scholarly journals Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jiabin Jin ◽  
Yusheng Shi ◽  
Mengmin Chen ◽  
Jianfeng Qian ◽  
Kai Qin ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Functional Recovery ◽  
High Volume ◽  
Phase Iii ◽  
Postoperative Adjuvant Chemotherapy ◽  
Randomized Controlled ◽  
Link Type ◽  
Robotic Pancreatoduodenectomy ◽  
Large Patient ◽  
Secondary Outcomes

Abstract Background Pancreatoduodenectomy is a complex and challenging procedure that requires meticulous tissue dissection and proficient suturing skills. Minimally invasive surgery with the utilization of robotic platforms has demonstrated advantages in perioperative patient outcomes in retrospective studies. The development of robotic pancreatoduodenectomy (RPD) in specific has progressed significantly, since first reported in 2003, and high-volume centers in pancreatic surgery are reporting large patient series with improved pain management and reduced length of stay. However, prospective studies to assess objectively the feasibility and safety of RPD compared to open pancreatoduodenectomy (OPD) are currently lacking. Methods/design The PORTAL trial is a multicenter randomized controlled, patient-blinded, parallel-group, phase III non-inferiority trial performed in seven high-volume centers for pancreatic and robotic surgery in China (> 20 RPD and > 100 OPD annually in each participating center). The trial is designed to enroll and randomly assign 244 patients with an indication for elective pancreatoduodenectomy for malignant periampullary and pancreatic lesions, as well as premalignant and symptomatic benign periampullary and pancreatic disease. The primary outcome is time to functional recovery postoperatively, measured in days. Secondary outcomes include postoperative morbidity and mortality, as well as perioperative costs. A sub-cohort of 128 patients with pancreatic adenocarcinoma (PDAC) will also be compared to assess the percentage of patients who undergo postoperative adjuvant chemotherapy within 8 weeks, in each arm. Secondary outcomes in this cohort will include patterns of disease recurrence, recurrence-free survival, and overall survival. Discussion The PORTAL trial is designed to assess the feasibility and safety of RPD compared to OPD, in terms of functional recovery as described previously. Additionally, this trial will explore whether RPD allows increased access to postoperative adjuvant chemotherapy, in a sub-cohort of patients with PDAC. Trial registration ClinicalTrials.govNCT04400357. Registered on May 22, 2020

scholarly journals Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Acupuncture Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

scholarly journals Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Julie Stevens ◽  
Peter Pype ◽  
Kim Eecloo ◽  
Luc Deliens ◽  
Koen Pardon ◽  
...  
Keyword(s):  
General Practice ◽  
Process Evaluation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Phase Iii ◽  
Practice Setting ◽  
Randomized Controlled ◽  
Advance Care ◽  
Secondary Outcomes ◽  
Cluster Randomized

Abstract Background Advance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner. Ideally situated for this initiation is the general practitioner (GP). The intervention to improve the initiation of ACP for patients with a chronic life-limiting illness in general practice (ACP-GP) includes an ACP workbook for patients, ACP communication training for GPs, planned ACP conversations, and documentation of ACP conversation outcomes in a structured template. We present the study protocol of a Phase-III randomized controlled trial (RCT) of ACP-GP that aims to evaluate its effects on outcomes at the GP, patient, and surrogate decision maker (SDM) levels; and to assess the implementation process of the intervention. Methods This RCT will take place in Flanders, Belgium. Thirty-six GPs, 108 patients with a chronic, life-limiting illness, and their (potential) SDM will be recruited, then cluster-randomized to the ACP-GP intervention or the control condition. The primary outcome for GPs is ACP self-efficacy; primary outcome for patients is level of ACP engagement. Secondary outcomes for GPs are ACP practices, knowledge and attitudes; and documentation of ACP discussion outcomes. Secondary outcomes for patients are quality of life; anxiety; depression; appointment of an SDM; completion of new ACP documents; thinking about ACP; and communication with the GP. The secondary outcome for the SDM is level of engagement with ACP. A process evaluation will assess the recruitment and implementation of the intervention using the RE-AIM framework. Discussion While the general practice setting holds promise for timely initiation of ACP, there is a lack of randomized trial studies evaluating the effectiveness of ACP interventions implemented in this setting. After this Phase-III RCT, we will be able to present valuable evidence of the effects of this ACP-GP intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice. The results of the process evaluation will provide insight into what contributes to or detracts from implementation success, as well as how the intervention can be adapted to specific contexts or needs. Trial registration Prospectively registered at with ISRCTN (ISRCTN12995230); registered 19/06/2020.

