Usefulness of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in elderly patients: a single-center retrospective cohort study.

BACKGROUND: The effectiveness of endoscopic treatment for superficial esophageal squamous cell carcinoma in the elderly is unclear. METHODS: We retrospectively studied efficacy and safety of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in 358 patients at our hospital from July 2005 to December 2018. Patients were divided into elderly (≥75 years) and young (≤74 years) groups. Efficacy was evaluated based on overall survival and disease-specific survival, whereas safety was investigated based on the frequency of endoscopic submucosal dissection-related adverse events. RESULTS: The median observation period was 50 months. The elderly group comprised 111 patients, and young group comprised 247 patients. In the elderly and young groups, 76 (68.5%) and 159 (64.4%) underwent curative resection (P = 0.450), 8 (7.2%) and 34 (13.8%) underwent non-curative resection plus additional treatment and 12 (10.8%) and 15 (6.0%) underwent follow-up, respectively. The frequency of additional treatment for non-curative resection was significantly lower in the elderly group (P = 0.023). The 3-year overall survival of the elderly and young groups was 85.6 and 94.1%, respectively (P = 0.003). The 3-year disease-specific survival of the elderly and young groups was 98.4 and 98.5% (P = 0.682), respectively. The frequency of endoscopic submucosal dissection-related adverse events did not differ significantly between the groups (P = 0.581). The Charlson Comorbidity Index ≥2 was an independent prognostic factor for survival in the elderly group (P = 0.010; hazard ratio, 5.570; 95% confidence interval, 1.519-20.421). CONCLUSIONS: Endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in elderly patients is as safe as that for young patients. The evaluation of Charlson Comorbidity Index was considered to help estimate the prognosis of elderly patients.

Clinical outcomes of endoscopic resection for undifferentiated intramucosal early gastric cancer larger than 2 cm.

BACKGROUND: This study investigated the long-term clinical outcomes of endoscopic resection (ER) for undifferentiated-type (UD) early gastric cancer (EGC), with tumor size > 2 cm as the only non-curative factor. METHODS: From among 1123 patients who underwent ER for UD EGC at 18 tertiary hospitals in Korea between 2005 and 2014, we identified 216 patients with UD intramucosal EGC > 2 cm, which was completely resected, with negative resection margins, and absence of ulceration and lymphovascular invasion. The patients were divided into the additional surgery (n = 40) or observation (n = 176) groups, according to post-ER management and were followed up for a median duration of 59 months for recurrence and 90 months for overall survival. RESULTS: Lymph node (LN) or distant metastasis or cancer-related mortality was not observed in the surgery group. In the observation group, two (1.1%) patients developed LN or distant metastasis with a 5-year cumulative risk of 0.7%, and one (0.6%) patient died of gastric cancer. The 5- and 8-year overall survival rates were 94.1% and 89.9%, respectively, in the observation group and 100.0% and 95.2%, respectively, in the surgery group (log-rank P = 0.159). Cox regression analysis did not reveal an association between the observation group and increased mortality. CONCLUSION: The risk of LN or distant metastasis was not negligible, but as low as 1% for patients undergoing non-curative ER for UD EGC, with tumor size > 2 cm as the only non-curative factor. Close observation may be an alternative to surgery, especially for older patients or those with poor physical status.

A nonrandomized, single-arm confirmatory trial of expanded endoscopic submucosal dissection indication for undifferentiated early gastric cancer: Japan Clinical Oncology Group study (JCOG1009/1010).

