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Drug clinical trials need to recruit suitable subjects to verify the safety and effectiveness of new drugs. Subject recruitment is a very important and challenging link in the whole process of drug clinical trials, and even directly affects the progress and final results of the trials. The medical ethics committee should give full play to the important function of ethical review, carefully review the whole process of subject recruitment from the perspective of science and ethics, and do a good job in the protection of the health and rights of subjects. This paper mainly discussed the basic principles of subject recruitment, the main problems existing in the recruitment process and the key contents of ethical review, so as to provide scientific references and suggestions for standardizing subject recruitment, protecting the rights and interests of subjects, and promoting the efficient and high-quality completion of drug clinical trials.
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Objective:To discuss ethical review and management of serious adverse events in anti-tumor drug clinical trials in a grade A tertiary cancer hospital for timely and effective protection of subjects.Methods:The main contents and ethical management of ethical review on serious adverse events were retrospectively analyzed including the number, distribution rules, and whether they were reported in time in clinical trials conducted in our hospital in 2021.Results:A total of 1 789 serious adverse events in 259 clinical trials were reported, with more male subjects than female, with an average age of 59.95 years, mainly concentrated in the 50~59 age and 60~69 age groups, accounting for 27.45% and 42.37% respectively. Digestive oncology department, thoracic oncology department and renal cancer melanoma department ranked in the top three for the number of clinical trials and reports of serious adverse events. The highest incidence of serious adverse events was hospitalization at 63.44% and the lowest incidence was disability at 0.39%. The highest proportion of serious adverse events possibly related to clinical trials was 35.72%. Expected serious adverse events accounted for 65.85% versus 34.15% unexpected ones, and the difference between different correlations of serious adverse events whether they were expected or not.was statistically significant. Among the measures taken by the investigator for the test drugs due to serious adverse events, drug discontinuation was the most, accounting for 42.54%, while 3.07% of the trial plans modified the study protocol/informed consent. Serious adverse events reported within 24 hours accounted for 87.20%, and those reported in 24 hours and beyond accounting for 12.80%. A statistically significant difference of the reporting time between the registered and investigator initiated clinical trials was observed.Conclusions:The ethics committee should attach importance to ethical review and management of serious adverse events, pay attention to whether they were reported timely and accurately, strengthen supervision, and effectively protect the safety and interests of the subjects.
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Objective:To analyze ethical management of subjects′ complaints in drug clinical trials in a cancer hospital.Methods:A retrospective analysis of the complaints of subjects received and properly handled by the ethics committee through telephone, e-mail and on-site reception during the drug clinical trial in our hospital. Case studies were conducted to analyze the reasons for the occurrence of some particular subjects′ complaints, processing procedures and resolution processes.Results:The number of subjects' complaints in clinical trials in our hospital decreased year by year. The ethics committee of our hospital would check it immediately and review it carefully after receiving the subjects′ complaints, and return the review decisions to the subjects and researchers, at the same time, follow up with board meeting report and documentation. Regarding to the reasons of the subject complaint, mainly identified were the failure to participate in clinical trials due to inclusion and exclusion criteria, withdraw by investigators due to safety concerns, and not satisfied with the compensation.Conclusions:When receiving subjects′ complaints, the ethics committee should manage them seriously, verify the reasons in time and follow up properly, act as a communication bridge between subjects, researchers and sponsors, try their best to resolve subjects′ complaints, and protect the rights and interests of subjects.
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Objective:To investigate the feasibility and safety of right-sided abdominal evisceration in retroperitoneal liposarcoma.Methods:The clinical data of 16 cases of retroperitoneal liposarcoma performed with right-sided abdominal evisceration at Sarcoma Center of Peking University Cancer Hospital from Sep 2015 to Feb 2019 were analyzed retrospectively.Results:Complete resection were successfully performed in all 16 cases.The median tumor size was 29cm(13-43 cm), the median operative time was 660 min(429-940 min), the median estimated blood loss was 2 000 ml(300-6 000 ml). The major postoperative complications rate (Clavien-Dindo classification Ⅲ-Ⅴ) was 38%. Median overall survival is 41.0 months while the median disease-free survival is 32.6 months.Conclusions:Right-sided abdominal evisceration is a favorable procedure to attain complete resection with acceptable complication rate.
