Outcomes of endoscopic submucosal dissection for esophageal cancer with segmental absence of intestinal musculature.

BACKGROUND AND AIMS: Perforation during esophageal endoscopic submucosal dissection (ESD) typically results from electrical damage. However, there are cases in which perforation occurs because of segmental absence of intestinal musculature (SAIM) without iatrogenic muscular injury. We investigated the occurrence rate and clinical course of SAIM during esophageal ESD. METHODS: We conducted a retrospective review of esophageal ESDs performed between 2013 and 2019 at 10 centers in Japan. RESULTS: Five of 1708 (0.29%) patients received ESD for esophageal cancer and had SAIM. The median muscular defect size was 20 mm. All lesions were resected without discontinuation. After resection, 3 patients were closed with Endoloop. Four patients had mediastinal emphysema. All patients were managed conservatively. CONCLUSIONS: SAIM is a very rare condition that is usually only diagnosed during ESD. Physicians performing esophageal ESD should be aware of SAIM. When SAIM is detected, the ESD technique should be modified to prevent full-thickness perforation.

Long-Term Outcomes of Endoscopic Submucosal Dissection for Early Remnant Gastric Cancer: A Retrospective Multicenter Study.

INTRODUCTION: Favorable long-term outcomes of endoscopic submucosal dissection (ESD) for early remnant gastric cancer (ERGC) have been reported in single-center studies from advanced institutions. However, no studies have examined the long-term outcomes using a multicenter database. This study aimed to investigate the long-term outcomes of the aforementioned approach using a large multicenter database. METHODS: This retrospective multicenter cohort study included 242 cases with 256 lesions that underwent ESD for ERGC between April 2009 and March 2019 across 12 centers. We investigated the long-term outcomes of these patients with the Kaplan-Meier method, and the relationship between curability, additional treatment, or hospital category, and the survival time was evaluated using the log-rank test. RESULTS: During the median follow-up period of 48.4 months, the 5-year overall survival rate was 81.3%, and the 5-year gastric cancer-specific survival rate was 98.1%. The survival time of patients of endoscopic curability (eCura) C-2 without additional surgery was significantly shorter than the corresponding of patients of eCura A/B/C-1 and eCura C-2 with additional surgery. There was no significant difference in either overall survival or gastric cancer-specific survival rate between the high-volume and non-high-volume hospitals. CONCLUSION: The gastric cancer-specific survival of ESD for ERGC using a multicenter database was favorable. ESD for ERGC is widely applicable regardless of the hospital case volume. Management in accordance with the latest guidelines will lead to long-term survival.

Characteristics of Gastric Stasis due to Deformation after Endoscopic Submucosal Dissection in the Lower Part of the Stomach.

INTRODUCTION: Gastric stasis due to deformation occurs after endoscopic submucosal dissection in the lower part of the stomach. Endoscopic balloon dilation can improve gastric stasis due to stenosis; however, endoscopic balloon dilation cannot improve gastric stasis due to deformation. Furthermore, the characteristics of gastric stasis due to deformation are unknown. This study aimed to evaluate the characteristics of gastric stasis due to deformation after endoscopic submucosal dissection in the lower part of the stomach, focusing on the differences between stenosis and deformation. METHODS: We retrospectively reviewed 41 patients with gastric stasis after endoscopic submucosal dissection in the lower part of the stomach. We evaluated the characteristics of cases with gastric stasis due to deformation, such as the risk factors of deformation and the rate of deformation in each group with risk factors. RESULTS: Deformation was observed in 12% (5/41) of the patients with gastric stasis. All cases of deformation had a circumferential extent of the mucosal defect greater than 3/4. The number of cases with pyloric dissection was significantly lower in the deformation group than in the non-deformation group (0% vs. 72%; p = 0.004). The deformation group also had a significantly higher number of cases with angular dissection than the non-deformation group (100% vs. 17%; p < 0.001). Moreover, the deformation cases had a significantly larger specimen diameter (p < 0.001). Deformation was observed only in cases with angular and non-pyloric dissections. Deformation was not observed in cases with angular and pyloric dissections. CONCLUSIONS: All cases of gastric stasis due to deformation had a circumferential extent of the mucosal defect greater than 3/4. Deformation was also likely to occur in cases with a larger dissection that exceeded the angular region without pyloric dissection.

