Clinical and Translational Gastroenterology最新文献

{"title":"Clinical Characteristics, Management, and Outcomes of Colitis-Associated Colorectal Cancer and the Comparison With Sporadic Colorectal Cancer in Taiwan.","authors":"Hsin-Yun Wu, Meng-Tzu Weng, Jen-Wei Chou, Hsu-Heng Yen, Chun-Chi Lin, Feng-Fan Chiang, Chen-Shuan Chung, Wei-Chen Lin, Chen-Wang Chang, Puo-Hsien Le, Chia-Jung Kuo, Ching-Pin Lin, Wen-Hung Hsu, Chiao-Hsiung Chuang, Tzung-Jiun Tsai, I-Che Feng, Shu-Chen Wei, Tien-Yu Huang","doi":"10.14309/ctg.0000000000000798","DOIUrl":"10.14309/ctg.0000000000000798","url":null,"abstract":"<p><strong>Introduction: </strong>We explored the clinical characteristics, treatment, and outcomes of colitis-associated colorectal cancer (CAC) and compared with sporadic colorectal cancer in Taiwan.</p><p><strong>Methods: </strong>In this retrospective study spanning 1987-2022, CACs diagnosed according to endoscopic and pathological reports from 14 tertiary centers were reported to our cohort. Clinical demographics, endoscopic findings, histological results, treatment modalities, and outcomes were analyzed. Sporadic colorectal cancer data were retrieved from the Cancer Registry Annual Report, Ministry of Health and Welfare, Taiwan.</p><p><strong>Results: </strong>We enrolled 65 patients with CAC (median age: 56 years; male: 66.2%). Distal colon was the most common tumor location (41.5%). Of patients with ulcerative colitis, 77.2% had extensive colitis, and 76.5% had Mayo endoscopic subscores of ≥2. Moreover, 50% of lesions were nonpolypoid with indistinct borders in 66.7%. Signet-ring cell subtype consisted of 12.3%. Surveillance colonoscopy adherence was 78.4%, yet 51.3% interval cancers occurred. Disease stage 0-4 distribution was 15%, 20%, 13.3%, 20%, and 31.7%, respectively. Endoscopic resection was feasible for 14%, whereas 67.7% required surgery. During follow-up (median: 21.5 months), we recorded 23.2% recurrence and 34.5% mortality. Lesions with indistinct borders were associated with adverse outcomes (adjusted odds ratio = 11.5 [1.35-98.16]). Colitis-associated rectal cancers, diagnosed later ( P < 0.001), had worse outcomes than sporadic rectal cancers.</p><p><strong>Discussion: </strong>This is the largest Asian CAC cohort study, emphasizing the need for stringent disease control, improving detection, and reducing interval cancers. Signet-ring cell subtype was prevalent. Rectal colitis-associated cancers were diagnosed later with poorer outcomes than sporadic rectal cancers.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00798"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Levels of Evidence Supporting Recommendations in Gastroenterology.","authors":"Miyabi Saito, Amy Yu, Nneka N Ufere, Andrew Chan, Bharati Kochar","doi":"10.14309/ctg.0000000000000797","DOIUrl":"10.14309/ctg.0000000000000797","url":null,"abstract":"<p><strong>Introduction: </strong>We aimed to analyze gastrointestinal guidelines to assess the quality of evidence and strength of recommendation.</p><p><strong>Methods: </strong>We abstracted clinical practice guidelines and guidance statements from 4 American gastroenterology societies (American College of Gastroenterology, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy, and American Association for the Study of Liver Disease) and the US Multi-Society Task Force.</p><p><strong>Results: </strong>Of the 3,609 statements analyzed, only 13% were supported by high level of evidence. The number of statements published annually is increasing, but the level of evidence supporting recommendations is declining over time.</p><p><strong>Discussion: </strong>This analysis highlights the need for high quality research in gastroenterology to support the development of stronger evidence-based guideline statements.