scholarly journals Utility of oxygen insufflation through working channel during fiberoptic intubation in apneic patients: a prospective randomized controlled study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Go Un Roh ◽  
Joon Gwon Kang ◽  
Jung Youn Han ◽  
Chul Ho Chang
Keyword(s):  
Visual Field ◽  
Gas Analysis ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Fiberoptic Intubation ◽  
Randomized Controlled ◽  
Link Type ◽  
Arterial Blood ◽  
Group Oxygen ◽  
Secondary Outcomes

Abstract Background Airway management is a part of routine anesthetic procedures; however, serious complications, including hypoxia and death, are known to occur in cases of difficult airways. Therefore, alternative techniques such as fiberoptic bronchoscope-assisted intubation (FOB intubation) should be considered, although this method requires more time and offers a limited visual field than does intubation with a direct laryngoscope. Oxygen insufflation through the working channel during FOB intubation could minimize the risk of desaturation and improve the visual field. Therefore, the aim of this prospective randomized controlled study was to evaluate the utility and safety of oxygen insufflation through the working channel during FOB intubation in apneic patients. Methods Thirty-six patients were randomly allocated to an N group (no oxygen insufflation) or an O group (oxygen insufflation). After preoxygenation, FOB intubation was performed with (O group) or without (N group) oxygen insufflation in apneic patients. The primary outcome was the velocity of decrease in the partial pressure of oxygen (PaO2) during FOB intubation (VPaO2, mmHg/sec) defined as the difference of PaO2 before and after intubation divided by the time to intubation. The secondary outcomes included the success rate for FOB intubation, time to intubation, visual field during FOB intubation, findings of arterial blood gas analysis, and occurrence of FOB intubation-related complications. Results We found that VPaO2 was significantly greater in the N group than in the O group (1.0 ± 0.4 vs. 0.4 ± 0.4; p < 0.001), while the visual field was similar between groups. There were no significant intergroup differences in the secondary outcomes. Conclusions These findings suggest that oxygen insufflation through the working channel during FOB intubation aids in extending the apneic window during the procedure. Trial registration ClinicalTrials.gov, NCT02625194, registered at December 9, 2015.

Postoperative adjuvant chemotherapy for thoracic pathological T3N0M0 esophageal cancer: A propensity score-matched analysis (APEC Study 1).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15537-e15537
Author(s):  
Qifeng Wang ◽  
Tao Li ◽  
Yongtao Han ◽  
Qiang Li ◽  
Lin Peng ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Propensity Score ◽  
Confidence Interval ◽  
Hazard Ratio ◽  
Postoperative Chemotherapy ◽  
Phase Iii ◽  
R0 Resection ◽  
Study Cohort ◽  
Postoperative Adjuvant Chemotherapy ◽  
Matched Samples

e15537 Background: The role of postoperative chemotherapy (POCT) in thoracic esophageal squamous cell carcinoma (TESCC) has not been addressed . The aim of this study was to investigate whether POCT after an R0 resection improves outcomes in pT3N0M0 TESCC compared with operation alone. Methods: This study included 604 patients with pT3N0M0 TESCC who were treated at Sichuan Cancer Hospital from January 2009 to December 2017. The patients were divided into two groups: a surgery plus postoperative chemotherapy group (PORT group) comprising Surgery alone patients who underwent after an R0 resection and a surgery group (S group). Propensity score matching was used to create patient groups that were balanced across several covariates (n= 246 in each group). Outcome measures included overall survival (OS), disease free survival (DFS). Results: In the whole group 5-year OS and PFS were 58.4% and 56.0%. In the overall study cohort, 5-year OS (68.3% versus 50.4%, p < 0.0001) and DFS (65.5% versus 45.8%, p < 0.0001) rates were significantly higher in the POCT group than in the S group. These data were confirmed in the matched samples (5-year OS, 68.3% versus 49.5% [p < 0.0001]; DFS, 65.5% versus 42.5% [p < 0.0001]). Multivariate Cox analyses in the matched samples revealed that surgery and postoperative POCT were independently associated with longer OS (hazard ratio = 0.553, 95% confidence interval: 0.391–0.726, p < 0.0001) and longer DFS (hazard ratio = 0.556, 95% confidence interval: 0.416–0.744, p < 0.0001) than resection alone. Subgroup analysis found : POCT with IIA in pT3N0M0 have not longer OS and DFS ( p = 0.122 and p = 0.193). POCT with IIB in pT3N0M0 have the longer OS and DFS(p < 0.0001 both). Conclusions: Postoperative adjuvant Chemotherapy is strongly associated with improved OS and DFS in patients with pT3N0M0 TESCC. A multicenter, randomized phase III clinical trial is warranted to confirm these findings.

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