Efficacy and safety of over-the-scope clip: Including complications after endoscopic submucosal dissection

AIM: To retrospectively review the results of over-thescope clip (OTSC) use in our hospital and to examine the feasibility of using the OTSC to treat perforations after endoscopic submucosal dissection (ESD). METHODS: We enrolled 23 patients who presented with gastrointestinal (GI) bleeding, fistulae and perforations and were treated with OTSCs (Ovesco Endoscopy GmbH, Tuebingen, Germany) between November 2011 and September 2012. Maximum lesion size was defined as lesion diameter. The number of OTSCs to be used per patient was not decided until the lesion was completely closed. We used a twin grasper (Ovesco Endoscopy GmbH, Tuebingen, Germany) as a grasping device for all the patients. A 9 mm OTSC was chosen for use in the esophagus and colon, and a 10 mm device was used for the stomach, duodenum and rectum. The overall success rate and complications were evaluated, with a particular emphasis on patients who had undergone ESD due to adenocarcinoma. In technical successful cases we included not only complete closing by using OTSCs, but also partial closing where complete closure with OTSCs is almost difficult. In overall clinical successful cases we included only complete closing by using only OTSCs perfectly. All the OTSCs were placed by 2 experienced endoscopists. The sites closed after ESD included not only the perforation site but also all defective ulcers sites.RESULTS: A total of 23 patients [mean age 77 years (range 64-98 years)] underwent OTSC placement during the study period. The indications for OTSC placement were GI bleeding (n = 9), perforation (n = 10), fistula (n = 4) and the prevention of post-ESD duodenal artificial ulcer perforation (n = 1). One patient had a perforation caused by a glycerin enema, after which a fistula formed. Lesion closure using the OTSC alone was successful in 19 out of 23 patients, and overall success rate was 82.6%. A large lesion size (greater than 20 mm) and a delayed diagnosis (more than 1 wk) were the major contributing factors for the overall unsuccessful clinical case     

Novel treatment options for perforations of the upper gastrointestinal tract:Endoscopic vacuum therapy and over-the-scope clips

Endoscopic management of leakages and perforations of the upper gastrointestinal tract has gained great importance as it avoids the morbidity and mortality of surgical intervention.In the past years,covered selfexpanding metal stents were the mainstay of endoscopic therapy.However,two new techniques are now available that enlarge the possibilities of defect closure:endoscopic vacuum therapy(EVT),and over-the-scope clip(OTSC).EVT is performed by mounting a polyurethane sponge on a gastric tube and placing it into the leakage.Continuous suction is applied via the tube resulting in effective drainage of the cavity and the induction of wound healing,comparable to the application of vacuum therapy in cutaneous wounds.The system is changed every 3-5 d.The overall success rate of EVT in the literature ranges from 84%to 100%,with a mean of 90%;only few complications have been reported.OTSCs are loaded on a transparent cap which is mounted on the tip of a standard endoscope.By bringing the edges of the perforation into the cap,by suction or by dedicated devices,such as anchor or twin grasper,the OTSC can be placed to close the perforation.For acute endoscopy associated perforations,the mean success rate is 90%(range:70%-100%).For other types of perforations(postoperative,other chronic leaks and fistulas)success rates are somewhat lower(68%,and59%,respectively).Only few complications have been reported.Although first reports are promising,further studies are needed to define the exact role of EVT and OTSC in treatment algorithms of upper gastrointestinal perforations.     