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00797"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multidisciplinary Approach Improves Eradication Rate and Safety in Refractory Helicobacter pylori Infection.","authors":"Na Dai, Yu-Qin Zhao, Wen-Juan Wu, Zheng-Lin Shen, Yan-Hua Xu, Xiao-Yang Wu, Gui-Zhen Zhang, Lan Wang, Qing-Hua Wang","doi":"10.14309/ctg.0000000000000804","DOIUrl":"10.14309/ctg.0000000000000804","url":null,"abstract":"<p><strong>Introduction: </strong>Helicobacter pylori (HP) infection is prevalent worldwide and contributes to various gastrointestinal diseases. Eradication therapy is crucial in managing HP infection, but antibiotic resistance has led to refractory cases, complicating treatment outcomes and increasing the risk of adverse events. This study aimed to evaluate the effectiveness of a multidisciplinary approach, termed HP Multidisciplinary Team (MDT) Clinic, in improving eradication rates and safety in patients with refractory HP infection.</p><p><strong>Methods: </strong>Between November 2020 and November 2023, 153 patients with refractory HP infection were included, with 51 patients in the non-HP-MDT group and 102 patients in the HP-MDT group. The HP-MDT clinic provided personalized treatment plans, patient education, and follow-up. Genetic testing was conducted in selected cases to assess resistance patterns.</p><p><strong>Results: </strong>Patients attending the HP-MDT clinic showed significantly higher eradication rates compared with those in the non-HP-MDT group (80.39% vs 50.98%, P < 0.001). Logistic regression analysis confirmed that HP-MDT clinic attendance was independently associated with higher eradication rates (odds ratio: 4.43, 95% CI: 2.02 to 9.71, P < 0.001). Genetic testing revealed high rates of antibiotic resistance, particularly to clarithromycin (10/11, 90.91%) and metronidazole (11/11, 100%). Despite resistance, the HP-MDT approach achieved a high eradication rate of 92.31%. Adverse drug reactions occurred in 12.75% of patients in the HP-MDT group, predominantly mild gastrointestinal symptoms.</p><p><strong>Discussion: </strong>The HP-MDT clinic, integrating medical, pharmaceutical, and nursing expertise, significantly improved eradication rates and safety in patients with refractory HP infection. Personalized treatment plans, patient education, and genetic testing contributed to successful outcomes with minimal adverse events.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00804"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effect of the Second Forward View on the Detection Rate of Sessile Serrated Lesions in the Proximal Colon: A Single-Center Prospective Randomized Controlled Study.","authors":"Jiandi Wu, Qingqing Zhang, Xueyan Li, Tao Bai, Xiaohua Hou, Gangping Li, Jun Song","doi":"10.14309/ctg.0000000000000805","DOIUrl":"10.14309/ctg.0000000000000805","url":null,"abstract":"<p><strong>Introduction: </strong>The detection rate of proximal sessile serrated lesion (PSSLDR) is linked to the incidence and mortality of colorectal cancer. However, research on second forward view (SFV) examinations for PSSLDR remains limited. This first randomized controlled trial assessed the impact of the proximal SFV on the PSSLDR.</p><p><strong>Methods: </strong>Patients were randomized into 2 groups during proximal colonoscopy: standard colonoscopy (SC) and SFV. The SC group underwent a standard examination, whereas the SFV group underwent a second examination of the proximal colon (cecum to splenic flexure). The primary outcome was PSSLDR, with secondary outcomes, including the proximal polyp detection rate (PPDR), proximal adenoma detection rate (PADR), and lesion miss rate, compared between the 2 groups.</p><p><strong>Results: </strong>Among 246 patients (SC = 124; SFV = 122), SFV significantly improved the PSSLDR by 7.4% compared with SC (9.8% vs 2.4%, P = 0.017). SFV increased the PPDR by 20.2% (55.7% vs 35.5%, P = 0.002) and PADR by 12.7% (37.7% vs 25%, P = 0.039). Multivariate analysis revealed that sessile serrated lesions (odds ratio [OR] = 7.70, 95% confidence interval [CI] [1.58, 37.59]), inflammatory polyps (OR = 4.24, 95% CI [1.73, 10.39]), and lesion size (OR = 0.76, 95% CI [0.60, 0.96]) were associated with proximal missed lesions. The overall polyp miss rate was 52.9%, with miss rates of 61.0% for polyps <5 mm, 80% for sessile serrated lesions, and 42.2% for adenomas. Furthermore, 12.3% of patients experienced changes in surveillance intervals from SFV examination.