Clinical Effects of a Pectin-Containing Oligomeric Formula in Tube Feeding Patients: A Multicenter Randomized Clinical Trial.

BACKGROUND: A pectin-containing oligomeric formula (POF) is a unique type of enteral formula that transforms from a liquid to a gel after reacting with gastric acid. Reports on its clinical effects have been limited. The present study was conducted to examine and verify the clinical effects of POF. METHODS: The study subjects were 201 stable patients receiving intragastric tube feeding. They were randomized into 2 groups to receive either POF or a standard polymeric formula (SPF) as a control. The duration of observation was 1 week. Analyses were conducted for the incidence of predefined composite events, including diarrhea, defecation treatments, and other enteral nutrition (EN) management-related events. RESULTS: Composite events occurred in 15 of 98 patients in the POF group and 30 of 100 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.011). In particular, diarrhea occurred in 2 patients in the POF group and 13 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.003). CONCLUSIONS: The results of this study suggest that POF is less likely to cause EN-related events, especially diarrhea, than SPF is.

Feasibility of International Proposed Standardized Enteral Connector for Semi-Solid Formula Feeding.

BACKGROUND/AIMS: The current study was undertaken to assess if the semi-solid formulas could be used with a new ENFit connector with similar force to current percutaneous endoscopic gastrostomy (PEG) tubes. METHODS: Experiment 1: We measured the applied pressure (force) needed to compress the syringe containing 7 viscous semi-solid formulas with a 20 Fr PEG tube and low-profile tube through the ENFit connector or the current connector. Experiment 2: This experiment was conducted to evaluate the compression force through 2 connectors in 3 infusion velocity, 7 PEG tube types with 2 semi-solid formulas. RESULTS: Experiment 1: The force needed to compress the syringe through the ENFit connector was higher in 3 semi-solid formulas with a 20 Fr low-profile tube; otherwise, there were no significant differences. Experiment 2: Each formula required a higher force in the ENFit connector in 6 settings out of 21. CONCLUSIONS: The ENFit connector will likely not show any remarkable change in the force to administer the semi-solid formula. However, a higher force was required under some conditions in the prototype ENFit connector. Further investigation of sensory test is needed to confirm the feasibility of the ENFit connector for using the semi-solid formulas.

Efficacy of a New Post-Mouthwash Intervention (Wiping Plus Oral Nutritional Supplements) for Preventing Aspiration Pneumonia in Elderly People: A Multicenter, Randomized, Comparative Trial.

BACKGROUND/AIMS: Aspiration pneumonia is a common cause of death among the elderly (≥90-year-old) in nursing homes. Studies suggest that its incidence could be reduced by oral care interventions. We aimed to evaluate the efficacy of a new oral care intervention: wiping plus oral nutritional supplements (ONS). METHODS: This prospective observational study was conducted in 252 patients (age 88.0 ± 6.5 years) in 75 nursing homes, rehabilitation hospitals, and other care facilities. Patients were randomly divided into an intervention group (n = 74) and a control group (n = 107), whose members received conventional oral care. Body mass index, activities of daily living (Barthel index), and complete blood count and biochemistry parameters were measured at 2, 4, 6, and 8 months. RESULTS: The cumulative incidence of pneumonia at 8 months tended to be lower in the intervention than in the control group (7.8 vs. 17.7%, p = 0.056) and was significantly lower for men in the intervention group (p = 0.046). CONCLUSIONS: Our new intervention "wiping plus providing ONS" method appears to help prevent aspiration pneumonia, thereby reducing mortality risk. In this study, we disseminate information on how this method is used in Japan.

The effects of non-viable Lactobacillus on immune function in the elderly: a randomised, double-blind, placebo-controlled study.