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Objective@#To summarize the characteristics of abdominal-pelvic unplanned reoperation (URO) in a cancer hospital.@*Methods@#Retrospectively descriptive cohort research was adopted. The classification of diseases was based on ICD-10, and surgical classification was based on ICD-9-CM-3. Medical record summary database from 2008 to 2018 in Beijing Cancer Hospital was collected, and all URO information of abdominal-pelvic surgery was retrieve. The time of URO, disease type, surgery type and cause were statistically analyzed. Distribution of main disease incidence and constituent ratio, and the application of major surgery and surgery type composition ratio were analyzed as well.@*Results@#From 2008 to 2018, a total of 46854 cases underwent abdominal-pelvic surgery (including gastrointestinal, hepatic-biliary-pancreatic, gynecological, urological, or esophageal cancer surgery) and 713 patients received URO (1.52%), including 486 males and 227 females (2.14:1.00) with a mean age of (58.1±12.2) years. A total of 246 patients (34.50%) had comorbidity, and with comorbidity: without comorbidity was 1.13:1.00. The hospital stay was (44.5±43.0) days, and the total cost was (178000±112000) yuan. There were 22 deaths (3.09%). The median interval between URO and the first operation was 8 (0 to 131) days. The highest rate of URO was 2.45% (89/3629) in 2012, while the lowest was 0.95% (53/5596) in 2015. The top 3 major cancer types of URO included colorectal cancer (222 cases, 31.14%), gastric cancer (166 cases, 23.28%) and esophageal cancer (45 cases, 6.31%). The cancer types with the highest URO rate included pancreatic cancer (3.97%, 30/756), gastric cancer (1.81%, 166/9171) and colorectal cancer (1.80%, 222/12333). The top 3 surgical procedures resulting in URO were rectal resection (109 cases, 15.29%), total gastrectomy (79 cases, 11.08%), and total pancreatectomy (64 cases, 8.98%). Focusing on 497 URO cases from 2012 to 2018, 465 cases (93.56%) followed relatively difficult grade III and IV surgery, while only 32 cases (6.44%) followed grade I and II surgery. The top 5 main causes of URO were bleeding (225 cases, 31.56%), anastomotic leak (225 cases, 31.56%), infection (89 cases, 12.48%), intestinal obstruction (53 cases, 7.43%), and wound dehiscence (35 cases, 4.91%), adding up to a total of 87.94% of all URO.@*Conclusion@#This study summarizes the epidemiology of abdominal - pelvic URO in our cancer institution, providing the solid baseline for future investigation of URO and the subsequent formulation of corresponding prevention and intervention measures.
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Desmoid-type fibromatosis (DF) is a rare monoclonal fibroblastic proliferation that is characterized by locally infiltrative but rarely metastatic lesions. Tyrosine kinase and γ-secretase inhibitors are primarily used in the targeted therapy of DF. The use of these drugs, however, is mainly based on the recommendations of retrospective studies with small sample sizes. Previous studies that focused on the mechanism, efficacy, and safety of targeted therapy for DF were reviewed to provide references for clinical applications and research. The efficacy and safety of targeted therapy were compared with those of other systemic therapy options. Targeted therapy does not provide considerable advantages in efficacy and safety over other medical treatments and is usually applied after the failure of antihormonal therapies, nonsteroidal anti-inflammatory drugs, and chemotherapy. Further studies are required to explore the mechanism, indications, and appropriate drug dosage of the targeted therapy of DF.
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Objective To discuss appropriate strategies of site visits in ethical committees ,to enhance the supervision of clinical trials effectively ,and standardize the implementation of clinical research .Methods In consideration of the lack of de-tailed normative description of site visit in ethical guidelines and relevant articles ,as well as the varying degrees of implementa-tion and understanding of site visits among different ethical committees .This article discussed the procedures ,contents and considerations of site visit based on the analysis of numerous site visits cases conducted .Results Site visit is one of the crucial procedures to more comprehensive ,in-depth and truly understanding of the implementation of clinical trials .It is helpful to help sponsors/investigators enhance awareness and compliance with the good clinical practice .It also helps to correct problems time-ly during the implementation process to assure the standardized implementation of follow-up studies ,and finally ,effectively protect the rights and interests and safety of subjects .Conclusions Standardized and efficient site visit strategy of the ethical committee is one of the important regulatory strategies in the implementation of clinical trials and is an effective supplement to the regular review of ethical materials .