BACKGROUND: While endoscopic submucosal dissection (ESD) is recognized as a minimally invasive standard treatment for differentiated early gastric cancers (EGCs), it has not been indicated for undifferentiated EGC (UD-EGC) because of a relatively high risk of lymph node metastasis (LNM). However, patients with surgically resected mucosal (cT1a) UD-EGC ≤ 2 cm in size with no lymphovascular invasion or ulceration are reported to be at a very low risk of LNM. This multicenter, single-arm, confirmatory trial was conducted to evaluate the efficacy and safety of ESD for UD-EGC. METHODS: The key eligibility criteria were endoscopically diagnosed cT1a/N0/M0, single primary lesion, size ≤ 2 cm, no ulceration and histologically proven components of undifferentiated adenocarcinoma on biopsy. Based on the histological findings after ESD, additional gastrectomy was indicated if the criteria for curative resection were not satisfied. The subjects of the primary analysis were patients with UD-EGC as the dominant component. The primary endpoint was 5-year overall survival (OS) of patients with UD-EGC. RESULTS: Three hundred 46 patients were enrolled from 49 institutions. The proportion of en bloc resection was 99%. No ESD-related Grade 4 adverse events were noted. Delayed bleeding and intraoperative and delayed perforation occurred in 25 (7.3%), 13 (3.8%), and 6 (1.7%) patients, respectively. Among the 275 patients who were the subjects of the primary analysis, curative resection was achieved in 195 patients (71%), and 5-year OS was 99.3% (95% CI: 97.1-99.8). CONCLUSIONS: ESD can be a curative and less invasive treatment for UD-EGC for patients meeting the eligibility criteria of this study.

Operative safety of curative gastrectomy after endoscopic submucosal dissection (ESD) for early gastric cancer - 1:2 propensity score matching analysis: A retrospective single-center study (cohort study).

BACKGROUND: This study aimed to evaluate the operative safety and long-term outcomes of additional curative gastrectomy (ACG) after non-curative endoscopic submucosal dissection (ESD), as compared with standard gastrectomy (SG) without ESD in patients with early gastric cancer. MATERIALS AND METHODS: Data from 101 patients receiving ACG after non-curative ESD (Post-ESD group) and 1080 patients after SG without ESD (Surgery-only group), between 2009 and 2016, were reviewed retrospectively. Clinicopathologic characteristics, overall survival (OS), disease-specific survival (DSS), and relapse-free survival (RFS) were compared between groups, using propensity score matching analysis. RESULTS: After propensity score matching, a total of 101 patients in the post-ESD group and 202 patients in the surgery-only group were analyzed. The post-ESD group had shorter operation times than did the surgery-only group (p = 0.005). Estimated blood loss and the incidence of postoperative morbidity did not differ between the two groups, and no differences were observed in pathologic outcomes, including N stage (p = 0.268). In addition, 5-year OS, DSS, and RFS rates were not significantly different between groups (OS; 95.1% vs. 98.2%, p = 0.535, DSS; 98.2% vs. 98.7%, p = 0.956, and RFS; 98.6% vs. 98.9%, p = 0.757, respectively). CONCLUSION: ACG can be performed safely after non-curative endoscopic submucosal dissection, with good operative outcomes.

Predictive Factors and Risk Model for Positive Circumferential Resection Margin Rate After Transanal Total Mesorectal Excision in 2653 Patients With Rectal Cancer.

OBJECTIVE: The aim of this study was to determine the incidence of, and preoperative risk factors for, positive circumferential resection margin (CRM) after transanal total mesorectal excision (TaTME). BACKGROUND: TaTME has the potential to further reduce the rate of positive CRM for patients with low rectal cancer, thereby improving oncological outcome. METHODS: A prospective registry-based study including all cases recorded on the international TaTME registry between July 2014 and January 2018 was performed. Endpoints were the incidence of, and predictive factors for, positive CRM. Univariate and multivariate logistic regressions were performed, and factors for positive CRM were then assessed by formulating a predictive model. RESULTS: In total, 2653 patients undergoing TaTME for rectal cancer were included. The incidence of positive CRM was 107 (4.0%). In multivariate logistic regression analysis, a positive CRM after TaTME was significantly associated with tumors located up to 1 cm from the anorectal junction, anterior tumors, cT4 tumors, extra-mural venous invasion (EMVI), and threatened or involved CRM on baseline MRI (odds ratios 2.09, 1.66, 1.93, 1.94, and 1.72, respectively). The predictive model showed adequate discrimination (area under the receiver-operating characteristic curve >0.70), and predicted a 28% risk of positive CRM if all risk factors were present. CONCLUSION: Five preoperative tumor-related characteristics had an adverse effect on CRM involvement after TaTME. The predicted risk of positive CRM after TaTME for a specific patient can be calculated preoperatively with the proposed model and may help guide patient selection for optimal treatment and enhance a tailored treatment approach to further optimize oncological outcomes.

