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Influence of the Functional Reserve of the Remnant Liver on Major Hepatectomy Combined With Pancreatoduodenectomy 残肝功能储备对肝大部切除联合胰十二指肠切除术的影响。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-11-11 DOI: 10.1002/jhbp.70026
Takashi Mizuno, Shunsuke Onoe, Nobuyuki Watanabe, Mihoko Yamada, Shoji Kawakatsu, Junpei Yamaguchi, Masaki Sunagawa, Taisuke Baba, Tomoki Ebata

Background/Purpose

Major hepatopancreatoduodenectomy (HPD) is associated with a high risk of postoperative mortality, often due to pancreatic fistula formation and liver failure. We evaluated the impact of the functional reserve of the remnant liver on postoperative pancreatic fistula (POPF) formation and mortality.

Methods

Patients who underwent resection of ≥ 3 hepatic segments with pancreatoduodenectomy were retrospectively analyzed. The association of the future liver remnant-to-body weight ratio (FLR/BW) with POPF formation and mortality was assessed. With receiver operating characteristic (ROC) curve analysis, the optimal cutoff values were determined. Underlying pancreatic conditions were also examined.

Results

POPFs occurred in 64% of 177 patients. The predictors of POPFs included a high BMI, low pancreatic CT attenuation, and small pancreatic duct diameter. The FLR/BW was not associated with POPF formation. Postoperative mortality occurred in 6% of patients, mostly due to Grade C postpancreatectomy hemorrhage. An FLR/BW < 0.8% was an independent predictor of mortality (OR 15.79); patients with a ratio below 0.8% had a 14% mortality rate.

Conclusions

Poor remnant liver functional reserve is not associated with POPF formation but significantly increases mortality after major HPD. Ensuring sufficient liver reserve, perhaps through more proactive use of portal vein embolization or parenchyma-sparing procedures, may improve outcomes.

背景/目的:大肝胰十二指肠切除术(HPD)与术后死亡率高相关,通常是由于胰瘘形成和肝功能衰竭。我们评估了残肝功能储备对术后胰瘘(POPF)形成和死亡率的影响。方法:回顾性分析行胰十二指肠切除术≥3肝段患者的资料。评估未来肝脏残体重量比(FLR/BW)与POPF形成和死亡率的关系。通过受试者工作特征(ROC)曲线分析,确定最佳截止值。同时也检查了潜在的胰腺状况。结果:177例患者中有64%发生popf。预测popf的因素包括高BMI、低胰腺CT衰减和小胰管直径。FLR/BW与POPF的形成无关。6%的患者术后死亡,主要是由于C级胰腺切除术后出血。结论:残肝功能储备不良与POPF的形成无关,但会显著增加严重HPD后的死亡率。确保足够的肝脏储备,可能通过更积极地使用门静脉栓塞或保留实质手术,可以改善预后。
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引用次数: 0
Mixed Reality–Based Education Using a Three-Dimensional Anatomical Model Before and During Transpapillary Pancreatic Duct Stenting 胰管经乳头支架植入术前后三维解剖模型的混合现实教育。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-11-11 DOI: 10.1002/jhbp.70025
Yuki Tanisaka, Shomei Ryozawa, Takao Itoi, Masafumi Mizuide, Akashi Fujita, Ryuichi Watanabe, Ryosuke Hamamura, Maki Sugimoto

Tanisaka and colleagues describe the use of mixed reality-based three-dimensional anatomical models for education and guidance before and during transpapillary pancreatic duct stenting. Using a head-mounted display and hand controllers, clinicians visualize patient-specific pancreatic duct anatomy from multiple perspectives, supporting preprocedural understanding and intraoperative navigation in a technically challenging procedure.

Tanisaka及其同事描述了在经乳头胰管支架置入之前和期间使用基于混合现实的三维解剖模型进行教育和指导。使用头戴式显示器和手部控制器,临床医生可以从多个角度可视化患者特定的胰管解剖,支持术前理解和术中导航。
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引用次数: 0
Evaluation of Contact Resistance Between Catheters and Guidewires in Pancreatobiliary Endoscopy: Influence of Material and Mechanical Properties 胰胆道内窥镜中导管与导丝接触电阻的评估:材料和力学性能的影响。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-11-05 DOI: 10.1002/jhbp.70024
Tadahisa Inoue, Shun Futagami, Masato Yano, Tomoya Kitada, Rena Kitano, Kazumasa Sakamoto, Satoshi Kimoto, Jun Arai, Kiyoaki Ito

Background

Guidewire manipulation is critical in pancreatobiliary endoscopy and is always performed in combination with catheters. However, the impact of catheter–guidewire interactions on contact resistance remains unclear. This study aimed to evaluate the contact resistance between various commercially available catheters and guidewires.