Forty-two participants in two nursing homes who were ≥65 years of age were randomised to receive a jelly containing 10 billion heat-killed Lactobacillus paracasei MCC1849 cells (LP group) or a placebo jelly without lactobacilli (placebo group) for 6 weeks. Three weeks after beginning jelly intake, all subjects received an influenza vaccination (A/H1N1, A/H2N3 and B). Blood samples were collected before and after the treatment period. There were no significant differences in immune parameters, including in antibody responses against the vaccination, between the groups. In the subgroup of the oldest old, defined as ≥85 years of age (n = 27), the antibody responses to the A/H1N1 and B antigens, which were impaired in the placebo group, were improved in the LP group. No significant effects of non-viable L. paracasei MCC1849 were observed in the elderly. A possible beneficial effect in the oldest old should be explored in further large-scale studies.

[A case of cardiac tamponade due to pericarditis carcinomatosa of breast cancer successfully treated via pericardiocentesis and systemic chemo-endocrine therapy].

We report a case of lung and bone metastases of right advanced breast cancer in a 33-year-old woman. Her breast cancer (T4bN1M1, StageIV)was resected in December 2003 (mastectomy [BT] plus axillary lymph node dissection [AX]) after local arterial infusion therapy and subsequent systemic chemo-endocrine therapy was initiated and continued. In June 2007, a computed tomography (CT) scan revealed cardiac tamponade due to pericarditis carcinomatosa. Pericardiocentesis was performed, and the bloody effusion was drained immediately. Subsequently, the sysytemic chemo-endocrine therapy was modified. In 2009, multiple cerebellar metastases were discovered and treated via whole brain irradiation. In 2010, multiple liver metastases appeared, and they were treated by intravenous (IV) administration of nab-paclitaxel. In 2011, superior vena cava syndrome appeared gradually, and it was treated via venous metallic stenting. In 2012, epidural spinal cord compression appeared gradually, and it was treated via irradiation. In November 2012, the patient died because of lymphangitis carcinomatosa; her prognosis was good, as it was approximately 5 years after the pericardiocentesis.

[A case report of liver metastasis of breast cancer successfully treated by hepatic arterial infusion of docetaxel and systemic administration of nab-paclitaxel].

We report the case of an effectively treated 50-year-old woman with liver metastasis of left breast cancer. Her breast cancer (T2N0M0, Stage IIA) was resected in November 1998 (radical mastectomy+axillary lymph nodes dissection). After this operation, tamoxifen(TAM 20 mg daily) was administered. In February 2002, a solitary liver metastasis(S5, 4 cm in diameter) was found by computed tomography(CT) scan. Hepatic arterial infusion of docetaxel(DOC 20 mg weekly)was started. In March 2003, the solitary liver metastasis had become smaller and showed partial remission (PR), but DOC intravenous injection(iv) therapy(40 mg weekly) was started because lung metastases appeared. Therefore, epirubicin+ cyclophosphamide therapy, DOC ia therapy (120 mg triweekly), and anastrozole (1 mg daily) were continued. However, in March 2005, she refused chemotherapy. In January 2011, a CT scan showed progressive disease of multiple liver and lung metastases. Nab-paclitaxel(PTX) iv therapy(400 mg triweekly) and exemestane(25 mg daily) were administered. In March 2012, a CT scan showed PR of the metastatic breast cancer. She has continued to receive nab-PTX iv therapy as an outpatient.

The Effects of Percutaneous Endoscopic Gastrostomy on Quality of Life in Patients With Dementia.

BACKGROUND: To examine the effects of percutaneous endoscopic gastrostomy (PEG) on quality of life (QOL) in patients with dementia. METHODS: We retrospectively included 53 Japanese community and tertiary hospitals to investigate the relationship between the newly developed PEG and consecutive dementia patients with swallowing difficulty between Jan 1st 2006 and Dec 31st 2008. We set improvements in 1) the level of independent living, 2) pneumonia, 3) peroral intake as outcome measures of QOL and explored the factors associated with these improvements. RESULTS: Till October 31st 2010, 1,353 patients with Alzheimer's dementia (33.1%), vascular dementia (61.7%), dementia with Lewy body disease (2.0%), Pick disease (0.6%) and others were followed-up for a median of 847 days (mean 805 ± 542 days). A total of 509 deaths were observed (mortality 59%) in full-followed patients. After multivariate adjustments, improvement in the level of independent living was observed in milder dementia, or those who can live independently with someone, compared with advanced dementia, characterized by those who need care by someone: Odds Ratio (OR), 3.90, 95% confidence interval (95%CI), 1.59 - 9.39, P = 0.003. Similarly, improvement of peroral intake was noticed in milder dementia: OR, 2.69, 95%CI, 1.17 - 6.17, P = 0.02. Such significant associations were not observed in improvement of pneumonia. CONCLUSIONS: These results suggest that improvement of QOL after PEG insertion may be expected more in milder dementia than in advanced dementia.

