scholarly journals Vonoprazan versus lansoprazole in the treatment of artificial gastric ulcers after endoscopic submucossal dissection: a randomized, open-label trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Daisuke Kawai ◽  
Ryuta Takenaka ◽  
Mikako Ishiguro ◽  
Shotaro Okanoue ◽  
Tatsuhiro Gotoda ◽  
...  
Keyword(s):  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Medical Information ◽  
Postoperative Bleeding ◽  
University Hospital ◽  
Gastric Ulcers ◽  
Open Label ◽  
Group V ◽  
Registration Number ◽  
Delayed Perforation

Abstract Background Vonoprazan is more potent and longer acting than traditional proton pump inhibitor. Although vonoprazan is expected to be superior to proton pump inhibitor, its efficacy in the treatment of gastric ulcers following endoscopic submucosal dissection (ESD) is not fully understood. The aim of this study was to evaluate the effectiveness of vonoprazan in artificial ulcer healing following ESD. Methods Patients with gastric tumors were randomly assigned to the vonoprazan group (group V) or lansoprazole group (group L) after ESD. Patients received intravenous lansoprazole (30 mg) twice on the day of ESD. Thereafter, patients were treated with vonoprazan (20 mg/day) in group V or lansoprazole (30 mg/day) in group L. Esophagogastroduodenoscopy was performed 4 and 8 weeks after the ESD. Results A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in group V versus group L (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups. Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD. Conclusions Vonoprazan might not be superior to lansoprazole in the healing of artificial gastric ulcer after ESD. Trial registration: University hospital Medical Information Network (registration number: UMIN000016642), Registered 27 February 2015, https://www.umin.ac.jp/ctr/index-j.htm.

scholarly journals Vonoprazan Versus Lansoprazole in the Treatment of Artificial Gastric Ulcers After Endoscopic Submucosal Dissection: a Randomized Controlled Trial

2020 ◽  
Author(s):  
Daisuke Kawai ◽  
Ryuta Takenaka ◽  
Mikako Ishiguro ◽  
Shotaro Okanoue ◽  
Tatsuhiro Gotoda ◽  
...  
Keyword(s):  
Proton Pump Inhibitor ◽  
Endoscopic Submucosal Dissection ◽  
Proton Pump ◽  
Medical Information ◽  
Controlled Trial ◽  
Postoperative Bleeding ◽  
University Hospital ◽  
Gastric Ulcers ◽  
Group V ◽  
Submucosal Dissection

Abstract Background: Vonoprazan is more potent and longer acting than traditional proton pump inhibitor. Although vonoprazan is expected to be superior to proton pump inhibitor, its efficacy in the treatment of gastric ulcers following endoscopic submucosal dissection (ESD) is not fully understood. The aim of this study was to evaluate the effectiveness of vonoprazan in artificial ulcer healing following ESD. Methods: Patients with gastric tumors were randomly assigned to the vonoprazan group (group V) or lansoprazole group (group L) after ESD. Patients received intravenous lansoprazole (30mg) twice on the day of ESD. Thereafter, patients were treated with vonoprazan (20 mg/day) in group V or lansoprazole (30 mg/day) in group L. Esophagogastroduodenoscopy was performed 4 and 8 weeks after the ESD. Results: A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in group V versus group L (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups. Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD. Conclusions: Vonoprazan might not be superior to lansoprazole in the healing of artificial gastric ulcer after ESD.Trial registration; University hospital Medical Information Network (registration number: UMIN000016642), Registered 27 February 2015, https://www.umin.ac.jp/ctr/index-j.htm

scholarly journals Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

2018 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Target Sample Size ◽  
Registration Number ◽  
Health Organization ◽  
Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

scholarly journals Outcome of Post Esophageal Variceal Band Ligation with Sucralfate and Proton Pump Inhibitor vs. Proton Pump Inhibitor Alone in Cirrhotic Patients

