[Show abstract][Hide abstract] ABSTRACT: We conducted a phase I study to determine the maximum tolerated dose and recommended dose (RD) of this gemcitabine plus cisplatin (GC) combination in the adjuvant setting for biliary tract cancer (BTC). GC has become a standard chemotherapy regimen for patients with locally advanced or metastatic BTC; however, the benefit of adjuvant therapy for BTC is unclear.
Patients with BTC were eligible if they met the following criteria: Stage IB or higher; and undergoing resection without major hepatectomy. The starting dose matched the standard dose of gemcitabine (1,000 mg/m(2)) and cisplatin (25 mg/m(2)) on days 1 and 8, every 3 weeks for up to 24 weeks. The dose limiting toxicities (DLTs) were determined during the first 6 weeks, and a 3+3 dose finding design with cohorts of 3-6 patients was used. Further cohort expansion took place.
One DLT, namely grade 4 neutropenia, was observed among six patients at the starting dosages. Then, we expanded the cohort with a total of eighteen patients to evaluate RD and no further DLTs were observed. During the entire study, the most common grade 3/4 adverse events were neutropenia (94 %) and leucopenia (56 %). Non-hematological toxicities were manageable.
We defined the standard dose of GC as the RD for adjuvant chemotherapy for BTC treated by curative resection without major hepatectomy. Further study is warranted to clarify the safety and efficacy of this regimen for all patients.
Cancer Chemotherapy and Pharmacology 03/2014; · 2.80 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We report a rare case of laparoscopic resection of lesions caused by extrahepatic seeding of hepatocellular carcinoma following percutaneous radiofrequency ablation (RFA). A 52-year-old man had undergone RFA for the treatment of hepatocellular carcinoma in April 2012. After 5 months, his serum tumor marker levels increased remarkably, and computed tomography (CT) revealed a 5 cm tumor and a small 1 cm nodule on the side of the spleen. He also had intrahepatic recurrence, but those lesions seemed to be controlled by transarterial embolization. Therefore, we performed laparoscopic resection of the extrahepatic lesion in November 2012. Histopathological examination revealed a moderately differentiated hepatocellular carcinoma. Two months later, the patient's serum tumor marker levels had decreased dramatically. The remaining intrahepatic recurrence has been stable, and we have not detected any other extrahepatic recurrence thus far. Our case supports the utility of surgical resection for the treatment of extrahepatic seeding of hepatocellular carcinoma.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2013; 40(12):1825-7.
[Show abstract][Hide abstract] ABSTRACT: A 70-year-old man presented with dysphagia to another institution and was referred to our hospital. We diagnosed the patient with primary neuroendocrine cell carcinoma and squamous cell carcinoma of the esophagus. Following 2 courses of CDDP+5-FU+ADM combination neoadjuvant chemotherapy, the primary tumor had reduced in size. Thereafter, we performed subtotal esophagectomy by right thoracotomy, retrosternal gastric tube reconstruction, and 2-field lymph node dissection. Computed tomography scan 3 months after the surgery revealed lung metastasis. He received CPT-11+CDDP chemotherapy, and the disease was diagnosed as cCR. At present, he is alive without any evidence of recurrence 12 months after the surgery.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2013; 40(12):2121-3.
[Show abstract][Hide abstract] ABSTRACT: Staples have been widely used for skin closure after open gastrointestinal surgery. The potential advantages of subcuticular sutures compared with staples have not been assessed. We assessed the differences in the frequency of wound complications, including superficial incisional surgical site infection and hypertrophic scar formation, depending on whether subcuticular sutures or staples are used.
We did a multicentre, open-label, randomised controlled trial at 24 institutions between June 1, 2009, and Feb 28, 2012. Eligible patients aged 20 years or older, with adequate organ function and undergoing elective open upper or lower gastrointestinal surgery, were randomly assigned preoperatively to either staples or subcuticular sutures for skin closure. Randomisation was done via a computer-generated permuted-block sequence, and was stratified by institution, sex, and type of surgery (ie, upper or lower gastrointestinal surgery). Our primary endpoint was the incidence of wound complications within 30 days of surgery. Analysis was done by intention to treat. This study is registered with UMINCTR, UMIN000002480.
