Pub Date : 2025-03-17DOI: 10.1016/s2468-1253(25)00012-3
Kristina Hugova, Jan Mares, Bengt Hakanson, Alessandro Repici, Burkhard H A von Rahden, Albert J Bredenoord, Raf Bisschops, Helmut Messmann, Tania Ruppenthal, Oliver Mann, Jakob Izbicki, Tomas Harustiak, Uberto Fumagalli Romario, Riccardo Rosati, Christoph-Thomas Germer, Marlies Schijven, Alice Emmermann, Daniel von Renteln, Sarah Dautel, Paul Fockens, Yuki B Werner
<h3>Background</h3>In this trial, we previously showed per-oral endoscopic myotomy (POEM) to be non-inferior to laparoscopic Heller's myotomy (LHM) plus Dor fundoplication in managing symptoms in patients with idiopathic achalasia 2 years post-procedure. However, post-procedural gastro-oesophageal reflux was more common after POEM at 2 years. Here we report 5-year follow-up data.<h3>Methods</h3>This study is a multicentre, randomised, open-label, non-inferiority trial performed at eight centres in six European countries (Germany, Italy, Czech Republic, Sweden, the Netherlands, and Belgium). Patients with symptomatic primary achalasia were eligible for inclusion if they were older than 18 years and had an Eckardt symptom score higher than 3. Patients were randomly assigned (1:1; randomly permuted blocks of sizes 4, 8, or 12) to undergo either POEM or LHM plus Dor fundoplication. The primary endpoint was clinical success, defined by an Eckardt symptom score of 3 or less without the use of additional treatments, at 2 years, and was reported previously. Prespecified secondary endpoints at 5 years were clinical success; Eckardt symptom score; Gastrointestinal Quality of Life Index score; lower oesophageal sphincter function by high-resolution manometry; and parameters of post-procedural reflux (reflux oesophagitis according to the Los Angeles classification; pH-metry, and DeMeester clinical score). We hypothesised that POEM would be non-inferior (with a non-inferiority margin of –12·5 percentage points) to LHM plus Dor fundoplication with regards to clinical success. All analyses were performed on a modified intention-to-treat (mITT) population, which included all patients who underwent the assigned procedure. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> (<span><span>NCT01601678</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>) and is complete.<h3>Findings</h3>Between Dec 7, 2012, and Oct 9, 2015, 241 patients were randomly assigned (120 to POEM and 121 to LHM) and 221 had the assigned treatment (112 POEM and 109 LHM; mITT). 5-year follow up data were available for 90 (80%) patients in the POEM group and 87 (80%) patients in the LHM group. Clinical success rate at 5 years was 75·0% (95% CI 66·2 to 82·1) after POEM and 70·8% (61·7 to 78·5) after LHM (difference 4·2 percentage points [95% CI –7·4 to 15·7]). The mean Eckardt symptom score decreased from baseline to 5 years in both groups and the overall difference in mean scores was –0·29 (95% CI –0·62 to 0·05). Change in Gastrointestinal Quality of Life Index scores, as well as in integrated relaxation pressure on manom
背景在这项试验中，我们曾发现在特发性贲门失弛缓症患者术后 2 年的症状控制方面，经口内镜下肌切开术（POEM）并不优于腹腔镜海勒氏肌切开术（LHM）加多尔胃底折叠术。然而，POEM术后2年胃食管反流的情况更为常见。本研究是一项多中心、随机、开放标签、非劣效试验，在六个欧洲国家（德国、意大利、捷克共和国、瑞典、荷兰和比利时）的八个中心进行。有症状的原发性贲门失弛缓症患者只要年龄在18岁以上，且埃卡症状评分高于3分，就有资格被纳入试验。患者被随机分配（1:1；大小为4、8或12的随机排列区块）接受POEM或LHM加Dor胃底折叠术。主要终点是临床成功，即在不使用额外治疗的情况下，埃卡症状评分达到或低于 3 分，时间为 2 年。5 年的预设次要终点是临床成功率、埃卡尔特症状评分、胃肠道生活质量指数评分、高分辨率测压法得出的下食道括约肌功能以及术后反流参数（根据洛杉矶分类法得出的反流性食管炎、pH 值测量法和 DeMeester 临床评分）。我们假设 POEM 在临床成功率方面不劣于 LHM 加 Dor 胃底折叠术（非劣效差为-12-5 个百分点）。所有分析均在改良意向治疗（mITT）人群中进行，包括所有接受指定手术的患者。该研究已在ClinicalTrials.gov（NCT01601678）上注册，并已完成。研究结果在2012年12月7日至2015年10月9日期间，241名患者被随机分配（120名患者接受POEM治疗，121名患者接受LHM治疗），221名患者接受了指定治疗（112名患者接受POEM治疗，109名患者接受LHM治疗；mITT）。POEM组有90名（80%）患者接受了5年随访，LHM组有87名（80%）患者接受了5年随访。POEM 组 5 年临床成功率为 75-0%（95% CI 66-2 至 82-1），LHM 组为 70-8%（61-7 至 78-5）（相差 4-2 个百分点 [95% CI -7-4 至 15-7]）。从基线到 5 年期间，两组患者的平均埃卡症状评分均有所下降，平均评分的总体差异为-0-29（95% CI -0-62至0-05）。胃肠道生活质量指数评分以及测压时的综合松弛压力从基线到 5 年的变化在两组之间没有显著差异。5 年后，63 名接受 POEM 治疗的患者中有 26 人（41%）患有反流性食管炎，58 名接受 LHM 治疗的患者中有 18 人（31%）患有反流性食管炎（差异为 10-2 个百分点 [95% CI -7-0 至 26-8]）。221例患者中有81例（37%）进行了pH测定，POEM的平均酸暴露时间（10-2% [95% CI 7-6 to 14-2]）高于LHM（5-5% [3-1 to 11-8]）。5年后，POEM组出现异常酸暴露时间的患者明显多于LHM组（45例中的28例[62%]对36例中的11例[31%]；差异为31-7个百分点[95% CI 9-8至50-5]）。两组患者 5 年后出现反流症状的情况相似，POEM 患者的平均 DeMeester 临床评分为 1-3（95% CI 1-0 至 1-6），LHM 患者的平均 DeMeester 临床评分为 1-1（0-9 至 1-4）。在控制贲门失弛缓症症状方面，POEM 作为一种创伤较小的肌切开术，其效果并不亚于 LHM。胃食管反流在两组患者中都很常见，但 POEM 组的反流率更高。因此，患者在做决定时应了解每种方法的优缺点。资助机构欧洲临床研究基础设施网络、汉堡科学、发展与文化基金会（Helmut und Hannelore Greve）、Carl-August Skröder 医学博士基金会、Gerhard Büchtemann 博士基金会、Agnes-Graefe 基金会、Georg und Jürgen Rickertsen 基金会、Reinhard Frank 基金会、Johann Max Böttcher 基金会、Richard und Annemarie Wolf Stiftung、Olympus Europa、德国胃肠病学与代谢学会和奥林巴斯欧洲基金会、欧洲联合胃肠病周、奥林巴斯 EuroNOTES 研究基金项目、哈佛催化剂、哈佛临床与转化科学中心、哈佛大学及其附属学术医疗中心。
