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A novel irradiation stent versus conventional irradiation stent for malignant dysphagia: A prospective randomized controlled trial.
Zhu, GY, Lu, J, Wang, C, Guo, JH
Journal of cancer research and therapeutics. 2021;(5):1261-1268
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Abstract
AIM: To evaluate whether a novel irradiation stent (NIS) could decrease the rate of recurrent dysphagia, compared to the conventional irradiation stent (CIS) in patients with malignant dysphagia. MATERIALS AND METHODS We performed an open-label randomized controlled trial of participants with malignant dysphagia. A total of 94 participants were parallelly allocated into the NIS group or the NIS group between April 2019 and April 2020. The primary endpoint was the rate of recurrent dysphagia. The secondary endpoints included technical success, clinical success, overall survival, and adverse events. RESULTS The technical success rate and the clinical success rate was 100.0% (47/47) in both groups. The median follow-up period was 189 days (range 14-422 days). Recurrent dysphagia was observed in 12.8% (6/47) of patients in the NIS group and 31.9% (15/47) in the CIS group (P = 0.026). Tissue/tumor growth occurred in 4 patients (8.5%) after NIS placement and 12 (25.5%) after CIS placement (P = 0.028). Stent migration occurred in 2 patients (4.3%) after NIS placement and 3 (6.4%) after CIS placement (P = 0.646). No food obstruction was found in both groups. The median overall survival was 177 days (95% confidence interval [CI] 139-214) in the NIS group and 168 days (95% CI 153-183) in the CIS group (P = 0.932). The incidence of severe adverse events was comparable between the two groups (21.3% vs. 17.0%, P = 0.600). CONCLUSIONS In patients with malignant dysphagia, compared with CIS, NIS could decrease the rate of tissue/tumor growth without increase the rate of stent migration and therefore decrease the rate of recurrent dysphagia.
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Comparison of efficacy of pharmacological therapies for gastric endoscopic submucosal dissection-induced ulcers: a systematic review and network meta-analysis.
Gao, H, Li, L, Zhang, C, Tu, J, Geng, X, Wang, J, Zhou, X, Jing, J, Pan, W
Expert review of gastroenterology & hepatology. 2020;(3):207-220
Abstract
Objectives: This study aimed to compare the efficacy of various anti-ulcer medications in preventing delayed bleeding and promoting ulcer healing after ESD.Methods: Asystematic search was conducted for articles up to August2019. The treatments of iatrogenic ulcer were analyzed by Bayesian network meta-analysis.Results: The analysis included 28 studies. Six treatments were compared. For the prevention of delayed bleeding, potassium-competitive acid blocker (P-CAB) alone was superior to proton-pump inhibitor (PPI) alone [RR = 1.02, 95%CI (1.00, 1.05)]. Treatments based on P-CAB tended to be better than the non-P-CAB groups [RR = 1.05, 95%CI (1.03, 1.07)]. Concerning the ulcer healing rate at 4 weeks, the combined treatment of PPI and mucoprotective agent (MP) was superior to PPI alone [RR = 1.81, 95%CI (1.19, 2.76)] and P-CAB alone [RR = 2.75, 95%CI (1.02, 7.44)]. At 8 weeks, PPI+MP and P-CAB+MP tend to be superior to than the other four groups. The healing effect of MP-based therapies was better than that of non-MP groups at 4 weeks [RR = 1.63, 95%CI (1.32, 2.01)] and 8 weeks [RR = 1.06, 95%CI (1.02, 1.11)].Conclusion: P-CAB may prevent delayed bleeding, but not significantly. MP agents have the potential to heal post-ESD ulcers.
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Robotic versus laparoscopic surgery for gastric cancer: an overview of systematic reviews with quality assessment of current evidence.
Hoshino, N, Murakami, K, Hida, K, Hisamori, S, Tsunoda, S, Obama, K, Sakai, Y
Updates in surgery. 2020;(3):573-582
Abstract
Many systematic reviews have been published to evaluate the clinical benefits of robotic surgery for gastric cancer. However, these reviews have investigated various outcomes and differ considerably in quality. In this overview, we summarize the findings and quality of these reviews. A comprehensive literature search was conducted using PubMed, Scopus, and the Cochrane Central Register of Controlled Trials to identify systematic reviews and meta-analyses that compared robotic surgery with laparoscopic surgery for gastric cancer. We summarized the results of the meta-analyses and evaluated the quality of the reviews using the AMSTAR-2 tool. The literature search identified 14 eligible reviews. The reviews showed that estimated blood loss was significantly less and time to resumption of oral intake was significantly shorter in patients who underwent robotic surgery than in those who underwent laparoscopic surgery. However, no significant differences in other outcomes were found between the two types of surgery. The quality of the included reviews was judged to be critically low. In conclusion, the available evidence, albeit of critically low quality, suggests that robotic surgery decreases estimated blood loss and shortens the time to resumption of oral intake in patients with gastric cancer. There is currently no high-quality evidence that robotic surgery has clinical benefits for gastric cancer patients.
