Need for Improvements in Medical Device Management in Low- and Middle-Income Countries: Applying Learnings from Japan's Experience.

Medical devices provide important infrastructural support in modern healthcare systems. However, in low- and middle-income countries (LMICs), inadequate maintenance and management of devices due to a shortage of healthcare personnel (not only doctors and nurses but also other professionals including biomedical engineers [BMEs]) has resulted in inefficient and weak healthcare systems. High-income countries, including Japan, have resolved these problems by developing human resources and technologies to maintain and manage these systems. In this paper, we discuss the possibility of mitigating these problems in LMICs through human resource development and technology, based on lessons from Japan's experience. The problem of medical device management in LMICs stems from the fact that there are few professionals, such as BMEs, in charge of the management of medical devices and that clinical engineering departments in charge of device management have not been established. Since the 1980s, Japan has introduced a licensing system for BMEs, establishing operational guidelines to clarify their responsibilities within hospitals and using technology to utilize data and reduce workloads. Nevertheless, workload problems and high costs required to introduce computerized management systems persist. Moreover, it would be difficult to implement the same measures as those adopted in Japan in LMICs where there is an overwhelming shortage of medical personnel. It may be necessary to further reduce workloads for data entry and device management; use up-to-date, inexpensive, and user-friendly technology; and train non-BME personnel to operate and maintain equipment.

[A Case of Remnant Gastric Necrosis after Laparoscopy-Assisted Distal Gastrectomy].

A 77-year-old man with a medical history of hypertension, dyslipidemia, angina pectoris, and internal carotid artery stenosis underwent laparoscopy-assisted distal gastrectomy, D2 lymphadenectomy, and Billroth Ⅰ reconstruction for advanced gastric cancer. Hematologic examination revealed severe anemia on postoperative day 2, and abdominal CT scan detected contrast media leakage into the remnant gastric lumen. Upper gastrointestinal endoscopy revealed mucosal necrosis and ulceration of a large range. The patient recovered with conservative treatment and was discharged on postoperative day 18. Endoscopic balloon dilation was required to improve anastomotic stenosis after discharge, after which the patient received adjuvant chemotherapy. The stomach is resistant to ischemic changes because of the microvascular networks in the stomach wall; thus, gastric remnant necrosis after gastrectomy is rare. However, for patients with arterial sclerosis, such as in this case, physicians must consider the range of gastrectomy and reconstruction methods.

[A Case of Laparoscopy-Assisted Surgery for Intestinal Malignant Lymphoma with Bowel Obstruction].

An 83-year-old woman visited our emergency department with a chief complaint of abdominal pain and vomiting. Abdominal computed tomography showed thickening of the wall of the small intestine in the right middle abdomen and marked bowel dilation and fluid retention in the oral side of the small intestine. The patient was diagnosed with adhesive bowel obstruction and hospitalized for conservative treatment. However, the treatment was unsuccessful, and laparoscopic surgery was performed. The intraoperative findings included thickening of the wall and hardening of the obstructed part, suggestive of an intestinal tumor; thus, this part was resected. A histopathological examination revealed diffuse infiltration of large-sized atypical lymphocytes in the tumor, and diffuse large B-cell lymphoma was diagnosed through immunochemical staining. The postoperative course was uneventful, and the lymphoma has not recurred. Intestinal malignant lymphoma rarely causes bowel obstruction without invagination. Here, we report this case and review the literature.

Rectal Cancer Surgery in Patients Older Than 80 Years: Is Hartmann's Procedure Safe?

BACKGROUND/AIM: The current study aimed to identify the safety and efficacy of Hartmann's procedure (HP) among elderly patients (age ≥80 years) with rectal cancer. PATIENTS AND METHODS: Data on surgical outcome, survival rate, and incidence of stoma reversal were retrospectively compared between patients aged over 80 years who underwent anterior resection (AR) and HP. RESULTS: In total, 79 elderly patients underwent rectal cancer surgery. Of these patients, 54 (68.4%) underwent AR and 25 (31.6%) HP. The two groups did not differ significantly in terms of age, nutrient status, and tumor characteristics. Eight (14.8%) patients who underwent AR and six (24.0%) who underwent HP presented with intra-abdominal complications (p=0.35). The overall survival and recurrent-free survival rates between the two groups did not differ. CONCLUSION: HP for elderly patients with rectal cancer has similar complication rates to AR, and achieved similar oncological outcomes.