1080 patients were enrolled and randomly assigned in a one to one ratio: 562 to subcuticular sutures and 518 to staples. 1072 were eligible for the primary endpoint and 1058 for the secondary endpoint. Of the 558 patients who received subcuticular sutures, 382 underwent upper gastrointestinal surgery and 176 underwent lower gastrointestinal surgery. Wound complications occurred in 47 of 558 patients (8·4%, 95% CI 6·3-11·0). Of the 514 who received staples, 413 underwent upper gastrointestinal surgery and 101 underwent lower gastrointestinal surgery. Wound complications occurred in 59 of 514 (11·5%, 95% CI 8·9-14·6). Overall, the rate of wound complications did not differ significantly between the subcuticular sutures and staples groups (odds ratio 0·709, 95% CI 0·474-1·062; p=0·12).
The efficacy of subcuticular sutures was not validated as an improvement over a standard procedure for skin closure to reduce the incidence of wound complications after open gastrointestinal surgery.
Johnson & Johnson.
The Lancet 09/2013; 382(9898):1105-12. · 39.06 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Few studies have reported the efficacy and safety of palliative chemotherapy in elderly patients with advanced biliary tract cancer. We aimed to investigate the clinical outcomes of palliative chemotherapy for advanced biliary tract cancer in elderly patients.
We retrospectively evaluated 403 consecutive patients who received palliative chemotherapy between April 2006 and March 2009 for pathologically confirmed unresectable or recurrent biliary tract cancer. Clinical outcomes of the elderly group (≥75 years old; n = 94) were compared with those of the non-elderly group (<75 years old; n = 309).
Except for the extent of disease, patient baseline characteristics were well-balanced between both groups. The median overall survival was 10.4 months in the elderly group and 11.5 months in the non-elderly group (hazard ratio, 1.14; 95% confidence interval, 0.89-1.45; P = 0.31). Although the frequency of adverse events between both groups was similar, interstitial pneumonitis was significantly more frequent in the elderly group than in the non-elderly group (4.3% vs. 0%, P < 0.01).
In advanced biliary tract cancer, overall survival of elderly patients receiving palliative chemotherapy is comparable to that of non-elderly patients. To our knowledge, this is one of the largest studies which have reported the clinical outcomes of elderly patients following palliative chemotherapy.
Journal of Gastroenterology and Hepatology 07/2013; · 3.33 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Prognostic factors for patients with advanced biliary tract cancer (BTC) who received palliative chemotherapy have not been fully established. Especially, the status of unresectable/recurrent disease has not been well studied because of a small number of patients with recurrent BTC in previous studies.
tj;4This multicenter retrospective study was conducted in 18 institutions in Japan. We retrospectively reviewed data regarding 403 patients with pathologically proven BTC who received palliative chemotherapy between April 2006 and March 2009. One hundred and ninety-two patients with recurrent BTC were included. Univariate and multivariate analyses were performed to identify prognostic factors.
The median overall survival was significantly longer in the recurrent BTC patients than in the unresectable BTC patients (398 days vs. 323 days, P = 0.004). After adjustment using multivariate analysis, the status of recurrent/unresectable disease remained an independent prognostic factor (hazard ratio 1.33, 95% confidence interval 1.04-1.70, P = 0.022) in addition to performance status, extent of disease, carbohydrate antigen 19-9 levels, and carcinoembryonic antigen levels.
The status of unresectable/recurrent disease was shown as an independent prognostic factor in the BTC patients. This result may help to predict life expectancy of BTC patients and design future clinical trials evaluating palliative chemotherapy in BTC.