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Objective To explore the clinical value of uncinate process resection combined with portalsuperior mesenteric vein resection and end-to-end anastomosis in distal pancreatectomy.Methods The retrospective cross-sectional study was conducted.The clinicopathological data of 11 patients who underwent distal pancreatectomy combined with portal-superior mesenteric vein resection and end-to-end anastomosis in the Peking University Cancer Hospital (8 patients) and Jilin Guowen Hospital (3 patients) between January 2014 to April 2018 were collected.During the vascular reconstruction,uncinate process of the pancreas was first resected for reducing anastomotic tension,and then end-to-end anastomosis was done after portal-superior mesenteric vein resection.Observation indicators:(1) intraoperative situations;(2) postoperative recovery situations;(3) postoperative pathological examination situations;(4) follow-up and survival situations.Follow-up using outpatient examination and imaging examination was performed to detect patients' postoperative survival,tumor recurrence and metastasis and postoperative venous anastomotic patency up to May 2018.Measurement data with normal distribution were represented as x±s.Measurement data with skewed distribution were described as M (range).The non-recurrence and non-metastasis survival curve,overall survival curve and survival rate were respectively drawn and calculated by the Kaplan-Meier method.Results (1) Intraoperative situations:11 patients received uncinate process resection of the pancreas,and successfully underwent distal pancreatectomy combined with portal-superior mesenteric vein resection and end-to-end anastomosis.Eight patients underwent distal pancreatectomy + Appleby combined with celiac axis resection due to pancreatic tumor involving common hepatic artery,including 2 undergoing combined total gastrectomy due to gastric ischemia;2 patients underwent distal pancreatectomy;1 patient underwent distal pancreatectomy + distal gastrectomy due to blood supply obstacle of distal stomach.Operation time and volume of intraoperative blood loss of 11 patients were (5.8± 1.1) hours and 800 mL (range,200-2 500 mL).(2) Postoperative recovery situations:there was no grade C of pancreatic fistula of 11 patients.Four patients had grade B of pancreatic fistula,including 2 were cured by drainage-tube indwelling of pancreatic wound ＞ 3 weeks,1 was cured by continous washing due to pancreatic fistula combined with infection,and 1 was cured by the second abdominal puncture drainage due to pancreatic fistula with fever;1 of 4 patients was combined with grade C of delayed gastric emptying and cured by conservative treatment,and other 3 patients didn't occur postoperative complications.Of 5 patients diagnosed as biochemical fistula,1 had esophagus-jejunum anastomotic leakage,and 1 had changes of hepatic ischemia in S2,S3 and S4b segments by CT examination and recovered normal liver function at 2 weeks postoperatively,with long-term hepatatrophia in S2 and S3 segments.There was no postoperative death and reoperation in 11 patients.Duration of postoperative hospital stay of 11 patients was (22± 5) days.(3) Postoperative pathological examination results:tumors of 11 patients were located in neck and body of the pancreas,with a maximum diameter of (4.8± 1.7)cm.Among 11 patients,10 were confirmed with moderate-or low-differentiated ductal adenocarcinoma and 1 with anaplastic carcinoma.The length of portal-superior mesenteric vein resection of 11 patients was (2.6± 0.8) cm.Seven of 11 patients occurred different degrees of tumor infiltration in the portal-superior mesenteric vein,and other 4 patients occurred inflammatory adhesion,without tumor infiltration.(4) Follow-up and survival situations:11 patients were followed up for 3.0-37.6 months,with a median time of 15.7 months.During the follow-up,8 patients died of tumor recurrence and /or metastasis,and 3 survived;the non-recurrence and non-metastais survival time and overall survival time were respectively 9.0 months (range,3.0-37.6 months) and 24.6 months (range,3.0-37.6 months).One patient was complicated with anastomotic stenosis and surrounding varices of portal-superior mesenteric vein by postoperative half-year reexamination,anastomotic vein anomalies and venous thrombosis were not found in other patients before local tumor recurrence and / or death.Conclusion The combined uncinate process resection of the pancreas cannot increase the risk of postoperative pancreatic fistula,and it could effectively reduce the anastomotic tension in the distal pancreatectomy combined with portal-superior mesenteric vein resection and reconstruction,meanwhile,it can also achieve end-to-end anastomosis after longer vein resection.