[Loco-regional chemotherapy at the outpatient clinic for gastric cancer patients with home enteral nutrition].

In over the 10 years from 2000-2010, 21 gastric cancer patients received loco-regional chemotherapy with home enteral nutrition (HEN) at an outpatient clinic because of insufficient oral intake. These loco-regional chemotherapy regimens consisted of 5 intra-aortic chemotherapies, 4 hepato-arterial infusions and 12 intra-peritoneal chemotherapies. Five out of 8 cases that had measurable lesions showed PR, and 3 cases revealed PD. The patients received HEN with peptide central formula, 400-1,200 kcal/day in night time. The average duration of HEN was 12.9 months. The post-operative nutritional management was needed for continuation and securing of outpatient chemotherapy. The author reported an experience of the outpatient loco-regional chemotherapy with HEN for the gastric cancer patients who could not eat a sufficient volume of food.

Survival of geriatric patients after percutaneous endoscopic gastrostomy in Japan.

AIM: To examine the long term survival of geriatric patients treated with percutaneous endoscopic gastrostomy (PEG) in Japan. METHODS: We retrospectively included 46 Japanese community and tertiary hospitals to investigate 931 consecutive geriatric patients (≥ 65 years old) with swallowing difficulty and newly performed PEG between Jan 1st 2005 and Dec 31st 2008. We set death as an outcome and explored the associations among patient's characteristics at PEG using log-rank tests and Cox proportional hazard models. RESULTS: Nine hundred and thirty one patients were followed up for a median of 468 d. A total of 502 deaths were observed (mortality 53%). However, 99%, 95%, 88%, 75% and 66% of 931 patients survived more than 7, 30, 60 d, a half year and one year, respectively. In addition, 50% and 25% of the patients survived 753 and 1647 d, respectively. Eight deaths were considered as PEG-related, and were associated with lower serum albumin levels (P = 0.002). On the other hand, among 28 surviving patients (6.5%), PEG was removed. In a multivariate hazard model, older age [hazard ratio (HR), 1.02; 95% confidence interval (CI), 1.00-1.03; P = 0.009], higher C-reactive protein (HR, 1.04; 95% CI: 1.01-1.07; P = 0.005), and higher blood urea nitrogen (HR, 1.01; 95% CI: 1.00-1.02; P = 0.003) were significant poor prognostic factors, whereas higher albumin (HR, 0.67; 95% CI: 0.52-0.85; P = 0.001), female gender (HR, 0.60; 95% CI: 0.48-0.75; P < 0.001) and no previous history of ischemic heart disease (HR, 0.69; 95% CI: 0.54-0.88, P = 0.003) were markedly better prognostic factors. CONCLUSION: These results suggest that more than half of geriatric patients with PEG may survive longer than 2 years. The analysis elucidated prognostic factors.

Relationship of psychological characteristics and self-efficacy in gastrointestinal cancer survivors.