{"title":"Per-oral endoscopic myotomy versus laparoscopic Heller's myotomy plus Dor fundoplication in patients with idiopathic achalasia: 5-year follow-up of a multicentre, randomised, open-label, non-inferiority trial","authors":"Kristina Hugova, Jan Mares, Bengt Hakanson, Alessandro Repici, Burkhard H A von Rahden, Albert J Bredenoord, Raf Bisschops, Helmut Messmann, Tania Ruppenthal, Oliver Mann, Jakob Izbicki, Tomas Harustiak, Uberto Fumagalli Romario, Riccardo Rosati, Christoph-Thomas Germer, Marlies Schijven, Alice Emmermann, Daniel von Renteln, Sarah Dautel, Paul Fockens, Yuki B Werner","doi":"10.1016/s2468-1253(25)00012-3","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00012-3","url":null,"abstract":"<h3>Background</h3>In this trial, we previously showed per-oral endoscopic myotomy (POEM) to be non-inferior to laparoscopic Heller's myotomy (LHM) plus Dor fundoplication in managing symptoms in patients with idiopathic achalasia 2 years post-procedure. However, post-procedural gastro-oesophageal reflux was more common after POEM at 2 years. Here we report 5-year follow-up data.<h3>Methods</h3>This study is a multicentre, randomised, open-label, non-inferiority trial performed at eight centres in six European countries (Germany, Italy, Czech Republic, Sweden, the Netherlands, and Belgium). Patients with symptomatic primary achalasia were eligible for inclusion if they were older than 18 years and had an Eckardt symptom score higher than 3. Patients were randomly assigned (1:1; randomly permuted blocks of sizes 4, 8, or 12) to undergo either POEM or LHM plus Dor fundoplication. The primary endpoint was clinical success, defined by an Eckardt symptom score of 3 or less without the use of additional treatments, at 2 years, and was reported previously. Prespecified secondary endpoints at 5 years were clinical success; Eckardt symptom score; Gastrointestinal Quality of Life Index score; lower oesophageal sphincter function by high-resolution manometry; and parameters of post-procedural reflux (reflux oesophagitis according to the Los Angeles classification; pH-metry, and DeMeester clinical score). We hypothesised that POEM would be non-inferior (with a non-inferiority margin of –12·5 percentage points) to LHM plus Dor fundoplication with regards to clinical success. All analyses were performed on a modified intention-to-treat (mITT) population, which included all patients who underwent the assigned procedure. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> (<span><span>NCT01601678</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>) and is complete.<h3>Findings</h3>Between Dec 7, 2012, and Oct 9, 2015, 241 patients were randomly assigned (120 to POEM and 121 to LHM) and 221 had the assigned treatment (112 POEM and 109 LHM; mITT). 5-year follow up data were available for 90 (80%) patients in the POEM group and 87 (80%) patients in the LHM group. Clinical success rate at 5 years was 75·0% (95% CI 66·2 to 82·1) after POEM and 70·8% (61·7 to 78·5) after LHM (difference 4·2 percentage points [95% CI –7·4 to 15·7]). The mean Eckardt symptom score decreased from baseline to 5 years in both groups and the overall difference in mean scores was –0·29 (95% CI –0·62 to 0·05). Change in Gastrointestinal Quality of Life Index scores, as well as in integrated relaxation pressure on manom","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"69 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143640869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-17DOI: 10.1016/s2468-1253(25)00048-2
Zaheer Nabi, D Nageshwar Reddy
No Abstract
无摘要