Methods

An ex vivo experiment was conducted using 9 catheters and 15 guidewires. Contact resistance during guidewire insertion and withdrawal was measured for each catheter–guidewire combination. Subgroup analyses were performed by categorizing the catheters and guidewires according to their materials and mechanical properties.

Results

In total, 750 insertion and withdrawal tests were performed. High-density polyethylene (HDPE) catheters consistently exhibited the lowest contact resistance across all guidewires. Among the guidewire materials, perfluoroalkoxy alkanes (PFAs) showed significantly lower resistance than the other materials. Guidewires with a friction-reducing surface had lower resistance, and stiffness showed a V-shaped correlation with insertion resistance. Both excessively high and low stiffness increased resistance.

Conclusions

Catheter–guidewire contact resistance was significantly influenced by material, surface processing, and guidewire stiffness. HDPE catheters and PFA guidewires with moderate stiffness and friction-reducing surfaces may optimize performance. These findings offer useful insights for the selection of clinical devices and guidewire development.

背景:导丝操作在胰胆道内窥镜检查中至关重要,通常与导管联合进行。然而,导管-导丝相互作用对接触电阻的影响尚不清楚。本研究旨在评估各种市售导管与导丝之间的接触电阻。方法:采用9根导管和15根导丝进行离体实验。测量导丝插入和拔出过程中导管-导丝组合的接触电阻。根据导管和导丝的材料和力学性能进行分组分析。结果:共进行了750次插拔试验。高密度聚乙烯(HDPE)导管在所有导丝上始终表现出最低的接触电阻。在导丝材料中,全氟烷氧基烷烃(PFAs)的电阻明显低于其他材料。具有减摩表面的导丝阻力较小,刚度与插入阻力呈v型相关。过高和过低的刚度都会增加阻力。结论:导管-导丝接触电阻受材料、表面加工和导丝刚度的显著影响。具有中等硬度和减少摩擦表面的HDPE导管和PFA导丝可以优化性能。这些发现为临床器械的选择和导丝的发展提供了有用的见解。
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引用次数: 0
A Novel Immunohistochemistry Classifier for Ampullary Carcinoma: Highlighting the Prognostic Power of CDX2 一种新的壶腹癌免疫组织化学分类器:强调CDX2的预后能力。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-11-04 DOI: 10.1002/jhbp.70021
Raiza Philip, M. J. Aparna, Rijo Issac, Shailaja Balakumar, Thomas Alex Kodiatte

Background

Ampullary carcinomas (AC) pose a diagnostic challenge while delineating into their prognostically distinct subtypes, pancreaticobiliary (PB) and intestinal (INT). This study aimed to correlate AC's histomorphological (HE) subtypes with its immunohistochemical (IHC) subtypes and evaluate their prognostic outcome.

Methods

This study was conducted in the Department of Pathology at a tertiary care cancer hospital. One hundred cases of ACs in pancreatoduodenectomy specimens were selected. Slides were reviewed for HE subtyping of ACs, including Intra-Ampullary papillary-tubular Neoplasms into HE-PB and HE-INT subtypes. IHCs (MUC1, MUC2, MUC5AC, CDX2 and CK20) were performed. ACs were classified into IHC-PB or IHC-INT types using various IHC schemata. IHC and HE subtypes were correlated using Pearson's Chi-square test. Sensitivity, specificity, positive predictive values, and negative predictive values were calculated for the IHCs. Survival status was analyzed using the Kaplan–Meier survival analysis.

Results and Conclusion

The PB subtype showed a higher pathological tumor stage than INT. Among the various schemas evaluated, the Harthimmer Integrated Liu Layered Scoring system performed best with a significant correlation between HE and IHC subtypes. INT subtypes had better prognostic outcomes than PB subtypes. We found an essential prognostic role of CDX2 in the stratification of ACs.

