Pub Date : 2024-05-01Epub Date: 2024-03-16DOI: 10.1016/S2468-1253(24)00037-2
Eduard A van Bodegraven, Alberto Balduzzi, Tess M E van Ramshorst, Giuseppe Malleo, Frederique L Vissers, Jony van Hilst, Sebastiaan Festen, Mohammad Abu Hilal, Horacio J Asbun, Nynke Michiels, Bas Groot Koerkamp, Olivier R C Busch, Freek Daams, Misha D P Luyer, Marco Ramera, Giovanni Marchegiani, Joost M Klaase, I Quintus Molenaar, Matteo de Pastena, Gabriella Lionetto, Pier Giuseppe Vacca, Hjalmar C van Santvoort, Martijn W J Stommel, Daan J Lips, Mariëlle M E Coolsen, J Sven D Mieog, Roberto Salvia, Casper H J van Eijck, Marc G Besselink
Background: Prophylactic passive abdominal drainage is standard practice after distal pancreatectomy. This approach aims to mitigate the consequences of postoperative pancreatic fistula (POPF) but its added value, especially in patients at low risk of POPF, is currently being debated. We aimed to assess the non-inferiority of a no-drain policy in patients after distal pancreatectomy.
Methods: In this international, multicentre, open-label, randomised controlled, non-inferiority trial, we recruited patients aged 18 years or older undergoing open or minimally invasive elective distal pancreatectomy for all indications in 12 centres in the Netherlands and Italy. We excluded patients with an American Society of Anesthesiology (ASA) physical status of 4-5 or WHO performance status of 3-4, added by amendment following the death of a patient with ASA 4 due to a pre-existing cardiac condition. Patients were randomly assigned (1:1) intraoperatively by permuted blocks (size four to eight) to either no drain or prophylactic passive drain placement, stratified by annual centre volume (<40 or ≥40 distal pancreatectomies) and low risk or high risk of grade B or C POPF. High-risk was defined as a pancreatic duct of more than 3 mm in diameter, a pancreatic thickness at the neck of more than 19 mm, or both, based on the Distal Pancreatectomy Fistula Risk Score. Other patients were considered low-risk. The primary outcome was the rate of major morbidity (Clavien-Dindo score ≥III), and the most relevant secondary outcome was grade B or C POPF, grading per the International Study Group for Pancreatic Surgery. Outcomes were assessed up to 90 days postoperatively and analysed in the intention-to-treat population and per-protocol population, which only included patients who received the allocated treatment. A prespecified non-inferiority margin of 8% was compared with the upper limit of the two-sided 95% CI (Wald) of unadjusted risk difference to assess non-inferiority. This trial is closed and registered in the Netherlands Trial Registry, NL9116.
Findings: Between Oct 3, 2020, and April 28, 2023, 376 patients were screened for eligibility and 282 patients were randomly assigned to the no-drain group (n=138; 75 [54%] women and 63 [46%] men) or the drain group (n=144; 73 [51%] women and 71 [49%] men). Seven patients in the no-drain group received a drain intraoperatively; consequently, the per-protocol population included 131 patients in the no-drain group and 144 patients in the drain group. The rate of major morbidity was non-inferior in the no-drain group compared with the drain group in the intention-to-treat analysis (21 [15%] vs 29 [20%]; risk difference -4·9 percentage points [95% CI -13·8 to 4·0]; pnon-inferiority=0·0022) and the per-protocol analysis (21 [16%] vs 29 [20%]; risk difference -4·1 percentage points [-13·2 to 5·0]; pnon-inferiority=0·0045). Grade B or C POPF was
背景：预防性被动腹腔引流是胰腺远端切除术后的标准做法。这种方法旨在减轻术后胰瘘（POPF）的后果，但其附加值，尤其是对胰瘘低风险患者的附加值，目前还存在争议。我们的目的是评估对胰腺远端切除术后患者采取不引流政策的非劣效性：在这项国际性、多中心、开放标签、随机对照、非劣效性试验中，我们招募了在荷兰和意大利 12 个中心接受开放或微创择期胰腺远端切除术的 18 岁或以上所有适应症患者。我们排除了美国麻醉学会（ASA）体能状态为 4-5 级或世界卫生组织（WHO）表现状态为 3-4 级的患者，这是在一名 ASA 为 4 级的患者因原有心脏病死亡后经修正增加的。患者在术中被随机分配（1:1）到无引流管或预防性被动引流管放置的包块（规模为4到8），并按年度中心量进行分层（研究结果显示，在2020年10月3日至2020年4月4日期间，患者的年中心量为1,000人次）：2020年10月3日至2023年4月28日期间，共筛选出376名符合条件的患者，并将282名患者随机分配到无引流管组（n=138；女性75[54%]，男性63[46%]）或引流管组（n=144；女性73[51%]，男性71[49%]）。无引流组中有七名患者在术中接受了引流；因此，按协议人群包括无引流组的131名患者和引流组的144名患者。在意向治疗分析（21 [15%] vs 29 [20%]；风险差异-4-9个百分点 [95% CI -13-8至4-0]；非劣效性=0-0022）和按协议分析（21 [16%] vs 29 [20%]；风险差异-4-1个百分点 [-13-2至5-0]；非劣效性=0-0045）中，无引流组的主要发病率与引流组相比并无劣势。不引流组中有 16 例（12%）患者观察到 B 级或 C 级 POPF，引流组中有 39 例（27%）患者观察到 B 级或 C 级 POPF（风险差异-15-5 个百分点 [95% CI -24-5 至 -6-5]；pn-非劣性解释：无引流政策在主要发病率方面是安全的，并减少了 B 级或 C 级 POPF 的检出率，应成为接受远端胰腺切除术的合格患者的新标准方法：英国Ethicon公司（强生医疗公司，英国爱丁堡）。
