Surgical risk model for acute diffuse peritonitis based on a Japanese nationwide database: an initial report on the surgical and 30-day mortality.

PURPOSE: Acute diffuse peritonitis (ADP) is an important surgical complication associated with high morbidity and mortality; however, the risk factors associated with a poor outcome have remained controversial. This study aimed in collecting integrated data using a web-based national database system to build a risk model for mortality after surgery for ADP. METHODS: We included cases registered in the National Clinical Database in Japan. After data cleanup, 8,482 surgical cases of ADP from 1,285 hospitals treated between January 1 and December 31, 2011 were analyzed. RESULTS: The raw 30-day and surgical mortality rates were 9.0 and 14.1 %, respectively. The odds ratios (>2.0) for 30-day mortality were as follows: American Society of Anesthesiologists (ASA) class 3, 2.69; ASA class 4, 4.28; ASA class 5, 8.65; previous percutaneous coronary intervention (PCI), 2.05; previous surgery for peripheral vascular disease (PVD), 2.45 and disseminated cancer, 2.16. The odds ratios (>2.0) for surgical mortality were as follows: ASA class 3, 2.27; ASA class 4, 4.67; ASA class 5, 6.54, and disseminated cancer, 2.09. The C-indices of 30-day and surgical mortality were 0.851 and 0.852, respectively. CONCLUSION: This is the first report of risk stratification after surgery for ADP using a nationwide surgical database. This system could be useful to predict the outcome of surgery for ADP and for evaluations and benchmark performance studies.

A pancreaticoduodenectomy risk model derived from 8575 cases from a national single-race population (Japanese) using a web-based data entry system: the 30-day and in-hospital mortality rates for pancreaticoduodenectomy.

OBJECTIVE: To create a mortality risk model after pancreaticoduodenectomy (PD) using a Web-based national database system. BACKGROUND: PD is a major gastroenterological surgery with relatively high mortality. Many studies have reported factors to analyze short-term outcomes. SUBJECTS AND METHODS: After initiation of National Clinical Database, approximately 1.2 million surgical cases from more than 3500 Japanese hospitals were collected through a Web-based data entry system. After data cleanup, 8575 PD patients (mean age, 68.2 years) recorded in 2011 from 1167 hospitals were analyzed using variables and definitions almost identical to those of American College of Surgeons-National Surgical Quality Improvement Program. RESULTS: The 30-day postoperative and in-hospital mortality rates were 1.2% and 2.8% (103 and 239 patients), respectively. Thirteen significant risk factors for in-hospital mortality were identified: age, respiratory distress, activities of daily living within 30 days before surgery, angina, weight loss of more than 10%, American Society of Anesthesiologists class of greater than 3, Brinkman index of more than 400, body mass index of more than 25 kg/m, white blood cell count of more than 11,000 cells per microliter, platelet count of less than 120,000 per microliter, prothrombin time/international normalized ratio of more than 1.1, activated partial thromboplastin time of more than 40 seconds, and serum creatinine levels of more than 3.0 mg/dL. Five variables, including male sex, emergency surgery, chronic obstructive pulmonary disease, bleeding disorders, and serum urea nitrogen levels of less than 8.0 mg/dL, were independent variables in the 30-day mortality group. The overall PD complication rate was 40.0%. Grade B and C pancreatic fistulas in the International Study Group on Pancreatic Fistula occurred in 13.2% cases. The 30-day and in-hospital mortality rates for pancreatic cancer were significantly lower than those for nonpancreatic cancer. CONCLUSIONS: We conducted the reported risk stratification study for PD using a nationwide surgical database. PD outcomes in the national population were satisfactory, and the risk model could help improve surgical practice quality.

A risk model for esophagectomy using data of 5354 patients included in a Japanese nationwide web-based database.