2019 ◽  
Vol 2 (2) ◽  
pp. 209-214
Author(s):  
Binod Karki ◽  
Ramila Shrestha ◽  
Bidhan Nidhi Paudel ◽  
Sudhamshu KC ◽  
Dibas Khadka ◽  
...  
Keyword(s):  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Primary Prophylaxis ◽  
Upper Gastrointestinal Endoscopy ◽  
Ulcer Formation ◽  
Open Label ◽  
Esophageal Variceal ◽  
Band Ligation ◽  
Mean Size ◽  
Group B

Introduction: Endoscopic band ligation is the mainstay of treatment in bleeding varices in cirrhosis.  Subsequent bleeding from the band ulcers is a possible complication. Proton pump inhibitors and Sucralfate are commonly used post band ligation and often in combination. The aim of the study was to identify the advantage of combining Sucralfate to proton pump inhibitor in reducing the number and size of band ulcers.Materials and Methods: This was an open-label comparative study conducted in a tertiary level hospital of Nepal. Patients with cirrhosis after band ligation were included. Eligible patients were randomized into a proton pump inhibitor alone (Group A) or proton pump inhibitor and sucralfate group (Group B) and they underwent upper gastrointestinal endoscopy after two weeks. Baseline parameters, number and mean size of band ulcers were compared.Results: A total of 58 patients, 29 in each group, were evaluated. The baseline characteristics were comparable. EBL was done for bleeding varices in 51.7% and as primary prophylaxis in the rest of them. All the patients had band ulcers after two weeks. The mean size of the largest ulcer was 1.62±0.72 and 1.10±0.60 (p=0.78) respectively in groups A and B. Low albumin was significantly associated with OR of 8.7 (95% CI:1.68-44.99) for the formation of multiple (more than two) ulcers (p=0.01).Conclusions: The ulcer formation was universal after band application. The addition of sucralfate did not offer more benefits in terms of the number and mean size of the ulcer. Low albumin was the independent predictor for multiple ulcer formation.

Effect of duloxetine on chemotherapy-induced painful peripheral neuropathy.

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 181-181 ◽  
Author(s):  
Yasuo Hirayama ◽  
Takeshi Terui ◽  
Kazuhiko Koike ◽  
Toshiro Kusakabe ◽  
Hiroto Horiguthi ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Effects ◽  
Medical Information ◽  
Japanese Patients ◽  
Drop Out ◽  
University Hospital ◽  
Open Label ◽  
Patients With Cancer ◽  
Vas Scores ◽  
Primary Hypothesis

181 Background: Approximately 20% to 40% of patients with cancer who receive neurotoxic chemotherapy will develop painful chemotherapy-induced peripheral neuropathy. Smith et. al firstly reported that duloxetine was effective on above neuropathy after taxanes and platinums (JAMA 2013), so we planed to evaluate the duloxetine effect in Japanese patients after above drugs and more expanding drugs include vinca alkaloids and bortezomib. Methods: Patients were randomized to receive either duloxetine followed by vitamin(V)B12 or VB12 by duloxetine. The initial treatment consisted of 20 mg of duloxetine or 1.5g VB12 for the first week and 40mg of duloxetine or VB12 daily for 3 additional weeks (an open label, randomized, crossover). Dose reduction by the adverse effects was permitted. The primary hypothesis was that duloxetine would be more effective than VB12 in decreasing chemotherapy-induced peripheral neuropathic pain. Numbness and Pain severity were assessed weekly using visual analogue scale (VAS). This research was approved by the Research Ethics Committee of Higashi Sapporo Hospital and University Hospital Medical Information Network (UMIN) Center in Japan.Thirty-four cases (Breast cancer: taxanes 2, gastric cancer: taxane 5, colon cancer: oxaliplatin 6, Malignant lymphoma: vincristine 13, multiple myeloma: bortezomib 8) were made an entry in our institution. Five cases dropped out because of the adverse effect with sleepy and general malaise. Results: Obvious improvements of VAS scores of numbness and pain were observed in duloxetine group. Significant differences of delta VAS (pre VAS scale – 4 weeks VAS after drug administration) were observed between duloxetine group and VB12 group in the aspect of numbness (p=0.02) and pain (p=0.03). Conclusions: Among patients with painful chemotherapy-induced peripheral neuropathy, the use of duloxetine compared with VB12 for 4 weeks resulted in a reduction in numbness and pain, but there are many cases with drop out by the adverse effects. Clinical trial information: 000011554.