Is Additional Surgery Always Sufficient for Preventing Recurrence After Endoscopic Submucosal Dissection with Curability C-2 for Early Gastric Cancer?

BACKGROUND: When a lesion does not meet the curative criteria of endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), referred to as non-curative resection or curability C-2 in the guidelines, an additional surgery is the standard therapy because of the risk of lymph node metastasis (LNM). OBJECTIVE: This study aimed to identify high-risk patients for recurrence after additional surgery for curability C-2 ESD of EGC. METHODS: This multicenter retrospective cohort study enrolled 1064 patients who underwent additional surgery after curability C-2 ESD for EGC. We evaluated the recurrence rate and the risk factors for recurrence after additional surgery in these patients. RESULTS: The 5-year recurrence rate after additional surgery was 1.3%. Multivariate Cox analysis revealed that the independent risk factors for recurrence after additional surgery were LNM (hazard ratio [HR] 32.47; p < 0.001) and vascular invasion (HR 4.75; p = 0.014). Moreover, patients with both LNM and vascular invasion had a high rate of recurrence after additional surgery (24.6% in 5 years), with a high HR (119.32) compared with those with neither LNM nor vascular invasion. Among patients with no vascular invasion, a high rate of recurrence was observed in those with N2/N3 disease according to the American Joint Committee on Cancer TNM staging system (27.3% in 5 years), in contrast with no recurrence in those with N1 disease. CONCLUSIONS: Patients with both LNM (N1-N3) and vascular invasion, as well as those with N2/N3 disease but no vascular invasion, would be candidates for adjuvant chemotherapy after additional surgery for curability C-2 ESD of EGC.

Short-term outcomes of traction-assisted versus conventional endoscopic submucosal dissection for superficial gastrointestinal neoplasms: a systematic review and meta-analysis of randomized controlled studies.

BACKGROUND: In recent years, some traction-assisted approaches have been introduced to facilitate endoscopic submucosal dissection (ESD) procedures by reducing the procedure time and risks related to the procedure. However, the relative advantages of traction-assisted endoscopic submucosal dissection (T-ESD) are still being debated. This study aimed to assess the efficacy of T-ESD for the treatment of superficial gastrointestinal neoplasms. METHODS: We searched MEDLINE, Embase, and Cochrane library up to March 31, 2019 for randomized controlled trials (RCTs) comparing T-ESD and conventional endoscopic submucosal dissection (C-ESD) for superficial gastrointestinal neoplasms. The main endpoints are en bloc resection, complete resection, procedure time, perforation, and delayed bleeding. Pooled risk ratio (RR), Peto odds ratio (OR), and mean difference (MD) were calculated to compare T-ESD and C-ESD. This study is registered with PROSPERO, number CRD42018108135. RESULTS: A total of 7 RCTs with 1007 patients were included in this meta-analysis. There were no significant differences between the T-ESD and C-ESD groups in the pooled estimate of en bloc resection, complete resection, and delayed bleeding (RR = 1.00, 95% CI 0.99, 1.01, I2 = 0%, P = 0.66; RR = 1.00, 95% CI 0.98, 1.03, I2 = 0%, P = 0.81; OR = 0.95, 95% CI 0.48, 1.86, I2 = 19%, P = 0.87,respectively). The pooled estimate indicated that the procedure time was significantly shorter in the T-ESD group (MD = - 16.19, 95% CI - 29.24, - 3.13, I2 = 87%, P = 0.02) than in the C-ESD group. Compared to C-ESD, T-ESD was associated with lower incidence of perforation (OR = 0.32, 95% CI 0.11, 0.91, I2 = 0%, P = 0.03). CONCLUSIONS: T-ESD is a safe and effective treatment option with a low perforation rate and shorter procedure time than C-ESD for superficial gastrointestinal neoplasms. Future multi-center (including European populations), randomized controlled trials of larger sample size and long-term outcomes of T-ESD are required.