Novel endoscopic over-the-scope clip system

This paper reports our experience with a new over-the-scope clip in the setting of recurrent bleeding and oesophageal fistula. We treated five patients with the over-the-scope Padlock Clip™. It is a nitinol ring, with six inner needles preassembled on an applicator cap, thumb press displaced by the Lock-It™ delivery system. The trigger wire is located alongside the shaft of the endoscope, and does not require the working channel. Three patients had recurrent bleeding lesions (bleeding rectal ulcer, post polypectomy delayed bleeding and duodenal Dieulafoy’s lesion) and two patients had a persistent respiratory-esophageal fistula. In all patients a previous endoscopic attempt with standard techniques had been useless. All procedures were conducted under conscious sedation but for one patient that required general anaesthesia due to multiple comorbidities. We used one Padlock Clip™ for each patient in a single session. Simple suction was enough in all of our patients to obtain tissue adhesion to the instrument tip. A remarkably short application time was recorded for all cases (mean duration of the procedure: 8 min). We obtained technical and immediate clinical success for every patient. No major immediate, early or late (within 24 h, 7 d or 4 wk) adverse events were observed, over follow-up durations lasting a mean of 109.4 d. One patient, treated for duodenal bulb bleeding from a Dieulafoy''s lesion, developed signs of mild pancreatitis 24 h after the procedure. The new over-the-scope Padlock Clip™ seems to be simple to use and effective in different clinical settings, particularly in “difficult” scenarios, like recurrent bleeding and respiratory-oesophageal fistulas.     

Management of a large mucosal defect after duodenal endoscopic resection

Duodenal endoscopic resection is the most difficult type of endoscopic treatment in the gastrointestinal tract (GI) and is technically challenging because of anatomical specificities. In addition to these technical difficulties, this procedure is associated with a significantly higher rate of complication than endoscopic treatment in other parts of the GI tract. Postoperative delayed perforation and bleeding are hazardous complications, and emergency surgical intervention is sometimes required. Therefore, it is urgently necessary to establish a management protocol for preventing serious complications. For instance, the prophylactic closure of large mucosal defects after endoscopic resection may reduce the risk of hazardous complications. However, the size of mucosal defects after endoscopic submucosal dissection (ESD) is relatively large compared with the size after endoscopic mucosal resection, making it impossible to achieve complete closure using only conventional clips. The over-the-scope clip and polyglycolic acid sheets with fibrin gel make it possible to close large mucosal defects after duodenal ESD. In addition to the combination of laparoscopic surgery and endoscopic resection, endoscopic full-thickness resection holds therapeutic potential for difficult duodenal lesions and may overcome the disadvantages of endoscopic resection in the near future. This review aims to summarize the complications and closure techniques of large mucosal defects and to highlight some directions for management after duodenal endoscopic treatment.     

Role of over the scope clips in the management of iatrogenic gastrointestinal perforations

Advances in endoscopic and surgical techniques have increased the frequency and complexity of these procedures and associated complications such as gastrointestinal perforation. With the advancements in the field of gastroenterology, the promising use of an over the scope clips (OTSC) has fulfilled the unmet need for a reliable endoscopic devise in approximation of gastrointestinal perforation. This novel approach has raised the level of confidence in endoscopist in dealing with this serious complication during endoscopy. Here we have shared our experience with OTSC to evaluate its efficacy and safety in managing iatrogenic gastrointestinal perforations during endoscopy.     

Endoscopic treatment of duodenal fistula after incomplete closure of ERCP-related duodenal perforation

Endoscopic retrograde cholangiopancreatography(ERCP)is an important diagnostic and therapeutic modality for various pancreatic and biliary diseases.The most common ERCP-induced complication is pancreatitis,whereas hemorrhage,cholangitis,and perforation occur less frequently.Early recognition and prompt treatment of these complications may minimize the morbidity and mortality.One of the most serious complications is perforation.Although the incidence of duodenal perforation after ERCP has decreased to1.0%,severe cases still require prolonged hospitalization and urgent surgical intervention,potentially leading to permanent disability or mortality.Surgery remains the mainstay treatment for perforations of the luminal organs of the gastrointestinal tract.However,evidence from case reports and case series support a beneficial role of endoscopic clipping in the closure of these defects.Duodenal fistulas are usually a result of sphincterotomies,perforated duodenal ulcers,or gastrectomy.Other causative factors include Crohn's disease,trauma,pancreatitis,and cancer.The majority of duodenal fistulas heal with nonoperative management.Those that fail to heal are best treated with gastrojejunostomy.Recently proposed endoscopic approaches for managing gastrointestinal leaks caused by fistulas include fibrin glue injection and positioning of endoclips.Our patient developed a secondary persistent duodenal fistula as a result of previous incomplete closure of duodenal perforation with hemoclips and an endoloop.The fistula was successfully repaired by additional clipping and fibrin glue injection.     