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A Phase II Study of Modified FOLFOX6 for Advanced Gastric Cancer Refractory to Standard Therapies.
Mitani, S, Kadowaki, S, Komori, A, Kondoh, C, Oze, I, Kato, K, Masuishi, T, Honda, K, Narita, Y, Taniguchi, H, et al
Advances in therapy. 2020;(6):2853-2864
Abstract
INTRODUCTION In patients with advanced gastric cancer refractory to chemotherapy, the treatment options are limited. Via this phase II study, we aimed to assess the efficacy and safety of oxaliplatin in combination with 5-fluorouracil and l-leucovorin (modified FOLFOX6). METHODS Patients who had histologically confirmed metastatic gastric cancer refractory to ≥ two previous chemotherapy regimens were included. The primary endpoint was the overall response rate (ORR) by an independent central review. According to an assumption of a threshold ORR of 10% and expected ORR of 25%, with α = 0.05 and β = 0.20, at least 33 patients were required. The secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life measured by EQ-5D, and safety. RESULTS Among the 35 enrolled patients, 33 were included in the primary analysis. All patients previously received fluoropyrimidines, cisplatin, and taxanes, and 24 (73%) were pretreated with irinotecan. The confirmed ORR was 27% [95% confidence interval (CI) 13-46]. The median PFS and OS were 2.2 (95% CI 1.2-3.2) and 5.6 (95% CI 4.1-7.0) months, respectively. In the multivariate analyses, immunotherapy within 90 days and a Glasgow Prognostic Score of 0 were associated with better treatment outcomes. The most common grade ≥ 3 adverse event was neutropenia (36%), and no febrile neutropenia was observed. The median EQ-5D scores did not change from baseline at 2, 4, and 8 weeks (p value = 0.38, 0.79, and 0.98, respectively). CONCLUSION Modified FOLFOX6 (mFOLFOX6) showed substantial activity and acceptable toxicity for chemotherapy-refractory advanced gastric cancer. TRIAL REGISTRATION UMIN Clinical Trial Registry (UMIN000016416).
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Well-designed retrospective study versus small-sample prospective study in research based on laparoscopic and open radical distal gastrectomy for advanced gastric cancer.
Wang, JB, Zhong, Q, Chen, QY, Lin, GT, Liu, ZY, Huang, XB, Xie, JW, Lin, JX, Lu, J, Cao, LL, et al
Surgical endoscopy. 2020;(10):4504-4515
Abstract
BACKGROUND Well-designed retrospective studies (RSs) and small-sample prospective studies (PSs) evaluating the efficacy of interventions have received much attention. This study was designed to evaluate the differences between well-designed RSs and small-sample randomized controlled trials based on the efficacy of laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) for advanced gastric cancer (GC). METHODS The clinicopathological data of 1360 patients with GC who underwent DG were analysed. After propensity score matching (1:1), 380 cases (ODG = 190, LDG = 190) were finally selected in a RS. Meanwhile, data from 120 patients (ODG = 60, LDG = 60) who enrolled in a PS were analysed. RESULTS In the PS, the LDG group had less intraoperative blood loss, shorter time to first flatus, and shorter time to fluid diet than the ODG group. In the RS, the LDG group had less intraoperative blood loss, and a shorter postoperative hospital stay than the ODG group. In the PS, the 3-year overall survival (OS) rate was 83.3% in the LDG group and 83.2% in the ODG group (p = 0.877). In the RS, the 3-year OS rate was 68.7% in the LDG group and 66.6% in the ODG group (p = 0.752). No significant interactions were observed between the two groups and any of the variables examined, either in the PS or RS. The recurrence patterns were similar in the two groups. Furthermore, Cox regression analysis showed that surgical method (LDG/ODG) was not a prognostic factor affecting OS or DFS, either prospectively or retrospectively. CONCLUSIONS The oncologic efficacy of laparoscopic and open distal gastrectomy for advanced GC is comparable. Well-designed RSs can be similar to small sample of PSs in assessing long-term oncologic outcomes of surgical interventions, but the short-term outcomes obtained should be treated with caution.
