Efficacy of hybrid endoscopic submucosal dissection with SOUTEN in gastric lesions: An ex vivo porcine model basic study

BACKGROUNDHybrid endoscopic submucosal dissection (ESD) that comprises mucosal incision and partial submucosal dissection followed by snaring in a planned manner, has been developed for endoscopic resection of gastrointestinal neoplasms to overcome the technical barrier of ESD. Although the superiority of hybrid ESD with SOUTEN, a single multifunctional device, over conventional ESD has been indicated, the actual effect of snaring itself remains unclear since SOUTEN could be applied to hybrid ESD group, but not to the conventional ESD group, due to ethical issue in clinical practice. AIMTo determine whether and how hybrid ESD was superior to conventional ESD in the endoscopic treatment of gastric lesions in an ex vivo porcine model basic study.METHODSSixteen endoscopists participated in this basic study in August 2020 at Kyushu University, performing 32 procedures each for hybrid ESD and conventional ESD. Mock lesions (10-15 mm, diameter) were created in the porcine stomach. The primary outcome was total procedure time and secondary outcomes were en bloc or complete resection, perforation, procedure time/speed for both, mucosal incision, and submucosal dissection. Factors associated with difficulty in ESD including longer procedure time, incomplete resection, and perforation, were also investigated. Categorical and continuous data were analyzed using the chi-square test or Fisher’s exact test and the Mann-Whitney U test, respectively.RESULTSThe median total procedure time of hybrid ESD was significantly shorter than that of conventional ESD (median: 8.3 min vs 16.2 min, P < 0.001). Time, speed, and the amount of hyaluronic acid during submucosal dissection were more favorable in hybrid ESD than conventional ESD (time, 5.2 min vs 10.4 min, P < 0.001; speed, 43.7 mm²/min vs 23.8 mm²/min, P < 0.00; injection volume, 1.5 mL vs 3.0 mL, P < 0.001), although no significant differences in those factors were observed between both groups during mucosal incision. There was also no significant difference between both groups in the en bloc/complete resection rate and perforation rate (complete resection, 93.8% vs 87.5%, P = 0.67; perforation, 0% vs 3.1%, P = 1). Selection of conventional ESD as the treatment method was significantly associated with difficulties during ESD (odds ratio = 10.2; highest among factors). CONCLUSIONHybrid ESD with SOUTEN improves the treatment outcomes of gastric lesions. It also has the potential to reduce medical costs since SOUTEN is a single multifunctional device that is inexpensive.     

The effectiveness and safety of endoscopic submucosal dissection compared with endoscopic mucosal resection for early gastric cancer: a systematic review and metaanalysis

Background  

Endoscopic submucosal dissection (ESD) allows en bloc resection of the entire lesion, permitting a higher curative resection rate and increased quality of life by minimizing the resection size compared with that of endoscopic mucosal resection (EMR). Although ESD has been implemented at most university hospitals in Korea, potential complications of ESD such as bleeding and perforation raise doubts in the therapeutic decision on use of the ESD procedure for early gastric cancer patients and in reimbursement decision making. This systematic review aimed to address both the effectiveness and safety outcomes of ESD versus EMR for early gastric cancer.     

Assistant skill in gastric endoscopic submucosal dissection using a clutch cutter

BACKGROUND A clutch cutter is a scissor-type knife used in endoscopic submucosal dissection(ESD) for gastrointestinal tract tumors. The assistant during the ESD using a clutch cutter(ESD-C) needs to rotate the device and grasp the target tissue appropriately; therefore, the assistant's skill may affect the technical outcomes of ESD-C.AIM To determine how assistant skill level affected the technical outcomes of gastric ESD-C using an ex vivo porcine training model.METHODS In this pilot study, mock lesions of 15-30 mm in diameter were created in the middle or lower third of the porcine stomach. A total of 32 ESD-C procedures were performed by 16 trainees. Each trainee operator performed two ESD-C procedures; one ESD-C was assisted by an expert(ESD-C-E), and the other was assisted by a non-expert(ESD-C-NE). The total procedure time of the ESD was set as the primary outcome, and en bloc resection rate, complete procedure rate, perforation rate, and each procedure time/speed for mucosal incision or submucosal dissection were set as the secondary outcomes. In addition, we investigated factors associated with the difficulty of ESD including incompletion of ESD procedure, a long procedure time(≥ 20 min) or intraoperative perforation.RESULTS The median total procedure time of the ESD-C-E was significantly shorter than that of the ESD-C-NE(12.9 min vs 21.9 min, P = 0.001). The en bloc resection rate was 100% in both groups. Complete resection rates of the ESD-C-E and ESD-C-NE groups were 100% and 93.8%, respectively. No intraoperative perforation was observed in both groups. In the multivariate analysis, assistant skill was significantly associated with the difficulty of ESD, with the highest odds ratio of 16.5.CONCLUSION Assistance by an expert is an important factor when trainees perform ESD-C procedures.     

