Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy

2020 ◽  
Vol 121 (4) ◽  
pp. 662-669 ◽  
Author(s):  
Chul Kyu Roh ◽  
Sang‐Yong Son ◽  
Sook Young Lee ◽  
Hoon Hur ◽  
Sang‐Uk Han
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Clinical Pathway ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Phase Ii Clinical Trial ◽  
Single Center ◽  
Safety And Efficacy

Tu1448 Intragastric Injection of Botulinum Toxin a to Treat Gastric Cancer: An Open-Label Phase II Clinical Trial

2016 ◽  
Vol 150 (4) ◽  
pp. S1251-S1252
Author(s):  
Gøran Andersen ◽  
Chun-Mei Zhao ◽  
Xing Cai ◽  
Hanne-Line Rabben ◽  
James G. Fox ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Botulinum Toxin ◽  
Phase Ii ◽  
Botulinum Toxin A ◽  
Phase Ii Clinical Trial ◽  
Open Label ◽  
Toxin A ◽  
Open Label Phase

Efficacy and safety of liposomal mitoxantrone (Lipo-MIT) in advanced breast cancer (ABC): A randomized, open label, active-controlled, single-center, phase II clinical trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1093-1093
Author(s):  
Leiping Wang ◽  
Yannan Zhao ◽  
Ting Li ◽  
Jun Cao ◽  
Yiqun Du ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Lower Incidence ◽  
Troponin T ◽  
Objective Response ◽  
Phase Ii Clinical Trial ◽  
Efficacy And Safety ◽  
Single Center ◽  
Open Label

1093 Background: Anthracyclines are associated with cardiotoxicity and myelosuppression in breast cancer (BC) patients. A new drug delivery system, liposomal preparation has shown higher anti-cancer effect and lower toxicity due to modified drug release and particle shape. This trial aimed to evaluate the efficacy and safety of Lipo-MIT in ABC. Methods: This is a randomized, open label, active-controlled, single-center, phase II clinical trial. Eligible patients were randomized in a ratio of 1:1 to receive Lipo-MIT or mitoxantrone hydrochloride injection (MIT) intravenously. The dosage was 20 mg/m2 for Lipo-MIT and 14 mg/m2 for MIT, once every four weeks (i.e., one treatment cycle). The primary endpoint was objective response rate(ORR). The secondary endpoints were progression free survival (PFS) and safety. Results: From Oct 2015 through Jul 2017, 60 patients were randomized to Lipo-MIT group (n = 30) or MIT group (n = 30). The Median (Q1,Q3) age was 56.0 (41.0,62.0) years in Lipo-MIT group and 54.5 (44.0,62.0) years in MIT group. Nineteen patients in Lipo-MIT group and 23 in MIT group received < 4 cycles of treatment, 11 patients in Lipo-MIT group and 7 in MIT group were treated for 4 or more cycles. When Lipo-MIT group was compared with MIT group, ORR was 13.3% (4/30) and 6.7% (2/30), disease control rate (PR+SD) was 50% (15/30) and 30% (9/30), median PFS was 2.30 (95% CI: 1.74-3.91) and 1.86 (95% CI: 1.74-2.40) months ( P> 0.05). Lipo-MIT showed significantly lower incidence of all-grade white blood cell decreased (86.7% vs 96.7%), neutrophil count decreased (80.0% vs 96.7%), conjugated bilirubin increased (53.3% vs 56.7%), aspartate aminotransferase increased (40.0% vs 53.3%), and troponin T increased (3.3% vs 36.7%) than MIT, but higher incidence of anemia (76.7% vs 46.7%), skin hyperpigmentation (66.7% vs 3.3%), and platelet count decreased (56.7% vs 53.3%) than MIT. Conclusions: Lipo-MIT provided numerically better ORR, DCR, and PFS than MIT in ABC. Lower incidence of troponin T increased might suggest lower cardiotoxicity of Lipo-MIT. It is worthwhile to further explore the clinical utility of Lipo-MIT in ABC. Clinical trial information: NCT02596373 .

scholarly journals Protocol for enhanced recovery after surgery improves short-term outcomes for patients with gastric cancer: a randomized clinical trial

2017 ◽  
Vol 20 (5) ◽  
pp. 861-871 ◽  
Author(s):  
Ryo Tanaka ◽  
Sang-Woong Lee ◽  
Masaru Kawai ◽  
Keitaro Tashiro ◽  
Satoshi Kawashima ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Short Term

scholarly journals Safety and efficacy of a novel neurosurgical enhanced recovery after surgery protocol for elective craniotomy: a prospective randomized controlled trial

2019 ◽  
Vol 130 (5) ◽  
pp. 1680-1691 ◽  
Author(s):  
Yuan Wang ◽  
Bolin Liu ◽  
Tianzhi Zhao ◽  
Binfang Zhao ◽  
Daihua Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Perioperative Management ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Tertiary Care ◽  
Hospital Length Of Stay ◽  
Control Group ◽  
Complication Rates ◽  
Safety And Efficacy ◽  
Eras Protocol

OBJECTIVEAlthough enhanced recovery after surgery (ERAS) programs have gained acceptance in various surgical specialties, no established neurosurgical ERAS protocol for patients undergoing elective craniotomy has been reported in the literature. Here, the authors describe the design, implementation, safety, and efficacy of a novel neurosurgical ERAS protocol for elective craniotomy in a tertiary care medical center located in China.METHODSA multidisciplinary neurosurgical ERAS protocol for elective craniotomy was developed based on the best available evidence. A total of 140 patients undergoing elective craniotomy between October 2016 and May 2017 were enrolled in a randomized clinical trial comparing this novel protocol to conventional neurosurgical perioperative management. The primary endpoint of this study was the postoperative hospital length of stay (LOS). Postoperative morbidity, perioperative complications, postoperative pain scores, postoperative nausea and vomiting, duration of urinary catheterization, time to first solid meal, and patient satisfaction were secondary endpoints.RESULTSThe median postoperative hospital LOS (4 days) was significantly shorter with the incorporation of the ERAS protocol than that with conventional perioperative management (7 days, p < 0.0001). No 30-day readmission or reoperation occurred in either group. More patients in the ERAS group reported mild pain (visual analog scale score 1–3) on postoperative day 1 than those in the control group (79% vs. 33%, OR 7.49, 95% CI 3.51–15.99, p < 0.0001). Similarly, more patients in the ERAS group had a shortened duration of pain (1–2 days; 53% vs. 17%, OR 0.64, 95% CI 0.29–1.37, p = 0.0001). The urinary catheter was removed within 6 hours after surgery in 74% patients in the ERAS group (OR 400.1, 95% CI 23.56–6796, p < 0.0001). The time to first oral liquid intake was a median of 8 hours in the ERAS group compared to 11 hours in the control group (p < 0.0001), and solid food intake occurred at a median of 24 hours in the ERAS group compared to 72 hours in the control group (p < 0.0001).CONCLUSIONSThis multidisciplinary, evidence-based, neurosurgical ERAS protocol for elective craniotomy appears to have significant benefits over conventional perioperative management. Implementation of ERAS is associated with a significant reduction in the postoperative hospital stay and an acceleration in recovery, without increasing complication rates related to elective craniotomy. Further evaluation of this protocol in large multicenter studies is warranted.Clinical trial registration no.: ChiCTR-INR-16009662 (chictr.org.cn)

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