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The borderline resectable pancreatic cancer is high a controversial hotspot in the field of pancreatic surgery,and the controversy mainly focuses on definition and treatment.Five famous experts and their teams in pancreatic surgery discussed present situation and dilemmas in treatment of borderline resectable pancreatic cancer based on clinical experiences.Professor Hao Chunyi has reviewed and analyzed origin of the definition and treatment model of borderline resectable pancreatic cancer,and proposed that high-level pancreatic disease center and multidisciplinary collaboration diagnosis and treatment may be the best choice for resectable pancreatic cancer.Professor Liu Xubao suggested surgical treatment for most of borderline resectable pancreatic cancer,and whether or not tumor invades adjacent blood vessels and invasion level will be used to decide direct surgery or neoadjuvant therapy.Professor Sun Bei proposed 6 causes,and direct surgery may be more realistic and feasible option for borderline resectable pancreatic cancer.Professors Liang Tingbo and Bai Xueli recommended that neoadjuvant therapy should be performed due to defeat hiding micrometastasis lesions and reduce tumor burden,and there was a higher R0 resection rate and lower lymph node metastasis rate after neoadjuvant therapy,meanwhile,it can also increase cure rate and is benefited to survival.
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To explore ethical issues related to the protection of AIDS patients' rights in the prevention and treatment of AIDS.This paper elaborated in detail the importance of protecting personal privacy of AIDS patients and protecting them against discrimination and unfair treatment in the prevention and treatment of AIDS.It also expounded the relevant ethical,legal and regulatory basis of AIDS patients'rights protection,and how to protect the individual rights of AIDS patients in AIDS prevention and control,while protecting the public health.
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At present,China has not formed a complete ethical review agency certification system,actively participating in international certification and seeking external quality assessment is of great significance for the improvement of standard management and review capacity of ethics committee.Combined with the experience of Peking University Cancer Hospital applying for SIDCER international certification,this paper expounded the responsibilities of ethical secretary in international certification from the overview of international certification system and the work practice during the certification process,to promote the progress ethics committee applying for certification and achieve satisfactory quality assessment results.
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Objective:To discuss the role of incision for short-term outcomes of simultaneous resection in synchronous colorec-tal liver metastases (sCRLM). Methods:We reviewed the data of 37 patients who underwent simultaneous resection between January 2009 and December 2014 in our department and compared the short-term outcomes between Mercedes and midline incisions. Results:Mercedes and midline incisions were used in 19 and 18 patients, respectively. The two groups showed similarities in patient characteris-tics, major hepatectomy, surgery time, blood loss, and hilar block time. The midline group comprised more rectal cancer patients (P<0.001). The two groups did not differ significantly in complication incidence (47.4%vs. 16.7%, P=0.08) and postoperative stay time (22.1 ± 9.5 d vs. 17.2 ± 6.7 d, P=0.08). At body mass index (BMI)<25, the complication incidence (P=0.046) and postoperative stay time (P=0.051) were lower in the midline group than in the Mercedes group. Conclusion:Midline incision provided similar exposure in simultaneous resection for sCRLM and was better than Mercedes incision in rectal cancer patients. Patients with midline incision may attain better short-term outcomes if BMI is<25.
