Purpose: Bladder preservation chemoradiotherapy (CRT) in patients with a clinical complete response (cCR) following cisplatin-based neoadjuvant chemotherapy (NAC) is a promising treatment strategy for muscle-invasive bladder urothelial carcinoma (MIBC). A combined analysis of raw data from two prospective phase II studies was performed to better evaluate the feasibility of selective bladder preservation CRT. Materials and Methods: The analysis was based on primary efficacy data from two independent studies, including 76 MIBC patients receiving NAC followed by bladder preservation CRT. The efficacy data included metastasis-free survival (MFS) and disease-free survival (DFS). For the present analysis, starting point of survival was defined as the date of commencing CRT. Results: Among 76 patients, 66 had a cCR following NAC. Sixty-four patients received gemcitabine and cisplatin (GC) combination chemotherapy in neoadjuvant setting, and 12 received nivolumab plus GC. Bladder preservation CRT following NAC was generally well-tolerated, with low urinary tract symptoms being the most common late complication. With a median follow-up of 64 months, recurrence was recorded in 43 patients (57%): intravesical only (n=20), metastatic only (n=16), and both (n=7). In 27 patients with intravesical recurrence, transurethral resection, and Bacillus Calmette-Guerin treatment was given to 17 patients. Salvage cystectomy was performed in 10 patients. Median DFS was 46.3 (95% confidence interval [CI], 25.1 to 67.5) months, and the median MFS was not reached. Neither DFS nor MFS appeared to be affected by any of the baseline characteristics. However, DFS was significantly longer in patients with a cCR than in those without (hazard ratio, 0.465; 95% CI, 0.222 to 0.976). Conclusion The strategy of NAC followed by selective bladder preservation CRT based on the cCR is feasible in the treatment of MIBC. A standardized definition of cCR is needed to better assess disease status post-NAC.

Purpose: The activity and safety of neoadjuvant nivolumab plus gemcitabine/cisplatin (N+GC) were tested in patients with muscle-invasive bladder urothelial carcinoma (MIBC). Materials and Methods: In a prospective phase II trial, patients with cT2-T4a N0 MIBC who were eligible for cisplatin and medically appropriate to undergo radical cystectomy (RC) were enrolled. Treatment with nivolumab 3 mg/kg on days 1 and 15 plus GC (cisplatin 70 mg/m2 on day 1, and gemcitabine 1,000 mg/m2 on days 1, 8, and 15) was repeated every 28 days up to 3 or 4 cycles, depending on the surgery schedules. The primary endpoint was pathologic complete response (pCR, ypT0). Secondary endpoints included pathologic downstaging (≤ ypT1), disease-free survival (DFS), and safety. Results: Between September 2019 and October 2020, 51 patients were enrolled. Neoadjuvant N+GC was well tolerated. Among 49 patients who completed neoadjuvant N+GC, clinical complete response (cCR) was achieved in 59% of intent-to-treat (ITT) population. RC was performed in 34 (69%) patients. pCR was achieved in 24% (12/49) of ITT population and 35% (12/34) of RC patients. Median DFS was not reached. Over a median follow-up of 24 months, 12 patients experienced disease recurrence and were treated with palliative therapy or surgery. Although 12 patients declined surgery and were treated with concurrent chemoradiotherapy, DFS was longer in patients with cCR after neoadjuvant therapy than those without. Preoperative programmed death-ligand 1 (PD-L1) did not correlate with pCR or pathologic downstaging rates. Conclusion Neoadjuvant N+GC was feasible and provided meaningful pathologic responses in patients with MIBC, regardless of baseline PD-L1 expression (ONO-4538-X41; CRIS.nih.go.kr, KCT0003804).

Background: and Purpose We aimed to develop a model predicting early recanalization after intravenous tissue plasminogen activator (t-PA) treatment in large-vessel occlusion. Methods: Using data from two different multicenter prospective cohorts, we determined the factors associated with early recanalization immediately after t-PA in stroke patients with large-vessel occlusion, and developed and validated a prediction model for early recanalization. Clot volume was semiautomatically measured on thin-section computed tomography using software, and the degree of collaterals was determined using the Tan score. Follow-up angiographic studies were performed immediately after t-PA treatment to assess early recanalization. Results: Early recanalization, assessed 61.0±44.7 minutes after t-PA bolus, was achieved in 15.5% (15/97) in the derivation cohort and in 10.5% (8/76) in the validation cohort. Clot volume (odds ratio [OR], 0.979; 95% confidence interval [CI], 0.961 to 0.997; P=0.020) and good collaterals (OR, 6.129; 95% CI, 1.592 to 23.594; P=0.008) were significant factors associated with early recanalization. The area under the curve (AUC) of the model including clot volume was 0.819 (95% CI, 0.720 to 0.917) and 0.842 (95% CI, 0.746 to 0.938) in the derivation and validation cohorts, respectively. The AUC improved when good collaterals were added (derivation cohort: AUC, 0.876; 95% CI, 0.802 to 0.950; P=0.164; validation cohort: AUC, 0.949; 95% CI, 0.886 to 1.000; P=0.036). The integrated discrimination improvement also showed significantly improved prediction (0.097; 95% CI, 0.009 to 0.185; P=0.032). Conclusions The model using clot volume and collaterals predicted early recanalization after intravenous t-PA and had a high performance. This model may aid in determining the recanalization treatment strategy in stroke patients with large-vessel occlusion.