内镜下黏膜剥离术治疗早期上消化道肿瘤的护理配合

目的 总结内镜下黏膜剥离术(ESD)治疗上消化道肿瘤的护理配合方法.方法 对62例上消化道肿瘤患者行ESD治疗,术中护士按标记、黏膜下注射、边缘切开、剥离、创面处理5个步骤配合术者完成手术过程,并加强术前、术中及术后护理,观察随访治疗效果及患者预后情况.结果 62例患者经治疗和密切的护理配合,59例成功,3例未成功,成功率为95.1％;平均住院日6.2d.1例于术后2周出现迟发性出血经转外科手术治疗,均无其他严重并发症发生.结论ESD术前做好患者心理护理及完善术前准备,术中与术者密切配合、加强患者病情监护,术后加强病情观察及健康教育等有效的护理配合,有助于顺利完成本中操作,减少并发症,促进患者术后康复.     

Factors related to the curability of early gastric cancer with endoscopic submucosal dissection

Background

Endoscopic submucosal dissection (ESD) yields substantially high rates for curative resection of early gastric cancer (EGC). It is suggested that larger, ulcerative, or upper EGCs may prevent successful ESD. A detailed analysis of factors associated with the curability of ESD was performed.

Methods

Endoscopic submucosal dissection was performed for patients with EGC that fulfilled the expanded criteria, which specified mucosal cancer without ulcer findings irrespective of tumor size, mucosal cancer with ulcers 3 cm in diameter or smaller, and minute submucosal invasive cancer 3 cm or smaller. Resectability (en bloc or by piecemeal resection), curability (curative or non-curative), and complications were assessed, and logistic regression analysis was used to analyze the related factors.

Results

Ulcerative EGCs showed a significantly higher risk associated with ESD on multivariate analysis. When the risk factors (tumor size, location, and ulcer findings) were combined, the larger EGCs (>30 mm) located in the upper third or ulcerative tumors located in the upper and middle portion of the stomach were at significantly higher risk of non-curative resection. Such lesions also were associated with increased risk of procedure-related perforation.

Conclusions

When risk factors including positive ulcer findings and larger size and upper location of tumors are combined, ESD should be performed more carefully.     

内镜黏膜下剥离术在胃肿瘤中应用的新进展

自从1968年应用高频电流在内镜下成功切除胃息肉后,陆续又有块状活检(1984年)和透明帽技术(1993年)问世,随后内镜下黏膜切除术(EMR)开始普遍推广。目前,     

In vitro porcine training model for colonic endoscopic submucosal dissection: an inexpensive and safe way to acquire a complex endoscopic technique

Background  

Colonic endoscopic submucosal dissection (ESD) has developed in recent years to permit en bloc resection of larger colorectal lesions that cannot be done by standard polypectomy or mucosal resection techniques. Colonic ESD is technically demanding and has a steep learning curve. Adequate training is essential to make ESD a reliable treatment for colorectal neoplasms. We aim to share our early experience with an in vitro porcine training model for colonic ESD.     

Long-term outcomes of endoscopic submucosal dissection for early gastric cancer: a single-center experience

Background

In Korea, endoscopic submucosal dissection (ESD) has been widely accepted for the treatment of early gastric cancers (EGCs). However, the understanding of the long-term clinical outcome of ESD for EGC remains insufficient. Therefore, the aim of the present study was to assess the long-term clinical outcome and efficacy of ESD for the treatment of EGCs, including the clinical application of the expanded criteria for ESD.

Methods

From January 2006 to December 2010, a total of 515 patients with 522 EGCs were treated by ESD in our hospital; study enrollment was based on the expanded criteria. Comparisons of resectability (en bloc or piecemeal resection), curability (curative or non-curative), and complications (bleeding and perforation) between the standard and expanded groups were assessed. Thereafter, 336 patients with 342 EGCs were finally included in a long-term analysis of local tumor recurrence, development of synchronous and metachronous cancers, and overall and disease-specific survival rates.