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<p><b>BACKGROUND</b>The management of Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma (HCC) is controversial due to the early recurrence after curative hepatectomy, and many variables were related to the prognosis. The purpose of this study was to predict the tumor recurrence in early postoperative period of the patients with BCLC stage B HCC.</p><p><b>METHODS</b>From January 2004 to January 2012, 104 patients with BCLC stage B HCC underwent hepatectomy. Clinicopathological factors and follow-up data were statistically analyzed to establish a predicting scoring system.</p><p><b>RESULTS</b>The overall survival rates for one, three, and five years were 69.2%, 52.7%, and 42.3%, and the disease-free survival rates for one, three, and five years were 52.9%, 47.3%, and 37.5%, respectively. The multiple factors analysis showed that the micro-vessel invasion, lymph nodes metastasis, multiple lesions, and the high expression of HMGB1 were independent factors (P < 0.05). A scoring system was established to predict the early recurrence within one year after the surgery for BCLC stage B HCC, according to the analysis results with a specificity of 85.1% and a sensitivity of 80.3%.</p><p><b>CONCLUSION</b>Variant clinicopathological factors were associated with early postoperative recurrence for BCLC stage B HCC and recurrence early after hepatectomy was more likely in patients with a higher score of the scoring system.</p>
Subject(s)
Female , Humans , Male , Middle Aged , Carcinoma, Hepatocellular , Metabolism , Pathology , General Surgery , Disease-Free Survival , HMGA1a Protein , Metabolism , Hepatectomy , Liver Neoplasms , Metabolism , Pathology , General Surgery , Neoplasm Recurrence, Local , Treatment OutcomeABSTRACT
Objective To introduce the standard procedure of Cattell Braasch maneuver and evaluate the complication and clinical value of this maneuver as a important exploration method in the surgery of pancreatic tumors. Method The clinical data of 13 cases of pancreatic tumors explored by Cattell Braanch maneuver before undergoing tumor resection were analyzed. Results Among these 13 cases there were 6 cases of tumors of the head (the pancreatic adeuocarcinoma in 4 cases, solid pseudo-papillary tumor and endocrine tumor in one each cases) and 7 cases of tumor of the body and tail of the pancreas (adenocarcinoma in 4 cases, solid pseudo-papillary tumor in 1 case, endocrine tumor in 2 cases) Pancreaticoduodenectomy was performed in 6 cases, including segmental resection of the tumor invading the superior mesenteric vein( SMV )with length varying from 3 to 7 cm and direct end-to-end reanastomosis in 3 cases. Distal pancreatectomy plus spleuectomy was performed in the other 7 cases, including the case in which extended tumor resection demanded left nephrectomy. Operations lasted from 2. 5 hrs to 11 hrs, in which only 10 ～ 15 mins were needed for Cattell Braasch maneuver . The blood lose was from 300 ml to 1000 ml. There were neither mortality nor severe complications in these series. Conclusion Cattell Braasch maneuver facilitates the exploration and tumor resection in patients suffering from pancreatic neoplasms especially malignances with better view of the operation field,it helps to avoid incidental iatrogenic injury, and also to the nongraft PV/SMV end-to-end anastomosis after the resection of tumor invaded segment.
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Objective To explore the feasibility of a novel incisionless laparoscopic technique in the treatment of colorectal tumor, and evaluate the preliminary clinical result of this technique. Methods The clinical data of 12 consecutive resected specimens of high located rectal or sigmoid tumor removed by traditional laparoscopic surgery were analyzed to probe the indication of this technique and the first 2 cases received incisionless laparoscopic anterior resection. Postoperative follow up was made to evaluate the clinical feasibilities. Results Among 12 explanted fresh specimens there were 1 adenoma and 3 adenocarcinoma cases in which the key steps of the new technique were successfully demonstrated. In two cases, the bowel above the tumor was cut and the distal end was inverted and pulled through the anus laparoscopically, the tumor along with the bowel resected, the stump pushed hack, and intralumen sigmoidproctostomy fashioned. In these two patients, one of sigmoid cancer and one of large rectal adenoma with focal canceration, the mean operation time was 200 min, mean blood lose was 50 ml, mean bowel function recovery time was 1.5 days. After 13 and 15 respective months fullow up there was no complications nor tumor recurrence. Conclusions Ineisionless laparoscopic surgery, while in line with tumor free principles, has the advantage of safety, cost-effectiveness and being cosmetic in selected cases.