To characterize gastrointestinal cancer survivors' ability to psychologically adjust, we examined the relationship between psychological characteristics (quality of life (QOL), anxiety, depression, and post-traumatic stress symptoms) and self-efficacy (perceived ability to initiate coping strategies). Forty-seven subjects (32 males and 15 females) were recruited from outpatient clinics or general surgical wards after readmission for therapy unrelated to cancer. All had undergone treatment for gastrointestinal cancer. Japanese version of the Functional Assessment of Cancer Therapy--General (FACT-G), Japanese version of Hospital Anxiety and Depression Scale (HADS), Japanese version of Impact of Event Scale--Revised (IES-R), and The Self-Efficacy Scale for Advanced Cancer (SEAC) were administered. Correlation analyses revealed a statistically significant positive correlation between three subscales of SEAC and QOL (total of FACT-G value) and a significant negative correlation between anxiety, depression (the total of HADS value), post-traumatic stress symptoms (the total of IES-R value), and SEAC. In multiple regression analysis, the influence from Affect Regulation Efficacy (subscale of SEAC) was the largest in anxiety and post-traumatic stress symptoms while the influence from Activities of Daily Living Efficacy (subscale of SEAC) was the largest in QOL and depression. Our findings revealed that a strong relationship between self-efficacy and psychological adjustment, and that there should be several psychological intervention forms performed at various treatment stages to enhance self-efficacy in this population of gastrointestinal cancer survivors. These results also imply the effectiveness of interventions on self-efficacy for gastrointestinal cancer survivors and the influence of psychological factors such as QOL, anxiety, depression, and post-traumatic stress symptoms.

[Two case reports of metastatic liver carcinoma with the effective treatment of radiofrequency ablation and intraarterial chemotherapy].

We report two cases of metastatic liver carcinoma with the treatment of radiofrequency ablation (RFA) and intraarterial chemotherapy. The 57-year-old man of Case 1 had resectable multiple liver metastases of rectal carcinoma in November 2007. He refused a liver resection, but accepted a low anterior resection of the rectum and RFA and intraarterial chemotherapy (5-FU 1,000 mg WHD). After this treatment, he had accepted systemic chemotherapy and found no liver recurrence within a year. The 66-year-old man of Case 2 had unresectable multiple liver metastases of locally-advanced esophageal carcinoma in July 2006. He had accepted radiochemotherapy (FP+65 Gy), and then RFA and intraarterial chemotherapy (5-FU 1,000 mg WHD). After this treatment, solitary brain metastasis and lymph node metastasis of mediastinum were found and treated, and now he has been alive with systemic chemotherapy.

[Two resected cases of pulmonary metastasis from post operative colorectal cancer after preoperative chemotherapy with FOLFOX].

UNLABELLED: We described two resected cases of pulmonary metastasis from postoperative colorectal cancer after preoperative FOLFOX chemotherapy. Pathologic histology inspection of the tumor was judged to be effective prior to resection. The first case is a 68-year-old male who underwent a sigmoidectomy as a stage III A sigmoid colon cancer in March 2003. Afterwards, distant metastases had occurred to the liver, the left lung and neck lymph nodes from 2003 to 2006. Three operations and systemic chemotherapy were performed. A new metastasis of the right lung occurred in November 2006. The FOLFOX chemotherapy was performed 7 times, the tumor was not changed in the image, and the effect judgment was SD. After the chemotherapy, a partial resection of the right lung was performed in November 2007. Half of the tumor resulted in necrosis on the specimen (Grade 1b). The second case is a 63-year-old female who underwent an anterior resection of the rectum as a stage II rectal cancer in January 2000, a partial resection of the right lung as a metachronous right pulmonary metastasis in March 2003, and post operative chemotherapy (IFL) were performed. A new metastasis of the right lung occurred in September 2005. The FOLFOX chemotherapy was performed 4 times, the tumor was not changed in the image, and the effect judgment was SD. After the chemotherapy, a partial resection of the right lung was performed in April 2006. One third of the tumor resulted in necrosis on the specimen (Grade 1a). COMMENT: It was thought that FOLFOX chemotherapy can be a promising candidate for neoadjuvant treatment of pulmonary metastasis from postoperative colorectal cancer.

[A case report of un-resectable pancreas body carcinoma successfully treated by chemoradiotherapy].