OBJECTIVE: This study aimed to create a risk model of mortality associated with esophagectomy using a Japanese nationwide database. METHODS: A total of 5354 patients who underwent esophagectomy in 713 hospitals in 2011 were evaluated. Variables and definitions were virtually identical to those adopted by the American College of Surgeons National Surgical Quality Improvement Program. RESULTS: The mean patient age was 65.9 years, and 84.3% patients were male. The overall morbidity rate was 41.9%. Thirty-day and operative mortality rates after esophagectomy were 1.2% and 3.4%, respectively. Overall morbidity was significantly higher in the minimally invasive esophagectomy group than in the open esophagectomy group (44.3% vs 40.8%, P = 0.016). The odds ratios for 30-day mortality in patients who required preoperative assistance in activities of daily living (ADL), those with a history of smoking within 1 year before surgery, and those with weight loss more than 10% within 6 months before surgery were 4.2, 2.6, and 2.4, respectively. The odds ratios for operative mortality in patients who required preoperative assistance in ADL, those with metastasis/relapse, male patients, and those with chronic obstructive pulmonary disease were 4.7, 4.5, 2.3, and 2.1, respectively. CONCLUSIONS: This study was the first, as per our knowledge, to perform risk stratification for esophagectomy using a Japanese nationwide database. The 30-day and operative mortality rates were relatively lower than those in previous reports. The risk models developed in this study may contribute toward improvements in quality control of procedures and creation of a novel scoring system.

Total gastrectomy risk model: data from 20,011 Japanese patients in a nationwide internet-based database.

OBJECTIVE: To construct a risk model for total gastrectomy outcomes using a nationwide Internet-based database. BACKGROUND: Total gastrectomy is a very common procedure in Japan. This procedure is among the most invasive gastrointestinal procedures and is known to carry substantial surgical risks. METHODS: The National Clinical Database was used to retrieve records on more than 1,200,000 surgical cases from 3500 hospitals in 2011. After data cleanup, 20,011 records from 1623 hospitals were analyzed for procedures performed between January 1, 2011, and December 31, 2011. RESULTS: The average patient age was 68.9 years; 73.7% were male. The overall morbidity was 26.2%, with a 30-day mortality rate of 0.9%, in-hospital mortality rate of 2.2%, and overall operative mortality rate of 2.3%. The odds ratios for 30-day mortality were as follows: ASA (American Society of Anesthesiologists) grade 4 or 5, 9.4; preoperative dialysis requirement, 3.9; and platelet count less than 50,000 per microliter, 3.1. The odds ratios for operative mortality were as follows: ASA grade 4 or 5, 5.2; disseminated cancer, 3.5; and alkaline phosphatase level of more than 600 IU/L, 3.1. The C-index of 30-day mortality and operative mortality was 0.811 (95% confidence interval [CI], 0.744-0.879) and 0.824 (95% CI, 0.781-0.866), respectively. CONCLUSIONS: We have performed the first reported risk stratification study for total gastrectomy, using a nationwide Internet-based database. The total gastrectomy outcomes in the nationwide population were satisfactory. The risk models that we have created will help improve the quality of surgical practice.

Mortality after common rectal surgery in Japan: a study on low anterior resection from a newly established nationwide large-scale clinical database.

BACKGROUND: The health-care system, homogenous ethnicity, and operative strategy for lower rectal cancer surgery in Japan are to some extent unique compared to those in Western countries. The National Clinical Database is a newly established nationwide, large-scale surgical database in Japan. OBJECTIVE: To illuminate Japanese national standards of clinical care and provide a basis for efforts to optimize patient care, we used this database to construct a risk model for a common procedure in colorectal surgery-low anterior resection for lower rectal cancer. DESIGN: Data from the National Clinical Database on patients who underwent low anterior resection during 2011 were analyzed. Multiple logistic regression analyses were performed to generate predictive models of 30-day mortality and operative mortality. Receiver-operator characteristic curves were generated, and the concordance index was used to assess the model's discriminatory ability. RESULTS: During the study period, data from 16,695 patients who had undergone low anterior resection were collected. The mean age was 66.2 years and 64.5% were male; 1.1% required an emergency procedure. Raw 30-day mortality was 0.4% and operative mortality was 0.9%. The postoperative incidence of anastomotic leakage was 10.2%. The risk model showed the following variables to be independent risk factors for both 30-day and operative mortality: BMI greater than 30 kg/m, previous peripheral vascular disease, preoperative transfusions, and disseminated cancer. The concordance indices were 0.77 for operative mortality and 0.75 for 30-day mortality. LIMITATIONS: The National Clinical Database is newly established and data entry depends on each hospital. CONCLUSIONS: This is the first report of risk stratification on low anterior resection, as representative of rectal surgery, with the use of the large-scale national surgical database that we have recently established in Japan. The resulting risk models for 30-day and operative mortality from rectal surgery may provide important insights into the delivery of health care for patients undergoing GI surgery worldwide.