Assessment of predictive factors associated with the technical difficulty of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma: Japanese multicenter retrospective study.

OBJECTIVES: Endoscopic submucosal dissection (ESD) for superficial esophageal squamous cell carcinoma (ESCC) is performed for the treatment of lesions with varied backgrounds and factors. However, the predictive factors associated with the technical difficulty of ESD remain unknown in patients with varied lesions. Therefore, this study aimed to identify the predictive factors associated with the technical difficulty of ESD for ESCC using a retrospective cohort. METHODS: This multicenter, retrospective study was conducted in 10 hospitals in Japan. Consecutive patients who underwent esophageal ESD between January 2013 and December 2019 were enrolled. Lesions of subepithelial tumors, adenocarcinoma, and adenoma were excluded. Difficult lesions were defined as ESD requiring a long procedure time (≥120 min), perforation development, piecemeal resection, or discontinued ESD. In the present study, the clinical factors were assessed to identify the technical difficulty of ESD using univariate and multivariate analyses. RESULTS: Among 1708 lesions treated with esophageal ESD, eight subepithelial tumors, 44 adenocarcinomas, and two adenomas were excluded. Finally, 1505 patients with 1654 lesions were analyzed, and 217 patients with 217 lesions (13.1%) were classified as patients with difficult lesions. In multivariate analysis, the predictive factors associated with the technical difficulty of ESD were as follows: tumors with varices, tumors with diverticulum, antiplatelet use (discontinued), circumference of tumor (≥1/2), preoperative tumor size ≥30 mm, trainee, and nonhigh-volume center. CONCLUSION: This multicenter retrospective study identified the predictive factors associated with the technical difficulty of ESD for ESCC with varied backgrounds and factors.

Safety and efficacy of endoscopic submucosal dissection for superficial esophageal cancer with esophageal varices.

BACKGROUND: Heavy drinking is associated with esophageal cancer and esophageal varices. However, there are limited reports of endoscopic resection for esophageal cancer with esophageal varices. In this multicenter study, we clarified the safety and efficacy of endoscopic submucosal dissection for superficial esophageal cancer with esophageal varices. METHODS: In this multicenter, retrospective, observational study, patients underwent esophageal endoscopic submucosal dissection at 10 referral centers in Japan from January 2013 to December 2019. We analyzed characteristics including backgrounds and varices, treatment outcomes, and adverse events in cases with esophageal varices. RESULTS: A total of 1708 patients were evaluated, 27 (1.6%) of whom had esophageal varices. In patients with esophageal varices, the en bloc resection rate and R0 resection rate were 100% and 77.8%, respectively. Patients with esophageal varices had longer procedure times than patients without esophageal varices (p = 0.015). There was no significant difference in adverse events. There was no significant difference in procedure time and number of adverse events between patients who underwent pretreatment and those who did not. There was no significant difference in these outcomes for patients with lesions on varices compared to those without. Child-Pugh classification and location of the lesions also did not affect these outcomes. CONCLUSIONS: Esophageal cancer with esophageal varices could be treated endoscopically safely and effectively.

The risk scoring system for assessing the technical difficulty of endoscopic submucosal dissection in cases of remnant gastric cancer after distal gastrectomy.