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Comparison of the short-term outcomes between totally laparoscopic total gastrectomy and laparoscopic-assisted total gastrectomy for gastric cancer: a meta-analysis.
Liao, G, Wang, Z, Zhang, W, Qian, K, Mariella Mac, S, Li, H, Huang, Z
Medicine. 2020;(7):e19225
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BACKGROUND Totally laparoscopic total gastrectomy (TLTG) and laparoscopic-assisted total gastrectomy (LATG) are two common surgical approaches for upper and middle gastric cancer. Which surgical approach offers more advantages is still controversial due to a lack of evidence from randomized controlled trials (RCTs). This meta-analysis was conducted to compare the short-term outcomes between the two surgical approaches. METHODS A systematic literature search was performed to evaluate short-term outcomes between TLTG and LATG, including overall postoperative complications, anastomosis-related complications, time for anastomosis, operation time, intraoperative blood loss, harvested lymph nodes, proximal margin, distal margin, time to first flatus, time to first diet, and postoperative hospital stay. Short-term outcomes were pooled and compared by meta-analysis using RevMan 5.3. Mean differences (MDs) or risk ratios (RRs) were calculated with 95% confidence intervals (CIs). P < .05 was considered statistically significant. RESULTS A total of 9 cohort studies fulfilled the selection criteria. The total sample included 1671 cases. The meta-analysis showed no significant difference between the two surgical approaches in overall postoperative complications (RR = 1.02, 95% CI = 0.82 to 1.26, P = .87),anastomosis-related complications (RR = 0.64, 95%CI = 0.39 to 1.03, P = .06),time for anastomosis (MD = -5.13, 95% CI = -10.54 to 0.27, P = .06),operation time (MD = -10.68, 95% CI = -23.62 to 2.26, P = .11), intraoperative blood loss (MD = -25.58, 95% CI = -61.71 to 10.54, P = .17), harvested lymph nodes (MD = 1.61, 95% CI = -2.09 to 5.31, P = .39), proximal margin (MD = -0.37, 95% CI = -0.78 to 0.05, P = .09), distal margin (MD = 0.79, 95% CI = -0.57 to 2.14, P = .25), time to first flatus (MD = 0.01, 95% CI = -0.13 to 0.15, P = .87), time to first diet (MD = -0.22, 95% CI = -0.45 to 0.02, P = .07), and postoperative hospital stay (MD = -0.51, 95% CI = -1.10 to 0.07, P = .09). CONCLUSIONS TLTG is a safe and feasible surgical approach for upper and middle gastric cancer, with short-term outcomes that are similar to LATG. Nevertheless, high-quality, large-sample and multicenter RCTs are still required to further verify our conclusions.
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Proximal versus total gastrectomy for proximal early gastric cancer: A systematic review and meta-analysis.
Xu, Y, Tan, Y, Wang, Y, Xi, C, Ye, N, Xu, X
Medicine. 2019;(19):e15663
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BACKGROUND Recently, the incidence of proximal early gastric cancer (EGC) has been rising rapidly. Prevalent surgical methods are proximal gastrectomy (PG) and total gastrectomy (TG); however, which method is superior remains controversial. We conducted a systematic review and meta-analysis of original articles to compare the short- and long-term clinical outcomes of PG with TG for proximal EGC. METHODS Databases, including PubMed, Embase, Web of Science, and Cochrane Library were searched up to October 2018. The Newcastle-Ottawa scale was utilized to conduct quality assessments, and publication bias was evaluated using Egger test. STATA version 14.0 was used to perform the meta-analysis. RESULTS A total of 2036 patients with proximal EGC in 18 studies were included in the meta-analysis. The results showed that PG was potentially superior to TG regarding operation time, intraoperative blood loss volume, and long-term nutritional status. Overall survival between the PG and TG groups was not significantly different. PG was associated with a high incidence of 2 kinds of postoperative complications: anastomotic stenosis and reflux esophagitis. However, the incidence of these complications associated with esophagojejunostomy with double-tract reconstruction (DTR) was comparable with that of TG. CONCLUSIONS PG has several advantages over TG for the treatment of proximal EGC, including surgical outcomes and long-term nutritional status. However, anastomotic stenosis and reflux esophagitis frequently occurred in patients undergoing PG. Esophagojejunostomy with DTR could offer a solution to reducing the incidence of these complications.