Impact of the Charlson Comorbidity Index on the treatment strategy and survival in elderly patients after non-curative endoscopic submucosal dissection for esophageal squamous cell carcinoma: a multicenter retrospective study.

BACKGROUND: In elderly patients with superficial esophageal squamous cell carcinoma (ESCC), the optimal treatment strategy after non-curative endoscopic submucosal dissection (ESD) remains unclear. We aimed to evaluate the validity of additional treatments after non-curative ESD and post-ESD survival predictors in elderly patients with ESCC. METHODS: Elderly patients (age > 75 years) treated with ESD for ESCC between January 2010 and July 2014 at six tertiary referral hospitals in Japan were retrospectively investigated and stratified according to lymph node metastasis risk, based on histological findings (high-risk factors: positive lymphovascular invasion, submucosal invasion, and positive/indeterminate vertical margin) and post-ESD treatment strategy: group A (287 patients; low risk), group B (41 patients; high risk, without additional treatment), and group C (32 patients; high risk, with additional treatment). We evaluated 3- and 5-year overall survival and disease-specific survival, and prognostic factors for post-ESD survival. RESULTS: At a median follow-up of 38, 40, and 49 months, respectively, there was 1 esophageal cancer-related death in group A, 1 in group B, and none in group C, whereas 22, 9, and 3 patients in groups A, B, and C died of other diseases. The groups differed significantly in overall survival (92.4%; 87.6%; 93.4%, p = 0.022), although not in disease-specific survival (99.4%; 96.3%; 100%, p = 0.217). On multivariate analysis, Charlson Comorbidity Index (CCI) ≥ 2 was the only independent risk factor for post-ESD death (hazard ratio 7.92; 95% confidence interval 3.42-18.3; p < 0.001). CONCLUSIONS: A follow-up strategy without additional treatment after ESD for ESCC may be acceptable in high-risk elderly patients, especially for CCI ≥ 2.

Comparison of long-term outcomes between esophagectomy and chemoradiotherapy after endoscopic resection of submucosal esophageal squamous cell carcinoma.

Esophagectomy represents the standard treatment strategy for superficial esophageal cancer diagnosed pathologically as submucosal disease (pT1b) following an endoscopic resection (ER). However, chemoradiotherapy (CRT) is expected to become an alternative treatment option. This study retrospectively compared the outcomes of patients who underwent ER of submucosal esophageal squamous cell carcinoma, and who received additional treatment in the form of surgery and CRT. Data were collected from 83 patients who underwent ER and were diagnosed as pT1b (sm) between January 2002 and December 2013. Of them, 52 patients underwent additional treatment (19 surgery, 33 CRT). The long-term outcomes, recurrent patterns, and recurrence risk factor were analyzed retrospectively. No significant differences were identified between the two groups regarding the following aspects: sex, Charlson comorbidity index, tumor size, macroscopic type, cut end positivity, and en bloc resection rate. On the contrary, significant differences were observed in age (P = 0.042) and lymphovascular invasion (P = 0.003) between the two groups. There were more patients with positive lymphovascular invasion, which was one of the strongest risk factors, in the surgery group. The 3-year overall survival (OS) and relapse-free survival (RFS) rates were both 100% in the surgery group and 90.4% and 87.4%, respectively, in the CRT group. The 5-year OS and RFS rates both decreased to 89.5% in the surgery group and to 80.3% and 70.4%, respectively, in the CRT group. The surgery group achieved a superior OS and RFS compared to the CRT group, though not significant (P = 0.172, P = 0.127). Tumor recurrence was observed in 6 patients. All these patients were in the CRT group (P = 0.075). They included 3 patients with hematogenous metastases (of the lung, bone, and adrenal gland) and 3 patients with regional lymph node metastasis. The patient with hematogenous adrenal gland metastasis had simultaneous extended lymph node metastasis. Through a univariate analysis, it was observed that tumor size (≥ 40 mm) and positive lymphatic invasion represented the significant risk factors for recurrence in the CRT group (P = 0.048 and P = 0.035, respectively). To achieve a better long-term survival, surgery is recommended as the additional treatment for ER-pT1b esophageal cancer. While CRT represents an acceptable alternative, the indication should be carefully decided, especially in high-risk patients for recurrence with large tumor size (≥ 40 mm) or positive lymphatic invasion.