BACKGROUND: Endoscopic submucosal dissection (ESD) for remnant gastric cancer (RGC) after distal gastrectomy (DG) is considered technically challenging due to the narrow working space, and severe fibrosis and staples from the previous surgery. Technical difficulties of ESD for RGC after DG have not been thoroughly investigated. This study aimed to develop and validate a risk-scoring system for assessing the technical difficulty of ESD for RGC after DG in a large multicenter cohort. METHODS: We investigated patients who underwent ESD for RGC after DG in 10 institutions between April 2008 and March 2018. A difficult case was defined as ESD lasting ≥ 120 min, involving piecemeal resection, or the occurrence of perforation during the procedure. A risk-scoring system for the technical difficulty of the procedure was developed based on multiple logistic regression analyses, and its performance was internally validated using bootstrapping. RESULTS: A total of 197 consecutive patients with 201 lesions were analyzed. There were 90 and 111 difficult and non-difficult cases, respectively. The scoring model consisted of four independent risk factors and points of risk scores were assigned for each as follows: tumor size > 20 mm: 2 points; anastomosis site: 2 points; suture line: 1 point; and non-expert endoscopist: 2 points. The C-statistics of the scoring system for technical difficulty was 0.72. CONCLUSIONS: We developed a validated risk-scoring model for predicting the technical difficulty of ESD for RGC after DG that can contribute to its safer and more reliable performance.

Timing of pyloric stenosis and effectiveness of endoscopic balloon dilation after pyloric endoscopic submucosal dissection.

BACKGROUND AND AIM: There have been studies on risk factors for stenosis after pyloric endoscopic submucosal dissection (ESD). However, the most appropriate strategies for the management of cases with these risk factors have not been established. This study aimed to investigate post-ESD management by evaluating the timing of stenosis and the effectiveness of endoscopic balloon dilation (EBD) after pyloric ESD. METHODS: We retrospectively reviewed cases of pyloric ESD. We first reassessed risk factors for stenosis in multivariate analysis and receiver operating characteristic curve and defined patients with the identified risk factors as the risk group. The primary outcome was the timing of stenosis in the risk group assessed by the Kaplan-Meier method. RESULTS: We reviewed 159 cases with pyloric ESD and observed pyloric stenosis in 25 cases. Cases with circumferential mucosal defect ≥ 76% were identified as the risk group. The stenosis-free probability in the risk group was 97% (95% confidence interval [CI]: 79-100%), 94% (95% CI: 76-98%), and 85% (95% CI: 66-93%) on days 7, 14, and 21, respectively. It decreased every week thereafter and did not significantly change after day 56. Twenty-three stenosis cases, except for conservative improvement, including six whole circumferential pyloric ESD cases, were improved by EBD without complications. CONCLUSIONS: Post-ESD stenosis often developed from the third to the eighth week. In all pyloric ESD cases, including whole circumferential pyloric ESD cases, pyloric stenosis was improved following EBD without complications.

Endoscopic submucosal dissection involving the anal canal presents a risk factor for postoperative stricture.

BACKGROUND: Although postoperative strictures after endoscopic submucosal dissection (ESD) in the rectum are relatively rare, some rectal lesions require resection involving the anal canal, which is a narrow tract comprising squamous epithelium. To the best of our knowledge, no studies have investigated narrow anal canals when evaluating post-ESD strictures. This study aimed to evaluate the impact of resections involving the anal canal on postoperative stricture development. METHODS: Between April 2005 and October 2017, 707 rectal lesions were treated with ESD. We retrospectively investigated 102 lesions that required ≥ 75% circumferential resection. Risk factors for post-ESD stricture and, among patients with strictures, obstructive symptoms, and number of dilation therapies required were investigated. RESULTS: Post-ESD stricture occurred in 18 of 102 patients (17.6%). In the multivariate analysis, circumferential resection ≥ 90% and ESD involving the anal canal (ESD-IAC) were risk factors for postoperative strictures (P ≤ 0.0001 and 0.0115, respectively). Among the patients with strictures, obstructive symptoms were significantly related to anal strictures compared to rectal strictures (100% vs. 27.2%, P = 0.0041). Furthermore, the number of dilation therapies required was significantly greater among patients with anal strictures compared to those with rectal strictures (6.5 times vs. 2.7 times, P = 0.0263). CONCLUSION: Not only circumferential resection ≥ 90% but also ESD-IAC was a significant risk factor for the stricture after rectal ESD. Furthermore, anal strictures were associated with a significantly higher frequency of obstructive symptoms and larger number of required dilation therapies than were rectal strictures.