Journal of hepato-biliary-pancreatic sciences. 06/2013;
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Surgical site infection (SSI) surveillance in Japan is based on the National Nosocomial Infection Surveillance system, which categorizes all hepato-biliary-pancreatic surgeries, except for cholecystectomy, into "BILI." We evaluated differences among BILI procedures to determine the optimal subdivision for SSI surveillance. METHODS: We conducted multicenter SSI surveillance at 20 hospitals. BILI was subdivided into choledochectomy, pancreatoduodenectomy, hepatectomy, hepatectomy with biliary reconstruction, pancreatoduodenectomy with hepatectomy, distal pancreatectomy and total pancreatectomy to determine the optimal subdivision. The outcome of interest was SSI. Univariate and multivariate analyses were performed to determine the predictive significance of variables in each type of surgery. RESULTS: 1,926 BILI cases were included in this study. SSI rates were 23.2 % for all BILI; for choledochectomy 23.6 %, pancreatoduodenectomy 39.3 %, hepatectomy 12.8 %, hepatectomy with biliary reconstruction 41.9 %, pancreatoduodenectomy with hepatectomy 27.3 %, distal pancreatectomy 31.8 %, and total pancreatectomy 20.0 %. SSI rates for hepatectomy were significantly lower than those for non-hepatectomy BILI. Risk factors for developing SSI with hepatectomy were drain placement and long operative duration, while for non-hepatectomy BILI, risk factors were use of intra-abdominal silk sutures, SSI risk index and long operative duration. CONCLUSIONS: Hepatectomy and non-hepatectomy BILI differ with regard to the incidence of and risk factors for developing SSI. These surgeries should be assessed separately when conducting SSI surveillance.
Journal of hepato-biliary-pancreatic sciences. 02/2013;
[Show abstract][Hide abstract] ABSTRACT: Background/Aims: Single incision laparoscopic cholecystectomy (SILC) has two serious problems; its feasibility and cost. We report our experience and benefits of our original SILC procedure using homemade trocars that can solve those problems. Methodology: SILC was attempted for thirty-four patients at our hospital. The SILSTM Port (Covidien, Inc) was used in 16 patients (SP group) and the original method using a surgical glove port with homemade trocars was performed in 18 patients (GP-HT group). A homemade trocar was made of a 2.5mL and a 5mL syringe. We performed the retrospective comparison of the operative and postoperative results between those two groups. Results: Thirty patients (14 in the SP group and 16 in the GP-HT group) successfully underwent SILC. No patient had a grade II or more severe postoperative complication based on the Clavien-Dindo classification. Our original homemade trocar was slim and compact enough to avoid clashes among surgical instruments and surgeon's hands. Operative time in the GP-HT group was significantly shorter than that in the SP group (p=0.0044). Conclusions: Although further prospective studies of larger series should be performed, this simple and cost-effective system can be one of the promising ways for SILC.
[Show abstract][Hide abstract] ABSTRACT: Background/Aims: Based on the criteria of International Study Group on Pancreatic Fistula (ISGPF), the risk factors for grade B/C pancreatic fistula (PF) after pancreaticoduodenectomy (PD) were analyzed in this study. Methodology: Between October 2006 and August 2010, 114 consecutive patients underwent PD at National Hospital Organization Osaka National Hospital. We compared the clinicopathological features between patients with grade B/C PF and those with PF-free/grade A PF. We also examined the relationship between PF formation and the drain amylase level on post-operative day (POD) 1 and POD 3. Results: Eighteen patients (15.8%) developed grade B/C PF. Of these patients, four patients underwent reoperation. The mortality rate in patients with grade B/C PF was 5.6% (1/18). The non-dilated pancreatic duct (<3mm) was the only independent risk factor for grade B/C PF by a multivariate analysis (p=0.026). There were 45 patients who showed low (< three times serum amylase level) drain amylase level on POD 1 and none of them developed PF. Conclusions: Although our study demonstrated that the non-dilated pancreatic duct is significantly correlated with the increased incidence of grade B/C PF, patients with low amylase level of drainage fluid on POD 1 are thought to be safe from developing PF.
[Show abstract][Hide abstract] ABSTRACT: The optimal treatment of liver metastases from gastric cancer (LMGC) remains uncertain. We retrospectively compared surgical treatment with chemotherapy alone and identified prognostic determinants.
We reviewed the records of 50 consecutive patients with LMGC: 25 patients with gastrectomy plus hepatic resection (group A), 13 patients with palliative gastrectomy (group B), and 12 patients with chemotherapy alone (group C). We compared the overall survival among these three groups, and assessed prognostic factors.