[Submucosal bacterial abscesses of the ascending colon and liver associated with portal and superior mesenteric vein thrombosis due to Enterococcus faecalis infection: a case report].

A 72-year-old woman with diabetes mellitus was admitted with fever and general fatigue. Blood biochemistry showed elevated hepatic and biliary enzyme levels, abdominal computed tomography showed multiple liver abscesses with portal and superior mesenteric vein thrombosis, and total colonoscopy revealed a submucosal bacterial abscess in the ascending colon. The abscesses were determined to be associated with Enterococcus faecalis infection. The patient was treated conservatively with antibiotics (meropenem) and anticoagulants (warfarin), which led to a gradual amelioration of symptoms and resolution of thrombosis.

Nationwide survey and establishment of a clinical database for gastrointestinal surgery in Japan: Targeting integration of a cancer registration system and improving the outcome of cancer treatment.

As there was no nationwide database for gastrointestinal surgery in Japan at the time, in 2006, a Clinical Database Committee was established in the Japanese Society of Gastrointestinal Surgery (JSGS) to create a clinical database in Japan. The Committee first organized preliminary nationwide Japanese surveys in gastrointestinal surgery in 2006 and 2007. Data from more than 770,000 patients were accumulated from these web-based surveys, including 333,627 patients in 1039 institutions in 2006 and 440,230 patients in 1464 institutions in 2007. The mortality rate was stratified by organ, surgical procedure and hospital volume without using risk-adjustment techniques. The overall mortality rate was 0.95% in the 2006 survey and 0.92% in the 2007 survey. The organ-based analysis found that the mortality rates were almost similar in 2006 and 2007. Hospital volume influenced the mortality rate in six major surgical procedures, namely esophagectomy, gastrectomy, total gastrectomy, low anterior rectal resection, hepatic resection and pancreaticoduodenectomy. A risk reduction of 30-80% was noted in each surgical procedure, at least in our non-risk-adjusted analysis, in hospitals with a high volume of operations. These preliminary surveys indicate that hospital volume might influence the mortality rate after major abdominal surgery. Further analysis using risk-adjustment techniques should be conducted to understand the specific contribution of hospital volume to surgical mortality. A nationwide database of patients who have undergone gastrointestinal surgery and risk-adjustment analysis of the data are currently planned in Japan.

Intraductal papillary growth of liver metastasis originating from colon carcinoma in the bile duct: report of a case.

Morphologically, liver metastases from colorectal carcinoma usually form as nodular tumor masses, whereas intraductal papillary growth in the bile duct is rare. A 65-year-old man underwent right hemicolectomy for advanced colon carcinoma, and histology of the primary carcinoma confirmed moderately differentiated adenocarcinoma with subserosal invasion, no vascular infiltration, and no lymph node metastasis. A liver tumor was found in the right paramedian Glisson pedicle and intraductal growth of cholangiocarcinoma was seen on imaging. We performed right hepatectomy and macroscopically, the resected specimen contained a growth in the bile duct lumen similar to cholangiocarcinoma. Histological examination revealed intraductal papillary proliferation of well-differentiated adenocarcinoma without vascular infiltration or lymph node metastasis in the hepatic hilum. Immunohistochemical staining revealed that the tumor cells were negative for cytokeratin-7 and positive for cytokeratin-20. Based on these findings, liver metastasis from colon carcinoma was diagnosed. Liver metastasis from colorectal carcinoma rarely arises as intraductal papillary growth in the bile duct, but the possibility of liver metastases with unusual morphology must be borne in mind for patients with a history of carcinoma in the digestive tract.

Risk factors preventing success of a minilaparotomy approach in the resection of colorectal cancer.