</p><p><strong>Discussion: </strong>SFV examination of the proximal colon significantly improved the PSSLDR by 7.4%, PPDR by 20.2%, and PADR by 12.7%, while shortening the detection interval by 12.3%, making it a valuable and cost-effective addition to routine colonoscopy.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00805"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845190/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Accuracy of Fecal Polymerase Chain Reaction Testing in Clarithromycin-Resistant Helicobacter Pylori: A Systematic Review and Meta-Analysis.","authors":"Ahmed Al Qady, Wafa Aldhaleei, Mohamed Salih, Marriam Ali, Sasmith Menakuru, Kapil Dev Nayar, Zhen Wang, Fernando F Stancampiano, Dana Harris, Yan Bi","doi":"10.14309/ctg.0000000000000792","DOIUrl":"10.14309/ctg.0000000000000792","url":null,"abstract":"<p><strong>Introduction: </strong>The increasing prevalence of clarithromycin (CLA)-resistant Helicobacter pylori(H. pylori) strains poses a significant challenge in the management of H. pylori infections. This systematic review and meta-analysis investigates the diagnostic accuracy of polymerase chain reaction (PCR) in identifying CLA-resistant H. pylori strains in stool.</p><p><strong>Methods: </strong>A comprehensive literature search was conducted using PubMed, Embase, and Cochrane databases from database inception to April 30, 2023. Eligible studies evaluated the effectiveness of PCR stool tests in detecting CLA-resistant H. pylori strains in adults (>18-year-old). Studies of pediatric populations, alternative methods to PCR or stool samples, and reference tests other than gastric biopsy were excluded. The bivariate random-effects model was used to pool diagnostic accuracy from the included studies.</p><p><strong>Results: </strong>The analysis of 11 prospective diagnostic studies with a total of 866 patients showed a pooled sensitivity of 0.97 (95% CI: 0.9-0.99) and a pooled specificity of 0.98 (95% CI: 0.81-1.00). Subgroup analysis based on the used technique demonstrated consistent findings without notable variations. The diagnostic odds ratio was calculated at 1843.92 (95% CI: 134.28-25,321.3). The positive likelihood ratio was determined as 51.02 (95% CI: 4.61-564.5), while the negative likelihood ratio was found to be 0.03 (95% CI: 0.01-0.1).</p><p><strong>Discussion: </strong>PCR testing for clarithromycin-resistant H. pylori was highly sensitive and specific across studies with proven reliability in clinical practice, particularly in outpatient settings. Their implementation offers cost-effectiveness and the potential for tailored treatment strategies, holding promise for improved patient outcomes.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00792"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845177/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Misdiagnosis and Underdiagnosis of Hepatic Encephalopathy.","authors":"Patricia P Bloom","doi":"10.14309/ctg.0000000000000784","DOIUrl":"10.14309/ctg.0000000000000784","url":null,"abstract":"<p><p>Patients with cirrhosis are at risk of developing hepatic encephalopathy (HE), which can present with a wide range of symptoms, including confusion, lethargy, inappropriate behavior, and altered sleep patterns. In addition to HE, patients with cirrhosis are at risk of developing mild cognitive impairment, dementia, and delirium, which have features closely resembling HE. Given the similar presentation of these conditions, misdiagnosis can and does occur. Mild cognitive impairment is common in individuals aged 50 years and older and can progress to dementia in those affected. Dementia and HE are both characterized by sleep disturbance and cognitive dysfunction, thus differentiating these conditions can be difficult. Furthermore, delirium can disrupt sleep patterns, and liver disease is recognized as a risk factor for its development. As HE is a cirrhosis-related complication, determining if a patient has undiagnosed cirrhosis is critical, particularly given the large number of patients with asymptomatic, compensated cirrhosis. Separately, underdiagnosis of minimal HE can occur even in patients with diagnosed liver disease, related, in part, to lack of testing. Given the availability of effective therapies for managing symptoms and preventing future episodes, accurate diagnosis of HE is essential.