Endoscopic full-thickness resection using an over-the-scope device: A prospective study

BACKGROUND Endoscopic submucosal dissection to treat mucosal and submucosal lesions sometimes results in low rates of microscopically margin-negative(R0)resection.Endoscopic full-thickness resection(EFTR)has a high R0 resection rate and allows for the definitive diagnosis and treatment of selected mucosal and submucosal lesions that are not suitable for conventional resection techniques.AIM To evaluate the efficacy and safety of EFTR using an over-the-scope clip(OTSC).METHODS This prospective,single-center,non-randomized clinical trial was conducted at the endoscopy center of Shengjing Hospital of China Medical University.The study included patients aged 18-70 years who had gastric or colorectal submucosal tumors(SMTs)(≤20 mm in diameter)originating from the muscularis propria based on endoscopic ultrasound(EUS)and patients who had early-stage gastric or colorectal cancer(≤20 mm in diameter)based on EUS and computed tomography.All lesions were treated by EFTR combined with an OTSC for wound closure between November 2014 and October 2016.We analyzed patient demographics,lesion features,histopathological diagnoses,R0 resection(negative margins)status,adverse events,and follow-up results.RESULTS A total of 68 patients(17 men and 51 women)with an average age of 52.0±10.5 years(32-71 years)were enrolled in this study,which included 66 gastric or colorectal SMTs and 2 early-stage colorectal cancers.The mean tumor diameter was 12.6±4.3 mm.The EFTR procedure was successful in all cases.The mean EFTR procedure time was 39.6±38.0 min.The mean OTSC defect closure time was 5.0±3.8 min,and the success rate of closure for defects was 100%.Histologically complete resection(R0)was achieved in 67(98.5%)patients.Procedure-related adverse events were observed in 11(16.2%)patients.The average post-procedure length of follow-up was 48.2±15.7 mo.There was no recurrence during follow-up.CONCLUSION EFTR combined with an OTSC is an effective and safe technique for the removal of select subepithelial and epithelial lesions that are not amenable to conventional endoscopic resection techniques.     

Role of endoscopic clipping in the treatment of oesophageal perforations

With advances in endoscopic technologies,endoscopic clips have been used widely and successfully in the treatment of various types of oesophageal perforations,anastomosis leakages and fistulas. Our aim was to summarize the experience with two types of clips: The through-the-scope(TTS) clip and the over-the-scope clip(OTSC). We summarized the results of oesophageal perforation closure with endoscopic clips. We processed the data from 38 articles and 127 patients using PubM ed search. Based on evidence thus far,it can be stated that both clips can be used in the treatment of early( 24 h),iatrogenic,spontaneous oesophageal perforations in the case of limited injury or contamination. TTS clips are efficacious in the treatment of 10 mm lesions,while bigger( 20 mm) lesions can be treated successfully with OTSC clips,whose effectiveness is similar to that of surgical treatment. However,the clinical success rate is significantly lower in the case of fistulas and in the treatment of anastomosis insufficiency. Tough prospective randomized multicentre trials,which produce the largest amount of evidence,are still missing. Based on experience so far,endoscopic clips represent a possible therapeutic alternative to surgery in the treatment of oesophageal perforations under well-defined conditions.     