{"title":"Endoscopic versus surgical myotomy: a 5-year perspective on achalasia treatment","authors":"Zaheer Nabi, D Nageshwar Reddy","doi":"10.1016/s2468-1253(25)00048-2","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00048-2","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"183 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143640858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-13DOI: 10.1016/s2468-1253(25)00061-5
Mark Christian Burgmans
No Abstract
{"title":"Software-based quantitative assessment of ablation margins: a new standard for liver tumour ablation","authors":"Mark Christian Burgmans","doi":"10.1016/s2468-1253(25)00061-5","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00061-5","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"45 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143618541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-13DOI: 10.1016/s2468-1253(25)00024-x
Bruno C Odisio, Jessica Albuquerque, Yuan-Mao Lin, Brian M Anderson, Caleb S O'Connor, Bastien Rigaud, Maria Briones-Dimayuga, Aaron K Jones, Bryan M Fellman, Steven Y Huang, Joshua Kuban, Zeyad A Metwalli, Rahul Sheth, Peiman Habibollahi, Milan Patel, Ketan Y Shah, Veronica L Cox, HyunSeon C Kang, Van K Morris, Scott Kopetz, Kristy K Brock
<h3>Background</h3>Tumour coverage with an optimal minimal ablative margin is crucial for improving local control of liver tumours following thermal ablation. The minimal ablative margin has traditionally been assessed through visual inspection of co-registered CT images. However, rates of local tumour control after thermal ablation are highly variable with visual assessment. We aimed to assess the use of a novel software-based method for minimal ablative margin assessment that incorporates biomechanical deformable image registration and artificial intelligence (AI)-based autosegmentation.<h3>Methods</h3>The COVER-ALL randomised, phase 2, superiority trial was conducted at The University of Texas MD Anderson Cancer Center (Houston, TX, USA). Patients aged 18 years or older with up to three histology-agnostic liver tumours measuring 1–5 cm and undergoing CT-guided thermal ablation were enrolled. Thermal ablation was performed with the aim of achieving a minimal ablative margin of 5 mm or greater. Patients were randomly assigned (1:1) to the experimental group (software-based assessment) or the control group (visual assessment) by use of dynamic minimisation to balance covariates. Randomisation was performed intraprocedurally after placement of the ablation applicator. Assessment of oncological outcomes and adverse events were masked to treatment allocation. All analyses were conducted on an intention-to-treat basis. The primary endpoint was the minimal ablative margin on post-ablation intraprocedural CT. A preplanned interim analysis for superiority was done at 50% patient enrolment. Adverse events were recorded with the Common Terminology Criteria for Adverse Events. This trial is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> (<span><span>NCT04083378</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>), and recruitment is complete.<h3>Findings</h3>Patients were enrolled and treated with thermal ablation between June 15, 2020, and Oct 5, 2023. 26 patients were randomly assigned to the control group (mean age 58·1 [SD 14·8] years; 18 [69%] male and eight [31%] female; 11 [42%] colorectal cancer liver metastasis; median tumour diameter 1·7 cm [IQR 1·3–2·3]) and 24 to the experimental group (mean age 60·5 [14·4] years; 16 [67%] male and eight [33%] female; ten [42%] colorectal cancer liver metastasis; median tumour diameter 1·8 cm [1·5–2·5]). The interim analysis showed a mean minimal ablative margin of 2·2 mm (SD 2·8) in the control group and 5·9 mm (2·7) in the experimental group (p<0·0001), prompting halting of enrolment in the control group. A further 50 patients were enrolled
