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result(s) for
"Kamei, Aya"
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CLEAN-NET: a modified laparoendoscopic wedge resection of the stomach to minimize the sacrifice of innocent gastric wall
2020
BackgroundTo avoid excessive sacrifice of the tissue surrounding the submucosal tumor in gastric wedge resection with a stapling device, we perform a “combined laparoscopic and endoscopic approach for neoplasia with a nonexposure technique” (CLEAN-NET). Herein the operative technique of CLEAN-NET is described and its short-term outcomes in 50 patients are evaluated.Patients and methodsBetween December 2015 and July 2017 CLEAN-NET was performed in 50 patients with gastric submucosal tumors. During the operation, the seromuscular layer above the tumor is dissected, while the mucosa is kept unbroken. When seromuscular layer is dissected all around the tumor, the full layer is lifted, and the mucosa is stretched. The mucosa is then transected with a stapling device to execute full-thickness resection of the specimen. Finally, the seromuscular defect is repaired by hand-sewn suture. The hospital records of the 50 patients were reviewed to assess the outcomes. The margin width was compared with those measured in another group with 19 patients, who underwent conventional wedge resection with a stapling device.ResultsThe operation was completed as CLEAN-NET and the tumor was resected en-bloc without rupture in all patients. The average operation time ranged from 50 to 220 min with an average of 105.4 min. The post-operative course was uneventful. Microscopically the surgical margin was tumor-negative (R0 resection) in all cases. The margin width in the CLEAN-NET group was smaller than that in the wedge resection group (5.4 mm ± 2.5 vs. 33.1 mm ± 14.7).ConclusionsCLEAN-NET can be performed safely with an acceptable operation time. CLEAN-NET can be a useful option in the laparoscopic surgical treatment of gastric submucosal tumors, when excessive sacrifice of the healthy gastric wall surrounding the endophytic tumor should be avoided.
Journal Article
Sensory evaluation of the bitterness of asenapine using D-sorbitol pretreatment: single-blind, placebo-controlled, crossover trial
2023
Background
Antipsychotics are essential in the acute treatment of and maintenance therapy for schizophrenia, but medication adherence and long-term treatment continuity are needed to maximize their effectiveness. Each antipsychotic has various side effects, which may affect adherence. Some patients with schizophrenia are reluctant to take asenapine because of its unique oral-related side effects, such as the bitter taste caused by sublingual administration. Our previous basic research found that D-sorbitol lowered the bitterness parameters of the taste sensors. However, whether D-sorbitol has the same effect in patients remains unclear. Therefore, using a D-sorbitol solution, we aim to evaluate changes in the bitterness of asenapine among patients with schizophrenia.
Methods
In this single-blind, placebo-controlled, crossover trial, we plan to recruit 20 adult patients with schizophrenia spectrum disorder who take sublingual asenapine tablets. The participants will be divided into two groups (
n
= 10 each). Each group will be given a D-sorbitol or placebo solution on the first day for rinsing before taking the sublingual asenapine tablets. After a 1-day interval, the participants will rinse their mouths again with a different liquid. Questionnaires regarding changes in taste and the willingness to continue asenapine will be conducted before the start of the study and after each rinse. The primary and secondary end points will be a taste evaluation of bitterness, and the willingness to continue asenapine, respectively. Differences in questionnaire scores between the D-sorbitol and placebo solutions will be calculated and analyzed using a McNemar test.
Discussion
This study aims to determine the efficacy of D-sorbitol in masking the bitter taste of asenapine. To our knowledge, it is the first intervention study using D-sorbitol for bitter taste of asenapine in patients with schizophrenia. Evidence of the efficacy of D-sorbitol could result in D-sorbitol pretreatment being an easy and inexpensive means of improving adherence to asenapine.
Trial registration
This study was registered in the Japan Registry of Clinical Trials jRCTs041210019, on May 14, 2021. Ethics approval was obtained from the Nagoya University Clinical Research Review Board.
Journal Article
Effect of single-administration of d-sorbitol pretreatment on the bitterness and continued willingness to take asenapine: a randomized, single-blind, placebo-controlled, crossover trial
by
Shuhei Wada
,
Aya Kamei
,
Masashi Ikeda
in
Adherence
,
Adult
,
Antipsychotic Agents - adverse effects
2024
Background
Asenapine has unique orally-related side effects, such as a bitter taste induced by sublingual administration, which often results in discontinuation of the medication. While the FDA has approved black-cherry-flavored asenapine, several countries have prescribed only unflavored versions. Specifically, Asians commonly report experiencing the bitterness of asenapine because they are more sensitive to bitter tastes than other ethnic groups. In this study, with the aim of improving adherence by reducing the bitterness of asenapine, we investigated the effects of
d
-sorbitol, which reduced the bitterness parameters of taste sensors in our previous basic study on the bitterness and continuity of asenapine among patients with schizophrenia.