{"title":"Prophylactic abdominal drainage after distal pancreatectomy (PANDORINA): an international, multicentre, open-label, randomised controlled, non-inferiority trial.","authors":"Eduard A van Bodegraven, Alberto Balduzzi, Tess M E van Ramshorst, Giuseppe Malleo, Frederique L Vissers, Jony van Hilst, Sebastiaan Festen, Mohammad Abu Hilal, Horacio J Asbun, Nynke Michiels, Bas Groot Koerkamp, Olivier R C Busch, Freek Daams, Misha D P Luyer, Marco Ramera, Giovanni Marchegiani, Joost M Klaase, I Quintus Molenaar, Matteo de Pastena, Gabriella Lionetto, Pier Giuseppe Vacca, Hjalmar C van Santvoort, Martijn W J Stommel, Daan J Lips, Mariëlle M E Coolsen, J Sven D Mieog, Roberto Salvia, Casper H J van Eijck, Marc G Besselink","doi":"10.1016/S2468-1253(24)00037-2","DOIUrl":"10.1016/S2468-1253(24)00037-2","url":null,"abstract":"<p><strong>Background: </strong>Prophylactic passive abdominal drainage is standard practice after distal pancreatectomy. This approach aims to mitigate the consequences of postoperative pancreatic fistula (POPF) but its added value, especially in patients at low risk of POPF, is currently being debated. We aimed to assess the non-inferiority of a no-drain policy in patients after distal pancreatectomy.</p><p><strong>Methods: </strong>In this international, multicentre, open-label, randomised controlled, non-inferiority trial, we recruited patients aged 18 years or older undergoing open or minimally invasive elective distal pancreatectomy for all indications in 12 centres in the Netherlands and Italy. We excluded patients with an American Society of Anesthesiology (ASA) physical status of 4-5 or WHO performance status of 3-4, added by amendment following the death of a patient with ASA 4 due to a pre-existing cardiac condition. Patients were randomly assigned (1:1) intraoperatively by permuted blocks (size four to eight) to either no drain or prophylactic passive drain placement, stratified by annual centre volume (<40 or ≥40 distal pancreatectomies) and low risk or high risk of grade B or C POPF. High-risk was defined as a pancreatic duct of more than 3 mm in diameter, a pancreatic thickness at the neck of more than 19 mm, or both, based on the Distal Pancreatectomy Fistula Risk Score. Other patients were considered low-risk. The primary outcome was the rate of major morbidity (Clavien-Dindo score ≥III), and the most relevant secondary outcome was grade B or C POPF, grading per the International Study Group for Pancreatic Surgery. Outcomes were assessed up to 90 days postoperatively and analysed in the intention-to-treat population and per-protocol population, which only included patients who received the allocated treatment. A prespecified non-inferiority margin of 8% was compared with the upper limit of the two-sided 95% CI (Wald) of unadjusted risk difference to assess non-inferiority. This trial is closed and registered in the Netherlands Trial Registry, NL9116.</p><p><strong>Findings: </strong>Between Oct 3, 2020, and April 28, 2023, 376 patients were screened for eligibility and 282 patients were randomly assigned to the no-drain group (n=138; 75 [54%] women and 63 [46%] men) or the drain group (n=144; 73 [51%] women and 71 [49%] men). Seven patients in the no-drain group received a drain intraoperatively; consequently, the per-protocol population included 131 patients in the no-drain group and 144 patients in the drain group. The rate of major morbidity was non-inferior in the no-drain group compared with the drain group in the intention-to-treat analysis (21 [15%] vs 29 [20%]; risk difference -4·9 percentage points [95% CI -13·8 to 4·0]; p<sub>non-inferiority</sub>=0·0022) and the per-protocol analysis (21 [16%] vs 29 [20%]; risk difference -4·1 percentage points [-13·2 to 5·0]; p<sub>non-inferiority</sub>=0·0045). Grade B or C POPF was ","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140159654","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 : 2024-05-01DOI: 10.1016/S2468-1253(24)00092-X
The Lancet Gastroenterology Hepatology
{"title":"Addressing the evolving landscape of global malnutrition.","authors":"The Lancet Gastroenterology Hepatology","doi":"10.1016/S2468-1253(24)00092-X","DOIUrl":"https://doi.org/10.1016/S2468-1253(24)00092-X","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872888","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 : 2024-05-01DOI: 10.1016/S2468-1253(23)00357-6
Serena Porcari, William Fusco, Igor Spivak, Marcello Fiorani, Antonio Gasbarrini, Eran Elinav, Giovanni Cammarota, Gianluca Ianiro