Results

En bloc and curative resection rates of 96.7 % and 88.3 %, respectively, were achieved. The curative resection rate was significantly lower in the expanded group than in the standard group (82.1 % vs. 91.5 %, p = 0.001). During a median follow-up of 24 months, the local tumor recurrence rate was also higher in the expanded group than in the standard group (7.0 % vs. 1.8 %, p = 0.025). Local recurrence was more frequent in lesions with non-curative resection than in those with curative resection (20.0 % vs. 1.3 %, p < 0.001). The 5-year overall and disease-specific survival rates were 88 % and 100 %, respectively; the difference between the standard and expanded groups was not significant (p = 0.834).

Conclusions

ESD appears to be a feasible and effective method for treating EGCs, based on the standard and expanded criteria. Close follow-up surveillance, after ESD, should be standard for all patients.     

Predictors of immediate bleeding during endoscopic submucosal dissection in gastric lesions

Background  Although there have been several reports regarding complications, especially immediate bleeding, of endoscopic mucosal resection for a gastric neoplasm, little is known about the predictors of complications of endoscopic submucosal dissection (ESD). Thus, this study was performed to evaluate the predictive factors for immediate bleeding during ESD procedures. Methods  We analyzed 167 patients with 167 gastric lesions from June 2006 to June 2007. Patient-related variables (age, gender, history of aspirin or anti-platelet agents, triple therapy for H. pylori, and use of a proton pump inhibitor), endoscopic variables (lesion size, location, type, and mucosal ulceration), procedure-related variables (procedure time and volume of submucosal injection), and the pathology diagnosis were evaluated as potential risk factors. Results  The mean age of the patients was 62 years. The mean size of the lesions was 15 mm. The overall en bloc resection rate was 98.2%. Immediate bleeding occurred in 20 out of 167 patients. Delayed bleeding was seen in only three patients within 24 h after the procedure. Older age and the location of the lesions (antrum) were associated with a lower frequency of bleeding (p = 0.006 and p = 0.007, respectively). On multivariate analysis, an older age (OR 0.931, 95% CI 0.88–0.98) and the location of the lesion (antrum; OR 0.254, 95% CI 0.09–0.69) were significant predictive factors for a successful ESD without bleeding. Conclusion  The results of this study demonstrated that age and lesion location were related to the ESD procedure outcome.     

Efficacy of endoscopic mucosal resection using a dual-channel endoscope compared with endoscopic submucosal dissection in the treatment of rectal neuroendocrine tumors

Background

Conventional endoscopic mucosal resection (EMR) for removing rectal neuroendocrine tumors (NETs) has a high risk of incomplete removal because of submucosal tumor involvement. EMR using a dual-channel endoscope (EMR-D) may be a safe and effective method for resection of polyps in the gastrointestinal tract. The efficacy of EMR-D in the treatment of rectal NET has not been evaluated thoroughly.

Methods

From January 2005 to September 2011, a total of 70 consecutive patients who received EMR-D or endoscopic submucosal dissection (ESD) to treat a rectal NET <16 mm in diameter were included to compare EMR-D with ESD for the treatment of rectal NETs.

Results

The EMR-D group contained 44 patients and the ESD group contained 26 patients. The endoscopic complete resection rate did not differ significantly between the EMR-D and ESD groups (100 % for each). The histological complete resection rate also did not differ significantly between groups (86.3 vs. 88.4 %). The procedure time was shorter for the EMR-D group than for the ESD group (9.75 ± 7.11 vs. 22.38 ± 7.56 min, P < 0.001). Minor bleeding occurred in 1 EMR-D patient and in 3 ESD patients (2.3 vs. 7.6 %). There was no perforation after EMR-D or ESD.

Conclusions

Compared with ESD, EMR-D is technically simple, minimally invasive, and safe for treating small rectal NETs contained within the submucosa. EMR-D can be considered an effective and safe resection method for rectal NETs <16 mm in diameter without metastasis.     

Factors associated with conversion to snare resection during gastric endoscopic submucosal dissection

Surgical Endoscopy - Although gastric endoscopic submucosal dissection (ESD) achieves a higher en-bloc resection rate compared to that with endoscopic mucosal resection (EMR) for gastric epithelial...     