Methods
Twenty adult patients with schizophrenia were included in this single-blind, placebo-controlled, crossover trial. Participants rinsed their mouths with single-administration of
d
-sorbitol or a placebo prior to each administration of asenapine. We then conducted the questionnaires and assessed changes in the bitterness of asenapine (primary end point) and willingness to continue its use (secondary end point).
Results
d
-sorbitol significantly improved the bitterness of asenapine (
p
= 0.038). Although it did not significantly increase the willingness to continue asenapine (
p
= 0.180), it did show improvement over the placebo in enhancing willingness to continue, especially in patients who were not accustomed to its taste.
Conclusion
Our findings indicate that single-administration of
d
-sorbitol significantly reduces the bitterness of asenapine. In countries where flavored asenapine is not available, this finding could benefit patients who were not accustomed to its bitter taste.
Trial registration
This study was registered in the Japan Registry of Clinical Trials (jRCTs041210019) on May 14, 2021.
Journal Article
Long-term outcomes of percutaneous endoscopic intragastric surgery in the treatment of gastrointestinal stromal tumors at the esophagogastric junction
2016
Background
The treatment options for gastrointestinal stromal tumors (GITSs) at the esophagogastric junction (EGJ) are controversial. There have been reports on enucleation for EGJ GISTs in order to avoid gastrectomy. But the number of patients is too small, or the follow-up period is too short to evaluate it. The purpose of this study was to review our experience of 59 patients with EGJ GISTs treated by enucleation by percutaneous endoscopic intragastric surgery (PEIGS) and assess the clinical outcomes.
Methods
PEIGS is performed as described below. Access ports are placed through the abdominal wall and the anterior wall of the stomach. Through the access ports, an endoscope and surgical instruments are inserted into the gastric lumen and tumor enucleation and closure of the defect are carried out. In this study, 59 patients with EGJ GISTs treated by PEIGS between 2005 and 2013 were enrolled. Their hospital records were reviewed, and follow-up data for 8 years were collected to analyze the outcomes.
Results
En-bloc enucleation was achieved without tumor rupture in all. Average operation time was 172.3 min. Postoperative complications occurred in 3 (one localized peritonitis, one bleeding, and one surgical site infection). Average tumor size was 35.6 mm. Pathological findings confirmed negative margin in all specimens. The maximum follow-up period was 101 months. Multiple liver metastases were detected in two patients (at 12 and 29 months). The survival rate was 100 %. The disease-free rate was 98.3 % at 12 months and 96.6 % at 29 months, respectively.
Conclusions
As far as the short- and long-term outcomes of our experience are reviewed, PEIGS seems as curative as other aggressive resection methods such as proximal gastrectomy. Tumor enucleation by PEIGS, offering a chance to preserve the stomach, can be a preferable option in carefully selected patients with EGJ GISTs, when performed by a skilled surgeon.
Journal Article
EFFECT OF POWDER DRY ADZUKI BEAN PASTE IN PLACE OF WHEAT FLOUR ON RESISTANT STARCH CONTENT AND SENSORY CHARACTERISTICS OF COOKIES
2017
Background and objectives: Traditional Japanese sweets have been popular among Japanese, and are often eaten particularly by middle-aged and elderly people. A lot of traditional Japanese sweets contain adzuki bean paste(ABP). Adzuki beans are a good source of carbohydrate as well as of protein, because these are starchy pulse. Furthermore, they contain a lot of dietary fiber and also include resistant starch (RS). RS escapes digestion until reaching colon and acts like dietary fiber. Recently, many studies recommend taking this new type of dietary fiber for health benefits. The purpose of this study was to investigate feasibility of replacing wheat flour to powder dry ABP by analyzing RS contents and sensory characteristics in cookies. Methods: Cookies were prepared from various blends of wheat flour(WF) and powder dry ABP(100%WF:0%ABP, 50%WF:50%ABP, 25%WF:75%ABP, 0%WF:100%ABP). RS content of these cookies were measured by Resistant Starch Assay Kit (Megazyme International Ireland, Ireland) and ranking test was applied for evaluating sensory characteristics. Results: RS content of powder dry ABP was 5.3% and RS contents of cookies blended flour with 50%ABP, 75%ABP, 100%ABP were 1.6%, 2.1%, 3.0%, respectively. As a ratio of ABP in the cookies increased, a ratio of RS content also increased. Sensory evaluation indicated that 50%ABP cookies was not different from 0%ABP cookies in terms of flavor, sweetness, texture and overall acceptability. Conclusions: These results implied that cookies made of powder dry ABP in place of wheat flour increased amount of RS in cookies. Taking account of sensory evaluation, 50% replacement of powder dry ABP cookies were found to be acceptable.