内镜分片黏膜切除术及黏膜下剥离术治疗十二指肠非壶腹部较大占位的临床观察

目的 评估内镜分片黏膜切除术（endoscopic piecemeal mucosal resection,EPMR）及内镜黏膜下剥离术（endocopic submucosal dissection, ESD）治疗十二指肠非壶腹部较大占位性病变（直径≥10～15 mm）的疗效和安全性。方法 2013年2月至2018年8月,因十二指肠非壶腹部较大占位性病变,在首都医科大学附属北京友谊医院消化分中心接受EPMR或ESD治疗的21例病例纳入回顾性分析,按治疗方式分成EPMR组（n=13）和ESD组（n=8）,主要总结各组的手术时间、手术的病理组织学评价和并发症发生情况等。结果 EPMR组13例病变均起源于黏膜层,内镜下病灶最大直径（22±12）mm,中位手术时间39.0（23.0,45.0）min,12例使用钛夹封闭创面,切除病理最大直径（26±15）mm,胃黏膜异位2例、低级别上皮内瘤变7例、高级别上皮内瘤变4例,水平切缘阳性5例（低级别上皮内瘤变）,2例发生并发症,其中1例围手术期菌血症经抗感染治疗后好转,1例为术中穿孔内镜下治疗不佳转外科急诊开腹行修补术。ESD组病变起源于黏膜层6例、黏膜下层2例,内镜下病灶最大直径（17±5）mm,中位手术时间47.5（34.0,68.0）min,8例均使用钛夹封闭创面,切除病理最大直径（20±7）mm,低级别上皮内瘤变3例、高级别上皮内瘤变3例、淋巴管瘤和囊肿各1例,8例水平切缘阴性,1例垂直切缘存在可疑低级别上皮内瘤变未能达到完全切除,3例发生并发症（围手术期出现穿孔）,其中1例行内镜下治疗后好转出院,1例内镜下治疗不佳转外科手术,1例来源于黏膜下层的病变较大（16 mm）行腹腔镜下十二指肠修补术。结论 对于十二指肠非壶腹部较大占位性病变（直径≥10～15 mm）,初步证实EPMR和ESD治疗均安全、有效,值得临床进一步研究。     

内镜下全层切除术联合OTSC吻合系统在治疗胃间质瘤中的应用研究

目的探究内镜下全层切除术(EFTR)联合OTSC吻合系统治疗胃间质瘤的安全性及有效性。 方法回顾性分析2016年9月至2018年10月经宁夏回族自治区人民医院行EFTR联合OTSC夹闭系统治疗胃间质瘤24例临床资料。 结果24例患者中,成功切除率及闭合率为100%,闭合穿孔直径最小为0.3 cm×0.3 cm,闭合穿孔直径最大为4.3 cm×3.8 cm,平均(2.5 ±1.5)cm,术中有少量渗血,均予以氩离子凝固术(APC)电凝止血,平均操作时间(45±60)min,术后平均住院时间为(3±5)d。术后无气胸、发热,无发生迟发性出血、消化道瘘、继发性胸腹腔感染及其它严重并发症。术后第1、3、6个月随访复查胃镜,观察创面愈合情况,病变均无复发现象,24例病理提示梭形细胞肿瘤及结合免疫组织化学诊断为间质瘤,位于胃底、胃窦及胃体;均为极低度、低度侵袭危险性,建议患者定期复查胃镜。 结论EFTR联合OTSC吻合系统治疗胃间质瘤是一种安全、有效的技术,值得在临床上推广使用。     

