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1.
目的 评估新型便携式内镜系统在上消化道内镜检查中的操作性能、有效性和安全性。方法 采用多中心、开放性、随机、非劣效性对照研究,2019年6月—2020年6月间由3个临床研究中心参与,纳入消化内科门诊就诊的90例患者作为研究对象,随机分配到试验组和对照组,试验组接受便携式内镜完成上消化道检查(n=44),对照组接受临床常规应用的奥林巴斯胃镜完成上消化道检查(n=46)。以后者作为参照,对新型便携式内镜系统的检查成功率、图像质量、操作性能、操作总体满意度、活检成功率和安全性进行评价。结果 试验组内镜检查成功率为97.73%(43/44),对照组为100.00%(46/46),差值为-2.27%(95%CI:-6.68%~2.13%),大于设定的非劣效界值(-10%);试验组与对照组图像质量综合评价优良率均为100%,差值为0,大于设定的非劣效界值(-10%)。对照组操作系统性能优良率为100.00%(46/46),试验组为97.67%(42/43),2组间差异无统计学意义(P=0.483);对照组操作总体满意率为100.00%(46/46),试验组为86.05%(37/43),2组间差异有统计学意义(P=0.011);共9例进行了内镜下活检,试验组5例、对照组4例,2组活检通道均顺畅,均能顺利完成活检。共16例出现不良事件,对照组5例[10.87%(5/46)],试验组11例[25.00%(11/44)],2组间不良事件发生率比较差异无统计学意义(χ2=3.07,P=0.080),所有不良事件均在48 h内消失,无严重不良事件及器械缺陷事件发生。结论 新型便携式内镜系统安全性高,操作性能与图像质量良好,与临床常用的日本奥林巴斯内镜系统效果相当,可推广应用。  相似文献   

2.
目的 比较新型便携式内镜系统和常规电子内镜系统用于动物腹部战创伤探查与紧急治疗的可行性与安全性。方法 将3头健康巴马猪分别编为1号、2号、3号,术前禁食水8 h。实验前进行诱导麻醉,从巴马猪的中腹壁逐层切开进入腹腔,利用腹腔镜气腹机建立人工气腹,置入子弹模型1枚,建立子弹创伤模型;取出子弹模型后置入弹片模型1枚,建立弹片创伤模型。分别应用新型便携式内镜系统和常规电子内镜系统对1号巴马猪进行子弹模型和弹片模型的探查及取出操作。上述操作结束后,两种内镜系统分别对2号、3号巴马猪进行同样操作过程。两种内镜操作的先后顺序根据随机数表法进行分配。分别记录两种内镜系统的手术成功情况、手术时间、内镜管道通畅性、内镜操作满意情况、不良事件和器械缺陷发生情况。结果 使用新型便携式内镜系统和常规电子内镜系统进行手术各3次,手术均成功。新型便携式内镜系统发现及取出子弹模型、发现及取出弹片模型的时间分别为(232.33±11.68)s、(300.33±57.70)s、(170.00±44.44)s、(52.67±2.52)s;常规电子内镜系统相应时间分别为[(232.67±21.20)s,t=-0.054,P=0.962]、[(256.67±67.00)s,t=0.880,P=0.472]、[(176.00±52.42)s,t=-0.111,P=0.922]、[(58.67±14.84)s,t=-0.832,P=0.493],差异无统计学意义(P>0.05)。实验过程中,两种内镜系统管道均通畅,操作者对两种内镜系统的内镜操作过程均满意。两组均无不良事件和器械缺陷发生。结论 新型便携式内镜系统用于动物腹部战创伤的救治操作成功情况与常规电子内镜系统相当,初步证实该系统用于动物腹部战创伤救治安全可行。  相似文献   