scholarly journals Microbiological and Clinical Effects of Sitafloxacin and Azithromycin in Periodontitis Patients Receiving Supportive Periodontal Therapy

2016 ◽  
Vol 60 (3) ◽  
pp. 1779-1787 ◽  
Author(s):  
Takako Nakajima ◽  
Takafumi Okui ◽  
Harue Ito ◽  
Mayuka Nakajima ◽  
Tomoyuki Honda ◽  
...  
Keyword(s):  
Medical Information ◽  
Periodontal Therapy ◽  
Clinical Isolates ◽  
University Hospital ◽  
Clinical Effects ◽  
Clinical Parameters ◽  
Content Type ◽  
Periodontopathic Bacteria ◽  
Supportive Periodontal Therapy ◽  
Registration Number

Sitafloxacin (STFX) is a newly developed quinolone that has robust antimicrobial activity against periodontopathic bacteria. We previously reported that oral administration of STFX during supportive periodontal therapy was as effective as conventional mechanical debridement under local anesthesia microbiologically and clinically for 3 months. The aim of the present study was to examine the short-term and long-term microbiological and clinical effects of systemic STFX and azithromycin (AZM) on active periodontal pockets during supportive periodontal therapy. Fifty-one patients receiving supportive periodontal therapy were randomly allocated to the STFX group (200 mg/day of STFX for 5 days) or the AZM group (500 mg/day of AZM for 3 days). The microbiological and clinical parameters were examined until 12 months after the systemic administration of each drug. The concentration of each drug in periodontal pockets and the antimicrobial susceptibility of clinical isolates were also analyzed. The proportions of red complex bacteria, i.e.,Porphyromonas gingivalis,Treponema denticola, andTannerella forsythia, which are the representative periodontopathic bacteria, were significantly reduced at 1 month and remained lower at 12 months than those at baseline in both the STFX and AZM groups. Clinical parameters were significantly improved over the 12-month period in both groups. An increase in the MIC of AZM against clinical isolates was observed in the AZM group. These results indicate that monotherapy with systemic STFX and AZM might be an alternative treatment during supportive periodontal therapy in patients for whom invasive mechanical treatment is inappropriate. (This study has been registered with the University Hospital Medical Information Network-Clinical Trials Registry [UMIN-CTR] under registration number UMIN000007834.)

scholarly journals Two Cases of Proton Pump Inhibitor (PPI)-resistant Gastric Ulcers Caused by Gastric Empting Disturbance

2005 ◽  
Vol 54 (2/3) ◽  
pp. 69-74
Author(s):  
Yuki NISHINO ◽  
Jun NISHIKAWA ◽  
Masaaki SATAKE ◽  
Toshihiko MATSUMOTO ◽  
Keiko AKASHI ◽  
...  
Keyword(s):  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Gastric Ulcers

Videoconference-Based Cognitive Behavioral Therapy in Symptomatic Panic Disorder Following Primary Pharmacotherapy: Randomized, Assessor-Blinded, Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Yoichi Seki ◽  
Ryo Takemura ◽  
Chihiro Sutoh ◽  
Remi Noguchi ◽  
Yoko Okamoto ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Cognitive Behavioral Therapy ◽  
Medical Information ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Cognitive Behavioral ◽  
University Hospital ◽  
Open Label ◽  
Post Intervention