Patient-reported functional and quality-of-life outcomes after transanal total mesorectal excision.

Follow-up of more than 1 year after transanal total mesorectal excision for rectal cancer demonstrated improved quality of life and stable or improved functional outcomes. Continued experience and operative efficiency hold promise for improved overall outcomes with this emerging technology. Key patient-reported outcomes.

Long-term outcomes after non-curative endoscopic submucosal dissection for early gastric cancer according to hospital volumes in Japan: a multicenter propensity-matched analysis.

BACKGROUND: There is a lack of data regarding the long-term outcomes of endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) without curative resection, and the relationship of these outcomes with hospital volumes remains unclear. This study evaluated long-term outcomes of patients who underwent ESD for EGC without curative resection according to hospital volumes in Japan. METHODS: This multicenter retrospective study evaluated 1,969 patients who did not meet the criteria of the Japanese Gastric Cancer Association for curative resection between January 2000 and August 2011. Hospitals were classified according to the annual number of ESD procedures: low- and medium-volume group (LMVG), high-volume group (HVG), and very high-volume group (VHVG). Clinicopathological features, overall survival (OS), disease-specific survival (DSS), and recurrence-free survival (RFS) were compared across groups after a generalized propensity score matching analysis. RESULTS: In 495 pairs of generalized propensity score-matched patients, the 5-year OS, DSS, and RFS rates were 81.5%, 97.9%, and 97.6% for LMVG; 86.9%, 98.2%, and 97.0% for HVG; and 85.4%, 98.5%, and 97.6% for VHVG, respectively. The 5-year DSS and RFS rates did not significantly differ among the three groups. However, 5-year OS was significantly worse in the LMVG than in the HVG and VHVG (P < 0.001 and P = 0.008, respectively). CONCLUSIONS: DSS and RFS in patients with EGC who did not meet the criteria for curative resection did not differ across hospital volumes in Japan. Even in cases in which ESD for EGC involved non-curative resection, the procedure is feasible across Japanese hospitals with different volumes.

Long-term outcome of endoscopic submucosal dissection for early gastric cancer in patients with severe comorbidities: a comparative propensity score analysis.

BACKGROUND: Recently, endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) has been performed on patients with severe comorbidities because it is less invasive, although little is known regarding long-term outcomes. This study aimed to assess the long-term outcomes of ESD for patients with severe and non-severe comorbidities. METHODS: We enrolled 1081 patients who underwent ESD for EGC between February 2004 and June 2013. Based on the American Society of Anesthesiologists Physical Status (ASA-PS) classification, we defined patients with severe and non-severe comorbidities as ASA-PS 3 and 1/2, respectively. We retrospectively compared the overall survival, risk factors for mortality, and adverse events between these two groups using propensity score matching and inverse probability of treatment weighting. RESULTS: A total of 488 patients met the eligibility criteria. After matching, the ASA-PS 3 group showed a significantly shorter survival than the ASA-PS 1/2 group (5-year overall survival rate, 79.1 vs. 87.7%; p < 0.01). In addition, only the ASA-PS 3 group had a significant risk factor for mortality using both the Cox analysis [hazard ratio (HR), 2.56; 95% confidence interval (CI) 1.18-5.52; p = 0.02] and the IPTW method (HR, 3.14; 95% CI 1.91-5.14; p < 0.01). There was no significant difference in adverse events after matching between the two groups (p = 0.21). CONCLUSIONS: The long-term outcome of gastric ESD for patients with severe comorbidities was worse than for those with non-severe comorbidities. Further studies will be necessary to determine if ESD is truly warranted in these patients.