BACKGROUND: A minilaparotomy approach is technically feasible for the resection of colorectal cancer in select patients. The aim of this study was to clarify the risk factors preventing the success of a minilaparotomy in the resection of colorectal cancer. METHODS: Between April 2005 and August 2008, 141 consecutive patients were enrolled in this prospective study and scheduled to undergo resection of colorectal cancer using a minimal skin incision. The minilaparotomy involved a colorectal resection performed through a skin incision <7 cm in length. Neither a hand-port nor a laparoscope was used. RESULTS: A minilaparotomy was successful in 74 (52.5%) of 141 patients. Multivariate logistic regression analysis revealed that the failure of the minilaparotomy in the remaining 67 (47.5%) was independently related to gender (male), BMI (> or =25.5), tumor location (splenic flexure and rectum), tumor adhesion/invasion on/into adjacent organs and the maximum tumor diameter (> or =7.0 cm). CONCLUSION: Gender (male), BMI (> or =25.5), tumor location (splenic flexure and rectum) and tumor aggressiveness [tumor adhesion/invasion on/into adjacent organs and maximum tumor diameter (> or =7.0 cm)] were independent risk factors preventing the success of the minilaparotomy approach in the resection of colorectal cancer.

[A case of endocrine carcinoma of the sigmoid colon].

We report a case of endocrine carcinoma of the sigmoid colon. A 71-year-old man was admitted to our hospital because of constipation and bloody stool. Colonoscopy showed a mass lesion with irregular ulceration in the sigmoid colon. He was given a diagnosis of the poorly differentiated adenocarcinoma of the colon, and underwent sigmoidectomy with dissection of the lymph nodes. Histological and immunohistochemical examinations of the resected specimen revealed endocrine carcinoma. Endocrine carcinoma of the colon is rare, and the prognosis is very poor. We discuss this case with references.

Laparotomy wound and anastomotic recurrences after resection for cecum cancer: a case report.

We report herein the case of a 46-year-old man who developed recurrences in both the incisional laparotomy wound of the abdominal wall and the stapled anastomotic site following ileo-colonic resection for cecum cancer. The patient had initially undergone laparoscopic surgery but had converted to conventional open surgery. Intestinal reconstruction had been performed by stapled functional end-to-end anastomosis between the ileum and ascending colon. The implantation of exfoliated cancer cells during the operation may have caused recurrence.

Polymorphism in the thymidylate synthase promoter enhancer region is not an efficacious marker for tumor sensitivity to 5-fluorouracil-based oral adjuvant chemotherapy in colorectal cancer.

Thymidylate synthase (TS) is the target enzyme of 5-fluoropyrimidines. The TS gene promoter enhancer region (TSER) possesses tandem, repeated, regulatory sequences that are polymorphic in humans. This polymorphism has been reported to influence TS expression in vitro and in vivo. In this study, we assessed whether or not the TSER genotype is an efficacious marker for tumor sensitivity to 5-fluorouracil (5-FU)-based oral adjuvant chemotherapy for colorectal cancer. One hundred and thirty-five Japanese patients who received curative resection and 5-FU-based oral adjuvant chemotherapy were studied. TSER genotypes of the tumors were analyzed by PCR. The numbers of repeated sequences of representative bands were determined by direct sequence. The genotypes of two-/two-repeats (TSER 2/2), two-/three-repeats (TSER 2/3), three-/three-repeats (TSER 3/3), and three-/five-repeats (TSER 3/5) were found in 11 (8.1%), 32 (23.7%), 85 (63.0%), and 7 (5.2%) tumors, respectively. Patients were classified into two groups: TSER 2/2 or 2/3 group; and the TSER 3/3 group. The relationship between the TSER genotype group and disease-free intervals was analyzed by univariate and multivariate analyses. Five-year disease-free survivals of the TSER 2/2 or 2/3 group and the TSER 3/3 group were 77% and 75%, respectively (P = 0.89). Multivariate analysis revealed that stage was the only independent prognostic factor and that the TSER genotype did not have a prognostic significance (hazard ratio for TSER 3/3, 0.91; P = 0.84). In conclusion, TSER genotype is not an efficacious marker for tumor sensitivity to 5-FU-based oral adjuvant chemotherapy for Japanese colorectal cancer patients after curative resection.

Comparative analysis of postoperative morbidity according to type and extent of hepatectomy.