BACKGROUND Background: Given the difficulty in accessing cognitive behavioral therapy, pharmacotherapy remains the standard of care for panic disorder (PD). OBJECTIVE Objectives: This study aimed to determine the effectiveness of videoconference-based cognitive behavioral therapy (VCBT) for patients who remain symptomatic after primary pharmacotherapy as an adjunct to usual care (UC) when compared with UC alone. METHODS Methods: This prospective, randomized, open-label endpoint trial enrolled 30 patients with PD who did not respond to primary pharmacotherapy, including antidepressants and anxiolytics, after ≥8 weeks of therapy, who underwent VCBT (n=15) or UC (n=15) between November 2017 and March 2020 at Chiba University Hospital in Chiba, Japan. They were evaluated at screening, week 0 (baseline), week 8 (mid-intervention), and week 16 (post-intervention). The primary outcome was the change in the PD Severity Scale (PDSS) score at week 16 from baseline. RESULTS Results: After 16 weeks, the adjusted mean changes in the PDSS score from baseline were −7.92 and 0.75 in the VCBT and UC groups, respectively, with a between-group difference of −8.67 (95% CI: −11.80 to −5.54, P<.0001). A higher proportion of patients in the VCBT group responded to treatment (≥40% reduction in the PDSS score at week 16) and experienced remission (PDSS score <8 points at week 8) than those in the UC group (P<.0001). CONCLUSIONS Conclusions: Our results suggest that VCBT is an effective treatment adjunct to UC in patients with PD who remain symptomatic following primary pharmacotherapy and improves PD symptoms in these patients. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000029987; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034247.

Proton pump inhibitor use for 12 months is not associated with changes in serum magnesium levels: a prospective open label comparative study

2017 ◽  
Vol 28 (2) ◽  
pp. 104-109 ◽  
Author(s):  
Elton Bahtiri ◽  
Hilmi Islami ◽  
Rexhep Hoxha ◽  
Afrim Gashi ◽  
Kujtim Thaci ◽  
...  
Keyword(s):  
Proton Pump Inhibitor ◽  
Comparative Study ◽  
Proton Pump ◽  
Serum Magnesium ◽  
Open Label

Peptic ulcer disease

2020 ◽  
pp. 2849-2861
Author(s):  
Joseph Sung
Keyword(s):  
Peptic Ulcer ◽  
Proton Pump Inhibitor ◽  
Peptic Ulcer Disease ◽  
Proton Pump ◽  
Gastric Ulcers ◽  
High Dose ◽  
Recurrent Bleeding ◽  
Ulcer Disease ◽  
H Pylori ◽  
Line Of Therapy

Helicobacter pylori infection, use of nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, and smoking are the most important causes of peptic ulcer disease. Peptic ulcer disease is characterized by a history of waxing and waning symptoms of localized, dull, aching pain in the upper abdomen. Bleeding is the most common complication; free perforation of the stomach or duodenum into the peritoneal cavity is uncommon but serious. The diagnosis of peptic ulcer disease is made by endoscopy, which offers an opportunity for biopsy of gastric ulcers (which may be malignant) and reveals important prognostic indicators in patients with bleeding ulcers. A single daily dose of a proton pump inhibitor gives quick relief of symptoms and effective healing of peptic ulcers in 4 to 6 weeks. The management of patients with upper gastrointestinal haemorrhage requires a multidisciplinary medical and surgical approach. Early risk stratification based on clinical and endoscopic criteria allows delivery of appropriate care, with endoscopic intervention now widely accepted as the first line of therapy. This should be followed by administration of a high dose of an intravenous proton pump inhibitor to further reduce recurrent bleeding. Treatment of H. pylori is a cure for peptic ulcer disease in most patients. This usually requires at least two antimicrobial agents, with the most popular triple therapy combining a proton pump inhibitor with any two of amoxicillin, metronidazole, and clarithromycin for 7 to 14 days. Eradication of H. pylori infection, avoidance of high-dose NSAIDs or aspirin, and the maintenance use of proton pump inhibitors in high-risk individuals are the best ways to prevent recurrence of ulcer and ulcer complications.

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