背景:壶腹癌(AC)在描述其预后不同亚型(胰胆(PB)和肠(INT))时提出了诊断挑战。本研究旨在将AC的组织形态学(HE)亚型与免疫组化(IHC)亚型联系起来,并评估其预后。方法:本研究在某三级肿瘤医院病理科进行。选择100例胰十二指肠切除术标本中的ACs。我们回顾了ACs的HE亚型,包括壶腹内乳头状管肿瘤分为HE- pb和HE- int亚型。进行IHCs (MUC1、MUC2、MUC5AC、CDX2和CK20)检测。采用不同的免疫组化模式将ac分为IHC- pb型和IHC- int型。IHC与HE亚型间的相关性采用Pearson卡方检验。计算ihc的敏感性、特异性、阳性预测值和阴性预测值。采用Kaplan-Meier生存分析分析生存状况。结果与结论:PB亚型肿瘤病理分期高于INT亚型。在评估的各种模式中,Harthimmer综合刘分层评分系统表现最好,HE和IHC亚型之间存在显著相关性。INT亚型预后优于PB亚型。我们发现CDX2在ACs分层中具有重要的预后作用。
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引用次数: 0
Preoperative Serum High-Density Lipoprotein Cholesterol Serves as a Prognostic Marker for Postoperative Prognosis of Distal Cholangiocarcinoma 术前血清高密度脂蛋白胆固醇可作为远端胆管癌术后预后的预后指标。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-30 DOI: 10.1002/jhbp.70022
Han-xuan Wang, Jin-can Huang, Shao-cheng Lyu, You-wei Ma, Qiang He, Ren Lang, Fei Pan

Background

Researches revealed a close correlation between serum lipid and tumor prognosis. The current study aimed to explore the predictive value of preoperative serum lipid levels for the postoperative prognosis of distal cholangiocarcinoma (dCCA).

Methods

This study retrospectively included 203 dCCA patients who underwent radical surgery in our department. The Kaplan–Meier method and Cox regression model were used for univariate and multivariate analysis. Six machine-learning models were used to build a prediction model for postoperative prognosis. Subgroup and correlation analyses were conducted to reveal influencing factors.

Results

Preoperative high-density lipoprotein cholesterol (HDL-c) had the best area under the ROC curve with a cutoff value of 0.415 mmol/L. Overall survival and disease-free survival were significantly lower in the low HDL-c group (p < 0.05). Univariate and multivariate analyses identified HDL-c ≤ 0.415 mmol/L as an independent risk factor for postoperative tumor recurrence and overall survival. The survival prediction model incorporating HDL-c constructed by the random forest model exhibited optimal prediction value. Subgroup analysis confirmed HDL-c ≤ 0.415 mmol/L as an independent risk factor for postoperative tumor recurrence and overall survival in patients with tumor infiltration depth ≥ 12 mm, lymph node metastasis and elevated preoperative CA19-9.

Conclusion

HDL-c ≤ 0.415 mmol/L is an independent risk factor for postoperative prognosis in dCCA patients.

背景:研究发现血脂与肿瘤预后密切相关。本研究旨在探讨术前血脂水平对远端胆管癌(dCCA)术后预后的预测价值。方法:回顾性分析203例在我科行根治性手术的dCCA患者。单因素和多因素分析采用Kaplan-Meier法和Cox回归模型。使用6个机器学习模型建立术后预后预测模型。通过亚组分析和相关分析揭示影响因素。结果:术前高密度脂蛋白胆固醇(HDL-c)的ROC曲线下面积最佳,截止值为0.415 mmol/L。结论:HDL-c≤0.415 mmol/L是影响dCCA患者术后预后的独立危险因素。
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引用次数: 0
Early Definitive Surgery for Congenital Biliary Dilatation in Children Is Associated With Lower Morbidity: Comparison of Infant and School-Age Children From 231 Consecutive Cases in a Multicenter Study in the Kyushu Area of Japan During the Past Decade 儿童先天性胆道扩张的早期决定性手术与较低的发病率相关:过去十年来日本九州地区一项多中心研究中231例连续病例的婴儿和学龄儿童的比较。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-29 DOI: 10.1002/jhbp.70023
Masakazu Murakami, Koshiro Sugita, Shohei Maeda, Kina Miyoshi, Yusuke Yamane, Taichiro Kosaka, Shun Onishi, Makoto Hayashida, Toshiharu Matsuura, Kimio Asagiri, Motofumi Torikai, Yukihiro Tatekawa, Takeshi Yamanouchi, Taizo Hibi, Tatsuro Tajiri, Satoshi Ieiri

Purpose

There has been little discussion on the differences in characteristics and long-term outcomes of congenital biliary dilation (CBD) by age group.

