclear whether post-surgery adjuvant chemotherapy is feasible following preoperative CRT. This retrospective study evaluates the feasibility of adjuvant therapy after preoperative CRT.The subjects of this study were 99 consecutive patients who underwent pancreatectomy for PDAC between January, 2007 and February, 2013 in our hospital. Sixty patients received preoperative CRT: as gemcitabine (GEM) and 40 Gy radiation in 28 (G-CRT group), and as GEM, S-1, and 50.4 Gy radiation in 32 (GS-CRT group). We also evaluated 39 patients who underwent surgery alone (SA group). We investigated adjuvant chemotherapy induction and completion rates and the frequency of adverse events rated ≥grade 3, based on Common Terminology Criteria for Adverse Events (version 4.0) in all three groups.In the G-CRT, GS-CRT, and SA groups, the induction rates were 78 % (22/28), 78 % (25/32), and 72 % (28/39), respectively; completion rates were 86 % (19/22), 88 % (22/25), and 82 % (23/28), respectively; and adverse event frequencies were 36 % (8/22), 28 % (7/25), and 43 % (12/28), respectively. No significant difference was found among the three groups.Preoperative CRT was demonstrated to be safe and did not compromise the feasibility of adjuvant chemotherapy.
The aim of this study was to evaluate whether sublobar resection could achieve recurrence and survival rates equivalent to lobectomy in high-risk elderly patients.We conducted a retrospective multicenter study that including all consecutive patients (aged >75 years) who underwent operation for clinical stage I non-small cell lung cancer (NSCLC). The clinicopathological data, postoperative morbidity and mortality, recurrence rate and vital status were retrieved. The overall survival, cancer-specific survival and disease-free survival were also assessed.Two hundred and thirty-nine patients (median age 78 years) were enrolled. Lobectomies were performed in 149 (62.3 %) patients and sublobar resections in 90 (39 segmentectomies, 51 wedge resections). There were no differences in the recurrence rates following lobar versus sublobar resections (19 versus 23 %, respectively; p = 0.5) or the overall survival (p = 0.1), cancer-specific survival (p = 0.3) or disease-free survival (p = 0.1). After adjusting for 1:1 propensity score matching and a matched pair analysis, the results remained unchanged. A tumor size >2 cm and pN2 disease were independent negative prognostic factors in unmatched (p = 0.01 and p = 0.0003, respectively) and matched (p = 0.02 and p = 0.005, respectively) analyses.High-risk elderly patients may benefit from sublobar resection, which provides an equivalent long-term survival compared to lobectomy.
We evaluated prognostic indicators based on inflammatory and nutritional factors, namely, the modified Glasgow Prognostic Score (mGPS), the Prognostic Nutritional Index (PNI), the neutrophil/lymphocyte ratio (NLR), and the platelet/lymphocyte ratio (PLR), to determine their efficiency and significance after pancreaticoduodenectomy for pancreatic cancer.The subjects of this study were 46 patients who underwent pancreaticoduodenectomy for pancreatic cancer between October 2007 and December 2014. Patients were divided into preoperative mGPS (0/1 and 2), PNI (<40 and ≥40), NLR (<2.5 and ≥2.5), and PLR (<200 and ≥200) groups, to evaluate various perioperative outcomes.Hemoglobin concentrations were significantly lower (P = 0.019), whereas intra-abdominal bleeding was significantly higher (P = 0.040) in the PNI (<40) group than in the PNI (≥40) group. The incidence of postoperative pneumonia was significantly higher in the mGPS (2) group (P = 0.009), and surgical complications greater than grade 3 (Clavien–Dindo classification) were significantly increased in the NLR (≥2.5) group (P = 0.041). Overall survival rates in the PNI (<40) (P = 0.019), NLR (≥2.5) (P = 0.001), and PLR (≥200) (P < 0.001) groups were significantly lower than those in the other groups. The PLR was the only independent prognostic indicator (P = 0.002) according to multivariate analysis.The mGPS, PNI, and NLR were effective predictive indicators of postoperative complications. The PLR was the most useful prognostic indicator for pancreatic cancer patients after pancreaticoduodenectomy.