Journal Article
Effect of Seasonings and Storage Temperature on Resistant Starch Contents of Japanese White Rice
2019
Background: Rice is staple food and major carbohydrate source in Japanese diet. Japanese white rice is cooked only with water. However, we cook white rice seasoned with salt or soy sauce and mixed with meat or seafood and vegetables. We also make vinegar rice for sushi. Starch retrogradation is one type of resistant starch (RS). RS escapes digestion until reaching colon and acts like dietary fiber. Recently, many studies suggest that RS, in addition to dietary fiber, may be beneficial for our health. The purpose of this study was to investigate the effect of salt or vinegar and storage temperature on RS synthesis of cooked rice. Methods: White rice was cooked using electrical rice cooker. The rice to water ratio was 1:1.5 (w:v). Rice were cooked with water contained 0%, 0.75% or 1.5% of NaCl and 0.1 M or 0.2 M of acetic acid. After cooking, RS contents were analyzed three storage temperature of rice: immediate after cooking, chilled (4C) for 24 hours after cooking and reheated using microwave after chilled for 24 hours. Results: The results showed that RS contents did not vary by adding different concentration of NaCl or acetic acid at immediate after cooking. All condition of cooked rice after chilled for 24 hours were higher RS contents than that of immediate after cooking. There were interesting findings that reheated rice cooked with 0.75% or 1.5% of NaCl increased RS contents compared with that of chilled for 24 hours. Conclusion: These results may imply that rice cooked with seasonings might be difficult to be re-gelatinized.
Journal Article
Transanal endoscopic microsurgery for surgical repair of rectovesical fistula following radical prostatectomy
2015
Background
Rectovesical fistula is a rare complication following prostatectomy, associated with significant symptoms such as urinary drainage from anus or faecaluria. While several surgical procedures have been described to treat this condition, none of them has been accepted as the universal standard. Transanal endoscopic microsurgery (TEM) is a well-established endoluminal procedure for local excision of rectal tumors. But its application to the repair of rectovesical fistula has been almost unknown.
Methods
We performed TEM as a surgical repair for refractory rectovesical fistula developing after radical prostatectomy in 10 patients. Under the magnified three-dimensional view, through the stereoscope, the fistula and the surrounding rectal mucosa were precisely resected. The defect and the muscle layer of the rectum were closed by hand-sew technique in four layers.
Results
Fistula was completely closed in 7 patients, who eventually underwent enterostomy closure, while in the other 3 patients the fistula recurred. In the three recurrent cases, the fistula was associated with wide, tough scar tissue due to previous irradiation, HIFU, or repeated surgical repair attempts.
Conclusions
Rectovesical fistulas associated with wide, tough scar tissue due to multi-time attempt of surgical repair or any type of energy ablation should not be indicated for repair by TEM. However, for simple fistulas without tough, fibrotic surroundings, TEM can be indicated as a minimally invasive surgical option with very low morbidity, without any incision in healthy tissue for approach.
Journal Article
Rituximab for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial
by
Ishikura, Kenji
,
Takahashi, Shori
,
Tanaka, Ryojiro
in
Adolescent
,
Antibodies, Monoclonal, Murine-Derived - adverse effects
,
Antibodies, Monoclonal, Murine-Derived - therapeutic use
2014
Rituximab could be an effective treatment for childhood-onset, complicated, frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS). We investigated the efficacy and safety of rituximab in patients with high disease activity.
We did a multicentre, double-blind, randomised, placebo-controlled trial at nine centres in Japan. We screened patients aged 2 years or older experiencing a relapse of FRNS or SDNS, which had originally been diagnosed as nephrotic syndrome when aged 1–18 years. Patients with complicated FRNS or SDNS who met all other criteria were eligible for inclusion after remission of the relapse at screening. We used a computer-generated sequence to randomly assign patients (1:1) to receive rituximab (375 mg/m2) or placebo once weekly for 4 weeks, with age, institution, treatment history, and the intervals between the previous three relapses as adjustment factors. Patients, guardians, caregivers, physicians, and individuals assessing outcomes were masked to assignments. All patients received standard steroid treatment for the relapse at screening and stopped taking immunosuppressive agents by 169 days after randomisation. Patients were followed up for 1 year. The primary endpoint was the relapse-free period. Safety endpoints were frequency and severity of adverse events. Patients who received their assigned intervention were included in analyses. This trial is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000001405.