[A Case of Neuroendocrine Tumor G1 of the Ileum with Multiple Liver Metastases].

A 74-year-old man was admitted to our hospital with multiple liver tumors detected by routine ultrasonography. Colonoscopy showed a type 2 tumor measuring approximately 25mm in diameter at the terminal ileum. The biopsy specimen showed neuroendocrine tumor(NET)G1. The patient was diagnosed with NET G1 of the ileum with multiple liver metastases. Thus, he underwent ileocecal resection with lymph node dissection and liver(S2)biopsy. A tumor was observed at the terminal ileum with serosal invasion, and the mesenteric lymph nodes were enlarged. Multiple liver metastatic tumors were observed in S2, S5, and S8. The patient was diagnosed with NET G1 of the ileum, T4N1M1, Stage Ⅳ. He is receiving octreotide therapy and has maintained stable disease for about 24 months.

A prospective randomized controlled trial of subcutaneous passive drainage for the prevention of superficial surgical site infections in open and laparoscopic colorectal surgery.

INTRODUCTION: A number of studies have evaluated the effects of subcutaneous drainage during digestive surgery. All of the previous studies assessed the usefulness of active-suctioning drain, including two randomized controlled studies which found no benefit for the placement of active-suctioning drains in digestive surgery. The utility of passive drainage has not been evaluated previously. The purpose of this study was to evaluate the efficacy of subcutaneous passive drainage system for preventing surgical site infections during major colorectal surgery. PATIENTS AND METHODS: A total of 263 patients who underwent major colorectal surgery were enrolled in this study. Patients were randomly assigned to receive subcutaneous passive drainage or no drainage. The primary outcome measured was the incidence of superficial surgical site infections. The secondary outcomes measured were the development of hematomas, seromas, and wound dehiscence. RESULTS: Finally, a total of 246 patients (124 underwent passive drainage, and 122 underwent no drainage) were included in the analysis after randomization. There was a significant difference in the incidence of superficial surgical site infections between patients assigned to the passive drainage and no drainage groups (3.2 % vs 9.8 %, respectively, P = 0.041). There were no cases that developed a hematoma, seroma, or wound dehiscence in either group. A subgroup analysis revealed that male gender, age ≥75 years, diabetes mellitus, American Society of Anesthesiologists (ASA) status ≥2, blood loss ≥100 ml, and open access were factors that were associated with a beneficial effect of subcutaneous passive drainage. CONCLUSIONS: Subcutaneous passive drainage provides benefits over no drainage in patients undergoing major colorectal surgery.

Clinical significance of STC1 gene expression in patients with colorectal cancer.

BACKGROUND: Recent studies suggest that altered patterns of stanniocalcin 1 (STC1) gene expression have a role in human carcinogenesis. This study examined the relationship between the relative expression of the STC1 gene and clinicopathological factors in patients with colorectal cancer. PATIENTS AND METHODS: Surgical specimens of cancer tissue and adjacent normal mucosa were obtained from 202 patients with colorectal carcinomas. The relative expression levels of STC1 mRNA in the cancer and the normal adjacent mucosa were measured by quantitative real-time, reverse-transcriptase polymerase chain reaction. RESULTS: The relative expression levels of the STC1 gene were higher in the cancer tissue than in the normal adjacent mucosa and high expression of STC1 correlated with poor postoperative survival. CONCLUSION: High expression of the STC1 gene might be a useful predictor of poor postoperative outcome in patients with colorectal cancer.

Massive portal vein tumor thrombus from colorectal cancer without any metastatic nodules in the liver parenchyma.