Feasibility of laparoscopic endoscopic cooperative surgery for non-ampullary superficial duodenal neoplasms: Single-arm confirmatory trial.

OBJECTIVE: Laparoscopic endoscopic cooperative surgery for duodenal tumors (D-LECS) has been developed to prevent duodenal leakage by reinforcing the endoscopic submucosal dissection site. However, there has been no prospective trial showing the feasibility of D-LECS. Herein, we conducted a single-arm confirmatory trial to evaluate the safety of D-LECS for non-ampullary superficial duodenal neoplasms. METHODS: This prospective single-center single-arm confirmatory trial analyzed patients with non-ampullary superficial duodenal neoplasms who underwent D-LECS. The primary endpoint was the incidence of any postoperative leakage occurring on the duodenal wall within 1 month postoperatively. The planned sample size was 20 patients, considering a threshold of 28% and one-sided alpha value of 5%. RESULTS: Between January 2015 and September 2018, 20 eligible patients were enrolled. Sixteen tumors were located in the second portion, three in the first portion, and one in the third portion of the duodenal region. The median operative time was 225 (134-361) min and the median blood loss was 0 (0-150) mL. Curative resection (R0) with negative margins was achieved in 19 cases. One case of postoperative leakage and one case of bleeding of grade 2 according to the Clavien-Dindo classification were observed in this series. The median duration of postoperative hospital stay was 9 (5-12) days. No local recurrence was observed in any patient during the median follow-up of 15.0 (12.0-38.0) months. CONCLUSIONS: This trial confirmed the safety and feasibility of D-LECS for non-ampullary superficial duodenal neoplasms with respect to the low incidence of postoperative duodenal leakage.

Novel per-oral endoscopic myotomy method preserving oblique muscle using two penetrating vessels as anatomic landmarks reduces postoperative gastroesophageal reflux.

BACKGROUND AND AIM: One of the main concerns related to peroral endoscopic myotomy (POEM) is postoperative gastroesophageal reflux (GER). The two penetrating vessels (TPVs) that are found at the boundary between the circular and oblique muscles in the posterior cardia wall have been suggested to be a good indicator of the optimal distal extent of POEM. However, the effect of performing myotomy using the TPVs as an anatomical reference on the frequency of post-POEM GER has not been studied. METHODS: This study involved consecutive patients who underwent POEM for the treatment of achalasia between April 2015 and June 2017. All enrolled patients underwent POEM in the 5 o'clock position and were divided into two groups: the conventional line group (CL group, n = 31), in which the TPVs were not exposed during submucosal tunnel dissection in the cardia, and the TPVs line group (TPVs group, n = 83), in which the TPVs were exposed and gastric myotomy was performed along the right side of the TPVs to preserve the oblique muscle. Examinations for post-POEM GER were conducted 3 months after the POEM. RESULTS: The frequency of grade B or higher reflex esophagitis was 26/83 (31.3%) in the TPVs group and 18/31 (58.1%) in the CL group (P = 0.017). Nine of 83 patients (10.8%) had GER symptoms in the TPVs group, and six of 31 (19.4%) had GER symptoms in the CL group (P = 0.23). CONCLUSIONS: The novel myotomy method preserving oblique muscle using TPVs as anatomical landmarks significantly reduced the frequency of post-POEM GER.

Endoscopic plombage with polyglycolic acid sheets and fibrin glue for gastrointestinal fistulas.