内镜下黏膜切除术与内镜黏膜下剥离术对早期胃癌疗效的Meta分析

目的：系统评价内镜下黏膜切除术（EMR）与内镜黏膜下剥离术（ESD）治疗早期胃癌（EGC）的疗效及安全性。 方法：检索多个国内外数据库,收集相关临床研究文献,筛选出符合纳入标准的合格文献后行Meta分析。 结果：最终纳入15个临床病例对照研究,共4 673例患者,其中ESD组2 154例,EMR组2 519例。Meta分析显示,ESD组的手术时间长于EMR组,但整块切除率、完整切除率、治愈切除率均高于EMR组（均P<0.05）;并发症方面,两组出血的发生率差异无统计学意义（P>0.05）,但ESD组的穿孔发生率高于EMR组（P<0.05）;ESD组术后局部复发率低于EMR组（P<0.05）。 结论：ESD治疗EGC切除率高、局部复发率低,但手术时间长、穿孔率高,但以上结论还需要大样本、高质量的研究进一步证实。     

Clinical outcomes for perforations during endoscopic submucosal dissection in patients with gastric lesions

Background

The endoscopic submucosal dissection (ESD) technique has been gaining popularity, with continued advances in this treatment approach. However, ESD still is associated with potential complications such as severe bleeding and perforation.

Methods

This study was performed to compare the clinical outcomes for macro- and microperforations with ESD procedures and to determine the short-term prognosis after ESD. A macroperforation was defined as a gross perforation that occurred during an ESD procedure, and a microperforation was defined by free air observed on simple radiography after the procedure. Immediate closure of macroperforations was performed using endoclips. From July 2003 through May 2008, 1,711 patients underwent ESD for gastric lesions such as dysplasia, early cancer, and subepithelial lesions.

Results

Among 39 perforation cases (2.3%), macroperforations occurred for 26 patients (67%) and microperforations for 13 patients (33%). All the patients except one who underwent emergency surgery because of severe bleeding and perforation during ESD were managed successfully by intravenous antibiotics and no oral intake. The clinical prognosis and endoscopic characteristics of the patients with macroperforations did not differ from those of the patients with microperforations.

Conclusions

Perforations associated with ESD could be managed safely and successfully by nonsurgical methods. The clinical prognoses for macro- and microperforations were favorable and comparable.     

Feasibility of endoscopic submucosal dissection for upper gastrointestinal submucosal tumors treatment and value of endoscopic ultrasonography in pre-operation assess and post-operation follow-up: a prospective study of 224 cases in a single medical center

Background and aims

Diagram, diagnosis, and treatment with endoscopic submucosal dissection (ESD) for upper gastrointestinal submucosal tumors (SMTs) remain controversial, although endoscopic ultrasonography (EUS) and ESD have been established in diagnosis and treatment of SMTs in decades, respectively. In this study, we have investigated prospectively the profile of upper gastrointestinal SMTs, assessed the effect and feasibility of ESD in upper gastrointestinal SMTs treatment, as well as value of EUS in pre-ESD diagnosis and post-ESD follow-up for gastrointestinal SMTs.

Methods

The upper gastrointestinal SMTs patients detected with endoscopy were further checked by EUS, then received series ESD treatment, and fulfilled 3- and 12-month follow-up EUS detection between July 2011 and March 2015. The parameters of SMTs with EUS examination (size, original layer) and treatment with ESD (en bloc resection rate, procedure time, procedure-related complications) were investigated and analyzed.

Results

A total number of 224 patients with upper gastrointestinal SMTs were enrolled, and 108 (48.2 %) were men. The mean age was 50.4 ± 12.0 years (range 19–77 years). In total, 92 (41.1 %), 14 (6.3 %), 61 (27.2 %), 22 (9.8 %), 25 (11.2 %), and 10 (4.5 %) SMTs were located in esophagus, cardiac, fundus, body and antrum of stomach, duodenum, respectively. Two hundred and eight (92.9 %) patients were successfully treated with an en bloc ESD, while other 16 patients (7.1 %) suffered ESD failure (5.3 %, 12 case) or severe complications (1.8 %, 4 cases). The mean procedure time of ESD was 47.4 ± 27.3 min (range 10–180 min). The mean size of the SMTs measured with ESD samples was 13.6 ± 9.5 mm (range 4–113 mm). In total, 87 (38.8 %), 23 (10.3 %), and 114 (50.9 %) tumors originated from muscularis mucosa, submucosa, and muscularis propria, respectively. The majority of SMTs were leiomyoma (109, 48.7 %) and gastrointestinal stromal tumors (GIST) (77, 34.4 %), while other SMTs were confirmed as ectopic pancreas (21, 9.4 %), adenoid tumor (8, 3.6 %), lipoma (5, 2.2 %), neuroendocrine tumor (3, 1.3 %), and granulosa cell tumor (1, 0.4 %). The accuracy rate of EUS in pathological diagnosis or original layer was 82.6 % (185/224) or 74.6 % (167/224). Residual tumors were detected with EUS in 3 patients (1.3 %) in 3-month follow-up and no recurrence during 12-month follow-up period.