Patients were centrally registered between Nov 13, 2008, and May 19, 2010. Of 52 patients who underwent randomisation, 48 received the assigned intervention (24 were given rituximab and 24 placebo). The median relapse-free period was significantly longer in the rituximab group (267 days, 95% CI 223–374) than in the placebo group (101 days, 70–155; hazard ratio: 0·27, 0·14–0·53; p<0·0001). Ten patients (42%) in the rituximab group and six (25%) in the placebo group had at least one serious adverse event (p=0·36).
Rituximab is an effective and safe treatment for childhood-onset, complicated FRNS and SDNS.
Japanese Ministry of Health, Labour and Welfare.
Journal Article
Long-term outcome of childhood-onset complicated nephrotic syndrome after a multicenter, double-blind, randomized, placebo-controlled trial of rituximab
2017
Background
Although rituximab effectively prevents relapses of complicated frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS), data of long-term outcomes and safety are limited.
Methods
Fifty-one patients (age, 3–38 years) with childhood-onset complicated FRNS or SDNS, who received rituximab in investigator-initiated multicenter prospective trials were enrolled. Rituximab was administered at 375 mg/m
2
once weekly for 4 weeks, and immunosuppressive agents were discontinued according to the study protocol. We investigated relapses, re-administration of immunosuppressive agents, additional rituximab treatment, body height, renal function, and late adverse events during the observation period.
Results
Forty-eight patients (94%) developed relapses during the observation period (median, 59 months) and the 50% relapse-free survival was 261 days. Thirty patients (59%) developed SDNS, 44 (86%) required re-administration of immunosuppressive agents, and 22 (43%) received additional rituximab treatment. All patients who were receiving immunosuppressive agents at rituximab treatment required either immunosuppressive agents or additional rituximab treatment. On the contrary, 5 of the 13 patients without immunosuppressive agents at rituximab treatment required neither immunosuppressive agents nor additional rituximab treatment and 3 of them did not develop relapse during observation period. Growth failure due to steroid toxicity did not progress and none of the patients developed chronic renal insufficiency. None of the patients suffered from rituximab-related late adverse events.
Conclusions
As most patients suffer from relapses after B-cell recovery, long-term immunosuppressive agents or additional rituximab treatment is necessary. However, some patients who can discontinue immunosuppressive agents before rituximab treatment may achieve long-term remission after rituximab treatment without immunosuppressive agents.
Journal Article
Effect of low energy availability during three consecutive days of endurance training on iron metabolism in male long distance runners
2020
We investigated the effect of low energy availability (LEA) during three consecutive days of endurance training on muscle glycogen content and iron metabolism. Six male long distance runners completed three consecutive days of endurance training under LEA or neutral energy availability (NEA) conditions. Energy availability was set at 20 kcal/kg fat‐free mass (FFM)/day for LEA and 45 kcal/kg FFM/day for NEA. The subjects ran for 75 min at 70% of maximal oxygen uptake ( V˙O2max) on days 1–3. Venous blood samples were collected following an overnight fast on days 1–4, immediately and 3 hr after exercise on day 3. The muscle glycogen content on days 1–4 was evaluated by carbon‐magnetic resonance spectroscopy. In LEA condition, the body weight and muscle glycogen content on days 2–4, and the FFM on days 2 and 4 were significantly lower than those on day1 (p < .05 vs. day1), whereas no significant change was observed throughout the training period in NEA condition. On day 3, muscle glycogen content before exercise was negatively correlated with serum iron level (immediately after exercise, 3 hr after exercise), serum hepcidin level immediately after exercise, and plasma IL‐6 level immediately after exercise (p < .05). Moreover, serum hepcidin level on day 4 was significantly higher in LEA condition than that in NEA condition (p < .05). In conclusion, three consecutive days of endurance training under LEA reduced the muscle glycogen content with concomitant increased serum hepcidin levels in male long distance runners. Three consecutive days of endurance training under low energy availability (LEA) decreased the muscle glycogen content and increased the serum hepcidin level in well‐trained male long distance runners. These results suggest that LEA is associated with a risk of exercise‐induced iron deficiency by an elevated hepcidin level in endurance athletes.
Journal Article