Background: and Purpose We aimed to develop a model predicting early recanalization after intravenous tissue plasminogen activator (t-PA) treatment in large-vessel occlusion. Methods: Using data from two different multicenter prospective cohorts, we determined the factors associated with early recanalization immediately after t-PA in stroke patients with large-vessel occlusion, and developed and validated a prediction model for early recanalization. Clot volume was semiautomatically measured on thin-section computed tomography using software, and the degree of collaterals was determined using the Tan score. Follow-up angiographic studies were performed immediately after t-PA treatment to assess early recanalization. Results: Early recanalization, assessed 61.0±44.7 minutes after t-PA bolus, was achieved in 15.5% (15/97) in the derivation cohort and in 10.5% (8/76) in the validation cohort. Clot volume (odds ratio [OR], 0.979; 95% confidence interval [CI], 0.961 to 0.997; P=0.020) and good collaterals (OR, 6.129; 95% CI, 1.592 to 23.594; P=0.008) were significant factors associated with early recanalization. The area under the curve (AUC) of the model including clot volume was 0.819 (95% CI, 0.720 to 0.917) and 0.842 (95% CI, 0.746 to 0.938) in the derivation and validation cohorts, respectively. The AUC improved when good collaterals were added (derivation cohort: AUC, 0.876; 95% CI, 0.802 to 0.950; P=0.164; validation cohort: AUC, 0.949; 95% CI, 0.886 to 1.000; P=0.036). The integrated discrimination improvement also showed significantly improved prediction (0.097; 95% CI, 0.009 to 0.185; P=0.032). Conclusions The model using clot volume and collaterals predicted early recanalization after intravenous t-PA and had a high performance. This model may aid in determining the recanalization treatment strategy in stroke patients with large-vessel occlusion.

Non-variceal upper gastrointestinal bleeding (NVUGIB) refers to bleeding that develops in the gastrointestinal tract proximal to the ligament of Treitz. NVUGIB is an important cause for visiting the hospital and is associated with significant morbidity and mortality. Although European and Asian-Pacific guidelines have been published, there has been no previous guidelines regarding management of NVUGIB in Korea. Korea is a country with a high prevalence of Helicobacter pylori infection and patients have easy accessibility to receive endoscopy. Therefore, we believe that guidelines regarding management of NVUGIB are mandatory. The Korean Society of Gastroenterology reviewed recent evidence and recommends practical management guidelines on NVUGIB in Korea.

Purpose: Quality of life (QOL) has become important in the trend of emphasizing patient satisfaction. This study aimed to evaluate the QOL in patients who underwent laparoscopic or robotic gastrectomy for gastric cancer. Methods: A prospective trial was performed involving patients who underwent laparoscopic or robotic gastrectomy for primary gastric cancer at 11 hospitals in Korea. Within this comparative trial, QOL, postoperative pain, and long-term complications were exanimated. The quality-of-life questionnaire (QLQ)-C30 and QLQ-STO22 developed by the European Organization for Research and Treatment of Cancer were used for the QOL survey. We compared the data after dividing it into several types of characteristics as follows; device (robotic or laparoscopic), operation type, pathological stage, and sex.Biased components were extracted by logistic regression analysis. Propensity score matching was applied to the data set with the biased components. Results: In total, 434 patients (211 for laparoscopic surgery and 223 for robotic surgery) were enrolled, out of which 321 patients who responded to both preoperative and postoperative surveys were selected for analysis. Robotic gastrectomy was not different from laparoscopic gastrectomy with respect to postoperative QOL. Distal gastrectomy showed better scores than total gastrectomy in terms of role functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, constipation, financial difficulties, dysphagia, eating restrictions, anxiety, taste, and body image. Male patients showed better scores on the 19 scales compared to female patients. Conclusion Robotic and laparoscopic approaches for gastric cancer surgery did not differ from each other with respect to QOL. Distal gastrectomy resulted in better QOL than total gastrectomy.

Nonvariceal upper gastrointestinal bleeding (NVUGIB) refers to bleeding that develops in the gastrointestinal tract proximal to the ligament of Treitz. NVUGIB requires hospitalization and is associated with significant morbidity and mortality.Although European and Asian-Pacific guidelines have been published, there have been no previous guidelines regarding management of NVUGIB in Korea. Korea has a high prevalence of Helicobacter pylori infections, and patients have easy accessibility to endoscopy. Therefore, we believe that guidelines regarding management of NVUGIB in Korea are essential. The Korean Society of Gastroenterology reviewed the recent evidence and recommends practical management guidelines on NVUGIB in Korea.