Conclusions

The predominant SMTs in upper gastrointestinal tract were leiomyoma in esophageal tumors which originated from muscularis mucosae and GIST in stomach which originated from muscularis propria detected satisfactorily with EUS. This study showed that ESD was a safe and effective treatment for upper gastrointestinal SMTs.

     

预荷包缝合在内镜黏膜下剥离术及全层切除术治疗胃黏膜下肿瘤的价值探讨

目的探讨预荷包缝合在内镜黏膜下剥离术（ESD）及全层切除术（EFR）治疗胃黏膜下肿瘤（GSMT）的价值。 方法回顾性分析2014年1月至2018年1月在西电集团医院行手术治疗的72例腔外生长型GSMT患者资料,根据手术方式分为观察组和对照组。观察组39例,于病灶未穿孔前行预荷包缝合,继而行EFR;对照组33例,行ESD常规剥离病灶穿孔后,再行荷包缝合。比较两组患者病变大小、手术时间、术后并发症、住院时间、术后恢复情况。 结果观察组手术时间为（3.7±0.8）h,显著低于对照组的（5.1±0.9）h,差异有统计学意义（t=4.159,P=0.038）;两组胃管留置时间、住院时间比较,差异均无统计学意义（t=0.605、0.416,P=0.524、0.702）;所有患者均顺利完成R0切除手术,术后观察组出现轻微腹痛3例（7.69%）,对照组出现腹痛6例（18.18%）,观察组术后并发症发生率显著低于对照组,差异有统计学意义（χ²=6.373,P=0.012）。术后1个月复查,观察组发生创面溃疡1例,对照组发生创面溃疡2例,差异无统计学意义（χ²=0.348,P=0.555）;术后2个月所有患者均恢复良好,未出现明显残留、复发症状。 结论对于腔外生长型GSMT,金属夹与尼龙绳联合行内镜下预荷包缝合术是一种可靠的治疗方式,因手术时间短、并发症发生率低、术后恢复快的特点,具有较高的临床应用价值。     

Sedation methods can determine performance of endoscopic submucosal dissection in patients with gastric neoplasia

Background

Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection (ESD), there is no research investigating the effects of sedation on ESD performance and complications. We aimed to evaluate the relationship among sedation methods, clinical outcomes, and complications after ESD for gastric neoplasia.

Methods

We retrospectively reviewed clinical data of 1,367 patients with 1,485 lesions who had undergone ESD for gastric adenoma or early gastric cancer at our tertiary teaching hospital in Seoul, Korea, between January 2008 and May 2011. Of these, 1,035 lesions in 958 patients were included in the intermittent midazolam/propofol injection by endoscopists (IMIE) group, and 450 lesions in 409 patients were included in the continuous propofol infusion with opioid administration by anesthesiologists (CPIA) group.

Results

En bloc resection and complete resection rates were higher in the CPIA group than in the IMIE group (CPIA vs. IMIE; en bloc resection, 99.8 and 95.0 %, P < 0.001; complete resection, 94.2 and 88.3 %, P < 0.001). Duration of procedure was shorter in the CPIA group than in the IMIE group (CPIA vs. IMIE; 48.2 ± 32.5 and 57.6 ± 41.3 min, P < 0.001). In multivariate analysis, sedation method was an independent factor associated with en bloc resection and complete resection. Additionally, sedation with CPIA was not a risk factor for bleeding (P = 0.403) or perforation (P = 0.474); however, aspiration pneumonia developed more frequently in patients sedated with CPIA (CPIA vs. IMIE, 4.4 and 1.5 %, P = 0.002).

Conclusions

Sedation with CPIA can improve ESD performance.