We report a case of unresectable pancreatic cancer who survived for 29 months after a successful treatment by concurrent chemo-radiotherapy by gemcitabine and systemic administration of gemcitabine. A 65-year-old woman who was diagnosed as unresectable pancreas body cancer received concurrent chemo (gemcitabine 800 mg/body/w) -radiotherapy (1.8x30 Gy) and systemic chemotherapy (gemcitabine 1,000 mg/body/w) at an outpatient clinic. Twenty nine months after the initial treatment, she was died of peritoneal dissemination. Recently, there are some reports of synergistic effect for combined treatment of gemcitabine and radiation. Clinical course of our case supports the synergistic effect of radiation and gemcitabine.

[Study on adjuvant MTX-5-FU intraperitoneal chemotherapy for advanced gastric cancer].

The intraperitoneal administration of anti-cancer drug is a rationale route to adjuvant chemotherapy. We applied adjuvant MTX-5-FU intraperitoneal chemotherapy for 60 advanced gastric cancer cases which had undergone gastrectomy (Stage II 18, Stage III A 19, Stage IIIB 13, and Stage IV 10 cases). A 5-year survival rate of Stage II, III A, IIIB and IV was 66.2%, 60.7%, 46.5% and 18.8%, respectively. Five-year survival rates of both Stage III A and IIIB on this study were likely to be higher than the rates of Stage III A and IIIB of other institutions. The 24 out of 42 cases with the serosal surface exposure of cancer demonstrated a cancer recurrence. Seventy percent (17 cases) of the 24 recurred cases developed a peritoneal recurrence, which means that the intraperitoneal chemotherapy did not touch a pattern of the recurrence of the gastric cancer with the serosal surface exposure.

[The future of loco-regional treatment for advanced gastric cancer].

We have evaluated the result of neo-adjuvant chemotherapy for advanced gastric cancer to estimate the future of loco- regional therapy. Twenty patients with advanced gastric cancer accepted 2 courses of neo-adjuvant chemotherapy with S- 1 and cisplatin. In 13 patients (52%), chemotherapy could successfully control the growth of tumor. Thirteen patients with curative resection demonstrated a better survival (MST 682 days) than 12 patients with non-curative resection (MST 377 days). Neo-adjuvant chemotherapy using S-1 and cisplatin was an effective treatment for advanced gastric cancer. However, no survival benefit could be obtained for patients with non-curative resection. Administration of loco-regional treatment, such as intra peritoneal paclitaxel, should be considered for those cases with positive peritoneal cytology.

[A case report of intra-operative radiotherapy and gemcitabine for unresectable pancreatic body cancer].

We report an effective case of fifty-seven year-old female with unresectable pancreatic cancer. Its chief complaint of the case was epigastralgia in April 2007, and the diagnosis was locally-advanced cancer of pancreatic body (4 cm, Stage IVa) in June 2007. Laparotomy was performed, but the locally-advanced cancer was unresectable because of the invasion to the celiac trunk and superior mesenteric artery. Tumor biopsy and intra-operative radiotherapy (IORT, 12 MeV, 20 Gy) were only performed. The result of biopsy was moderately-differentiated adenocarcinoma. After laparoptomy, systemic chemotherapy (gemcitabine 1,000 mg/body) was performed once a week. After 4-set chemotherapy, her cancer pain was completely relieved and the tumor size was decreased to 25 mm on CT scan in October 2007. She has been treated as an outpatient.

[Outpatient chemotherapy with home enteral nutrition for gastric cancer patients].

The jejunostomy catheters were placed with needle catheter jejunostomy (NCJ) kits at the time of gastrectomy for the gastric cancer patients. When the oral intake of the post-operative patient is insufficient, home enteral nutrition (HEN) was introduced to the patient. Forty seven cases out of the 278 gatrectomy patients with jejunostomy were applied to HEN (400-1,200 kcal/day in the night). Twenty nine HEN gastric cancer cases received the chemotherapy in the outpatient clinic. The mean age was 71 years old, the number of total gastrectomy and distal gastrectomy were 21 and 8, respectively, and the number of Stage III and IV were 21 and 8, respectively. The chemotherapy for these 29 cases was continued for a long period unevenly in the outpatient clinic, even though the oral intake of the cases was insufficient. HEN is a good arm for keeping the chemotherapy secure and efficient in the outpatient clinic.