{"title":"Software-based versus visual assessment of the minimal ablative margin in patients with liver tumours undergoing percutaneous thermal ablation (COVER-ALL): a randomised phase 2 trial","authors":"Bruno C Odisio, Jessica Albuquerque, Yuan-Mao Lin, Brian M Anderson, Caleb S O'Connor, Bastien Rigaud, Maria Briones-Dimayuga, Aaron K Jones, Bryan M Fellman, Steven Y Huang, Joshua Kuban, Zeyad A Metwalli, Rahul Sheth, Peiman Habibollahi, Milan Patel, Ketan Y Shah, Veronica L Cox, HyunSeon C Kang, Van K Morris, Scott Kopetz, Kristy K Brock","doi":"10.1016/s2468-1253(25)00024-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00024-x","url":null,"abstract":"<h3>Background</h3>Tumour coverage with an optimal minimal ablative margin is crucial for improving local control of liver tumours following thermal ablation. The minimal ablative margin has traditionally been assessed through visual inspection of co-registered CT images. However, rates of local tumour control after thermal ablation are highly variable with visual assessment. We aimed to assess the use of a novel software-based method for minimal ablative margin assessment that incorporates biomechanical deformable image registration and artificial intelligence (AI)-based autosegmentation.<h3>Methods</h3>The COVER-ALL randomised, phase 2, superiority trial was conducted at The University of Texas MD Anderson Cancer Center (Houston, TX, USA). Patients aged 18 years or older with up to three histology-agnostic liver tumours measuring 1–5 cm and undergoing CT-guided thermal ablation were enrolled. Thermal ablation was performed with the aim of achieving a minimal ablative margin of 5 mm or greater. Patients were randomly assigned (1:1) to the experimental group (software-based assessment) or the control group (visual assessment) by use of dynamic minimisation to balance covariates. Randomisation was performed intraprocedurally after placement of the ablation applicator. Assessment of oncological outcomes and adverse events were masked to treatment allocation. All analyses were conducted on an intention-to-treat basis. The primary endpoint was the minimal ablative margin on post-ablation intraprocedural CT. A preplanned interim analysis for superiority was done at 50% patient enrolment. Adverse events were recorded with the Common Terminology Criteria for Adverse Events. This trial is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> (<span><span>NCT04083378</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>), and recruitment is complete.<h3>Findings</h3>Patients were enrolled and treated with thermal ablation between June 15, 2020, and Oct 5, 2023. 26 patients were randomly assigned to the control group (mean age 58·1 [SD 14·8] years; 18 [69%] male and eight [31%] female; 11 [42%] colorectal cancer liver metastasis; median tumour diameter 1·7 cm [IQR 1·3–2·3]) and 24 to the experimental group (mean age 60·5 [14·4] years; 16 [67%] male and eight [33%] female; ten [42%] colorectal cancer liver metastasis; median tumour diameter 1·8 cm [1·5–2·5]). The interim analysis showed a mean minimal ablative margin of 2·2 mm (SD 2·8) in the control group and 5·9 mm (2·7) in the experimental group (p<0·0001), prompting halting of enrolment in the control group. A further 50 patients were enrolled ","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"23 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143618597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<h3>Background</h3>Timely administration of the hepatitis B virus (HBV) birth dose vaccine, along with identifying high-risk pregnant individuals for antiviral prophylaxis, is essential for the global elimination of vertical transmission of HBV. However, in resource-limited settings, access to HBV DNA testing is scarce, and accurate rapid tests for HBeAg are lacking. We aimed to assess the diagnostic performance of a newly developed hepatitis B core-related antigen (HBcrAg) rapid diagnostic test (RDT) to identify women who are HBsAg-positive and eligible for antiviral prophylaxis.<h3>Methods</h3>In this multicountry diagnostic accuracy study, we retrospectively validated the HBcrAg-RDT using stored plasma from pregnant women who were HBsAg-positive in cohort studies from Cambodia and Cameroon and prospectively using finger-prick capillary blood from postpartum mothers at rural health centres in Burkina Faso. We estimated the sensitivity and specificity of the HBcrAg-RDT for diagnosing high HBV DNA concentrations (≥200 000 IU/mL) using real-time PCR (rtPCR) as the reference. We compared the diagnostic performance of the HBcrAg-RDT with that of conventional HBeAg assays based on the area under the receiver operating characteristic curve (AUROC).