Long-term outcomes and prognostic factors with non-curative endoscopic submucosal dissection for gastric cancer in elderly patients aged ≥ 75 years.

BACKGROUND: Little is known about the long-term outcomes and prognostic factors with non-curative endoscopic submucosal dissection (ESD) in elderly patients with early gastric cancer. METHODS: Clinicopathological findings and long-term outcomes were evaluated in 87 patients with early gastric cancer (EGC) aged ≥ 75 years who were treated with non-curative ESD. Prognostic factors for overall survival (OS) were analyzed with the Kaplan-Meier method and a Cox proportional hazards model. RESULTS: During the follow-up period, among 27 patients who died of any cause, only one patient died of gastric cancer. OS probabilities after 3 and 5 years were 89.7% and 79.3%, respectively. Univariate analyses revealed that Eastern Cooperative Oncology Group performance status 2-3, Charlson comorbidity index (CCI) ≥ 3, neutrophil/lymphocyte ratio ≥ 3.3, prognostic nutritional index < 44.8, distal tumor location and macroscopically depressed or flat configuration were associated with poor OS. Cox multivariate analysis revealed high CCI (≥ 3) to be an independent prognostic factor associated with OS (hazard ratio: 2.63, 95% confidence interval [CI] 1.06-6.49, P = 0.037). CONCLUSIONS: CCI may be a useful parameter for decision-making regarding additional surgery for elderly patients with gastric cancer treated by non-curative ESD.

Recurrence Patterns and Outcomes of Salvage Surgery in Cases of Non-Curative Endoscopic Submucosal Dissection without Additional Radical Surgery for Early Gastric Cancer.

BACKGROUND/AIMS: The outcomes of salvage surgery for recurrence after non-curative endoscopic submucosal dissection (ESD) without additional radical surgery for early gastric cancer (EGC) remain unclear. We determined the recurrence patterns and outcomes of salvage surgery in such cases using data from a multicenter, retrospective study. METHODS: Of 15,785 patients who underwent ESD for EGC at 19 participating institutions between January 2000 and August 2011, 1,969 failed to meet the current curative criteria after ESD. Of these, 905 patients received no additional treatment. We evaluated the pattern of recurrence, clinical course after salvage surgery, and long-term survival rate for these patients. RESULTS: Over a median 64-month follow-up period, recurrence was detected in 27 patients. Two patients with missing data were excluded. Three, seven, and 15 (60%) patients showed intragastric relapse, regional lymph node metastasis, and distant metastasis, respectively. The first line of treatment for recurrence in 1, 7, 6, and 11 patients was endoscopic treatment, salvage surgery, chemotherapy, and best supportive care, respectively. One patient survived without recurrence for 31 months after salvage surgery, one died of acute myocardial infarction 1 month after salvage surgery, and 5 showed recurrence at 0, 2, 3, 5, and 30 months after salvage surgery and eventually succumbed to the disease. The median survival times for all patients with recurrence and the 7 patients who underwent salvage surgery were 5 months after recurrence and 7 months after salvage surgery, respectively. CONCLUSION: The survival rate after salvage surgery for recurrence after non-curative ESD without additional radical surgery for EGC is quite low, with distant metastasis being the most common recurrence pattern in these cases.

A comparative study on endoscopic submucosal dissection and laparoscopy-assisted radical gastrectomy in the treatment of early gastric carcinoma.