[Intra-gastric change of the semi-solid formula with pectin liquid, "REF-P1"].

Pectin liquid, "REF-P1" is supposed to make the enteral formula semi-solid in the stomach. The consequence after injecting "REF-P1" and the enteral formula into the stomach was observed under gastric endoscopy. When the acidity of gastric juice was stronger than pH 2, "REF-P1" reacted with the gastric juice and was solidified into a hard gel. The general feature of the formula was uneven with the liquid and minute hard gel formation. On the other hand, when the acidity was weak, "REF-P1" and the formula were mixed together, pectin liquid was transformed to the regular soft gel. The feature of the semi-solid formula with "REF-P1" depends on the acidity of gastric juice.

Two-dimensional analysis of elements and mononuclear cells in hard metal lung disease.

RATIONALE: Hard metal lung disease is caused by exposure to hard metal, a synthetic compound that combines tungsten carbide with cobalt as well as a number of other metals. Interstitial lung disease caused by hard metal is uniquely characterized by giant cell interstitial pneumonia. The pathogenesis of hard metal lung disease is unclear. OBJECTIVES: To elucidate the distribution of inhaled hard metal and reactive inflammatory cells in biopsy lung tissue from patients with hard metal lung disease. METHODS: Seventeen patients with interstitial lung disease in which tungsten was detected and five control subjects were studied. Detection and mapping of elements were performed with an electron probe microanalyzer equipped with a wavelength dispersive spectrometer. We immunohistochemically stained mononuclear cells, in tissue samples available from five patients, with anti-human CD4, CD8, CD20, CD68, and CD163 antibodies, and compared the distribution of positive cells with hard metal elements. MEASUREMENTS AND MAIN RESULTS: Thirteen of 17 patients were pathologically diagnosed as having giant cell interstitial pneumonia. Tungsten and cobalt were accumulated in the centrilobular fibrotic lesions, but were never found in the control lungs. CD8+ lymphocytes and CD163+ monocyte-macrophages were distributed predominantly in centrilobular fibrotic lesions around the hard metal elements. CD163+ colocalized with tungsten. Small numbers of CD8+ and CD163+ cells were also immunohistochemically shown in peribronchiolar areas and alveolar walls. CONCLUSIONS: Macrophages may phagocytose inhaled tungsten via CD163 and play an important role in forming the fibrotic lesion of hard metal lung disease with cytotoxic T lymphocytes.

Oral rehydration solution for providing water and electrolytes following laparoscopic cholecystectomy and recovery of intestinal function.

BACKGROUND/AIMS: Oral rehydration solution (OS-1: Na+ 50mEq/L, K+ 20mEq/L, Cl- 50mEq/L, and glucose 1.8%) was administered orally to patients from the early phase following laparoscopic cholecystectomy to assess its effects on water and electrolyte supplementation and recovery from postoperative intestinal paralysis. METHODOLOGY: OS-1 group (n = 22) received OS-1 orally and KN3B group (n = 22) received KN3B (an intravenous maintenance solution) intravenously. The OS-1 group was instructed to consume approximately 1000-1500mL of OS-1 postoperatively from as soon as oral intake was possible up to before lunch on postoperative day 1. RESULTS: The average dose in the OS-1 group (1178 +/- 319 mL) was significantly lower than that in the KN3B group (1371 +/- 196 mL), but within the target dose. The two solutions were equally effective and safe for water and electrolyte supplementation. The time for 50% of patients to pass bowel gas after surgery (indicating recovery from intestinal paralysis) was significantly shorter in the OS-1 group (14.00 hours) than in the KN3B group (23.75 hours). CONCLUSIONS: Oral rehydration solution (OS-1), administered from the early postoperative phase, is safe and effective for the provision of water and electrolytes and promotes early recovery from intestinal paralysis as assessed by the passage of bowel gas following laparoscopic cholecystectomy.