Methods

We conducted a regional multicenter study to investigate all pediatric cases of CBD in the Kyushu area of Japan over the past decade. Patient background, operative results, and postoperative complications were investigated. Results were compared between preschool children under 7 years of age and school-age children over 7 years of age.

Results

A total of 187 preschool children and 44 school-aged children with CBD were included. The preschool group had a significantly shorter operative time and lower blood loss. The school-age group had significantly more biliary leakage (4.8% vs. 13.6%, p = 0.03) and more anastomotic stenosis (2.1% vs. 9.1%, p = 0.02). For biliary leakage and anastomotic stenosis, an ROC analysis demonstrated the moderate predictive power for age in months at surgery (AUC = 0.739, 95% CI: 0.577–0.901), with 75.0% sensitivity and 74.0% specificity at a cutoff value of 65.0.

Conclusions

Relative to preschool children, school-age children were more likely to suffer postoperative complications such as biliary leakage and anastomotic stenosis. Early definitive surgery in the infantile period is recommended for pediatric CBD.

目的:关于不同年龄组先天性胆道扩张症(CBD)的特点和长期预后差异的讨论很少。方法:我们进行了一项区域多中心研究,调查过去十年日本九州地区所有儿童CBD病例。研究了患者背景、手术结果和术后并发症。结果比较了7岁以下学龄前儿童和7岁以上学龄儿童。结果:共纳入学龄前儿童187例,学龄儿童44例。学龄前组手术时间明显缩短,出血量明显减少。学龄组胆漏发生率(4.8% vs. 13.6%, p = 0.03)和吻合口狭窄发生率(2.1% vs. 9.1%, p = 0.02)显著高于学龄组。对于胆道渗漏和吻合口狭窄,ROC分析显示手术时年龄的预测能力中等(AUC = 0.739, 95% CI: 0.577-0.901),敏感性为75.0%,特异性为74.0%,临界值为65.0。结论:与学龄前儿童相比,学龄儿童更容易出现术后胆漏、吻合口狭窄等并发症。小儿CBD建议在婴儿期早期进行决定性手术。
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引用次数: 0
Is Prophylactic Drainage Tube Placement Clinically Useful After Laparoscopic Cholecystectomy in Patients With Gallbladder Drainage for Acute Cholecystitis? A Propensity Score-Matched Study: A Secondary Analysis of the CSGO-HBP-017 急性胆囊炎腹腔镜胆囊切除术后胆囊引流患者预防性置管是否有临床意义?倾向评分匹配研究:CSGO-HBP-017的二次分析
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-26 DOI: 10.1002/jhbp.70020
Shohei Takaichi, Yoshito Tomimaru, Kazuhiko Hashimoto, Nariaki Fukuchi, Shigekazu Yokoyama, Takuji Mori, Masahiro Tanemura, Shogo Kobayashi, Makoto Fujii, Yuichiro Doki, Hidetoshi Eguchi

Background

The aim of the study was to investigate whether prophylactic drainage tube (PD) is clinically useful after laparoscopic cholecystectomy (LC) in patients who undergo gallbladder drainage for acute cholecystitis (AC).

Method

Using data from our previous multicenter retrospective study exploring the optimal timing of LC after gallbladder drainage for AC, we performed a secondary analysis in which we compared surgical outcomes between patients who underwent gallbladder drainage and subsequent LC for AC with (n = 134) or without (n = 149) PD placement. The results of the comparison were verified by propensity score matching with 84 patients in each group.

Results

The postoperative length of stay (LOS) in the hospital was significantly longer in patients with a PD than those without a PD, and we identified several significant differences in preoperative and intraoperative characteristics between the two groups. After propensity score matching, the LOS remained significantly longer in patients with PDs, but there were no differences in postoperative complications. Matched multivariate analysis identified PD placement as an independent predictor of a prolonged postoperative hospital stay.

Conclusions

PD placement after LC in patients with gallbladder drainage for AC did not impact the postoperative outcome and could prolong the postoperative LOS.

