1.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
Background/Aims:
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods:
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results:
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
2.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
Background/Aims:
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods:
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results:
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
3.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
Background/Aims:
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods:
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results:
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
4.A case of laparoscopic resection of carcinoma arising at a colostomy site
Takehiro TAKAGI ; Satoshi KOBAYASHI ; Atsushi SEKIMURA ; Takashi MAEDA ; Shinji KATO ; Akihiro HORI
Journal of the Japanese Association of Rural Medicine 2023;71(5):398-405
We report a case of a 72-year-old woman with a tumor arising from a colostomy site that had been created 25 years earlier when rectal amputation was performed for perforated sigmoid cancer. She was referred to our hospital due to complaints of pain from the colostomy. The diagnosis was carcinoma arising at the colostomy site with lymph node metastasis. Laparoscopic surgery was performed by attaching an Applied Alexis® wound retractor to the incision site of the colostomy. Lymph node dissection was performed and the left hemicolon was resected. Carcinoma arising from a colostomy site is rare. Laparoscopic surgery was considered to be a useful procedure because it allows for lymph node dissection and intestinal mobilization with minimal invasiveness.
5.A case of a mesenteric lipoma in the transverse colon
Takashi MAEDA ; Satoshi KOBAYASHI ; Takehiro TAKAGI ; Kenichi KOMAYA ; Shinji KATOU ; Masayuki SAITO ; Akihiro HORI
Journal of the Japanese Association of Rural Medicine 2023;71(5):406-411
A chest X-ray taken during a medical checkup for a 75-year-old man revealed a nodular shadow in the right middle lung field. Chest computed tomography (CT) for further examination showed an intra-abdominal tumor as an additional finding, and the patient was referred to our department. Contrast-enhanced CT revealed a tumor (16×10×5 cm) in the left upper to middle abdomen. The tumor had a clear border and uniform fat density inside. It compressed the stomach to the ventral side, but the patient had no subjective symptoms. Magnetic resonance imaging also showed the tumor contained a uniform fatty component inside, as well as no obvious non-fatty components. An intra-abdominal lipoma was suspected, but the possibility of a welldifferentiated liposarcoma could not be ruled out due to its size. During curative surgery, intraoperative findings revealed a soft tumor, weighing 612 g, with a well-defined border in the mesentery of the transverse colon. Pathological findings showed proliferation of mature adipocytes without malignancy. We report here this case of mesenteric lipoma, a rare intraabdominal tumor, and review the relevant literature.
6.A case of autoimmune enteropathy with CTLA4 haploinsufficiency
Haruka MIYAZAKI ; Namiko HOSHI ; Michitaka KOHASHI ; Eri TOKUNAGA ; Yuna KU ; Haruka TAKENAKA ; Makoto OOI ; Nobuyuki YAMAMOTO ; Suguru UEMURA ; Noriyuki NISHIMURA ; Kazumoto IIJIMA ; Keisuke JIMBO ; Tsubasa OKANO ; Akihiro HOSHINO ; Kohsuke IMAI ; Hirokazu KANEGANE ; Ichiro KOBAYASHI ; Yuzo KODAMA
Intestinal Research 2022;20(1):144-149
Autoimmune enteropathy (AIE) is a rare disease, characterized by intractable diarrhea, villous atrophy of the small intestine, and the presence of circulating anti-enterocyte autoantibodies. Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome, and mutations in FOXP3, which is a master gene of regulatory T cells (Tregs), are major causes of AIE. Recent studies have demonstrated that mutations in other Treg-associated genes, such as CD25 and CTLA4, show an IPEX-like phenotype. We present the case of a 13-year-old girl with CTLA4 haploinsufficiency, suffering from recurrent immune thrombocytopenic purpura and intractable diarrhea. We detected an autoantibody to the AIE-related 75 kDa antigen (AIE-75), a hallmark of the IPEX syndrome, in her serum. She responded well to a medium dose of prednisolone and a controlled dose of 6-mercaptopurine (6-MP), even after the cessation of prednisolone administration. Serum levels of the soluble interleukin-2 receptor and immunoglobulin G (IgG) were useful in monitoring disease activity during 6-MP therapy. In conclusion, autoimmune-mediated mechanisms, similar to the IPEX syndrome, may be involved in the development of enteropathy in CTLA4 haploinsufficiency. Treatment with 6-MP and monitoring of disease activity using serum levels of soluble interleukin-2 receptor and IgG is suggested for such cases.
7.A Case of Advanced Gastric Cancer That Was Difficult to Treat During Chemotherapy for Advanced Lung Cancer
Satoshi KOBAYASHI ; Kenichi KOMAYA ; Takehiro TAKAGI ; Takashi MAEDA ; Masashi KATO ; Atsushi SEKIMURA ; Toshiyuki YOKOYAMA ; Akihiro HORI
Journal of the Japanese Association of Rural Medicine 2022;70(5):504-509
The patient was an 80-year-old man who was diagnosed with cStage IIIB non-small cell lung cancer (NSCLC) and early gastric cancer. The advanced lung cancer was treated with chemotherapy while the gastric cancer was monitored. Immune checkpoint inhibitors were effective against the lung cancer for a long period, but new gastric cancer appeared and progressed to an advanced stage, necessitating total gastrectomy 5 years after the diagnosis of NSCLC. The patient is currently being treated with a molecular targeted agent for progression of the lung cancer after gastrectomy. In the future, the number of cases with multiple primary cancers will increase alongside aging of the population and advances in cancer treatment, and a system for tumor-agnostic treatment selection and medical treatment will be necessary.