BACKGROUND/AIMS: The aim of our retrospective study was to compare the factors contributing to postoperative complications according to the extent of hepatectomy. METHODOLOGY: We examined 166 patients with hepatobiliary carcinoma who underwent hepatectomy. Patients were divided into three groups according to the type and extent of hepatectomy: 1) left lobectomy (n=27), 2) right lobectomy or posterior segmentectomy (n=55) and 3) other hepatectomies (n=84). Patient demographics, major complications (infection, ascites, pleural effusion, atelectasis, static symptoms of the stomach, biliary leakage and hepatic failure) after hepatectomy were analyzed. RESULTS: In patients with obstructive jaundice, lobectomy was the most commonly performed operation due to the extent of tumor along the main hepatic duct. Prolonged ascites or massive pleural effusion was frequently observed after right lobectomy (p=0.001) and posterior segmentectomy (p=0.002). However, the incidences of these complications were similar in patients with chronic viral hepatitis. Symptoms related to gastric stasis and biliary leakage were significantly more common after left lobectomy than other surgeries. The incidence of hepatic failure was higher (p<0.05) after major hepatectomy, particularly right lobectomy, than other surgeries. CONCLUSIONS: Our results emphasize the need to understand characteristics of specific complications occurring after different types of hepatic resection surgery to prevent post-hepatectomy complications.

Oncological outcome of ultra-low anterior resection with total mesorectal excision for carcinoma of the lower third of the rectum: Comparison of intrapelvic double-stapled anastomosis and transanal coloanal anastomosis.

BACKGROUND/AIMS: The purpose of this study was to determine whether the type of ultra-low anterior resection (intrapelvic double-stapled anastomosis or transanal hand-sewn coloanal anastomosis) with total mesorectal excision for primary adenocarcinoma of the lower third of the rectum affects survival and recurrence after curative surgery. METHODOLOGY: This retrospective study included 112 patients who underwent curative surgery achieved by ultra-low anterior resection in combination with either intrapelvic anastomosis using a double-stapling technique (DST group; n=82) or transanal hand-sewn coloanal anastomosis (CAA group; n=30). Univariate and corrected (multivariate regression) analyses were used to evaluate data. Median follow-up was 51.2 months for patients alive at the conclusion of this study. RESULTS: Disease-free and disease-specific survivals, and the frequency and location of recurrence after surgery did not differ between the two types of operations. Multivariate analyses showed that the type of operation was not a significant independent variable in predicting disease-free survival or in the development of both local and distant recurrences after surgery. Tumor-related factors (stage or histologic grade) were significant predictors of oncological outcome. CONCLUSIONS: The type of ultra-low anterior resection (DST or CAA) did not affect survival and recurrence after curative resection for carcinoma of the lower third of the rectum.

Increased expression of sialyl Lewis(x) antigen as a prognostic factor in patients with stage 0, I, and II gastric cancer.

Immunohistochemically detected expression of sialyl Lewis(x) (Le(x)) antigen was analyzed in 101 stage 0-II gastric cancers to clarify its prognostic value after curative gastrectomy. Patients with a high-expression of sialyl Le(x) antigen within their tumors had shorter disease-specific intervals than those with negative- or low-expressing tumors (P<0.0001). This difference was noted particularly in stage I-B or II disease. Multivariate Cox's regression analysis revealed sialyl Le(x) antigen expression to be an independent predictor of disease-specific survival (Hazard ratio=9.10). In conclusion, the increased expression of sialyl Le(x) antigen may serve as a prognostic factor after curative surgery for stages 0-II gastric cancer.

Tumor dihydropyrimidine dehydrogenase in stage II and III colorectal cancer: low level expression is a beneficial marker in oral-adjuvant chemotherapy, but is also a predictor for poor prognosis in patients treated with curative surgery alone.