BACKGROUND AND STUDY AIMS: Gastrointestinal (GI) fistulas arise as adverse events of GI surgery and endoscopic treatment as well as secondary to underlying diseases, such as ulceration and pancreatitis. Until a decade ago, they were mainly treated surgically or conservatively. Bioabsorbable polyglycolic acid (PGA) sheets and fibrin glue, which are commonly used in surgical procedures, have also recently been used in endoscopic procedures for the closure of GI defects. However, there have only been few case reports about successful experiences with this approach. There have not been any case-series studies investigating the strengths and weaknesses of such PGA sheet-based treatment. In this study, we evaluated the clinical effectiveness of using PGA sheets to close GI fistulas. PATIENTS AND METHODS: Cases in which patients underwent endoscopic filling with PGA sheets and fibrin glue for GI fistulas at Kobe University Hospital between January 2013 and April 2018 were retrospectively reviewed. RESULTS: A total of 10 cases were enrolled. They included fistulas due to leakage after GI surgery, aortoesophageal/bronchoesophageal fistulas caused by chemoradiotherapy, or severe acute pancreatitis. The fistulas were successfully closed in 7 cases (70%). The unsuccessful cases involved a fistula due to leakage after surgical esophagectomy and bronchoesophageal fistulas due to chemoradiotherapy or severe acute pancreatitis. Unsuccessful treatment was related to fistula epithelization. CONCLUSION: Endoscopic plombage with PGA sheets and fibrin glue could be a promising therapeutic option for GI fistulas.

Development of a Model for the Acquisition and Assessment of Advanced Laparoscopic Suturing Skills Using an Automated Device.

BACKGROUND: Needs assessment identified a gap regarding laparoscopic suturing skills targeted in simulation. This study collected validity evidence for an advanced laparoscopic suturing task using an Endo StitchTM device. METHODS: Experienced (ES) and novice surgeons (NS) performed continuous suturing after watching an instructional video. Scores were based on time and accuracy, and Global Operative Assessment of Laparoscopic Surgery. Data are shown as medians [25th-75th percentiles] (ES vs NS). Interrater reliability was calculated using intraclass correlation coefficients (confidence interval). RESULTS: Seventeen participants were enrolled. Experienced surgeons had significantly greater task (980 [964-999] vs 666 [391-711], P = .0035) and Global Operative Assessment of Laparoscopic Surgery scores (25 [24-25] vs 14 [12-17], P = .0029). Interrater reliability for time and accuracy were 1.0 and 0.9 (0.74-0.96), respectively. All experienced surgeons agreed that the task was relevant to practice. CONCLUSION: This study provides validity evidence for the task as a measure of laparoscopic suturing skill using an automated suturing device. It could help trainees acquire the skills they need to better prepare for clinical learning.

A novel and effective delivery method for polyglycolic acid sheets to post-endoscopic submucosal dissection ulcers.

Background and aims Shielding methods for post-endoscopic submucosal dissection (ESD) ulcers have delivery-related problems. We developed an enveloped device for this purpose and evaluated its usefulness. Materials and methods Polyglycolic acid (PGA) sheets were delivered to six 3.0-cm ulcers in two resected porcine stomachs and six 5.0-cm ulcers in another three stomachs. In the regular method group, small PGA sheets were delivered via forceps. In the novel method group, a large PGA sheet was delivered via the new device. The methods were compared in terms of time, and macroscopic and histological findings of the ulcer floor. Results The median time required to cover a 3.0-cm ulcer was 0.39 min/cm2 in the novel method group and 1.03 min/cm2 in the regular method group (P = 0.03), and to cover a 5.0-cm ulcer was 0.38 min/cm2 and 0.85 min/cm2, respectively (P = 0.03). In the novel method group, the PGA sheets were in close contact, fully covering the ulcer floor. In the regular method group, the sheets were partly elevated from the ulcer floor. Conclusions This novel technique seems promising in this preliminary study.

Method and timing of resection of superficial non-ampullary duodenal epithelial tumors.