8.Internal Hernia Through the Defect Following Resection of the Ligament of Treitz During Pancreaticoduodenectomy: A Case Report
Takashi MAEDA ; Satoshi KOBAYASHI ; Takehiro TAKAGI ; Kenichi KOMAYA ; Shinji KATOU ; Hirona BANNO ; Akihiro HORI
Journal of the Japanese Association of Rural Medicine 2022;71(1):46-50
A 57-year-old man was admitted to our hospital with adhesive bowel obstruction following pancreaticoduodenectomy performed for cholangiocarcinoma 4 months earlier. After admission, the patient remained nil per os and was closely observed. On the third day of admission, he developed worsening abdominal pain, and computed tomography revealed strangulation of the small intestinal mesentery dorsal to the superior mesenteric artery, with prolapse of the small intestine into the right upper quadrant to form a closed loop. Strangulated bowel obstruction secondary to internal hernia was diagnosed, and he underwent emergency surgery. Intraoperatively, we detected a hernia orifice formed by the mesentery and peritoneum at the site of the defect following resection of the ligament of Treitz, and we observed that approximately 2 m of the small intestine had prolapsed into the right upper quadrant. The herniated intestine was returned to the abdominal cavity, and the hernia orifice was sutured following hernia reduction. Few reports have described an internal hernia after pancreaticoduodenectomy; however, it has been reported that this operation can result in various types of internal hernia because of the complicated reconstructive procedure. Here we report our findings in this unique case together with a literature review.
9.Advanced esophagogastric junction cancer with brain, bone and gastric intramural metastases responding to combined modality therapy
Takehiro TAKAGI ; Satoshi KOBAYASHI ; Atsushi SEKIMURA ; Kenichi KOMAYA ; Yuji YAMAUCHI ; Akihiro HORI
Journal of Rural Medicine 2021;16(3):179-183
A 63-year-old man was admitted to our hospital in March 2017 with dysphagia and right homonymous hemianopsia. We diagnosed him with esophagogastric junction cancer (adenocarcinoma) with metastases to the cerebral occipital lobe, bone, and lymph nodes. After one cycle of 5FU + cisplatin (FP), the brain metastasis was resected because of the hemiplegic symptoms he developed. Histology of the resected tissue showed no viable tumor cells. After three cycles of FP, the primary lesion and metastases were resolved. Upper gastrointestinal endoscopy revealed a scar at the primary site. This was considered a complete response (CR). In April 2018, CT revealed a mass at the cardia, which was considered as lymph node metastases with gastric wall invasion. Although two additional cycles of FP were administered for recurrent tumors, the efficacy was progressive. In August 2018, proximal gastrectomy and D1 + lymph node dissection were performed. The pathological diagnosis was gastric intramural metastases and lymph node metastases (ypN1 [2/22]). Weekly paclitaxel therapy was administered for three months after surgery. Two years have passed since the last surgery without recurrence. We report a rare case of esophagogastric junction cancer with brain, bone, and gastric intramural metastases that responded to combined modality therapy.
10.Seven days triple therapy for eradication of Helicobacter pylori does not alter the disease activity of patients with inflammatory bowel disease.
Shinichiro SHINZAKI ; Toshimitsu FUJII ; Shigeki BAMBA ; Maiko OGAWA ; Taku KOBAYASHI ; Masahide OSHITA ; Hiroki TANAKA ; Keiji OZEKI ; Sakuma TAKAHASHI ; Hiroki KITAMOTO ; Kazuhito KANI ; Sohachi NANJO ; Takeshi SUGAYA ; Yuko SAKAKIBARA ; Toshihiro INOKUCHI ; Kazuki KAKIMOTO ; Akihiro YAMADA ; Hisae YASUHARA ; Yoko YOKOYAMA ; Takuya YOSHINO ; Akira MATSUI ; Misaki NAKAMURA ; Taku TOMIZAWA ; Ryosuke SAKEMI ; Noriko KAMATA ; Toshifumi HIBI
Intestinal Research 2018;16(4):609-618
BACKGROUND/AIMS: The influences of Helicobacter pylori eradication therapy on the disease course of inflammatory bowel disease (IBD) are still unclear. We therefore conducted a multicenter, retrospective cohort study to evaluate the safety of H. pylori eradication therapy for IBD patients. METHODS: IBD patients with H. pylori eradication from 2005 to 2015 (eradication group) and control patients (non-eradication group; 2 paired IBD patients without H. pylori eradication matched with each eradicated patient) were included. IBD exacerbation (increased/additional IBD drug or IBD-associated hospitalization/surgery) and disease improvement based on the physicians’ global assessment were investigated at baseline, and at 2 and 6 months after eradication or observation. RESULTS: A total of 429 IBD (378 ulcerative colitis, 51 Crohn’s disease) patients, comprising 144 patients in the eradication group and 285 patients in the non-eradication group, were enrolled at 25 institutions. IBD exacerbation was comparable between groups (eradication group: 8.3% at 2 months [odds ratio, 1.76; 95% confidence interval, 0.78–3.92; P=0.170], 11.8% at 6 months [odds ratio, 1.60; 95% confidence interval, 0.81–3.11; P=0.172]). Based on the physicians’ global assessment at 2 months, none of the patients in the eradication group improved, whereas 3.2% of the patients in the non-eradication group improved (P=0.019). Multivariate analysis revealed that active disease at baseline, but not H. pylori eradication, was an independent factor for IBD exacerbation during 2 months’ observation period. The overall eradication rate was 84.0%–comparable to previous reports in non-IBD patients. CONCLUSIONS: H. pylori eradication therapy does not alter the short-term disease activity of IBD.
Clarithromycin
;
Cohort Studies
;
Colitis, Ulcerative
;
Helicobacter pylori*
;
Helicobacter*
;
Humans
;
Inflammatory Bowel Diseases*
;
Metronidazole
;
Multivariate Analysis
;
Retrospective Studies


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