PURPOSE: To compare the clinical efficacy and safety of endoscopic submucosal dissection (ESD) and laparoscopy-assisted radical gastrectomy (LARG) in the treatment of early gastric carcinoma (EGC) with different risks of lymph node metastasis. METHODS: The clinical data of 194 EGC patients who underwent ESD (ESD group, n=58) or LARG (LARG group, n=136) in our hospital from January 2014 to January 2016 were collected. The baseline data, pathological features of tumor, perioperative indexes and long- and short-term complications were compared between the two groups, the overall survival (OS) rate of patients was recorded through follow-up, and the tumor-free survival (TFS) rate was compared after ESD and LARG for EGC with different risks of lymph node metastasis. RESULTS: The general clinical features were comparable between the two groups of patients, and there was no perioperative death. The pathological features of the tumor had no statistically significant differences between the two groups (p>0.05). The operation time in ESD group (73.57±21.30 min) was significantly shorter than that in LARG group (159.22±39.40 min) (p<0.001), and the time of first ambulation after operation in ESD group (1.6±0.8 d) was also overtly shorter than that in LARG group (3.5±1.7 d) (p<0.001). Postoperatively, no drainage tube was placed in the ESD group, while it was placed for 5.7±2.4 days on average in the LARG group. The time of first flatus after operation, time of first liquid diet after operation, and total hospitalization time in the ESD group were significantly compared with the LARG group (p<0.001). The incidence rate of short-term complications after surgery was 10.3% and 7.4% in the two groups, (p=0.570), while long-term complications were 17.6% (9/51) and 20.9% (24/115) in the two groups (p=0.631). The in situ tumor recurrence by the end of follow-up was 3.92% (2/51) and 0.87% (1/115) in the two groups, while the ectopic recurrence rate was 5.89% (3/51) and 0.87% (1/115) (p=0.173, p=0.087). OS survival was 96.1% (49/51) and 97.4% (112/115) in the two groups (p=0.751). The postoperative TFS of EGC patients with a low risk of lymph node metastasis was 93.8% (30/32) and 98.6% (70/71) in the two groups, again without significant difference (p=0.197). The postoperative TFS of EGC patients with a high risk of lymph node metastasis was 84.2% (16/19) and 97.7% (43/44) in the two groups, with statistically significant difference (log-rank, p=0.034). CONCLUSIONS: ESD is characterized by small trauma, rapid postoperative recovery, postoperative recurrence and survival comparable to those after surgical operation and high safety for EGC with a low risk of lymph node metastasis. LARG can reduce the postoperative recurrence rate of EGC in patients with high risk of lymph node metastasis.

Current status and future perspectives of endoscopic full-thickness resection.

Flexible endoscopy has developed from a diagnostic tool for tissue biopsy sampling to a treatment tool for endoscopic resection of neoplasms in the digestive tract. In the near future, one of the advanced endoscopic techniques, endoscopic full-thickness resection (EFTR), is expected to be a feasible endoscopic procedure. In the present review, systematic review of conventional exposed EFTR was carried out. Search queries were (endoscopic full-thickness resection or EFTR) (over-the-scope clip or OTSC) (Overstitch System) from 2015 to 2017. Four retrospective, single-center studies with regard to conventional EFTR were identified. With regard to indication for conventional exposed EFTR, gastrointestinal stromal tumor was a good indication for EFTR. Mean tumor size of all four studies was 20.71 mm. In two studies, endoclips were used to close the resected opening without any complications, but the other two studies reported complications such as delayed perforation even using OTSC. Procedure times were reported from a minimum of 40 min to a maximum of 105 min. We also refer to introduction of a newly developed procedure of EFTR (non-exposed EFTR), and development of a new suturing device in Japan.

Outcomes after endoscopic mucosal resection or esophagectomy for submucosal esophageal adenocarcinoma.