Metastatic lesions in the liver derived from colorectal cancer rarely invade the portal vein macroscopically. Portal vein tumor thrombus is commonly associated with hepatocellular carcinoma. Colorectal liver metastases are usually accompanied by microscopic tumor invasion into the intrahepatic portal vein, and the incidence of macroscopic tumor thrombus in the trunk of the portal vein is rare. Here, we provide unique appearance of metastatic colorectal cancer. To the best of our knowledge, macroscopically, the right portal vein filled with the tumor thrombus without any tumor in liver parenchyma has been quite rare.

Overexpression of tissue inhibitor of metalloproteinase-1 gene correlates with poor outcomes in colorectal cancer.

Tissue inhibitor of metalloproteinase-1 (TIMP-1) is a major endogenous regulator of matrix metalloproteinases. This study examined the relation between TIMP-1 gene expression and postoperative mortality in patients with colorectal cancer (CRC). Specimens of CRC were obtained from 202 patients. The relative expression levels of TIMP-1 mRNA in cancer and in normal adjacent mucosa were measured by quantitative real-time reverse-transcriptase polymerase chain reaction. The expression level of the TIMP-1 gene was categorized as low or high according to the median value. The TIMP-1 level did not correlate with any clinicopathological feature. On Kaplan-Meier analysis, the 5-year overall survival rate was significantly lower in patients with high TIMP-1 (62.6%) than in those with low TIMP-1 (80.6%; p=0.0113). High TIMP-1 mRNA expression was associated with significantly poorer overall survival on univariate Cox regression analysis (p=0.013) and multivariate analysis (p=0.019). [corrected]. Overexpression of TIMP-1 thus correlated with poor outcomes in patients with CRC. Our results suggest that the TIMP-1 gene expression level might be a useful, independent prognostic factor in CRC.

Relation of MT1-MMP gene expression to outcomes in colorectal cancer.

BACKGROUND: Matrix metalloproteinases are members of a large family of endopeptidases that participate in the extracellular-matrix degradation that accompanies cancer cell invasion, metastasis and angiogenesis. The membrane-type 1 matrix metalloproteinase (MT1-MMP) gene has been reported in various cancers and is associated with tumor invasion and metastasis. This study examined the relation of the relative expression of MT1-MMP gene to clinicopathological factors and outcomes in patients with colorectal cancer (CRC). METHODS: We studied surgical specimens of cancer tissue and adjacent normal mucosa obtained from 202 patients with untreated CRC. The relative expression levels of MT1-MMP mRNA in cancer and in normal adjacent mucosa were measured by quantitative real-time reverse-transcriptase polymerase chain reaction. RESULTS: MT1-MMP gene expression was higher in cancer tissue than in adjacent normal mucosa. The level of MT1-MMP gene expression was not related to any clinicopathological factor. Overall survival at 5 years differed significantly between patients with high MT1-MMP gene expression and those with low expression. CONCLUSIONS: Overexpression of the MT1-MMP gene is considered a useful independent predictor of outcomes in patients with CRC.

Overexpression of MMP-13 gene in colorectal cancer with liver metastasis.

Matrix metalloproteinase-7 (MMP-7), MMP-9, MMP-13, and tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) are considered to have important roles in the invasiveness and outcomes of colorectal cancer (CRC). This study examined the clinicopathological significance of the relative expression of these genes in patients with colorectal cancer, especially as related to liver metastasis. The study analysed surgical specimens of cancer tissue and adjacent normal mucosa obtained from 202 patients with untreated colorectal cancer. MMP-7, MMP-9, MMP-13, TIMP-1, and beta-actin mRNA of cancer tissue and adjacent normal mucosa were measured by quantitative real-time, reverse-transcriptase polymerase chain reaction. Expression levels of MMP-7, MMP-9, MMP-13 and TIMP-1 were higher in cancer tissue than in adjacent normal mucosa. On analysis of the relations between gene expression and clinicopathological factors, MMP-13 expression was found to correlate with liver metastasis. Moreover, MMP-13 expression levels were higher in tumour tissue with liver metastasis than in that without liver metastasis. It is concluded that MMP-13 gene expression is a useful predictor of liver metastasis in patients with CRC.

Risk factors for intrahepatic recurrence after curative surgical treatment of colorectal liver metastases.