<h3>Findings</h3>In total, plasma samples were available for 1964 participants: 1194 stored plasma samples available for analysis from the Cambodian cohort, 501 stored samples from the Cameroonian cohort, and 269 prospectively collected samples from women in the Burkina Faso cohort. In the pooled population, the mean age was 28·1 years (SD 6·0), and 382 (20·0%) were HBeAg positive. The HBcrAg-RDT showed an overall sensitivity of 93·1% (95% CI 90·5–95·2) and specificity of 94·3% (93·0–95·4). Sensitivity and specificity were 93·4% (90·7–95·5) and 94·4% (92·9–95·6) in the retrospective laboratory-based analyses of samples from Cambodia and Cameroon, and 89·7% (75·8–97·1) and 93·9% (90·0–96·6) in the prospective real-world analysis of samples of HBsAg-positive women from Burkina Faso. The AUROC for HBcrAg-RDT (0·937 [95% CI 0·924–0·950]) in distinguishing high versus low HBV DNA concentrations at the 200 000 IU/mL threshold in the pooled data set was significantly higher than that of HBeAg rapid tests (0·822 [0·798–0·845]; p<0·0001) and similar to laboratory-based HBeAg immunoassays (ELISA and chemiluminescence assay; 0·926 [0·897–0·955]; p=0·72). In Burkina Faso, the median turnaround time for HBV DNA testing was 46 days (IQR 31–72), whereas HBcrAg-RDT provided same-day results for all participants.<h3>Interpretation</h3>HBcrAg-RDT might offer a practical solution for integrating the prevention of vertical transmission of HBV into decentralised antenatal care in resource-limited settings, enabling timely identification and management of pregnant individuals who are at high risk of transmission.<h3>Funding</h3>Agence Nationale de Recherches sur le Sida et les Hépatites Virales, Total Foundation, Gilead Scienc
{"title":"Hepatitis B core-related antigen rapid diagnostic test for point-of-care identification of women at high risk of hepatitis B vertical transmission: a multicountry diagnostic accuracy study","authors":"Jeanne Perpétue Vincent, Olivier Ségéral, Dramane Kania, Laurence Borand, Jean-Pierre Adoukara, Adeline Pivert, Amariane Koné, Abdoul Salam Eric Tiendrebeogo, Haoua Tall, Laura Schaeffer, Muriel Vray, Armel Moumouni Sanou, Richard Njouom, Gavin Cloherty, Naofumi Hashimoto, Tetsuo Miura, Wataru Sugiura, Saren Sovann, Jee-Seon Yang, Gauthier Delvallez, Takehisa Watanabe","doi":"10.1016/s2468-1253(25)00015-9","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00015-9","url":null,"abstract":"<h3>Background</h3>Timely administration of the hepatitis B virus (HBV) birth dose vaccine, along with identifying high-risk pregnant individuals for antiviral prophylaxis, is essential for the global elimination of vertical transmission of HBV. However, in resource-limited settings, access to HBV DNA testing is scarce, and accurate rapid tests for HBeAg are lacking. We aimed to assess the diagnostic performance of a newly developed hepatitis B core-related antigen (HBcrAg) rapid diagnostic test (RDT) to identify women who are HBsAg-positive and eligible for antiviral prophylaxis.<h3>Methods</h3>In this multicountry diagnostic accuracy study, we retrospectively validated the HBcrAg-RDT using stored plasma from pregnant women who were HBsAg-positive in cohort studies from Cambodia and Cameroon and prospectively using finger-prick capillary blood from postpartum mothers at rural health centres in Burkina Faso. We estimated the sensitivity and specificity of the HBcrAg-RDT for diagnosing high HBV DNA concentrations (≥200 000 IU/mL) using real-time PCR (rtPCR) as the reference. We compared the diagnostic performance of the HBcrAg-RDT with that of conventional HBeAg assays based on the area under the receiver operating characteristic curve (AUROC).