OBJECTIVES: Endoscopic mucosal resection (EMR) is a diagnostic and potentially therapeutic option for patients with submucosal esophageal adenocarcinoma. However, there are significant concerns regarding the risk of lymph node metastasis. Our purpose was to construct a comparative effectiveness analysis comparing recurrence patterns after therapeutic EMR or esophagectomy. METHODS: Patients who underwent therapeutic EMR or esophagectomy from 2007 to 2015 with pathologically staged submucosal adenocarcinoma were identified from a departmental database. Cancer-related outcomes were compared among an unmatched as well as a propensity matched cohort. Risk stratification was also used to compare results among those with a low, medium, or high risk of nodal metastasis. RESULTS: Seventy-two patients met criteria for analysis, among whom 23 underwent therapeutic EMR with esophageal preservation and 49 underwent esophagectomy. Median follow-up was 43 months. Patients who underwent esophagectomy had larger, deeper tumors. Esophageal preservation was associated with an increased risk of local recurrence (P = .01), but not distant recurrence (P = .44). After propensity matching, there continued to be no difference in distant recurrence rate (P = .66). In a risk-stratified analysis, low-risk patients showed no recurrences or cancer-related deaths, however, high-risk patients showed a trend toward increased distant recurrence after therapeutic EMR. CONCLUSIONS: Esophageal preservation after therapeutic EMR was associated with an increased risk of local recurrence. Among low-risk patients, either strategy resulted in excellent cancer control. However, among high-risk patients, esophageal preservation showed a trend toward increased distant failure. These findings should prompt further investigation to determine optimal treatment for patients with submucosal esophageal adenocarcinoma.

Long-Term Clinical Outcomes of Endoscopic Submucosal Dissection in Patients with Early Gastric Cancer: A Prospective Multicenter Cohort Study.

Background/Aims: Endoscopic submucosal dissection (ESD) has been regarded as a curative treatment for early gastric cancer (EGC) in indicated cases. The aim of this study was to evaluate the nationwide long-term clinical outcomes of ESD for EGC in Korea. Methods: A prospective multicenter cohort study was performed to evaluate the long-term efficacy of ESD for EGC within pre-defined indications at 12 institutes in Korea. The cases that met the expanded criteria upon pathological review after ESD were followed for 5 years. The primary outcome was 5-year disease specific free survival. Results: Six hundred ninety-seven patients with 722 EGCs treated with ESD were prospectively enrolled and followed for 5 years. Complete resection was achieved in 81.3% of the cases, and curative resection was achieved in 86.1%. During the 5-year follow-up, the overall survival rate was 96.6%, and the disease specific free survival rate was 90.6%. Local recurrence developed in 0.9%, and metachronous tumor development occurred in 7.8%; both conditions were treated by endoscopic or surgical treatment. Distant metastasis developed in 0.5% during follow-up. Conclusions: ESD showed excellent long-term clinical outcomes and can be accepted as a curative treatment for patients with EGC who meet the expanded criteria in final pathology studies.

The influence of procedural volume and proficiency gain on mortality from upper GI endoscopic mucosal resection.

OBJECTIVE: Endoscopic mucosal resection (EMR) is established for the management of benign and early malignant upper GI disease. The aim of this observational study was to establish the effect of endoscopist procedural volume on mortality. DESIGN: Patients undergoing upper GI EMR between 1997 and 2012 were identified from the Hospital Episode Statistics database. The primary outcome was 30-day mortality and secondary outcomes were 90-day mortality, requirement for emergency intervention and elective cancer re-intervention. Risk-adjusted cumulative sum (RA-CUSUM) analysis was used to assess patient mortality risk during initial stage of endoscopist proficiency gain and the effect of endoscopist and hospital volume. Mortality was compared before and after the change point or threshold in the RA-CUSUM curve. RESULTS: 11 051 patients underwent upper GI EMR. Endoscopist procedure volume was an independent predictor of 30-day mortality. Fifty-eight per cent of EMR procedures were performed by endoscopists with annual volume of 2 cases or less, and had a higher 30-day and 90-day mortality rate for patients with cancer, 6.1% vs 0.4% (p<0.001) and 12% vs 2.1% (p<0.001), respectively. The requirement for emergency intervention after EMR for cancer was also greater with low volume endoscopists (1.8% vs 0.1%, p=0.002). In patients with cancer, the RA-CUSUM curve change points for 30-day mortality and elective re-intervention were 4 cases and 43 cases, respectively. CONCLUSIONS: EMR performed by high volume endoscopists is associated with reduced adverse outcomes. In order to reach proficiency, appropriate training and procedural volume accreditation training programmes are needed nationally.