{"title":"Personal Best: From Rock Bottom to the Top of the World | Adele Roberts, Personal Best: From Rock Bottom to the Top of the World, Hodder Catalyst (2024), p. 272, £22·00, ISBN: 978-1399732826","authors":"Emma Starbuck","doi":"10.1016/s2468-1253(24)00323-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00323-6","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142397762","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}
Man-Fung Yuen, Young-Suk Lim, Ki Tae Yoon, Tien-Huey Lim, Jeong Heo, Pisit Tangkijvanich, Won Young Tak, Vaidehi Thanawala, Daniel Cloutier, Shenghua Mao, Andre Arizpe, Andrea L Cathcart, Sneha V Gupta, Carey Hwang, Edward Gane
{"title":"VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study","authors":"Man-Fung Yuen, Young-Suk Lim, Ki Tae Yoon, Tien-Huey Lim, Jeong Heo, Pisit Tangkijvanich, Won Young Tak, Vaidehi Thanawala, Daniel Cloutier, Shenghua Mao, Andre Arizpe, Andrea L Cathcart, Sneha V Gupta, Carey Hwang, Edward Gane","doi":"10.1016/s2468-1253(24)00237-1","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00237-1","url":null,"abstract":"<h3>Background</h3>Chronic hepatitis B virus (HBV) remains a global concern, with current treatments achieving low rates of HBsAg seroclearance. VIR-2218 (elebsiran), a small interfering RNA agent against HBV transcripts, reduces HBsAg concentrations. We aimed to evaluate the safety and antiviral activity of VIR-2218 with and without pegylated interferon-alpha-2a treatment in participants with chronic HBV.<h3>Methods</h3>This open-label, phase 2 study was conducted at 23 sites in six countries (New Zealand, Australia, Hong Kong, Thailand, South Korea, and Malaysia). Adults (aged 18–65 years) with chronic HBV infection without cirrhosis and with HBsAg more than 50 IU/mL and HBV DNA less than 90 IU/mL who were on continued nucleoside or nucleotide reverse transcriptase inhibitor (NRTI) therapy for 2 months or longer were eligible. Participants were enrolled into one of six cohorts to receive VIR-2218 200 mg subcutaneously every 4 weeks, with or without 180 μg subcutaneous pegylated interferon-alfa-2a once per week. Cohort 1 received six doses of VIR-2218 (total 20 weeks); cohort 2 received six doses of VIR-2218 starting at day 1, plus 12 doses of pegylated interferon-alfa-2a starting at week 12 (total 24 weeks); cohort 3 received six doses of VIR-2218 and 24 doses of pegylated interferon-alfa-2a (total 24 weeks); cohort 4 received six doses of VIR-2218 and up to 48 doses of pegylated interferon-alfa-2a (total 48 weeks); cohort 5 received up to 13 doses of VIR-2218 and up to 44 doses of pegylated interferon-alfa-2a (total 48 weeks); and cohort 6 received three doses of VIR-2218 and 12 doses of pegylated interferon-alfa-2a (total 12 weeks). The primary endpoints were the incidence of adverse events and clinical assessments (including results of laboratory tests). Secondary endpoints were the mean maximum reduction of serum HBsAg at any timepoint; the proportion of participants with serum HBsAg seroclearance at any timepoint and for more than 6 months after the end of treatment; and the proportion of participants with anti-HBs seroconversion at any timepoint. For patients who were HBeAg-positive, we also assessed the proportion with HBeAg seroclearance or anti-HBe seroconversion at any timepoint. 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>NCT03672188</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 ongoing.<h3>Findings</h3>Between July 2, 2020, and Nov 2, 2021, 124 individuals were screened for eligibility, 84 of whom were enrolled (15 in cohort 1, 15 in cohort 2, 18 in cohort 3, 18 in cohort 4, 13 in cohort 5, and five in cohort 6). Participant","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142384498","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}
{"title":"The promise of indocyanine green in colorectal surgery.","authors":"Zoe Garoufalia","doi":"10.1016/S2468-1253(24)00235-8","DOIUrl":"10.1016/S2468-1253(24)00235-8","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997032","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}
Alexander Seager, Linda Sharp, Laura J Neilson, Andrew Brand, James S Hampton, Tom J W Lee, Rachel Evans, Luke Vale, John Whelpton, Nathania Bestwick, Colin J Rees
{"title":"Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial.","authors":"Alexander Seager, Linda Sharp, Laura J Neilson, Andrew Brand, James S Hampton, Tom J W Lee, Rachel Evans, Luke Vale, John Whelpton, Nathania Bestwick, Colin J Rees","doi":"10.1016/S2468-1253(24)00161-4","DOIUrl":"10.1016/S2468-1253(24)00161-4","url":null,"abstract":"<p><strong>Background: </strong>Increased polyp detection during colonoscopy is associated with decreased post-colonoscopy colorectal cancer incidence and mortality. The COLO-DETECT trial aimed to assess the clinical effectiveness of the GI Genius intelligent endoscopy module for polyp detection, comparing colonoscopy assisted by GI Genius (computer-aided detection [CADe]-assisted colonoscopy) with standard colonoscopy in routine practice.