<h3>Findings</h3>In total, plasma samples were available for 1964 participants: 1194 stored plasma samples available for analysis from the Cambodian cohort, 501 stored samples from the Cameroonian cohort, and 269 prospectively collected samples from women in the Burkina Faso cohort. In the pooled population, the mean age was 28·1 years (SD 6·0), and 382 (20·0%) were HBeAg positive. The HBcrAg-RDT showed an overall sensitivity of 93·1% (95% CI 90·5–95·2) and specificity of 94·3% (93·0–95·4). Sensitivity and specificity were 93·4% (90·7–95·5) and 94·4% (92·9–95·6) in the retrospective laboratory-based analyses of samples from Cambodia and Cameroon, and 89·7% (75·8–97·1) and 93·9% (90·0–96·6) in the prospective real-world analysis of samples of HBsAg-positive women from Burkina Faso. The AUROC for HBcrAg-RDT (0·937 [95% CI 0·924–0·950]) in distinguishing high versus low HBV DNA concentrations at the 200 000 IU/mL threshold in the pooled data set was significantly higher than that of HBeAg rapid tests (0·822 [0·798–0·845]; p<0·0001) and similar to laboratory-based HBeAg immunoassays (ELISA and chemiluminescence assay; 0·926 [0·897–0·955]; p=0·72). In Burkina Faso, the median turnaround time for HBV DNA testing was 46 days (IQR 31–72), whereas HBcrAg-RDT provided same-day results for all participants.<h3>Interpretation</h3>HBcrAg-RDT might offer a practical solution for integrating the prevention of vertical transmission of HBV into decentralised antenatal care in resource-limited settings, enabling timely identification and management of pregnant individuals who are at high risk of transmission.<h3>Funding</h3>Agence Nationale de Recherches sur le Sida et les Hépatites Virales, Total Foundation, Gilead Scienc","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"88 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143618615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-12DOI: 10.1016/s2468-1253(25)00064-0
Holly Baker
<h2>Section snippets</h2><section><section><h2>Simvastatin plus rifaximin for decompensated cirrhosis</h2>The addition of simvastatin plus rifaximin to standard therapy does not improve outcomes in patients with decompensated liver cirrhosis, according to the <span><span>LIVERHOPE phase 3 trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>.Elisa Pose and colleagues randomly assigned patients with decompensated cirrhosis to receive simvastatin plus rifaximin (n=117) or placebo (n=120) for 12 months in addition to standard therapy. In the simvastatin plus rifaximin group, 21 (18%) patients experienced acute-on-chronic liver failure compared with 17 (14%) in</section></section><section><section><h2>Nivolumab plus ipilimumab for metastatic colorectal cancer</h2>Nivolumab plus ipilimumab shows potential as a new standard of care for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer, according to the <span><span>CheckMate 8HW phase 3 trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>.Thierry André and colleagues randomly assigned immunotherapy-naive patients to receive either nivolumab plus ipilimumab (n=354) or nivolumab alone (n=353). At median follow-up of 47·0 months (IQR 38·4–53·2), median progression-free survival was not reached in the nivolumab plus ipilimumab</section></section><section><section><h2>Tiragolumab for advanced liver cancer</h2>The addition of tiragolumab, an anti-TIGIT monoclonal antibody, to the established atezolizumab–bevacizumab regimen shows promise in patients with locally advanced or metastatic unresectable hepatocellular carcinoma, according to the <span><span>MORPHEUS-Liver phase 1b–2 study</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>.Richard S Finn and colleagues randomly assigned previously untreated patients to receive either tiragolumab plus atezolizumab plus bevacizumab (n=41) or atezolizumab plus bevacizumab (n=18) every 3 weeks. At clinical cutoff, the</section></section><section><section><h2>Carbon footprint of gastrointestinal endoscopy</h2>Gastrointestinal endoscopy procedures contribute significantly to healthcare-related carbon emissions and waste generation, according to <span><span>new research</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> from India.Hardik Rughwani and colleagues analysed data from 3873 procedures