Median survival time in groups A, B, and C was 33.4, 10.5, and 8.7 months, respectively. Univariate analysis found T stage, number of liver metastases, and treatment group to be significant prognostic factors. In the multivariate analysis, T stage was shown to be an independent prognostic determinant, while gastrectomy plus hepatic resection was of marginal significance compared with chemotherapy alone.
T Stage was a significant prognostic determinant, and gastrectomy plus hepatic resection could be a promising treatment for patients with LMGC.
Anticancer research 02/2012; 32(2):665-70. · 1.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A 64-year-old man was diagnosed as gastric cancer (cT4N1M0, Stage IIIB). Left upper abdominal evisceration was performed in July 2008. CT scan revealed liver metastases in the segments 6 and 8 about 4-month after the surgery. Liver metastases increased during postoperative adjuvant chemotherapy. We treated the metastases with local therapy. He received radiotherapy (total of 60 Gy) for a liver metastasis in the segment 8 in November 2009. He received radiotherapy (total of 50 Gy) for a liver metastasis in the segment 6 in November 2010 after a total of 3-radiofrequency ablation (RFA) was performed. Partial response was obtained. We have experienced a successful case of liver metastases from gastric cancer treated with RFA and radiotherapy.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2011; 38(12):1957-9.
[Show abstract][Hide abstract] ABSTRACT: A 76-year-old woman consulted her local physician because she experienced anal pain during defecation. She was diagnosed with squamous cell anal carcinoma and underwent chemoradiation (59.4 Gy + UFT 500 mg/5 days/week). The examinations after chemoradiation revealed a complete remission of the tumor. She was followed up and 8 months later, she experienced anal erosion and pain. Local recurrence was observed, however, distant metastasis was not observed. Abdominoperineal resection (APR) was performed as salvage treatment, and she has been disease free for 10 months. Functional preservation employing concomitant chemoradiation has become the standard treatment for most case of squamous cell anal carcinoma, with APR backup being a salvage procedure. However, approximately 30% of the cases require a salvage operation because of primary non-response or recurrence. We predict that the incidence of such cases will increase in the future.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2010; 37(12):2659-61.
[Show abstract][Hide abstract] ABSTRACT: A 62-year-old man with internal piles tested positive for infection with HIV and was admitted to our hospital. He presented with an anal tumor with bilateral inguinal nodal metastasis and pain in the anus; the tumor was diagnosed as stage IIIb (cA1N2M0). The patient's immune system was unstable. Therefore, he was administered chemoradiotherapy [low dose 5-fluorouracil plus cisplatin (FP) and radiotherapy (RT)] following HAART. Chemoradiotherapy resulted in complete response. However, CT performed 2 years after the diagnosis showed a recurrence in the hilar and mediastinal lymph node. The patient was administered chemotherapy with 5-fluorouracil and cisplatin (5-FU/CDDP) to the metastatic lymph node. However, the treatment response was graded as progressive disease, and the treatment was changed from CDDP to mitomycin C (MMC). The patient developed non-hematologic toxicity and died within 3 years of the diagnosis. We report a case of squamous cell carcinoma of the anus with associated HIV infection.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2010; 37(12):2656-8.
[Show abstract][Hide abstract] ABSTRACT: In this study, we report four cases of re-resection of the liver as reduction surgery for a failure of transcatheter hepatic arterial embolization (TAE) for multiple intrahepatic recurrences after hepatic resection. In all of the 4 cases, a liver function was well preserved and portal vein thrombosis was not revealed in preoperative CT scan. Although bile leakage was observed in one case, no major complications were observed in other 3 cases and their hospital stay after surgery was within 13 days. To date, one year survival rate after re-resection is 100%, and a short-term prognosis is good. On the basis of the result, re-resection of the liver as reduction surgery could be considered as one of options of the locoregional treatment for a failure of TAE for multiple intrahepatic recurrences.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2010; 37(12):2673-5.
[Show abstract][Hide abstract] ABSTRACT: A 53-year-old man, who was diagnosed as having an anal canal cancer associated with anal fistula, was introduced to our hospital. By CT and MRI examination, fluid collections were detected in the perirectal space and fistula was connected to bladder. Total pelvic exenteration was performed under the consideration of keeping the margin for the large skin defect. We reconstructed the perianal skin defect using a VY advancement of bilateral gluteus maximus musculocutaneous flaps. After the surgery, no sign of recurrence has been observed in 1 year and 4 months. This constructive technique was effective for anal defects.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2010; 37(12):2650-2.