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The investigation of diet recovery after distal gastrectomy.
Kim, TH, Lee, YJ, Bae, K, Park, JH, Hong, SC, Jung, EJ, Ju, YT, Jeong, CY, Park, TJ, Park, M, et al
Medicine. 2019;(41):e17543
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This study aims to investigate the adaptation process of the alimentary tract after distal gastrectomy and understand the impact of remnant stomach volume (RSV) on diet recovery.One year after gastrectomy, although patients' oral intake had increased, the RSV was decreased and small bowel motility was enhanced. Patients with a larger RSV showed no additional benefits regarding nutritional outcomes.We prospectively enrolled patients who underwent distal gastrectomy with Billroth II reconstruction to treat gastric cancer at a tertiary hospital cancer center between September 2009 and February 2012. Demographic data, diet questionnaires, computed tomography (CT), and contrast fluoroscopy findings were collected. Patients were divided into 2 groups according to the RSV calculated using CT gastric volume measurements (large vs small). Dietary habits and nutritional status were compared between the groups.Seventy-eight patients were enrolled. Diet volume recovered to 90% of baseline by the 36 postoperative month, and RSV was 70% of baseline at 6 months after surgery and gradually decreased over time. One year after surgery, small bowel transit time was 75% compared to the 1st postoperative month (P < .05); however, transit time in the esophagus and remnant stomach showed no change in any studied interval. Compared to patients with a small RSV, those with a large RSV showed no differences in diet volume, habits, or other nutritional benefits (P > .05).Diet recovery for distal gastrectomy patients was achieved by increased small bowel motility. The size of the remnant stomach showed no positive impact on nutritional outcomes.
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A prospective randomized trial of a potassium competitive acid blocker vs proton pump inhibitors on the effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia.
Komori, H, Ueyama, H, Nagahara, A, Akazawa, Y, Takeda, T, Matsumoto, K, Matsumoto, K, Asaoka, D, Hojo, M, Yao, T, et al
The Journal of international medical research. 2019;(4):1441-1452
Abstract
BACKGROUND/AIMS: Vonoprazan is a new a potassium-competitive acid blocker (P-CAB) that was recently developed in Japan. However, vonoprazan's efficacy in healing gastric ulcers after endoscopic submucosal dissection (ESD) remains controversial. This study aimed to compare the efficacy of P-CABs and proton pump inhibitors (PPIs) in healing post-ESD ulcers. MATERIALS AND METHODS This prospective randomized controlled trial (UMIN000017386) enrolled 40 patients with gastric neoplasia, who underwent ESD at our hospital from April 2015 to January 2016. Before ESD, patients were randomly divided into the following two groups: group V, vonoprazan 20 mg/day; or group R, rabeprazole 10 mg/day. Medications were taken 1 day before to 4 weeks after ESD. The ESD-induced artificial ulcer size was measured just after ESD and 4 weeks after ESD to calculate the reduction rate as follows: (ulcer area 4 weeks after ESD)/(ulcer area just after ESD) × 100. RESULTS Eighteen patients in group V and 15 patients in group R were analyzed. The mean reduction rate was significantly different in groups V and R (93.3% vs 96.6%, respectively). Post-ESD bleeding was observed in two patients in group R and drug-induced hepatic injury in one patient in group R. CONCLUSION Rabeprazole facilitated the healing process post-ESD.
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Proximal gastrectomy versus total gastrectomy for adenocarcinoma of the esophagogastric junction: a meta-analysis.
Chen, YC, Lu, L, Fan, KH, Wang, DH, Fu, WH
Journal of comparative effectiveness research. 2019;(10):753-766
Abstract
Aim: To compare efficacy between total gastrectomy (TG) and proximal gastrectomy (PG) for upper-third gastric cancer. Materials & methods: PubMed, Embase and Cochrane library were searched to select suitable researches. Stata was used for meta-analysis including 5-year overall survival rate, recurrence rate, complication morbidities and serum nutritional levels. Results: Ten retrospective English researches were contained. Our study showed no significant difference of 5-year overall survival rate, recurrence rate, reflux symptoms and anastomotic leakage. TG experienced longer operation time, more lymph nodes-retrieved number, more estimated blood loss and higher ileus, but less anastomotic stricture. PG showed advantages over TG in terms of serum nutritional levels. Conclusion: PG is more preferable to TG for treatment of upper-third gastric cancer.