3.
目的初步评价一次性电子胃镜和一次性结肠镜用于消化道检查及配合手术器械进行诊治的性能和安全性。方法应用EndoFresh一次性电子内镜系统对拟行消化道检查的2例患者行消化道内镜检查,同时进行规范化采图,对内镜操作性能、内镜图像质量以及并发症进行评估。结果2例患者在静脉全身麻醉状态应用一次性胃镜和一次性结肠镜成功完成上消化道及全结肠检查。应用一次性内镜顺利完成规范图像采集,内镜吸气、送气及送水,大小钮弯曲以及镜身旋转等动作。利用配套的主机系统可进行图像拍照、视频录像、图文报告以及数据的传输。2例患者的胃镜及结肠镜检查过程顺利,术中、术后均未发生内镜操作相关的不良事件和并发症,操作时间和普通内镜检查相近。结论一次性电子消化内镜系统初步临床应用安全可行,操作性能及内镜图像质量良好,值得进一步研究。  相似文献   

4.
目的 评估国产一次性经口胆道镜在动物胆道镜检查中的有效性和安全性。方法 6头健康巴马小型猪分别于麻醉后行国产一次性经口胆道镜检查,评价其操作性能、图像质量并记录术中和术后并发症。结果 6例动物均完成国产一次性经口胆道镜检查。该胆道镜操作性能良好,能顺利通过十二指肠镜进入胆道,注水、吸引及器械通道通畅。胆道镜图像清晰、颜色分辨率良好,未出现图像变形及失真,可准确评估管腔内情况及清晰观察黏膜表面情况。检查过程中未产生出血、穿孔等操作性损伤,以及呼吸抑制、心脏骤停等不良事件。术后所有猪存活状态良好,无不良反应。结论 国产一次性经口胆道镜操作性能良好,图像质量高,安全性较好。  相似文献   

5.
目的初步评估新型柔性、双臂、主从操作的消化内镜微创手术机器人——DREAMS(dual-arm robotic endoscopic assistant for minimally invasive surgery)系统辅助内镜黏膜下剥离术(endoscopic submucosal dissection, ESD)的可行性。方法选用新鲜剥离的健康猪胃作为模型, 设计不同大小的类圆形病变10个(胃窦和胃体各5个), 由2名内镜医生(甲和乙)独自完成内镜下剥离操作, 观察DREAMS系统辅助下的剥离效果(黏膜下剥离速度)、安全性(肌层损伤、穿孔发生率)和操作性能(抓取效率:用每个病变需要夹钳夹取的次数来评估)。结果 10例机器人辅助下的ESD均顺利完成, 10个病变均实现整块切除, 病变直径(22.34±2.39)mm, 剥离时间(15.00±8.90)min, 剥离速度(141.79±79.12)mm2/min, 平均每个病变需要夹取4.2次, 共有4例(40.0%)ESD出现肌层损伤, 无一例穿孔发生。结论初步动物实验结果显示, DREAMS系统辅助ESD安全、可行。  相似文献   

6.
目的分析上消化道外源性异物的临床表现和内镜治疗效果。方法对该院2004-10~2016-05接诊的165例上消化道外源性异物患者使用Olympus V-70和Olympus CV-150电子胃镜及Olympus CV-260电子胃镜进行治疗。结果共实施内镜下治疗165例,其中3例学龄儿童患者实施丙泊酚(1~2 mg/kg)静脉麻醉无痛胃镜下取异物,74例患者辅助使用胃镜外套管,21例相对光滑食管异物内镜下游离并推送异物至胃腔后退镜,胃内异物65例(其中15例患者内镜检查后未行处理随诊观察待异物自行排出,50例患者内镜下取出),2例转外科手术治疗。所有异物患者均得到治愈。结论上消化道外源性异物使用内镜治疗取物效果满意,值得推广应用。  相似文献   