[Show abstract][Hide abstract] ABSTRACT: Postoperative antimicrobial therapy is generally administered as standard prophylaxis against postoperative infection, despite a lack of sufficient evidence for its usefulness. This study was a phase II study to evaluate the necessity of postoperative antibiotic prophylaxis in patients undergoing a colectomy.
Patients received 1 g cefmetazole or flomoxef immediately after anesthetic induction, every 3 h during surgery, and then later once again on the next day. They were randomly assigned to receive either cefmetazole or flomoxef.
Ninety-one patients were enrolled in the study. A surgical site infection (SSI) occurred in 7.7% (7/91) of patients. All cases were superficial incisional infections. When comparing the two drugs, SSI occurred in 8.3% (4/48) of patients treated with cefmetazole and in 7.0% (3/43) treated with flomoxef, showing no significant difference (P > 0.99).
Antimicrobial prophylaxis was well tolerated when used on the day of a colectomy and once again on the next day.
Surgery Today 10/2010; 40(10):954-7. · 0.96 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A large scale survey was conducted to examine risk factors for surgical site infections (SSIs) among Japanese patients undergoing gastrointestinal surgery. The purposes of the study were: (i) to investigate age as a risk factor for SSIs in gastrointestinal surgery; and (ii) to examine the differences in risk factors for SSIs between laparoscopic cholecystectomy and open cholecystectomy. Surveillance data were prospectively collected from 20 participating hospitals in Japan between July 2003 and November 2007. SSIs were identified by use of the Centers for Disease Control and Prevention criteria. SSIs were identified in 1471 of 12 015 available cases, with an overall incidence of 12.2%. In the final logistic regression model, age was a risk factor in open cholecystectomy, gastrectomy and appendicectomy. Length of operation was a risk factor for SSIs for six surgical procedures, and wound class and drain use were also risk factors in most procedures. When comparing laparoscopic surgery against open procedure, use of silk sutures was a risk factor for SSIs in laparoscopic cholecystectomy. Drain use, wound class, operation duration, male gender and age were additional risk factors for SSIs in open cholecystectomy. In summary, patient age is a significant predictor for SSIs in some gastrointestinal procedures, although risk factors for SSIs in laparoscopic procedures appear quite different from those in open procedures.
The Journal of hospital infection 07/2010; 75(3):183-7. · 3.01 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A 67-year-old man was admitted to our hospital because of fecal occult blood. Colonoscopy revealed a 7 mm rectal submucosal tumor, which was diagnosed as rectal carcinoid on biopsy. No metastasis was found on abdominal CT scan. We performed an endoscopic mucosal resection (EMR), but the vertical margin of the specimen was positive. We therefore performed a laparoscopic low anterior resection. There was no residue of carcinoid tumor in the resected specimen, but metastasis to a pararectal lymph node was found. In general, endoscopic treatment is performed for SM invasive rectal carcinoid less than 10 mm in diameter. However, several cases of lymph node metastasis with small carcinoid tumor have been reported. Therefore, the possibility of lymph node metastasis must be considered in patients with rectal carcinoid.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2009; 36(12):2251-3.
[Show abstract][Hide abstract] ABSTRACT: The aim of this study is to investigate the safety and efficacy of neoadjuvant chemotherapy for patients with hepatic colorectal cancer metastases who underwent hepatic resection. Surgical complications and survival rates of the patients with/without neoadjuvant chemotherapy were analyzed. Neoadjuvant chemotherapy was not associated with sever surgical complications after hepatic resection. Postoperative survival rate of the patients with neoadjuvant chemotherapy was not superior to that of patients without neoadjuvant chemotherapy. Neoadjuvant chemotherapy for patients with hepatic colorectal cancer metastases who underwent hepatic resection is safe, but further studies are required to clarify its efficacy.
Gan to kagaku ryoho. Cancer & chemotherapy 11/2009; 36(12):2022-4.