scholarly journals Effect of preoperative CT angiography examination on the clinical outcome of patients with BMI ≥ 25.0 kg/m2 undergoing laparoscopic gastrectomy: study protocol for a multicentre randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Cheng Meng ◽  
Shougen Cao ◽  
Xiaodong Liu ◽  
Leping Li ◽  
Qingsi He ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Ct Angiography ◽  
Laparoscopic Gastrectomy ◽  
Financial Burden ◽  
Controlled Trial ◽  
Second Primary ◽  
Clinical Value ◽  
Open Label ◽  
Randomized Controlled ◽  
Hospitalization Costs

Abstract Background Gastric cancer, which is the fifth most common malignancy and the third most common cause of cancer-related death, is particularly predominant in East Asian countries, such as China, Japan and Korea. It is a serious global health issue that causes a heavy financial burden for the government and family. To our knowledge, there are few reports of multicentre randomized controlled trials on the utilization of CT angiography (CTA) for patients who are histologically diagnosed with gastric cancer before surgery. Therefore, we planned this RCT to verify whether the utilization of CTA can change the short- and long-term clinical outcomes. Method The GISSG 20–01 study is a multicentre, prospective, open-label clinical study that emphasises the application of CTA for patients who will undergo laparoscopic gastrectomy to prove its clinical findings. A total of 382 patients who meet the inclusion criteria will be recruited for the study and randomly divided into two groups in a 1:1 ratio: the CTA group (n = 191) and the non-CTA group (n = 191). Both groups will undergo upper abdomen enhanced CT, and the CTA group will also receive CT angiography. The primary endpoint of this trial is the volume of blood loss. The second primary endpoints are the number of retrieved lymph nodes, postoperative recovery course, hospitalization costs, length of hospitalization days, postoperative complications, 3-year OS and 3-year DFS. Discussion It is anticipated that the results of this trial will provide high-level evidence and have clinical value for the application of CTA in laparoscopic gastrectomy. Trial registration ClinicalTrials.gov, NCT04636099. Registered November 19, 2020

Effect of Preoperative CT Angiography Examination on the Clinical Outcome of Patients With BMI≥25.0kg/m2 Undergoing Laparoscopic Gastrectomy: Study Protocol for a Multicenter Randomized Controlled Trial

2021 ◽  
Author(s):  
Cheng Meng ◽  
Shougen Cao ◽  
Xiaodong Liu ◽  
Leping Li ◽  
Qingsi He ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Outcome ◽  
Ct Angiography ◽  
Laparoscopic Gastrectomy ◽  
Financial Burden ◽  
Controlled Trial ◽  
Second Primary ◽  
Clinical Value ◽  
Multicenter Randomized Controlled Trial ◽  
Hospitalization Costs

Abstract Background Gastric cancer, which ranks the fifth most common malignant and causes the third oncological death, especially in east Asian countries, such as China, Japan and Korea, is still a serious global healthy issue that caused heavy financial burden for the government and family. To our knowledge, there is seldom reports of multicenter randomized control trial on the utilization of CT angiography (CTA)for the patients who are diagnosed histological gastric cancer before surgery. Therefore, we conduct this RCT to verify whether the utilization of CTA can possibly change the short- and long-term clinical outcome or not. Method: The GISSG 20 − 01 study is a multicenter, prospective, open-lable clinical study that emphasis on the application of the CTA for the patients who will undergo the laparoscopic gastrectomy to prove the clinical outcome of it. 382 patients that meet the inclusion criteria and not in accordance with exclusion criteria will be recruited in the study and randomly divided into two groups with a 1:1 ratio: CTA group(n = 191) and Non-CTA group (n = 191). Apart from both of the two groups receive the examination of upper abdomen enhanced CT, the CTA group receive the examination of CT angiography. The primary endpoint of this trial is the volume of blood loss, the second primary endpoints are retrieved number of lymph nodes, postoperative recovery course, hospitalization costs, length of hospitalization days, postoperative complications, 3 years OS and 3 years DFS. Discussion It is anticipated that the result of this trial can provide high-level evidence and have clinical value on the application of CTA in laparoscopic gastrectomy. Trial registration: ClinicalTrials.gov, NCT04636099, Registered November 19, 2020

Comparison of 3D laparoscopic gastrectomy with a 2D procedure for gastric cancer: A phase 3 randomized controlled trial

Surgery ◽  
2018 ◽  
Vol 163 (2) ◽  
pp. 300-304 ◽  
Author(s):  
Chao-Hui Zheng ◽  
Jun Lu ◽  
Hua-Long Zheng ◽  
Ping Li ◽  
Jian-Wei Xie ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Laparoscopic Gastrectomy ◽  
Controlled Trial ◽  
Phase 3 ◽  
Randomized Controlled ◽  
3D Laparoscopic Gastrectomy

Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

2020 ◽  
pp. 27-37
Author(s):  
Suresh Durgam ◽  
Willie Earley ◽  
Rui Li ◽  
Dayong Li ◽  
Kaifeng Lu ◽  
...  
Keyword(s):  
Safety Profile ◽  
Relapse Prevention ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Time To Relapse

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

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