BACKGROUND/AIM: Hepatic resection has been regarded as the only curative treatment for colorectal liver metastases. After a first hepatectomy, 30% to 70% of patients develop intrahepatic recurrence. In this study, we retrospectively analyzed risk factors for intrahepatic recurrence. METHODS: From April 1990 to December 2006, 86 patients with colorectal liver metastases underwent curative hepatic resection at Kanagawa Cancer Center. Clinicopathological characteristics of 35 patients in the intrahepatic recurrence group were compared with those of 30 patients in the no recurrence group. RESULTS: The 5-year survival rate was 18.7% for patients in the intrahepatic recurrence group. Lymph node metastases of primary colorectal cancer and synchronous liver metastases were found to be independently associated with intrahepatic recurrence. CONCLUSION: We suggest that neoadjuvant chemotherapy before hepatectomy should be considered as feasible treatment for reducing intrahepatic recurrence in two cases; One case is resectable synchronous liver metastases from colorectal cancer, and the other is resectable metachronous liver metastases with primary regional lymph node metastases from colorectal cancer.

[Multiple hepatic metastases and ovarian metastases of colon cancer responding to combined therapy with S-1 and CPT-11--a case report].

We report a patient with multiple hepatic metastases and ovarian metastases of transverse colon cancer treated by combination of S-1 and CPT-11. The patient was a 51-year-old woman with cancer of the transverse colon and multiple hepatic metastases. She had undergone surgery. Resection of the transverse colon and left ovary was performed because left ovarian metastases were found during the operation. After the operation, the patient was given chemotherapy with S-1 (120 mg/body on days 1-14) and CPT-11 (150 mg/body on day 1). After completion of 11 courses of chemotherapy, abdominal CT scans revealed that the LDAs of the liver had disappeared, so the patient was judged to have achieved CR. No adverse event was observed. This case suggests that the combination of S-1 and CPT-11 may be an effective regimen for advanced colon cancer with multiple hepatic metastases.

The validity of sentinel lymph node biopsy using dye technique alone in patients with gastric cancer.

BACKGROUND/AIMS: We investigated whether sentinel lymph node biopsy using dye technique alone is useful or not in decision-making for less invasive surgery in patients with gastric cancer. METHODOLOGY: The subjects were 43 patients who had undergone laparotomy for gastric cancer and consented to undergo sentinel lymph node biopsy using patent blue dye. The patients enrolled were 26 males and 17 females, with a mean age of 62.5 years. The tumor sites were upper third of the stomach in 14, middle third in 16, and lower third in 13 patients. The depth of invasion was mucosa in eight, submucosa in 19, muscularis propria in five, subserosa in five, and serosa in six patients. Total gastrectomy was performed in 12, subtotal gastrectomy in 28, and proximal gastrectomy in three patients. RESULTS: The mean number of sentinel lymph node biopsies per surgery was 3.5 +/- 4.1. We were able to perform blue node biopsy in 40 out of 43 patients, but could not find any blue nodes in three patients. Among the 40 patients in whom blue nodes were identified, 29 patients with no metastasis in blue nodes had no evidence of lymph node metastasis (NO). The depth of invasion was not deeper than subserosa in all these patients. Metastasis was observed in one out of the three patients in whom no blue nodes were found. CONCLUSIONS: When the depth of invasion was not deeper than the subserosa and blue nodes were identified, no metastases in either non-blue nodes or blue nodes could be found in the absence of metastatic blue nodes. Therefore, if the depth of invasion is not deeper than the subserosa in gastric cancer, metastatic search in blue nodes seems sufficient and less invasive surgery can be performed safely. Even when the invasion depth is not deeper than the submucosa, the tumor could be metastatic to Group 2 lymph nodes in patients in whom blue node biopsy revealed metastases. When metastasis is found in lymph nodes by intraoperative frozen section diagnosis, less invasive surgery for gastric cancer is not indicated.

13C-urea breath test in patients having undergone total gastrectomy.