7.
目的 探讨消化内镜模拟机评估学习者内镜操作经验可能的应用价值.方法 50名学习者按照内镜工作经验分成初级组、中级组、高级组和专家级组,应用消化内镜模拟机中的手眼协调训练评估各组学习者的内镜操作技能,评估参数包括完成总时间、两次触击的间隔时间和触壁次数.结果 以胃镜操作经验分组时,学习者手眼协调训练完成总时间分别为(302.43±108.96)s、(188.00 ±59.88)s、135.00(40.00)s、150.00(69.00)s,两次触击的间隔时间分别为(14.29 ±5.47)s、(8.82 ±3.28)s、6.00(2.00)s、7.00(4.00)s,上述两个指标除了高级组与专家级组组间比较差异无统计学意义(P>0.05)以外,其他各组间比较差异均有统计学意义(P<0.01).以结肠镜操作经验分组时,学习者手眼协调训练完成总时间分别为220.00 (91.00)s、127.00(28.25)s、155.50 (81.00)s、150.00(58.50)s,组间比较差异均有统计学意义(P<0.01);两次触击的间隔时间分别为10.00(4.00)s、5.50(1.50)s、7.00(3.75)s、7.00(3.50)s,除了初级组与高级组比较以及中级组与专家级组比较差异无统计学意义(P>0.05)以外,其他各组间比较差异均有统计学意义(P <0.05或P<0.01).在触壁次数这一指标上,除了以胃镜操作经验进行分组的初级组与高级组间差异有统计学意义(P<0.05)外,其他以胃镜操作经验进行分组的各组间以及以结肠镜操作经验分组的各组间差异均无统计学意义(P>0.05).结论 消化内镜模拟机手眼协调训练的完成总时间可能可以作为实际操作内镜前陕速区分学习者内镜操作经验的一种方法,但对于高级与专家级的精确评估仍需其他指标进行补充.  相似文献   

8.
内镜模拟训练在上消化道内镜培训中的作用研究   总被引:1,自引:0,他引:1  
目的 探讨内镜模拟训练在上消化道内镜教学中的作用.方法 2005年1月-2007年3月41名无内镜操作经验的进修医师、研究生、住院医师,随机分为两组.非内镜模拟训练组于内镜中心观摩学习1个月后开始操作内镜,内镜模拟训练组于观摩学习的同时接受10 h的内镜模拟训练.由专人对所有受训者最初20例内镜操作进行评价、记录,包括插入食管是否成功、胃内观察是否成功、通过幽门是否成功、进入降段是否成功、总的操作时间.结果 插入食管成功率、进入降段成功率两组间差异无统计学意义;胃内观察成功率(P<0.001)、通过幽门成功率(P<0.001)、总操作时间(P=0.032),内镜模拟训练组均优于非内镜模拟训练组,两组间差异有统计学意义.结论 内镜模拟训练在上消化道内镜教学中有重要作用,有助于受训者迅速掌握内镜操作方法,缩短教学时间,减少患者痛苦.  相似文献   

9.
目的 探究国产上消化道超声内镜的有效性及安全性。方法 采用分层区组随机化方法,选取2021年3月至7月中国医科大学附属盛京医院(中心1)和深圳市人民医院(中心2)的160例需要进行超声内镜诊治的患者作为研究对象,试验组使用中国开立EG⁃UC5T超声内镜,对照组使用日本富士EG⁃580UT超声内镜。有效性主要评价指标为超声图像质量优良率,比较采用非劣性验证;次要评价指标为内镜图像质量优良率、操作性能优良率和系统稳定性评价。安全性评价指标为患者术中、术后的不良事件发生情况。结果 在意向治疗分析集,试验组与对照组的超声图像质量优良率分别为100.0%(78/78)和100.0%(77/77),率差为0.0%(95%CI:-4.7%~4.8%);在符合方案分析集,试验组与对照组的超声图像质量优良率分别为100.0%(78/78)和100.0%(75/75),率差为0.0%(95%CI:-4.7%~4.9%),两个数据集的超声图像质量优良率置信区间下限均大于非劣效界值-8%,可推断试验机非劣于对照机的非劣效假设成立。试验组与对照组的内镜图像质量优良率和操作性能优良率在意向治疗和符合方案分析中均为100.0%,差异无统计学意义(P=1.000)。系统不稳定事件发生率试验组为0.0%(0/78),对照组为3.9%(3/77),差异无统计学意义(P=0.120)。两组均无不良事件发生。结论 国产上消化道超声内镜在正常条件使用下有效性、安全性和稳定性均满足临床应用的要求。  相似文献   