Creating a three-dimensional (3D)-printed liver model is costly, and the visibility of the inner structures is slightly hindered. We developed a novel structure that simultaneously solves both of these problems. The outer frames were set up along the liver surface. Our structure did not use the transparent loading material because this material increases the printing cost. Therefore, we were able to directly observe the inside of the structure. We performed hepatectomy using this novel 3D-printed liver model. Using this model, we were able to clearly simulate the resection line and safely perform the surgery. Our process was more cost effective, had a shorter production time, and improved the visibility than other processes. We developed a novel 3D-printed liver for hepatectomy, which made the procedure easier, reduced the production cost, and improved the visibility; this approach may be useful for future surgeries.
We herein evaluated the status of circulating tumor cells (CTC) dislodged from the tumor during surgery in patients who underwent pulmonary resection for non-small cell lung cancer (NSCLC) to assess the clinical implications.Tumor cells in the peripheral arterial blood before surgery (Before) and immediately after lung resection (After) and in the blood from the pulmonary vein of the resected lung were detected using a size selective method. The clinicopathological characteristics and the prognosis were then analyzed according to the CTC status: no tumor cells detected (N), single tumor cell or total number less than 4 cells (S), and existence of clustered cells (C).According to the CTC status, the patients were classified into the following three groups: Before-C and After-C, Group I (n = 6); Before-S or N and After-C, Group II (n = 9); and Before-S or N and After-S or N, Group III (n = 8). Group III showed a high rate of p-stage IA, smaller tumor size, lower CEA level, lower SUVmax level, and a higher relapse-free survival rate than the other groups.CTCs were detected in patients after undergoing lung resection, some of which may have been dislodged by the surgical procedure. The presence of clustered CTCs after the operation indicated an unfavorable outcome.
Ulcerative colitis (UC) is a chronic, relapsing, and refractory disorder of the intestine. Total proctocolectomy with ileal pouch anal anastomosis (IPAA) is the preferred and standard surgical procedure for patients’ refractory to medical therapy. Pouchitis is one of the most common long-term complications after IPAA. In the present study, the safety and efficacy of Clostridium butyricum MIYAIRI (CBM) as a probiotic were examined.A randomized and placebo-controlled study was performed. Seventeen patients were recruited from 2007 to 2013. Nine tablets of MIYA-BM® or placebo were orally administered once daily. The cumulative pouchitis-free survival, pouch condition (using the modified pouch disease activity index), and blood parameters were evaluated. A fecal sample analysis was also performed.Subjects were randomly allocated to receive MIYA-BM or placebo (9 and 8 subjects, respectively). One subject in the MIYA-BM group and four subjects in the placebo group developed pouchitis. No side effects occurred in either group. Characteristic intestinal flora was observed in each group.Our results suggest that probiotic therapy with CBM achieved favorable results with minimal side effects and might be a useful complementary therapy for the prevention of pouchitis in patients with UC who have undergone IPAA.
The indications of liver transplantation for hepatobiliary malignancies have been carefully expanded in a stepwise fashion, despite the fundamental limitations in oncological, immunological, and technical aspects. A new era of “Transplant Oncology,” the fusion of transplant surgery and surgical oncology, has begun, and we stand at the dawn of a paradigm shift in multidisciplinary cancer treatment. For hepatocellular carcinoma, new strategies have been undertaken to select recipients based on biological and dynamic markers instead of conventional morphological and static parameters, opening the doors for a more deliberate expansion of the Milan criteria and locoregional therapies before liver transplantation. Neoadjuvant chemoradiation therapy followed by liver transplantation for unresectable perihilar cholangiocarcinoma developed by the Mayo Clinic provided excellent outcomes in a US multicenter study; however, the surgical indications are not necessarily universal and await international validation. Similarly, an aggressive multidisciplinary approach has been applied for other tumors, including intrahepatic cholangiocarcinoma, hepatoblastoma, liver metastases from colorectal and neuroendocrine primary and gastrointestinal stromal tumors as well as rare tumors, such as hepatic undifferentiated embryonal sarcoma and infantile choriocarcinoma. In conclusion, liver transplantation is an important option for hepatobiliary malignancies; however, prospective studies are urgently needed to ensure the appropriate patient selection, organ allocation and living donation policies, and administration of antineoplastic immunosuppression.