The gut microbiome is acknowledged as a key determinant of human health, and technological progress in the past two decades has enabled the deciphering of its composition and functions and its role in human disorders. Therefore, manipulation of the gut microbiome has emerged as a promising therapeutic option for communicable and non-communicable disorders. Full exploitation of current therapeutic microbiome modulators (including probiotics, prebiotics, and faecal microbiota transplantation) is hindered by several factors, including poor precision, regulatory and safety issues, and the impossibility of providing reproducible and targeted treatments. Artificial microbiota therapeutics (which include a wide range of products, such as microbiota consortia, bacteriophages, bacterial metabolites, and engineered probiotics) have appeared as an evolution of current microbiota modulators, as they promise safe and reproducible effects, with variable levels of precision via different pathways. We describe the landscape of artificial microbiome therapeutics, from those already on the market to those still in the pipeline, and outline the major challenges for positioning these therapeutics in clinical practice.
{"title":"Fine-tuning the gut ecosystem: the current landscape and outlook of artificial microbiome therapeutics.","authors":"Serena Porcari, William Fusco, Igor Spivak, Marcello Fiorani, Antonio Gasbarrini, Eran Elinav, Giovanni Cammarota, Gianluca Ianiro","doi":"10.1016/S2468-1253(23)00357-6","DOIUrl":"https://doi.org/10.1016/S2468-1253(23)00357-6","url":null,"abstract":"<p><p>The gut microbiome is acknowledged as a key determinant of human health, and technological progress in the past two decades has enabled the deciphering of its composition and functions and its role in human disorders. Therefore, manipulation of the gut microbiome has emerged as a promising therapeutic option for communicable and non-communicable disorders. Full exploitation of current therapeutic microbiome modulators (including probiotics, prebiotics, and faecal microbiota transplantation) is hindered by several factors, including poor precision, regulatory and safety issues, and the impossibility of providing reproducible and targeted treatments. Artificial microbiota therapeutics (which include a wide range of products, such as microbiota consortia, bacteriophages, bacterial metabolites, and engineered probiotics) have appeared as an evolution of current microbiota modulators, as they promise safe and reproducible effects, with variable levels of precision via different pathways. We describe the landscape of artificial microbiome therapeutics, from those already on the market to those still in the pipeline, and outline the major challenges for positioning these therapeutics in clinical practice.</p>","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140855774","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 : 2024-05-01DOI: 10.1016/S2468-1253(24)00081-5
Mads Israelsen, Mary E Rinella, Aleksander Krag
{"title":"Validating the new nomenclature of steatotic liver disease in patients with excessive alcohol intake - Authors' reply.","authors":"Mads Israelsen, Mary E Rinella, Aleksander Krag","doi":"10.1016/S2468-1253(24)00081-5","DOIUrl":"https://doi.org/10.1016/S2468-1253(24)00081-5","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140861592","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 : 2024-05-01Epub Date: 2024-02-28DOI: 10.1016/S2468-1253(24)00036-0
Elisa Bannone, Giovanni Marchegiani
{"title":"Robotic pancreatoduodenectomy: preparing for the future.","authors":"Elisa Bannone, Giovanni Marchegiani","doi":"10.1016/S2468-1253(24)00036-0","DOIUrl":"10.1016/S2468-1253(24)00036-0","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140013806","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 : 2024-05-01Epub Date: 2024-03-19DOI: 10.1016/S2468-1253(24)00046-3
Zachary T Berman, Rebekah R White
{"title":"Local ablation in pancreatic cancer: some answers and more questions.","authors":"Zachary T Berman, Rebekah R White","doi":"10.1016/S2468-1253(24)00046-3","DOIUrl":"10.1016/S2468-1253(24)00046-3","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186398","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 : 2024-05-01DOI: 10.1016/S2468-1253(24)00073-6
Mathurin Fumery, Anthony Buisson
{"title":"Has the time come for a systematic top-down approach in Crohn's disease?","authors":"Mathurin Fumery, Anthony Buisson","doi":"10.1016/S2468-1253(24)00073-6","DOIUrl":"https://doi.org/10.1016/S2468-1253(24)00073-6","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140875048","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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