背景:本研究旨在探讨急性胆囊炎(AC)患者行腹腔镜胆囊切除术(LC)后预防性引流管(PD)在临床上是否有用。方法:利用我们之前的多中心回顾性研究数据,探讨AC胆囊引流后LC的最佳时机,我们进行了二次分析,比较了接受胆囊引流和LC治疗AC的患者(n = 134)和未放置PD的患者(n = 149)的手术结果。通过倾向评分匹配每组84例患者,验证比较结果。结果:PD患者的术后住院时间(LOS)明显长于无PD患者,我们发现两组患者在术前和术中特征上存在一些显著差异。倾向评分匹配后,pd患者的LOS持续时间明显更长,但术后并发症没有差异。匹配的多变量分析确定PD放置是术后住院时间延长的独立预测因子。结论:胆囊引流AC患者LC后放置PD不影响术后疗效,可延长术后LOS。
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引用次数: 0
Proposal of a Modified Adhesion Score as a Predictor of Technical Difficulty and Surgical Risks of Repeat Hepatectomy: The TORAD Score, Version 2.0 改良粘连评分作为重复肝切除术技术难度和手术风险预测指标的建议:TORAD评分,2.0版。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-24 DOI: 10.1002/jhbp.70019
Junichi Shindoh, Yuta Kobayashi, Satoshi Okubo, Yasutaka Kuno, Hisashi Murakami, Takuma Okada, Masaru Matsumura, Masaji Hashimoto

Background

TORAD score is a grading system that evaluates the technical difficulty of repeat hepatectomy (ReHx), and its clinical relevance has been reported in several studies. However, recent advances in minimally invasive surgery have rendered the ability of this scoring system to discriminate between different levels of adhesion severity inadequate.

Method

We developed a modified grading system to accurately evaluate the adhesion severity related to the difficulty of ReHx through a video review of 214 patients.

Results

The modified grading system consists of three parts: (1) A score, the severity of adhesions around the hepatic hilum; (2) B score, the severity of adhesions around the liver; and (3) C score, the severity of adhesions at the site of the previous cut surface. Each of the scores is based on a four-level severity scale, and the sum of the three scores is termed the TORAD score, v2.0. High inter-observer agreement was confirmed in the assessment of these adhesion categories (kappa value: 0.972–1.000), and the TORAD scores, v2.0 were found to show good correlations with the short-term surgical outcomes.

Conclusion

The modified grading system offers promise as an optimal scale for evaluating the technical difficulty and surgical risk of ReHx associated with adhesions.

背景:TORAD评分是一种评估重复肝切除术(ReHx)技术难度的分级系统,其临床相关性已在多项研究中得到报道。然而,微创手术的最新进展使得该评分系统区分不同粘连严重程度的能力不足。方法:通过对214例患者的视频回顾,我们建立了一套改进的分级系统,以准确评估与ReHx难度相关的粘连严重程度。结果:改进后的分级体系由三部分组成:(1)A分,肝门周围粘连的严重程度;(2) B评分,肝周粘连严重程度;(3) C评分,表示先前切口处粘连的严重程度。每一个分数都是基于一个四级严重程度量表,三个分数的总和被称为TORAD分数,v2.0。观察者间对这些粘连类别的评价一致性较高(kappa值:0.972-1.000),TORAD评分v2.0与近期手术结果有较好的相关性。结论:改进后的分级系统有望作为评估ReHx合并粘连的技术难度和手术风险的最佳量表。
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引用次数: 0
Global Trends in Perioperative Imaging Workups and Records for Hepatobiliary and Pancreatic Surgery: Reports From 103 Facilities Worldwide 肝胆胰手术围手术期影像学检查和记录的全球趋势:来自全球103家机构的报告。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-14 DOI: 10.1002/jhbp.70017
Yoshihiro Sakamoto, Goro Honda, Taizo Hibi, Tomoyuki Yoshida, Shohei Kudo, Nobuhiro Hasui, Hirokazu Momose, Ryota Matsuki, Masaharu Kogure, Mureo Kasahara

Background

Perioperative imaging workups and records, including preoperative schema-drawing, three-dimensional tomographic image simulation, intraoperative ultrasonography, fluorescence imaging in hepatectomy, and postoperative record with illustration, may be helpful to perform and educate safe and accurate hepato-biliary-pancreatic (HBP) surgery. The purpose of this study is to elucidate the global usage of image-analyzing methods in HBP surgery.

Methods

Twenty-four questions were sent to 182 HBP and transplantation surgeons in 177 academic institutions in 34 countries worldwide to examine the usage of perioperative image-analyzing methods, surgical volume, and introduction of minimally invasive (MI) approaches.

Results

Questionnaire responses were obtained from 107 surgeons at 103 institutions across 27 countries (response rate, 58.2%). Perioperative schema-drawing (97% vs. 41%), three-dimensional simulation (100% vs. 58%), and operation record with illustration (100% vs. 41%), were best utilized in Japan (p < 0.001). The number of hepatectomy, liver transplantation, pancreatectomy, introduction of MI approaches was significantly associated with a larger number of surgical staffs (≥ 12) in each institution, but not with the imaging workups and records.