10.
经胃与结肠双内镜联合猪胆囊切除术   总被引:2,自引:0,他引:2  
目的 探讨经胃(口腔)和结肠(肛门)双内镜联合切除猪胆囊的可行性和安全性.方法 采用雌性小型猪5头.经胃内镜下.用针型刀和扩张球囊切开胃壁,将内镜送人腹腔.用同样方法将另一条内镜经结肠送入腹腔,双镜联合切除胆囊.术后胃肠壁切口用止血夹闭合.术后动物饲养14 d,剖腹探查.结果 3头猪因胆囊暴露困难,无法完成胆囊切除术.1头在切除胆囊过程中因出血过多,操作失败.另1头成功切除胆囊,但在经胃内镜进入腹腔时发现横膈有3处穿孔,可能是经结肠内镜进入腹腔时误伤临近结肠壁.动物存活14 d后体重下降4kg,开腹探查见胃和结肠壁切口全层愈合.右下腹肠管粘连较严重,并见一脓肿.膈肌穿孔1处愈合,另2处融合并形成憩室,肝脏表面与之粘连并嵌顿其内.结论 经胃与经结肠双内镜联合切除猪胆囊有一定困难,且安全性尚不肯定.  相似文献   

11.
目的探讨急诊内镜下止血治疗老年非静脉曲张性上消化道大出血的疗效及安全性。方法对68例活动性出血患者行床边急诊内镜检查,并内镜下喷药及注射止血治疗。结果所有患者包括高龄、高危患者均安全接受急诊内镜下治疗,急诊镜下止血68例,即时止血64例,近期再止血6例,1次止血成功58例,2次止血成功3例,急诊手术7例,死亡3例。结论急诊内镜下止血治疗老年非静脉曲张性上消化道大出血安全有效,对老年人及高危患者应作为首选治疗方法。  相似文献   

12.
A capsule endoscope is a swallowable wireless miniature camera for getting images of the gastrointestinal (GI) mucosa. The initial capsule endoscope model was developed by Given Imaging and approved in Western countries in 2001. Before the introduction of capsule endoscopy (CE) and double-balloon endoscopy (DBE), there was no effective modality for the evaluation and management of patients with obscure GI bleeding. Obscure GI bleeding is defined as bleeding of unknown origin that persists or recurs after a negative initial or primary endoscopy (colonoscopy or upper endoscopy) result. The first capsule endoscope model, which is now regarded as a first-line tool for the detection of abnormalities of the small bowel, was the PillCam SB. It was approved in Japan in April 2007. The main indication for use of the PillCam SB is obscure GI bleeding. Almost the only complication of CE is capsule retention, which is the capsule remaining in the digestive tract for a minimum of 2 weeks. A retained capsule can be retrieved by DBE. There are some limitations of CE in that it cannot be used to obtain a biopsy specimen or for endoscopic treatment. However, the combination of a PillCam SB and DBE seems to be the best strategy for management of obscure GI bleeding. Recently, several new types of capsule endoscope have been developed, such as Olympus CE for the small bowel, PillCam ESO for investigation of esophageal diseases, and PillCam COLON for detection of colonic neoplasias. In the near future, CE is expected to have a positive impact on many aspects of GI disease evaluation and management.  相似文献   

13.
Upper gastrointestinal (UGI) endoscopy is an important diagnostic modality in evaluation of patients with upper gastrointestinal (GI) disorders. However, lesions located in the cricopharyngeal area and upper esophagus can be missed, as this area may not be well visualized during endoscopy. This study was conducted to study the utility of a new technique of endoscopic examination of the upper esophagus by withdrawal of endoscope over guide wire in diagnosing esophageal disorders. Patients with suspected upper esophageal disorders on history and radiological investigations were assessed using guide wire assisted endoscopic examination during withdrawal of the endoscope. In this technique, endoscope is inserted into the esophagus under vision and thereafter the whole of esophagus, stomach and proximal duodenum is examined. The endoscope is then withdrawn into the mid-esophagus, a guide wire is fed into the biopsy channel, and thereafter inserted into the esophagus. Once guide wire has been advanced into the esophagus, the endoscope is withdrawn gently over the guide wire into esophagus carefully examining for lesions in upper esophagus and cricopharyngeal area. Twenty cases of various abnormalities localized to the upper esophagus were studied. The final diagnosis in these patients was cervical esophageal web (10), post transhiatal esophagectomy leak (4), heterotopic gastric mucosa (3), posttraumatic esophageal perforation (2), and Zenker's diverticulum (1). Intact web was detected in 2 patients and in 8 patients fractured web was seen. Guide wire assisted examination of upper esophagus improved the ability to visualize and characterize these lesions and no complications were encountered as a result of this procedure. Endoscopic examination of the upper esophagus by withdrawal of endoscope over guide wire is safe and effective in diagnosing anatomical abnormalities of the upper esophagus that may be missed or poorly characterized during standard endoscopy.  相似文献   