</p><p><strong>Methods: </strong>We did a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial in 12 National Health Service (NHS) hospitals (ten NHS Trusts) in England, among adults (aged ≥18 years) undergoing planned colonoscopy for gastrointestinal symptoms or for surveillance due to personal or family history (ie, symptomatic indications), or colorectal cancer screening. Randomisation (1:1) to CADe-assisted colonoscopy or standard colonoscopy was done with a web-based dynamic adaptive algorithm, immediately before colonoscopy, with stratification by age group, sex, colonoscopy indication (screening or symptomatic), and NHS Trust. Recruiting staff, participants, and colonoscopists were unmasked to trial allocation; histopathologists, co-chief investigators, and trial statisticians were masked. CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal. The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures); the key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma). Analysis was by intention to treat (ITT), with outcomes compared between groups by mixed-effects regression modelling, in which effect estimates were adjusted for randomisation stratification variables. Data were imputed for outcome measures with more than 5% missing values. All participants who underwent colonoscopy were assessed for safety. The trial is registered on ISRCTN (ISRCTN10451355) and ClinicalTrials.gov (NCT04723758), and is complete.</p><p><strong>Findings: </strong>Between March 29, 2021, and April 6, 2023, 2032 participants (1132 [55·7%] male, 900 [44·3%] female; mean age 62·4 years [SD 10·8]) were recruited and randomly assigned: 1015 to CADe-assisted colonoscopy and 1017 to standard colonoscopy. 1231 (60·6%) participants were undergoing screening and 801 (39·4%) had symptomatic indications. Mean adenomas per procedure was 1·56 (SD 2·82; n=1001 participants with available data) in the CADe-assisted colonoscopy group versus 1·21 (1·91; n=1009) in the standard colonoscopy group, representing an adjusted mean difference of 0·36 (95% CI 0·14-0·57; adjusted incidence rate ratio 1·30 [95% CI 1·15-1·47], p<0·0001). Adenomas were detected in 555 (56·6%) of 980 participants in the CADe-assisted colonoscopy group versus 477 (48·4%) of 986 in the standard colonoscopy group, representing a proportion d","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997031","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}
{"title":"Metastatic pancreatic cancer: a new standardised dose-reduction regimen?","authors":"Paula Ghaneh, Daniel Palmer","doi":"10.1016/S2468-1253(24)00227-9","DOIUrl":"10.1016/S2468-1253(24)00227-9","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142006004","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}
Ashwin D Dhanda, Victoria Allgar, Neeraj Bhala, Lynne Callaghan, Joana Castro, Shilpa Chokshi, Amanda Clements, Colin Drummond, Ewan H Forrest, Lesle Manning, Richard Parker, Debbie L Shawcross, Jennifer Towey
{"title":"Breaking down barriers between liver, addiction, and mental health services for people with alcohol-related liver disease.","authors":"Ashwin D Dhanda, Victoria Allgar, Neeraj Bhala, Lynne Callaghan, Joana Castro, Shilpa Chokshi, Amanda Clements, Colin Drummond, Ewan H Forrest, Lesle Manning, Richard Parker, Debbie L Shawcross, Jennifer Towey","doi":"10.1016/S2468-1253(24)00189-4","DOIUrl":"10.1016/S2468-1253(24)00189-4","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141473047","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}
Nurulamin M Noor, Shaji Sebastian, Miles Parkes, Tim Raine
{"title":"The need for affordable, pragmatic, investigator-led clinical trials of treatment strategies in inflammatory bowel disease.","authors":"Nurulamin M Noor, Shaji Sebastian, Miles Parkes, Tim Raine","doi":"10.1016/S2468-1253(24)00225-5","DOIUrl":"10.1016/S2468-1253(24)00225-5","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141879868","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}
Robin A Faber, Ruben P J Meijer, Daphne H M Droogh, Jasmijn J Jongbloed, Okker D Bijlstra, Fran Boersma, Jeffrey P B M Braak, Elma Meershoek-Klein Kranenbarg, Hein Putter, Fabian A Holman, J Sven D Mieog, Peter A Neijenhuis, Esther van Staveren, Johanne G Bloemen, Jacobus W A Burger, Tjeerd S Aukema, Mark A M Brouwers, Andreas W K S Marinelli, Marinke Westerterp, Pascal G Doornebosch, Annelies van der Weijde, Koop Bosscha, Henricus J M Handgraaf, Esther C J Consten, Daan J Sikkenk, Jacobus Burggraaf, Stijn Keereweer, Joost R van der Vorst, Merlijn Hutteman, Koen C M J Peeters, Alexander L Vahrmeijer, Denise E Hilling