Conclusion

Japan made optimal use of perioperative image-analyzing methods; however, they are not of global standard. Surgical volume and introduction of MI-HBP surgery were associated with the number of surgical staff.

背景:围手术期影像学检查和记录,包括术前方案绘制、三维断层图像模拟、术中超声检查、肝切除术中的荧光成像以及术后有插图的记录,可能有助于实施和指导安全、准确的肝胆胰(HBP)手术。本研究的目的是阐明图像分析方法在HBP手术中的整体应用。方法:向全球34个国家177个学术机构的182名HBP和移植外科医生发送24个问题,以检查围手术期图像分析方法的使用、手术量和微创(MI)入路的引入。结果:对27个国家103家机构的107名外科医生进行问卷调查(回复率为58.2%)。围手术期方案绘制(97%对41%)、三维模拟(100%对58%)和手术记录插图(100%对41%)在日本得到了最好的利用(p结论:日本对围手术期图像分析方法的利用是最佳的,但它们不是全球标准。手术量和MI-HBP手术的引入与手术人员的数量有关。
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引用次数: 0
A Pilot Study on the Efficacy and Safety of Sedation With Remimazolam in Japanese Patients Undergoing Endoscopic Retrograde Cholangiopancreatography 日本患者行内窥镜逆行胆管造影时使用雷马唑仑镇静的有效性和安全性的初步研究。
IF 2.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-12 DOI: 10.1002/jhbp.70018
Shuhei Shintani, Takayoshi Mizuno, Jun Matsubayashi, Takuya Okamoto, Kosuke Hiroe, Atsushi Nishida, Hirotoshi Kitagawa, Osamu Inatomi, Takuji Iwashita

Objectives

Remimazolam is a novel, ultra-short-acting benzodiazepine. Remimazolam is characterized by rapid induction and recovery and low cardiopulmonary effects. The present study aimed to examine the safety and efficacy of a sedation method combining remimazolam and pentazocine during endoscopic retrograde cholangiopancreatography (ERCP) in a Japanese cohort.

Methods

The present investigation was a single-center, single-arm, Phase 2 study. The primary endpoint was successful endoscopic sedation. The initial dose was induced with remimazolam (0.1 mg/kg) and pentazocine (3.75 mg). Remimazolam (0.05 mg/kg) and the same dose of pentazocine as the initial dose were added as needed in response to body movements or signs of discomfort during the procedure.

Results

A total of 59 patients [median age (range): 75 years (48–87 years), 47 male (79.7%)] were enrolled. Successful endoscopic sedation was achieved in all patients. One patient (1.7%) experienced transient circulatory depression, with no instances of respiratory depression or need for flumazenil reversal. Post-procedure alertness was achieved within 5 and 10 min in 52 (88.1%) and 58 patients (98.3%), respectively.

Conclusion

Sedation with remimazolam and pentazocine in ERCP demonstrated high efficacy and a favorable safety profile in the Japanese population.

Trial Registration

This trial was registered in the Japan Registry of Clinical Trials (jRCTs051230088)

目的:雷马唑仑是一种新型超短效苯二氮卓类药物。雷马唑仑的特点是诱导和恢复快,对心肺的影响小。本研究旨在研究雷马唑仑和戊唑嗪联合镇静方法在内镜逆行胆管胰胆管造影(ERCP)中的安全性和有效性。方法:本研究为单中心、单组、2期研究。主要终点是成功的内镜镇静。初始剂量为雷马唑仑(0.1 mg/kg)和戊唑嗪(3.75 mg)。在手术过程中,根据身体运动或不适迹象的需要,加入雷马唑仑(0.05 mg/kg)和与初始剂量相同剂量的戊唑嗪。结果:共入组59例患者,中位年龄(范围):75岁(48 ~ 87岁),男性47例(79.7%)。所有患者均成功实现内窥镜镇静。1例患者(1.7%)出现短暂性循环抑制,无呼吸抑制或需要氟马西尼逆转。52例(88.1%)和58例(98.3%)患者分别在5分钟和10分钟内达到术后警觉。结论:在日本人群中,雷马唑仑和戊唑嗪在ERCP中显示出较高的镇静效果和良好的安全性。试验注册:该试验已在日本临床试验注册中心注册(jRCTs051230088)。
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Journal of Hepato‐Biliary‐Pancreatic Sciences
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