14.
Background: Recent advances in capsule endoscopy (CE) and double balloon endoscopy (DBE) have enabled an endoscopic approach to small bowel diseases. However, CE is simply a diagnostic tool and DBE is fairly complicated to handle. Methods: We developed a single balloon endoscopy (SBE) in cooperation with Olympus Medical Systems. The single balloon enteroscope consists of an endoscope and a splinting tube. In this system, a balloon is attached to the splinting tube, but not to the scope itself. The single‐person insertion method was effective for SBE cases, but two persons were needed for DBE. The patients we examined had undergone upper and lower gastrointestinal endoscopy and were suspected of having small intestinal diseases. We examined a total of 30 cases (nine women, 21 men; range 19–78 years), and carried out a total of 48 examinations. Results: In fifteen cases, the cause of bleeding was diagnosed as either ulcer, angiodysplasia, Crohn's disease, inflammatory polyp, or metastatic cancer, but in eight cases, the cause was not identified. Four obstruction cases comprised ulcers, adhesion, and jejunal volvulus. For treatment, clippings were performed for bleeding in three patients, polypectomy for two, reversal of volvulus for one, and balloon dilation for ilial stenosis in one. The entire small intestine was observed in 71% of patients when the intention was to examine the whole bowel. No complications were encountered. Conclusions: The newly developed SBE is useful for diagnosis and treatment of small bowel diseases.  相似文献   

15.
A 59-year-old Japanese man with a history of chronic hepatitis C and cirrhosis was admitted to hospital because of severe abdominal pain and diarrhea. His discomfort had begun 2 months earlier and was localized to the upper abdomen. Upper gastrointestinal endoscopy showed multiple ulcerative lesions from the duodenal bulb to the descending part of the duodenum, one of which was a giant ulcer that filled half of the intestinal lumen. Despite continuous intravenous lansoprazole therapy, his abdominal symptoms did not improve. Upper gastrointestinal endoscopy was again performed to detect the tumor, but it was difficult to observe the tumor with a conventional endoscope. We then inverted a transnasal endoscope into the duodenum, and this enabled us to detect a 15-mm submucosal tumor in the upper wall of the duodenal bulb. Examination of specimens from endoscopic ultrasonography fine-needle aspiration biopsy of the tumor revealed gastrinoma in the duodenal bulb. We decided to perform an operative resection. The patient’s symptoms resolved after surgery, and he remained asymptomatic at follow-up 18 months later. Therefore, when it is difficult to detect the tumor directly by conventional endoscopy, we recommend that attempts be made to detect the tumor by inverting a transnasal endoscope into the duodenal bulb.  相似文献   

16.
Endoscopic examinations and procedures are essential for diagnosis and treatment of gastrointestinal diseases. As a result of poor reprocessing practice microorganisms can be transmitted via endoscope. The majority of infection transmissions is due to insufficient performance of cleaning and disinfection disregarding guidelines of societies of gastrointestinal endoscopy. A review of the literature and a comparison of European and American guidelines for reprocessing flexible endoscopes are given. Differences in the classification of endoscopic devices, on the possibility of prion transmission, recommendations on staff training and protection, quality assurance of reprocessing and evidence-based graduation of guidelines are stressed and discussed. With respect to the procedure of endoscope reprocessing, differences concerning the cleaning solution to choose, necessity of thoroughly manual cleaning and brushing of the accessible endoscope channels (even in the case of subsequent automatic reprocessing endoscopes in washers-disinfectors), disinfection solution, microbiological quality of water for final rinsing and rationale for alcohol flush of endoscope channels for better drying are mentioned. The need for experimental investigations of the cleaning and disinfection process is stressed. In contrast to recent guidelines of European and American societies of gastrointestinal endoscopy, the now updated recommendations of the Robert Koch-Institute for reprocessing flexible endoscopes and endoscopic accessories are evidence-based and graduated.  相似文献   