The aim of this study was to evaluate the prognostic significance of tumor dihydropyrimidine dehydroganase (DPD) in curatively resected colorectal cancer patients who received or did not receive oral 5-FU based-adjuvant chemotherapy. Among 182 patients with stage II-III colorectal cancers, 89 patients (adjuvant chemotherapy group) received oral 5-FU based-adjuvant chemotherapy, and 93 patients (surgery alone group) did not receive 5-FU. DPD expressions in the tumors and in the normal colonic mucosa were measured by enzyme-linked immunosorbent assays. The mean DPD expression of the tumors was significantly lower than that of the normal mucosa (54.4 +/- 40.4 versus 72.3 +/- 23.3 Unit/mg protein, P < 0.01). For survival analyses, we designated the cut-off value of tumor DPD as its median value (46.3). In the adjuvant chemotherapy group, high tumor DPD levels were associated with poor survival (HR, 5.24; P = 0.03). In the surgery alone group, high tumor DPD levels were associated with better survival (HR, 0.32; P = 0.02). In conclusion, tumor DPD level is an efficacious marker in oral 5-FU based-adjuvant chemotherapy for colorectal cancer; however, low tumor DPD predicts reduced survival in patients treated with curative surgery alone.

Increased serum levels of interleukin-6 in malnourished patients with colorectal cancer.

Peri-operative serum levels of interleukin-6 (IL-6) were determined in 62 patients who underwent resection of colorectal cancer to clarify the relationship between nutritional status and IL-6 response. Patients were divided into two groups based on creatinine height index: malnourished group (n=13) and normally nourished group (n=49). The preoperative median serum level of IL-6 in the malnourished group was significantly higher than in the normally nourished group (P=0.041). The postoperative median serum level of IL-6 in the malnourished group also tended to be higher. In conclusion, the peri-operative IL-6 response may be activated in malnourished colorectal cancer patients.

Pre- and post-operative adjuvant chemotherapy in colorectal cancer.

A multi-center randomized controlled study was conducted in order to investigate the usefulness of pre- and post-operative adjuvant chemotherapy in colorectal cancer. The patients were stratified into those with colon cancer and those with rectal cancer and divided into 2 groups, Group A and Group B. The patients in Group A received tegafur suppositories (750 mg/day) from 1 to 2 weeks prior to surgery, to 2 weeks following surgery and then oral administration of tegafur and uracil (UFT) (260 mg/m(2)) for 1 year. The patients in Group B, on the other hand, received only UFT (260 mg/m(2)) for 1 year beginning week 2 after surgery. Although there was no significant difference between Groups A and B in the 5-year survival rate, the 5-year disease-free survival rate was significantly higher in Group A, especially for rectal cancer (p<0.05). In addition, remote metastases tended to be suppressed for both colon and rectal cancer in Group A (p=0.08 and p=0.072). There was no serious adverse reaction to tegafur. Pre- and post-operative adjuvant chemotherapy with tegafur had fewer adverse reactions and was convenient to administer. Thus, it was considered useful for suppression of postoperative distant metastasis in colorectal cancer.

Tumor dihydropyrimidine dehydrogenase expression is a useful marker in adjuvant therapy with oral fluoropyrimidines after curative resection of colorectal cancer.

PURPOSE: Dihydropyrimidine dehydrogenase (DPD) is the rate-limiting enzyme of 5-fluoropyrimidine (5-FU) catabolism. We examined whether tumor DPD expression is an effective marker in adjuvant therapy with oral fluoropyrimidines after curative resection of colorectal cancer. METHODS: We studied 89 patients with stage II-III colorectal cancers who had undergone curative resections and received oral 5-FU-based adjuvant chemotherapy. The levels of DPD expression in tumor and normal colonic mucosa were measured by an enzyme-linked immunosorbent assay. In 53 tumor samples, DPD enzymatic activity was also analyzed in order to evaluate the relationship between DPD expression and enzymatic activity. RESULTS: DPD expression significantly correlated with DPD enzymatic activity in these 53 tumors ( r=0.56; P<0.001). DPD expression in the tumors was significantly lower than in normal mucosa (47.1+/-30.8 and 56.4+/-18.5 U/mg protein, respectively; P<0.05). We designated the cut-off value of tumor DPD as its median value (46.0 U/mg protein). Patients with low DPD expression had longer disease-free intervals than those with high DPD expression according to univariate analysis ( P=0.026). In a multivariate analysis, low DPD expression was significantly and independently associated with better survival. CONCLUSIONS: Tumor DPD expression is a useful marker for use with adjuvant chemotherapy with oral fluoropyrimidines after curative resection of colorectal cancer.