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":"e00784"},"PeriodicalIF":3.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fact or Myth? Black Patients Do Not Want to Participate in Clinical Trials.","authors":"Krystal Mills, Francisco Figueroa, RaKetra Knight, Emem Ekpo, Lilian C Lee, Lance Baldo, Chuanbo Xu, Siqi Wang, Robert M Adelman, Priscilla Pemu, Theodore Levin, Aasma Shaukat, Julia J Liu","doi":"10.14309/ctg.0000000000000826","DOIUrl":"10.14309/ctg.0000000000000826","url":null,"abstract":"<p><strong>Introduction: </strong>To assess strategies for optimizing participation of underserved minorities in a blood-based early colorectal cancer detection test study (PREEMPT CRC; NCT04369053) at a hospital serving primarily Black individuals.</p><p><strong>Methods: </strong>Culturally sensitive, racially congruent research staff approached individuals undergoing average-risk screening colonoscopy. Consent/study procedures were synchronized with clinical appointments. Enrolled and not-enrolled patient characteristics were compared. Recruitment was compared with other study sites.</p><p><strong>Results: </strong>In total, 247 of 509 eligible individuals were enrolled; most were identified as Black (88.7%). No baseline characteristics were associated with participation. Recruitment was high compared with other sites (11th centile).</p><p><strong>Discussion: </strong>Recruitment barriers for Black individuals can be overcome when easy, culturally sensitive access is facilitated.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143058071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine Learning-Guided Fluid Resuscitation for Acute Pancreatitis Improves Outcomes.","authors":"Niwen Kong, Patrick Chang, Ira A Shulman, Ubayd Haq, Maziar Amini, Denis Nguyen, Farhaad Khan, Rachan Narala, Nisha Sharma, Daniel Wang, Tiana Thompson, Jonathan Sadik, Cameron Breze, David C Whitcomb, James L Buxbaum","doi":"10.14309/ctg.0000000000000825","DOIUrl":"10.14309/ctg.0000000000000825","url":null,"abstract":"<p><strong>Introduction: </strong>Ariel Dynamic Acute Pancreatitis Tracker (ADAPT) is an artificial intelligence tool using mathematical algorithms to predict severity and manage fluid resuscitation needs based on the physiologic parameters of individual patients. Our aim was to assess whether adherence to ADAPT fluid recommendations vs standard management impacted clinical outcomes in a large prospective cohort.</p><p><strong>Methods: </strong>We analyzed patients consecutively admitted to the Los Angeles General Medical Center between June 2015 and November 2022 whose course was richly characterized by capturing more than 100 clinical variables. We inputted these data into the ADAPT system to generate resuscitation fluid recommendations and compared with the actual fluid resuscitation within the first 24 hours from presentation. The primary outcome was the difference in organ failure in those who were over-resuscitated (>500 mL) vs adequately resuscitated (within 500 mL) with respect to the ADAPT fluid recommendation. Additional outcomes included intensive care unit admission, systemic inflammatory response syndrome (SIRS) at 48 hours, local complications, and pancreatitis severity.</p><p><strong>Results: </strong>Among the 1,083 patients evaluated using ADAPT, 700 were over-resuscitated, 196 were adequately resuscitated, and 187 were under-resuscitated. Adjusting for pancreatitis etiology, gender, and SIRS at admission, over-resuscitation was associated with increased respiratory failure (odd ratio [OR] 2.73, 95% confidence interval [CI] 1.06-7.03) as well as intensive care unit admission (OR 2.40, 1.41-4.11), more than 48 hours of hospital length of stay (OR 1.87, 95% CI 1.19-2.94), SIRS at 48 hours (OR 1.73, 95% CI 1.08-2.77), and local pancreatitis complications (OR 2.93, 95% CI 1.23-6.96).</p><p><strong>Discussion: </strong>Adherence to ADAPT fluid recommendations reduces respiratory failure and other adverse outcomes compared with conventional fluid resuscitation strategies for acute pancreatitis. This validation study demonstrates the potential role of dynamic machine learning tools in acute pancreatitis management.