Digestive and Liver Disease最新文献

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Neoadjuvant pembrolizumab with a watch‑and‑wait strategy for localized MSI/dMMR colon cancer: Study protocol for a randomized GERCOR 109 – PRODIGE 84 phase II trial (PREMICES) 新辅助派姆单抗对局部MSI/dMMR结肠癌的观察和等待策略：随机GERCOR 109 - PRODIGE 84 II期试验的研究方案（premess）。

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01 DOI: 10.1016/j.dld.2025.11.003

Jérémie H. Lefevre , Olivier Dubreuil , Raphael Colle , David Tougeron , Angélique Vienot , Aurélien Dupré , Clémence Toullec , Denis Smith , Rosine Guimbaud , Benoist Chibaudel , Marie-Line Garcia Larnicol , Dewi Vernerey , Romain Cohen , PREMICES Study Group

Background

Microsatellite instability (MSI) or mismatch‑repair deficiency (dMMR) defines a biologically distinct subgroup of colorectal cancers that are highly responsive to immune checkpoint inhibition. Major and complete pathological responses have been observed with neoadjuvant immunotherapy, raising the possibility of avoiding upfront surgery in selected patients.

Methods

PREMICES is a multicenter, open‑label, randomized (1:1), non‑comparative phase II trial evaluating neoadjuvant pembrolizumab followed by a structured watch‑and‑wait strategy versus standard-of-care surgery ± adjuvant chemotherapy in adults with resectable, localized MSI/dMMR colon or upper rectal adenocarcinoma. Sixty patients will be randomized across nine French centers. The primary endpoint is 6-month strategy success after randomization (or after two successive colonoscopies), defined as the absence of death, disease progression, a decision to operate due to residual tumor on biopsies, or any primary‑tumor surgery. Secondary endpoints include the 24-month success, event‑free and overall survival, postoperative morbidity, health‑related quality of life (EORTC QLQ‑C30/CR29), tumor regression, and endoscopic complete response. Embedded translational studies include circulating tumor DNA and gut microbiota analyses. Randomization started in September 2025.

Discussion

PREMICES will determine whether a neoadjuvant PD‑1 blockade‑based non‑operative approach can be pursued safely and effectively in localized MSI/dMMR colon cancer and will generate prospective patient‑centered outcomes and biomarker data to inform future phase III trials.

Trial registration

EU‑CT (CTIS) number: 2023‑509322‑22‑00. Registered prior to first patient enrolment.

背景：微卫星不稳定性（MSI）或错配修复缺陷（dMMR）定义了对免疫检查点抑制高度敏感的结直肠癌的一个生物学上不同的亚群。新辅助免疫治疗已观察到主要和完全的病理反应，这提高了某些患者避免前期手术的可能性。方法：PREMICES是一项多中心，开放标签，随机（1:1），非比较II期试验，评估新辅助派姆单抗，然后是结构化的观察和等待策略，与标准护理手术±辅助化疗相比，可切除的，局限性MSI/dMMR结肠或上直肠腺癌的成人。60名患者将被随机分配到法国的9个中心。主要终点是随机分组后（或连续两次结肠镜检查后）6个月的策略成功，定义为无死亡、疾病进展、因活检残留肿瘤决定手术或任何原发性肿瘤手术。次要终点包括24个月的成功、无事件和总生存期、术后发病率、健康相关生活质量（EORTC QLQ - C30/CR29）、肿瘤消退和内镜下完全缓解。嵌入式转化研究包括循环肿瘤DNA和肠道微生物群分析。随机化开始于2025年9月。讨论：preices将确定基于PD - 1阻断的新辅助非手术方法是否可以安全有效地治疗局部MSI/dMMR结肠癌，并将产生以患者为中心的前瞻性结果和生物标志物数据，为未来的III期试验提供信息。试验注册：EU‑CT （CTIS）编号：2023‑509322‑22‑00。在首次患者入组前登记。

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引用次数: 0

Diagnostic accuracy of non-invasive tests for helicobacter pylori infection in children: A multicenter retrospective study by SIGENP 儿童幽门螺杆菌感染的无创检测诊断准确性：SIGENP的多中心回顾性研究

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01 DOI: 10.1016/j.dld.2025.11.013

Tonia Raso , Giulia D’Arcangelo , Sara Renzo , Caterina Strisciuglio , Antonio Colucci , Marco Deganello Saccomani , Matteo Bramuzzo , Francesca Bravin , Naire Sansotta , Giusy Russo , Paolo Lionetti , Angelo Zullo , Salvatore Oliva

Background

Helicobacter pylori (H. pylori) infection remains prevalent in children, with significant clinical implications. While endoscopy with biopsy is the gold standard for diagnosis, non-invasive tests such as the stool antigen test (SAT) and urea breath test (UBT) may offer alternatives.

Objectives

To assess the diagnostic accuracy of SAT and UBT in children with suspected H. pylori infection and identify clinical predictors of infection.

Methods

This retrospective multicenter study included pediatric patients undergoing endoscopy for suspected H. pylori across six Italian centers. Histological analysis served as the reference standard. Diagnostic metrics of SAT and UBT were calculated. Demographic and clinical factors were analyzed to identify independent predictors.

Results

Of 256 patients, 150 (58.6 %) had confirmed infection. SAT showed higher sensitivity [94 % (95 % CI: 0.87–0.97)] than UBT [87 % (CI: 0.64–0.98)] but lower specificity [55 % vs 67 %], with lower PPV (64 % vs 78 %) and higher NPV (91 % vs 80 %). Independent predictors for H. pylori infection included family history [OR 4.4], positive SAT [OR 16.29], and non-Caucasian ethnicity [OR 4.3].