17.
Abstract A worldwide concern has emerged with regard to endoscope disinfection and many gastrointestinal endoscopy associations have developed guidelines for proper disinfection of endoscopes and endoscopic accessories. A working party was convened to formulate guidelines for the Asia–Pacific region, pertaining to any setting in which gastrointestinal endoscopy is performed. Endoscope reprocessing that meets the established standard of practice helps to ensure a microbial-free endoscope for all patients, reduces the risk of disease transmission and helps to prolong the life of the endoscope. The recommendations included mechanical cleaning as the first and most important step followed by immersion in 2% glutaraldehyde for a minimum period of 10 min. Automated disinfectors have been recommended for busy endoscopy centres to ensure better compliance. Reuse of endoscopic accessories meant for 'single use' remains a controversial issue. Strict quality assurance programmes are a must to preclude lack of compliance with these guidelines.  相似文献   

18.
Capsule endoscopy (CE) is now recognized as a significant technologic advancement in gastrointestinal endoscopy that provides noninvasive, high-resolution imaging of the small bowel and esophagus. There is also growing evidence that it may be useful in the colon. Since the introduction of CE to clinical practice, its diagnostic utility has become well established for evaluation of patients with obscure gastrointestinal bleeding. It seems also to be useful in evaluating small-bowel Crohn's disease, compared with other imaging modalities. With respect to esophageal diseases, CE shows promise in the screening of esophageal varices and possibly Barrett's esophagus. A colon capsule endoscope has also been developed, and its potential use in screening for colorectal neoplasia is currently being studied. The technology and software of CE is also rapidly expanding to allow the physician to read and evaluate the capsule videos in a more efficient manner. The Given Imaging system has progressed significantly over the past several years. In addition to Given Imaging, Olympus now offers a small-bowel capsule endoscope system. This new Olympus capsule technology and how it compares with the Given Imaging System is reviewed, in addition to the various clinical uses of CE.  相似文献   

19.
We developed an endoscopic echo probe that can be passed via the biopsy channel of a flexible fiberoptic or video endoscope with a 3.5-mm channel. The probe moves along the gastrointestinal wall under direct endoscopic vision. The translational scanning action is sensed by a position potentiometer and combines with the ultrasonic B-mode echoes to produce a cross-sectional image of the wall. The system uses an ultrasound frequency of 20 MHz to produce high-resolution images. The device was used to image canine gastrointestinal tissue in vitro and in vivo during endoscopy. Ultrasound images of the gut wall correlate with histologic structure. This probe overcomes some of the problems associated with the combined ultrasound endoscopes now in use. Use of the probe with video endoscopy allows the endoscopic and ultrasound images to be displayed side by side, simplifying coordination of application of the two techniques.  相似文献   

20.
目的 评估胃肠道病变磁体预标记辅助腹腔镜定位术的可行性及安全性。方法 2019年4月-6月,拟行腹腔镜根治术的胃、结直肠肿瘤住院患者8例,在行腹腔镜切除术前接受了内镜下磁体预标记。术中通过腹腔镜孔道送入另一枚磁体,在磁体相互吸引力导引下,快速与病变附近预标记的磁体隔胃肠道壁而吸引在一起,实现病变定位。采用回顾性分析方法,对8例患者术前标记及手术情况进行分析和总结。结果 8例患者全部术前内镜下成功标记病灶, 并实现了术中快速准确定位。内镜下标记平均用时为5.75±2.45min,术中定位平均用时1.94±0.56min。所有患者均完成腹腔镜肿瘤切除术,定位准确,结直肠肿瘤病灶平均近端和远端切除边缘分别为105和74mm,无不良并发症发生。结论 胃肠道病变磁体预标记辅助腹腔镜定位术简便、安全、准确;同时不增加额外诊治设备、无需消化内镜术中配合操作,大大减少院内感染风险。  相似文献   

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