Primary spontaneous pneumothorax (PSP) generally occurs in young adults, whereas pediatric PSP is uncommon. It is difficult to source reliable data on pediatric PSP, the management of which is based on guidelines for adult PSP; however, the rate of recurrence after video-assisted thoracoscopic surgery (VATS) for pediatric PSP is reported to be higher.We reviewed retrospectively a collective total of 66 surgical cases of a first pneumothorax episode in 46 children under 16 years of age, who were treated at our hospital between February, 2005 and November, 2017.The surgical cases were divided into two groups, depending on how the treated lesions were covered. In the dual-covering (DC) group, the PSP was covered by oxidized regenerated cellulose and polyglycolic acid (8 patients; 13 cases) and in the single-covering (SC) group, the PSP was covered by oxidized regenerated cellulose (38 patients; 53 cases). There was no incidence of recurrence after surgery in the DC group, but 17 cases (32.1%) of recurrence after surgery in the SC group. This difference was significant.The DC method prevented the recurrence of PSP more effectively than the SC method after VATS in pediatric patients. Long-term follow-up after VATS for pediatric PSP is also important because of the risk of delayed recurrence.
Preoperative pulmonary dysfunction has been associated with increased operative mortality and morbidity after cardiac surgery. This study aimed to determine whether values for the diffusing capacity of the lung for carbon monoxide (DLCO) could predict postoperative complications after cardiac surgery.This study included 408 consecutive patients who underwent cardiac surgery between June 2008 and December 2015. DLCO was routinely determined in all patients. A reduced DLCO was clinically defined as %DLCO < 70%. %DLCO was calculated as DLCO divided by the predicted DLCO. The association between %DLCO and in-hospital mortality was assessed, and independent predictors of complications were identified by a logistic regression analysis.Among the 408 patients, 338 and 70 had %DLCO values of ≥ 70% and < 70%, respectively. Complications were associated with in-hospital mortality (P < 0.001), but not %DLCO (P = 0.275). A multivariate logistic regression analysis with propensity score matching identified reduced DLCO as an independent predictor of complications (OR, 3.270; 95%CI, 1.356–7.882; P = 0.008).%DLCO is a powerful predictor of postoperative complications. The preoperative DLCO values might provide information that can be used to accurately predict the prognosis after cardiac surgery.UMIN000029985.
Cancer-induced spiculation (CIS) on computed tomography, which is reticular or linear opacification of the pericolorectal fat tissues around the cancer site, is generally regarded as cancer infiltration into T3 or T4, but its clinicopathological significance is unknown. This study examines the correlation between CIS and clinicopathological findings to establish its prognostic value.The subjects of this retrospective study were 335 patients with colorectal cancer (CRC), who underwent curative surgery between January, 2010 and December, 2011, at the National Defense Medical College Hospital in Saitama Prefecture, Japan.The level of interobserver agreement in the evaluation of CIS was substantial (83%; kappa value, 0.65). The presence of CIS was specific for T3/T4 disease (positive predictive value, 88.3%), and was significantly associated with tumor size and venous invasion. The 5-year relapse-free survival rate was significantly lower in patients with CIS than in those without CIS (68.6% and 84.0%, respectively, p = 0.001). Subgroup analysis revealed remarkable prognostic differences in patients with stage III and T3 disease. Multivariate analysis revealed that CIS was a significant independent prognostic factor.CIS was a significant preoperative prognostic factor and could be useful in the selection of preoperative therapy for patients with CRC.