Conclusions

SAT demonstrates high sensitivity and NPV, supporting its role as a screening tool. In children without alarm symptoms, a negative SAT may safely exclude infection and help avoid unnecessary endoscopy.

背景：幽门螺杆菌（h.p ylori）感染在儿童中仍然普遍存在，具有重要的临床意义。虽然内窥镜活检是诊断的金标准，但非侵入性检查，如粪便抗原试验（SAT）和尿素呼气试验（UBT）可能提供替代方案。目的：评估SAT和UBT对疑似幽门螺杆菌感染儿童的诊断准确性，并确定感染的临床预测因素。方法：这项回顾性多中心研究包括意大利6个中心接受疑似幽门螺旋杆菌内窥镜检查的儿科患者。以组织学分析为参考标准。计算SAT和UBT的诊断指标。分析人口学和临床因素以确定独立的预测因素。结果：256例患者中，确诊感染150例（58.6%）。SAT的敏感性[94% (95% CI: 0.87-0.97)]高于UBT [87% (CI: 0.64-0.98)]，但特异性较低[55%对67%]，PPV较低（64%对78%），NPV较高（91%对80%）。幽门螺杆菌感染的独立预测因子包括家族史[OR 4.4]、SAT阳性[OR 16.29]和非白种人[OR 4.3]。结论：SAT具有高灵敏度和NPV，支持其作为筛查工具的作用。在没有警报症状的儿童中，SAT阴性可以安全地排除感染，并有助于避免不必要的内窥镜检查。

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引用次数: 0

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01

引用次数: 0

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01

引用次数: 0

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01

引用次数: 0

Beyond the mucosa: The emerging role of endoscopic ultrasound in the diagnosis and management of inflammatory bowel disease 超越粘膜：内镜超声在炎症性肠病的诊断和治疗中的新作用。

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01 DOI: 10.1016/j.dld.2025.10.027

Federica Di Vincenzo , Livio Enrico Del Vecchio , Carlo Covello , Franco Scaldaferri , Cristiano Spada , Gianenrico Rizzatti

Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic immune-mediated conditions of the gastrointestinal tract. Accurate diagnosis, disease monitoring, and prediction of treatment response remain major challenges. Endoscopic ultrasound (EUS), originally developed for pancreatobiliary indications, offers high-resolution, transmural imaging and is gaining relevance in IBD assessment.

This review comprehensively examines the emerging applications of EUS in IBD, including its potential role in diagnosis, in distinguishing CD from UC, in evaluating disease activity and predicting clinical outcomes and therapeutic responses to biologic agents, through parameters such as bowel wall thickness, parietal stratification, vascular patterns and lymphadenopathy. EUS also enables detailed evaluation and characterization of colorectal lesions and supports real-time, minimally invasive therapeutic interventions, including drainage of intra-abdominal fluid collections, management of perianal fistulas, and guidance during endoscopic dilation of strictures. Technological advancements like contrast-enhanced EUS, elastography, and through-the-scope mini-probes have further enhanced diagnostic accuracy and procedural versatility.

While promising, widespread adoption of EUS in IBD management is limited by the need for standardized protocols and adequate training. Nonetheless, ongoing technological developments and integration with artificial intelligence are expected to expand its role in precision medicine, ultimately improving patient outcomes through better disease characterization, monitoring, and individualized therapeutic strategies.

炎症性肠病（IBD），包括克罗恩病（CD）和溃疡性结肠炎（UC），是胃肠道的慢性免疫介导疾病。准确的诊断、疾病监测和治疗反应预测仍然是主要的挑战。内镜超声（EUS）最初用于胰胆管指征，提供高分辨率，跨壁成像，并在IBD评估中获得相关性。这篇综述全面探讨了EUS在IBD中的新应用，包括它在诊断、区分CD和UC、评估疾病活动性、预测临床结果和生物制剂治疗反应方面的潜在作用，通过肠壁厚度、肠壁分层、血管模式和淋巴结病变等参数。EUS还可以对结直肠病变进行详细的评估和表征，并支持实时的微创治疗干预，包括腹腔内积液的引流，肛周瘘的处理，以及内镜下狭窄扩张的指导。造影增强EUS、弹性成像和通过镜微型探针等技术的进步进一步提高了诊断的准确性和手术的通用性。尽管前景光明，但由于需要标准化的方案和充分的培训，EUS在IBD管理中的广泛采用受到限制。尽管如此，持续的技术发展以及与人工智能的整合有望扩大其在精准医疗中的作用，最终通过更好的疾病表征、监测和个性化治疗策略改善患者的预后。

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引用次数: 0

Author's Reply: “Pathologists emphasize diagnostic consistency in colorectal early neoplasia” 作者回复：“病理学家强调结直肠早期肿瘤诊断的一致性”。

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01 DOI: 10.1016/j.dld.2025.10.019

Federica Grillo , Alessandro Gambella , Paola Parente , Alessandro Vanoli , Luca Mastracci , Paola Cassoni , Matteo Fassan

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Charting the next frontier in Ustekinumab optimization for Crohn's disease: A digital health and AI-driven perspective on the MUST study 绘制克罗恩病Ustekinumab优化的下一个前沿：MUST研究的数字健康和人工智能驱动视角

IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01 DOI: 10.1016/j.dld.2025.10.034

Salman Khan, Yinghui Liu

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IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01

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IF 3.8 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease

Pub Date : 2026-01-01

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