BACKGROUND AND AIM: Non-ampullary duodenal epithelial tumors (NADET) are rare, and there is no consensus regarding treatment indications and methods for superficial lesions. Records of patients with NADET over a 10-year period were reviewed to clarify the present state of clinical management of superficial NADET. METHODS: Data related to clinicopathological characteristics, selection of treatment, and outcomes were collected and analyzed. RESULTS: Of 95 lesions, 73 were either adenoma or mucosal or submucosal invasive cancers. Half of the patients with a biopsy diagnosis of low-grade adenoma were followed up without treatment. Results of endoscopic resection (ER), including endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for patients with high-grade adenoma (HGA) or cancer showed a high en bloc resection rate. However, the risk of perforation was high among ESD cases. Surgery was done for patients with a diagnosis of cT1a or cT1b cancer, of which half underwent local resection. An upgrade in pathology between preoperative biopsy and final pathology was observed in 11/13 lesions with a biopsy diagnosis of HGA. CONCLUSIONS: Superficial NADET, including HGA, should be treated endoscopically or surgically. For lesions with no risk of metastasis, local resection by EMR may be reasonable or clinically sufficient regarding the high complication rate of ESD. However, surgery remains a standard treatment for lesions that are technically impossible to remove by ER.

Percutaneous endoscopic gastrostomy for decompression of malignant bowel obstruction.

BACKGROUND: Previous reports on percutaneous endoscopic gastrostomy (PEG) for bowel decompression have included a relatively small number of patients and the details of post-procedural outcomes and complications are lacking. The aim of the present study was to evaluate the outcomes and safety of PEG for bowel decompression in a relatively large number of patients with malignant bowel obstruction. PATIENTS AND METHODS: Over a 10-year period, 76 patients with malignant bowel obstruction were referred to the main referral cancer center in Shizuoka prefecture for PEG to obtain decompression. The method for gastrostomy was carried out by the pull-method, the modified introducer method and the percutaneous endoscopic gastrojejunostomy method. Patient demographics, procedural success, complications, elimination of nasal intubation, and survival were reviewed. RESULTS: Successful placement was achieved in 93% of patients (71/76). Procedure-related complications occurred in 21% ofpatients (15/71), of which the majority involved stomal leakage (eight patients), and wound infection (six patients). There were no procedure-related deaths. Among the 55 patients who required nasal intubation before PEG, a trans-gastrostomy intestinal tube was inserted in 16 patients. The need for further nasal intubation was eliminated in 96% of the patients (53/55). The median survival time was 63 days (range, 8-444 days) after PEG placement. CONCLUSIONS: PEG for bowel decompression in patients with malignant obstruction can be carried out with an acceptable risk of minor complications. In combination with a trans-gastrostomy intestinal tube insertion, the elimination of nasal intubation can be achieved in most patients.

Usefulness of three-dimensional imaging in a flexible endoscopic surgery platform with multi-degrees-of-freedom articulating devices.

BACKGROUND AND AIMS: Recent studies on endoscopic submucosal dissection have aimed to reduce the difficulty of the procedure by using multi-degrees-of-freedom articulating devices. In this study, we evaluated the usefulness of adding three-dimensional (3D) video imaging into simulated endoscopic submucosal dissection tasks using multi-degrees-of-freedom devices. METHODS: We designed an endoscopic platform with a 3D camera and two multi-degrees-of-freedom devices. Four ex vivo bench tasks were created, and a crossover study comparing 2D and 3D conditions was conducted on 15 volunteers. In each task, performance such as procedure time and accuracy were objectively evaluated. Additionally, a comprehensive visual analogue scale questionnaire was conducted. RESULTS: In the tasks simulating submucosal flap grasping, marking, and full-area incision, the use of 3D imaging significantly improved the speed and accuracy of the multi-degrees-of-freedom device manipulation (p < .01). No significant differences were observed in the task that simulated the dissection procedure. Furthermore, it appears that the accuracy of recognizing curved surfaces may be reduced in the 3D environment. Operators reported subjective increases in recognizability and operability with the 3D camera, along with an increase in asthenopia (p < .01). CONCLUSIONS: 3D vision improves the technical accuracy of certain simulated multi-degrees-of-freedom endoscopic submucosal dissection tasks and subjectively improved operating conditions, at the cost of increased eye strain.