{"title":"Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial.","authors":"Robin A Faber, Ruben P J Meijer, Daphne H M Droogh, Jasmijn J Jongbloed, Okker D Bijlstra, Fran Boersma, Jeffrey P B M Braak, Elma Meershoek-Klein Kranenbarg, Hein Putter, Fabian A Holman, J Sven D Mieog, Peter A Neijenhuis, Esther van Staveren, Johanne G Bloemen, Jacobus W A Burger, Tjeerd S Aukema, Mark A M Brouwers, Andreas W K S Marinelli, Marinke Westerterp, Pascal G Doornebosch, Annelies van der Weijde, Koop Bosscha, Henricus J M Handgraaf, Esther C J Consten, Daan J Sikkenk, Jacobus Burggraaf, Stijn Keereweer, Joost R van der Vorst, Merlijn Hutteman, Koen C M J Peeters, Alexander L Vahrmeijer, Denise E Hilling","doi":"10.1016/S2468-1253(24)00198-5","DOIUrl":"10.1016/S2468-1253(24)00198-5","url":null,"abstract":"<p><strong>Background: </strong>Anastomotic leakage is a severe postoperative complication in colorectal surgery and compromised bowel perfusion is considered a major contributing factor. Conventional methods to assess bowel perfusion have a low predictive value for anastomotic leakage. We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage.</p><p><strong>Methods: </strong>This multicentre, randomised, controlled, phase 3 trial was done in eight hospitals in the Netherlands. We included adults (aged >18 years) who were scheduled for laparoscopic or robotic colorectal surgery (with planned primary anastomosis) for benign and malignant diseases. Preoperatively, patients were randomly assigned (1:1) to fluorescence-guided bowel anastomosis (FGBA) or conventional bowel anastomosis (CBA) by variable block randomisation (block sizes 4, 6, and 8) and stratified by site. The operating surgeon and investigators analysing the data were not masked to group assignment. Patients were unmasked after the surgical procedure or after study end. In the FGBA group, surgeons marked anastomosis levels per conventional perfusion assessment and then administered 5 mg of ICG by 2 mL intravenous bolus. They assessed bowel perfusion using NIR fluorescence imaging and adjusted (or kept) transection lines accordingly. Only conventional methods for bowel perfusion assessment were used in the CBA group. The primary outcome was the difference in the rate of clinically relevant anastomotic leakage (ie, requiring active therapeutic intervention but manageable without reoperation [grade B] or requiring reoperation [grade C], per the International Study Group of Rectal Cancer) between the FGBA group and the CBA group within 90 days post-surgery. The primary outcome and safety were assessed in the intention-to-treat population. This study was registered with ToetsingOnline.nl (NL7502) and ClinicalTrials.gov (NCT04712032) and is complete.</p><p><strong>Findings: </strong>Between July 2, 2020, and Feb 21, 2023, 982 patients were enrolled, of whom 490 were assigned to FGBA and 492 were assigned to CBA. After excluding 51 patients, the intention-to-treat population comprised 931 (463 assigned FGBA and 468 assigned CBA). Patients had a median age of 68·0 years (IQR 59·0-75·0) and 485 (52%) were male and 446 (48%) were female. Ethnicity data were not available. The overall 90-day rate of clinically relevant anastomotic leakage was not significantly different between the FGBA group (32 [7%] of 463 patients) and the CBA group (42 [9%] of 468 patients; relative risk 0·77 [95% CI 0·50-1·20]; p=0·24). No adverse events related to ICG use were observed. 313 serious adverse events in 229 (25%) patients were at 90-day follow-up (159 serious adverse events in 113 [24%] patients in the FGBA group and 154 serious adverse events in 116 [25%] patients in the CBA group). 18 ","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997030","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}
Ryan J Jalleh, Chris K Rayner, Trygve Hausken, Karen L Jones, Michael Camilleri, Michael Horowitz
{"title":"Gastrointestinal effects of GLP-1 receptor agonists: mechanisms, management, and future directions.","authors":"Ryan J Jalleh, Chris K Rayner, Trygve Hausken, Karen L Jones, Michael Camilleri, Michael Horowitz","doi":"10.1016/S2468-1253(24)00188-2","DOIUrl":"10.1016/S2468-1253(24)00188-2","url":null,"abstract":"<p><p>The availability of glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) such as liraglutide and semaglutide, and a GLP-1 and glucose dependent insulinotropic polypeptide coagonist (tirzepatide) represents a paradigm shift in the management of both type 2 diabetes and obesity. There is now considerable attention, including in the public media, on the effect of both long-acting and short-acting GLP-1RAs to delay gastric emptying. Although slowed gastric emptying is integral to reducing post-prandial blood glucose responses in type 2 diabetes, marked slowing of gastric emptying might also increase the propensity for longer intragastric retention of food, with a consequent increased risk of aspiration at the time of surgery or upper gastrointestinal endoscopy. This Personal View summarises current knowledge of the effects of GLP-1 and GLP-1RAs on gastrointestinal physiology, particularly gastric emptying, and discusses the implications for the development of sound pre-operative or pre-procedural guidelines. The development of pre-procedural guidelines is currently compromised by the poor evidence base, particularly in relation to the effect of long-acting GLP-1RAs on gastric emptying. We suggest pre-procedural management pathways for individuals on GLP-1RA-based therapy and discuss priorities for future research.</p>","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141891119","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}