内镜下治疗非壶腹部早期十二指肠癌的疗效分析

目的　评估内镜下治疗非壶腹部早期十二指肠癌的临床疗效。方法　以2015年1月—2021年1月在首都医科大学附属北京友谊医院接受内镜下治疗的非壶腹部早期十二指肠癌患者为研究对象,回顾性研究患者基线信息、内镜治疗方式、创面封闭方式、病理分析和并发症的发生与转归等资料。结果　47例患者资料入选并均成功完成内镜下治疗,其中内镜黏膜切除术（endoscopic mucosal resection,EMR）17例,内镜黏膜下剥离术（endoscopic submucosal dissection,ESD）5例,ESD+EMR 7例,因ESD剥离困难转为ESD+EMR 6例,耙状金属夹闭合系统（over?the?scope clip system,OTSC）辅助的全层切除4例,分片内镜黏膜切除术（piecemeal EMR,EPMR）8例。47例早期癌病变中,整块切除率83.0%（39/47）,完全切除率85.1%（40/47）。全组47例中,围手术期发生穿孔并发症4例（8.5%）,均发生于降部,其中2例（4.3%）经内镜治疗后好转,另外2例（4.3%）内镜治疗效果不佳,经外科手术治疗后好转。围手术期未出现术后出血、感染等并发症。结论　内镜下治疗非壶腹部早期十二指肠癌是安全有效的,可根据病灶的位置、大小及个体情况选择有针对性的治疗方案。对于十二指肠降段的操作,要更加警惕穿孔并发症的发生。     

Short-and long-term outcomes of endoscopically treated superficial non-ampullary duodenal epithelial tumors

BACKGROUND It is widely recognized that endoscopic resection(ER) of superficial nonampullary duodenal epithelial tumors(SNADETs) is technically challenging and may carry high risks of intraoperative and delayed bleeding and perforation.These adverse events could be more critical than those occurring in other levels of the gastrointestinal tract. Because of the low prevalence of the disease and the high risks of severe adverse events, the curability including short-and long-term outcomes have not been standardized yet.AIM To investigate the curability including short-and long-term outcomes of ER for SNADETs in a large case series.METHODS This retrospective study included cases that underwent ER for SNADETs at our university hospital between March 2004 and July 2017. Short-term outcomes of ER were measured based on en bloc and R0 resection rates as well as adverse events. Long-term outcomes included local recurrence detected on endoscopic surveillance and disease-specific mortality in patients followed up for ≥ 12 mo after ER.RESULTS In the study, 131 patients with 147 SNADETs were analyzed. The 147 ERs consisted of 136 endoscopic mucosal resections(EMRs)(93%) and 11 endoscopic submucosal dissections(ESDs)(7%). The median tumor diameter was 10 mm.The pathology diagnosis was adenocarcinoma(56/147, 38%), high-grade intraepithelial neoplasia(44/147, 30%), or low-grade intraepithelial neoplasia(47/147, 32%). The R0 resection rate was 68%(93/136) in the EMR group and73%(8/11) in the ESD group, respectively. Cap-assisted EMR(known as EMR-C)showed a higher rate of R0 resection compared to the conventional method of EMR using a snare(78% vs 62%, P = 0.06). No adverse event was observed in the EMR group, whereas delayed bleeding, intraoperative perforation, and delayed perforation in 3, 3, and 5 patients occurred in the ESD group, respectively. One patient with perforation required emergency surgery. In the 43 mo median follow-up period, local recurrence was found in four EMR cases and all cases were treated endoscopically. No patient died due to tumor recurrence.CONCLUSION Our findings suggest that ER provides good long-term outcomes in the patients with SNADETs. EMR is likely to become the safe and reliable treatment for small SNADETs.     

A new hemostatic clip for endoscopic surgery that can maintain blood flow after clipping

AIM: To develop a new hemostatic device for endoscopic surgery that can control the bleeding without completely occluding the bleeding vessel. METHODS: A hemostatic clip and its applier that can stanch bleeding while maintaining blood flow through the clipped vessel was introduced, and the performance of the proposed clip was evaluated using in vitro and in vivo experiments. RESULTS: During in vitro experiments, no leakage was found after clipping at cuts made in artificial vessels, and flow was maintained through the clipped artificial vessels. In experiments on rats, all the implanted clips occluded the target vessels successfully, and no bleeding or tissue damage was observed at the operative site after the rats were euthanized on postoperative day 7. In experiments on pigs, bleeding stopped immediately after partial clipping of a damaged vessel, and some amount of blood flow was consistently maintained through the clipped vessel after hemostasis. CONCLUSION: We believe that the proposed hemostatic clip and clip applier can enhance patient safety during laparoscopic surgery.