{"title":"Research in Brief","authors":"Holly Baker","doi":"10.1016/s2468-1253(25)00064-0","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00064-0","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Simvastatin plus rifaximin for decompensated cirrhosis</h2>The addition of simvastatin plus rifaximin to standard therapy does not improve outcomes in patients with decompensated liver cirrhosis, according to the <span><span>LIVERHOPE phase 3 trial</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>.Elisa Pose and colleagues randomly assigned patients with decompensated cirrhosis to receive simvastatin plus rifaximin (n=117) or placebo (n=120) for 12 months in addition to standard therapy. In the simvastatin plus rifaximin group, 21 (18%) patients experienced acute-on-chronic liver failure compared with 17 (14%) in</section></section><section><section><h2>Nivolumab plus ipilimumab for metastatic colorectal cancer</h2>Nivolumab plus ipilimumab shows potential as a new standard of care for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer, according to the <span><span>CheckMate 8HW phase 3 trial</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>.Thierry André and colleagues randomly assigned immunotherapy-naive patients to receive either nivolumab plus ipilimumab (n=354) or nivolumab alone (n=353). At median follow-up of 47·0 months (IQR 38·4–53·2), median progression-free survival was not reached in the nivolumab plus ipilimumab</section></section><section><section><h2>Tiragolumab for advanced liver cancer</h2>The addition of tiragolumab, an anti-TIGIT monoclonal antibody, to the established atezolizumab–bevacizumab regimen shows promise in patients with locally advanced or metastatic unresectable hepatocellular carcinoma, according to the <span><span>MORPHEUS-Liver phase 1b–2 study</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>.Richard S Finn and colleagues randomly assigned previously untreated patients to receive either tiragolumab plus atezolizumab plus bevacizumab (n=41) or atezolizumab plus bevacizumab (n=18) every 3 weeks. At clinical cutoff, the</section></section><section><section><h2>Carbon footprint of gastrointestinal endoscopy</h2>Gastrointestinal endoscopy procedures contribute significantly to healthcare-related carbon emissions and waste generation, according to <span><span>new research</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> from India.Hardik Rughwani and colleagues analysed data from 3873 procedures","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"32 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143608381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-12DOI: 10.1016/s2468-1253(25)00005-6
Paweł Mroczkowski, Michał Mik
No Abstract
{"title":"How reliable and generalisable are the results of the LASRE trial?","authors":"Paweł Mroczkowski, Michał Mik","doi":"10.1016/s2468-1253(25)00005-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00005-6","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"183 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143608385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-12DOI: 10.1016/s2468-1253(25)00047-0
Kang Y-K, Terashima M, Kim Y-W, et al. Adjuvant nivolumab plus chemotherapy versus placebo plus chemotherapy for stage III gastric or gastro-oesophageal junction cancer after gastrectomy with D2 or more extensive lymph-node dissection (ATTRACTION-5): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol 2024; 9: 705–17—In this Article, the penultimate sentence of the Findings section of the Summary should read: “Discontinuation due to treatment-related adverse events was more frequent in the nivolumab plus chemotherapy group (34 [9%] of 371 patients) than the placebo plus chemotherapy group (13 [4%] of 374 patients).” Reasons for treatment discontinuation have been clarified in figure 1 and some rounding errors have been corrected in tables 1 and 2. In figure 2B, the CI for the hazard ratio has been corrected to read “95% CI”. The third sentence of the second paragraph of the Results section should read: “339 (90%) of 377 patients in the nivolumab group and 338 (89%) of 378 patients in the placebo group resided in Japan or South Korea.” The third paragraph of the Results section has been updated to read “Overall, 495 (66%) of 755 patients (228 [60%] of 377 in the nivolumab plus chemotherapy group; 267 [71%] of 378 in the placebo plus chemotherapy group) completed the prespecified adjuvant therapy and 128 (17%) of 755 patients (75 [20%] of those in the nivolumab plus chemotherapy group; 53 [14%] of those in the placebo plus chemotherapy group) discontinued both nivolumab and chemotherapy or placebo and chemotherapy (figure 1). 