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143031613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Whole Transcriptome-wide Analysis Combined With Summary Data-Based Mendelian Randomization Identifies High-Risk Genes for Cholelithiasis Incidence.","authors":"Xuxu Liu, Heming Wang, Zhihong Xie, Lianghao Li, Yuanhang He, Ziang Meng, Jiachen Li, Jingjing Yu, Zhiwei Du, Yi Zheng, Tianming Liu, Chenjun Hao, Dongbo Xue, Liyi Wang, Enjun Gao","doi":"10.14309/ctg.0000000000000800","DOIUrl":"10.14309/ctg.0000000000000800","url":null,"abstract":"<p><strong>Introduction: </strong>Cholelithiasis is influenced by various factors, including genetic elements identified in genomewide association studies, but their biological functions are not fully understood.</p><p><strong>Methods: </strong>Analyzing data from the Finngen database with 37,041 cholelithiasis cases and 330,903 controls, this study combined SNP data from GTEx v8 and linkage disequilibriums data from the 1000 Genomes Project. Using the Transcriptomewide Association Studies FUSION protocol and summary data-based Mendelian randomization analysis, it investigated the relationship between gene expression and cholelithiasis, using colocalization tests and conditional analyses to explore causality.</p><p><strong>Results: </strong>The study identified genes associated with cholelithiasis in the liver and whole blood, such as LINC01595, TTC39B, and UGT1A3, with several showing colocalization traits. Notably, RP11-378A13.1 and adenosine deaminase acting on RNA (ADAR) were significantly associated with the disease in both tissues.</p><p><strong>Discussion: </strong>This research provides insights into the genetic underpinnings of cholelithiasis, highlighting the significant role of gene expression in its development. It establishes new gene associations and identifies potential genetic markers for the disease.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (X842) and Lansoprazole for the Treatment of Patients With Erosive Esophagitis.","authors":"Siying Zhu, Muzhou Han, Ye Zong, Fandong Meng, Qi Liu, Biguang Tuo, Zhenyu Zhang, Qizhi Wang, Xiaowei Liu, Song He, Yanbo Zhen, Dong Shao, Shenglan Wang, Baohong Xu, Xing Li, Haitao Tang, Yangde Miu, Chengxia Liu, Jiuye Hu, Pingsheng Hu, Jin Xiu, Ming Lu, Yongdong Wu, Shutian Zhang","doi":"10.14309/ctg.0000000000000803","DOIUrl":"10.14309/ctg.0000000000000803","url":null,"abstract":"<p><strong>Introduction: </strong>X842 is a new type of gastric acid-suppressing agent with a rapid onset of action and a long duration of effect. We aim to investigate the efficacy and safety of different doses of X842 vs lansoprazole in the treatment of patients with erosive esophagitis (EE).</p><p><strong>Methods: </strong>This phase 2 study included 90 patients with EE (Los Angeles grades A-D) who were randomized (1:1:1) to receive oral low-dose X842 (50 mg/d, n = 31), high-dose X842 (100 mg/d, n = 31), or lansoprazole (30 mg/d, n = 30) for 4 weeks. The main efficacy end point was the EE healing rate, which was the proportion of patients who achieved endoscopic healing after 4 weeks of treatment.</p><p><strong>Results: </strong>For intention-to-treat analysis, the EE healing rates at 4 weeks were 93.6% (29/31), 79.3% (23/29), and 80.0% (24/30) for the X842 50 mg, the X842 100 mg, and the lansoprazole 30 mg groups. For per-protocol analysis, the EE healing rates at 4 weeks were 93.6% (29/31), 80.8% (21/26), and 82.1% (23/28) in the 3 groups, respectively. The EE healing rate did not significantly differ among the 3 groups in either the intention-to-treat ( P = 0.2351) or per-protocol ( P = 0.3320) analysis. The incidence of drug-related treatment-emergent adverse events did not differ among groups. No severe drug-related treatment-emergent adverse events occurred in the X842 group.</p><p><strong>Discussion: </strong>Our findings confirmed that X842 had efficacy and a favorable safety profile similar to those of lansoprazole. Therefore, X842, a novel potassium-competitive acid blocker, is expected to become a promising therapeutic agent for EE.</p>","PeriodicalId":10278,"journal":{"name":"Clinical and Translational Gastroenterology","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}