BACKGROUND/AIMS: In this study, we performed 13C-urea breath test in patients who had undergone total gastrectomy and investigated the content of (13)CO2 in the CO2 gas expired after direct influx of 13C-urea into the small intestine. METHODOLOGY: 13C-Urea breath test was performed in 31 patients who had undergone total gastrectomy at this department for the treatment of stomach cancer and consented to participate in this study. The test was performed in two ways, i.e. with and without mouth washing (gargling) on taking 13C-urea. RESULTS: Among 41 measurements, the delta13C was less than 2.5% per hundred in 9 measurements (22.2%) and less than 2.0% per hundred in 6 measurements (14.6%). The delta13C exceeded 50% per hundred, in 4 subjects (9.8%). There were no differences between the methods with and without gargling. CONCLUSIONS: The results of this study suggested the possibility that 13C-urea is decomposed even in the jejunum or the lower part of intestine resulting in absorption of H(13)CO3 and another possibility that 13C-urea is directly absorbed from the intestine and decomposed in the blood.

Bone disorder and vitamin D after gastric cancer surgery.

BACKGROUND/AIMS: The present study was conducted to investigate the relationship between bone metabolic disorder after gastrectomy for gastric cancer and vitamin D metabolites or the hormones involved in calcium metabolism. METHODOLOGY: Twenty-one patients who had undergone gastrectomy for gastric cancer and had been followed for less than 10 years were assessed for bone disorder by microdensitometry. The levels of 1,25-dihydroxy vitamin D (1,25(OH)2VD), 25-hydroxy vitamin D (25(OH)VD), 24,25-dihydroxy vitamin D (24,25(OH)2VD), N-PTH, calcitonin, estradiol, osteocalcin, and ALP were measured and assessed for correlations with clinicopathological factors, including the operative procedure and the number of years since surgery. RESULTS: Bone disorder was found in 9 out of 21 patients (42.9%). The prevalence was significantly higher in patients who had undergone surgery more than 2 years before assessment, so there was a relationship between the period after surgery and bone disorder. Among the vitamin D metabolites, the level of 1,25(OH)2VD was normal in all patients, whereas 25(OH)VD was reduced in 6 out of 21 patients (28.6%) and 24,25(OH)2VD was reduced in 17 patients (81.0%). The 1,25(OH)2VD was significantly higher in the patients with Grade I to III bone disorder compared to the patients with normal bones or early bone disease. The 1,25(OH)2VD/25(OH)VD ratio was significantly higher in the patients without passage of food through the duodenum due to the reconstructive method, while the 25(OH)VD/24,25(OH)2VD ratio was significantly higher in the patients with remaining of duodenal food passage. PTH was decreased in about 50% of the patients, while calcitonin was normal in all patients. Estradiol was decreased in one female patient, while it was elevated in 10 of the 17 men (58.8%). The osteocalcin level was high in all patients irrespective of the period after surgery. CONCLUSIONS: After gastrectomy, the incidence of bone metabolic disorder increases with time. Changes of vitamin D metabolites, particularly 25(OH)VD and 24,25(OH)2VD, seem to be closely associated with post-gastrectomy bone disease.

Laparoscopy-assisted distal gastrectomy with 3-cm laparotomy, left hepatic lobe compression technique, and selection of automatic anastomosis device.

In this study, we performed laparoscopy-assisted distal gastrectomy (LADG) and lymph node dissection with an incision of 3 cm aiming at radical cure and low invasiveness. We introduce and discuss this technique of minilaparotomy and recommend a device for anastomosis. In LADG, a skin incision of 5cm or greater is made in order to pull out the stomach in other institutes. Whether function is distinctly better after laparoscopy-assisted surgery than after abdominal section has not been elucidated so far, so we should seek an aesthetic advantage. We have used a 3-cm abdominal wound to date. If the wound is smaller than this, the body of the SDH25 cannot be inserted, and currently a wound less than 3cm may thus not be possible. The shaft of the SDH is straight, making it easy to confirm the direction even through a laparoscope. The shaft of the anvil head of the PPCEEA is too long, so that when it is connected with the body through the 3-cm incision, it is necessary to draw it through the remnant stomach to a great extent.