18 (24%) of 75 patients discontinued both components of therapy in the nivolumab plus chemotherapy group solely due to unacceptable toxicity, as did five (9%) of 53 in the placebo plus chemotherapy group.” The start of the fifth line of the ninth paragraph of the Results section has been revised to state “Similarly, discontinuation due to treatment-related adverse events was…”. In table 3, the number of patients in the placebo plus chemotherapy group who had grade 3 diarrhoea has been corrected to read “13 (3%)”. Details of deaths in the trial have been updated; the final two sentences of the Results section has been replaced with: “There was one death (subarachnoid haemorrhage) in the placebo plus chemotherapy group and two (asphyxia; pneumonitis) in the nivolumab plus chemotherapy group. Only the death due to pneumonitis in the nivolumab plus chemotherapy group was considered to be related to treatment.” These corrections have been made as of March 12, 2025.
{"title":"Correction to Lancet Gastroenterol Hepatol 2024; 9: 705–17","authors":"","doi":"10.1016/s2468-1253(25)00047-0","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00047-0","url":null,"abstract":"<em>Kang Y-K, Terashima M, Kim Y-W, et al. Adjuvant nivolumab plus chemotherapy versus placebo plus chemotherapy for stage III gastric or gastro-oesophageal junction cancer after gastrectomy with D2 or more extensive lymph-node dissection (ATTRACTION-5): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.</em> Lancet Gastroenterol Hepatol <em>2024; <strong>9:</strong> 705–17</em>—In this Article, the penultimate sentence of the Findings section of the Summary should read: “Discontinuation due to treatment-related adverse events was more frequent in the nivolumab plus chemotherapy group (34 [9%] of 371 patients) than the placebo plus chemotherapy group (13 [4%] of 374 patients).” Reasons for treatment discontinuation have been clarified in figure 1 and some rounding errors have been corrected in tables 1 and 2. In figure 2B, the CI for the hazard ratio has been corrected to read “95% CI”. The third sentence of the second paragraph of the Results section should read: “339 (90%) of 377 patients in the nivolumab group and 338 (89%) of 378 patients in the placebo group resided in Japan or South Korea.” The third paragraph of the Results section has been updated to read “Overall, 495 (66%) of 755 patients (228 [60%] of 377 in the nivolumab plus chemotherapy group; 267 [71%] of 378 in the placebo plus chemotherapy group) completed the prespecified adjuvant therapy and 128 (17%) of 755 patients (75 [20%] of those in the nivolumab plus chemotherapy group; 53 [14%] of those in the placebo plus chemotherapy group) discontinued both nivolumab and chemotherapy or placebo and chemotherapy (figure 1). 18 (24%) of 75 patients discontinued both components of therapy in the nivolumab plus chemotherapy group solely due to unacceptable toxicity, as did five (9%) of 53 in the placebo plus chemotherapy group.” The start of the fifth line of the ninth paragraph of the Results section has been revised to state “Similarly, discontinuation due to treatment-related adverse events was…”. In table 3, the number of patients in the placebo plus chemotherapy group who had grade 3 diarrhoea has been corrected to read “13 (3%)”. Details of deaths in the trial have been updated; the final two sentences of the Results section has been replaced with: “There was one death (subarachnoid haemorrhage) in the placebo plus chemotherapy group and two (asphyxia; pneumonitis) in the nivolumab plus chemotherapy group. Only the death due to pneumonitis in the nivolumab plus chemotherapy group was considered to be related to treatment.” These corrections have been made as of March 12, 2025.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"213 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143608384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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