Purpose: Isoform 2 of tight junction protein claudin-18 (CLDN18.2) is a potential target for gastric cancer treatment. A treatment targeting CLDN18.2 has shown promising results in gastric cancer. We investigated the clinical significance of CLDN18.2 and other cell-adherens junction molecules (Rho GTPase-activating protein [RhoGAP] and E-cadherin) in metastatic diffuse-type gastric cancer (mDGC). Materials and Methods: We evaluated CLDN18.2, RhoGAP, and E-cadherin expression using two-plex immunofluorescence and quantitative data analysis of H-scores of 77 consecutive mDGC patients who received first-line platinum-based chemotherapy between March 2015 and February 2017. Results: CLDN18.2 and E-cadherin expression was significantly lower in patients with peritoneal metastasis (PM) than those without PM at the time of diagnosis (P=0.010 and 0.013, respectively), whereas it was significantly higher in patients who never developed PM from diagnosis to death than in those who did (P=0.001 and 0.003, respectively). Meanwhile, CLDN18.2 and E-cadherin expression levels were significantly higher in patients with bone metastasis than in those without bone metastasis (P=0.010 and 0.001, respectively).Moreover, we identified a positive correlation between the expression of CLDN18.2 and E-cadherin (P<0.001), RhoGAP and CLDN18.2 (P=0.004), and RhoGAP and E-cadherin (P=0.001). Conversely, CLDN18.2, RhoGAP, and E-cadherin expression was not associated with chemotherapy response and survival. Conclusions CLDN18.2 expression was reduced in patients with PM but significantly intactin those with bone metastasis. Furthermore, CLDN18.2 expression was positively correlated with other adherens junction molecules, which is clinically associated with mDGC and PM pathogenesis.

Purpose: Expanded indications for endoscopic submucosal dissection (ESD) in early gastric cancer (EGC) remain controversial due to the potential risk of undertreatment after adequate lymph node dissection (LND). Regional LND (RLND) is a novel technique used for limited lymphadenectomy to avoid gastrectomy. This study established the safety and effectiveness of RNLD as an additional treatment option after ESD for expanded indications. Materials and Methods: A total of 69 patients who met the expanded indications for ESD were prospectively enrolled from 2014 to 2017. The tumors were localized using intraoperative esophagogastroduodenoscopy (EGD) before RLND. All patients underwent RLND first, followed by conventional radical gastrectomy with LND. The locations of the preoperative and intraoperative EGD were compared. Pathologic findings of the primary lesion and the RLND status were analyzed. Results: The concordance rates of tumor location between the preoperative and intraoperative EGD were 79.7%, 76.8%, and 63.8% according to the longitudinal, circumferential, and regional locations, respectively. Of the 4 patients (5.7%) with metastatic LNs, 3 were pathologically classified as beyond the expanded indication for ESD and 1 had a single LN metastasis in the regional lymph node. Conclusions RLND is a safe additional option for the treatment of EGC in patients meeting expanded indications after ESD.

PURPOSE: The surgical outcomes of end-stage renal disease (ESRD) patients undergoing radical gastrectomy for gastric cancer were inferior compared with those of non-ESRD patients. This study aimed to evaluate the short- and long-term surgical outcomes of ESRD patients undergoing laparoscopic gastrectomy (LG) and open gastrectomy (OG) for gastric cancer. MATERIALS AND METHODS: Between 2004 and 2014, 38 patients (OG: 21 patients, LG: 17 patients) with ESRD underwent gastrectomy for gastric cancer. Comparisons were made based on the clinicopathological characteristics, surgical outcomes, and long-term survival rates. RESULTS: No significant differences were noted in the clinicopathological characteristics of either group. LG patients had lower estimated blood loss volumes than OG patients (LG vs. OG: 94 vs. 275 mL, P=0.005). The operation time and postoperative hospital stay were similar in both the groups. The postoperative morbidity for LG and OG patients was 41.1% and 33.3%, respectively (P=0.873). No significant difference was observed in the long-term overall survival rates between the 2 groups (5-year overall survival, LG vs. OG: 82.4% vs. 64.7%, P=0.947). CONCLUSIONS: In ESRD patients, LG yielded non-inferior short- and long-term surgical outcomes compared to OG. Laparoscopic procedures might be safely adopted for ESRD patients who can benefit from the advantages of minimally invasive surgery.
Gastrectomy* ; Humans ; Kidney Failure, Chronic* ; Laparoscopy ; Length of Stay ; Minimally Invasive Surgical Procedures ; Renal Insufficiency ; Stomach Neoplasms* ; Survival Rate