ЦЕЛЬ: предварительный анализ переносимости и безопасности тотальной неоадъювантной терапии с тремя консолидирующими курсами химиотерапии по схеме XELOX у больных раком прямой кишки. ПАЦИЕНТЫ И МЕТОДЫ: Пациентов с гистологически подтвержденной аденокарциномой прямой кишки рандомизировали в две группы: в группе ТНТ после неоадъюватной ХЛТ СОД 50-54 Гр с капецитабином проводили 3 курса консолидирующей химиотерапии по схеме XELOX, в группе ХЛТ проводили неоадъюватную ХЛТ СОД 50-54 Гр с капецитабином. Для оценки лучевых реакций применяли шкалу RTOG, для оценки токсических реакций использовали шкалу NCI-CTC v5.0. Отобранным больным с полным клиническим ответом предлагали тактику «наблюдения и выжидания». Характер и тяжесть послеоперационных осложнений оценивали по шкале Clavien-Dindo. Первичная точка исследования: частота полных ответов опухоли (клинических и патоморфологических). Вторичные точки исследования: частота и структура интра-и послеоперационных осложнений, частота осложнений 3-4 степени лучевой терапии и химиотерапии, частота R0-резекций. Исследование зарегистрировано на портале ClinicalTrials.gov (NCT04747951). РЕЗУЛЬТАТЫ: За период с октября 2020 по март 2022 гг. в рандомизированное исследование включено 145 пациентов: 72 пациента в группе ТНТ и 73 пациента в группе ХЛТ. Полный курс неоадъювантной терапии в группе ТНТ завершили 90% пациентов против 96% в группе ХЛТ (р = 0,65). Общая частота осложнений лучевой терапии составила 59% в группе ТНТ против 67% в группе ХЛТ (р = 0,48), при этом лучевые реакции 3-4 степени по шкале RTOG были отмечены только в двух случаях в группе ХЛТ. Общая частота осложнений химиотерапии составила 54% в группе ТНТ против 19% в группе ХЛТ(p < 0,001). Частота тяжелых токсических реакций в группе ТНТ составила 3% против 2% в группе ХЛТ. По частоте интра-и послеоперационных осложнений группы не различались. ЗАКЛЮЧЕНИЕ: предварительные результаты рандомизированного исследования продемонстрировали, что ТНТ является безопасной альтернативой стандартной неоадъюватной ХЛТ.
The article is a review of the literature on new systems for assessing the severity and predicting the outcomes of acute pancreatitis. The authors cite current literature data on the effectiveness of various new scales, as well as information on developed systems that undergo a clinical information test in determining the severity of acute pancreatitis.
To assess the efficacy of total neoadjuvant therapy (TNT) for rectal carcinoma in comparison with conventional chemoradiotherapy (CRT). Methods: A systematic review was performed according to the PRISMA guidelines. A Bayesian network meta-analysis was done using NetMetaXL and WinBUGS. This study was registered in PROSPERO on March 3, 2022 (No. CRD-42022307867). Results: Outcomes of 2,719 patients from 10 randomized trials between 2010 and 2022 were selected. Of these 1,191 (44%) had conventional long-course CRT (50-54 Gy) and capecitabine, 506 (18%) had induction chemotherapy followed by CRT (50-54 Gy) and capecitabine (iTNT), 230 (9%) had long-course CRT (50-54 Gy) followed by consolidation chemotherapy (cTNT), and 792 (29%) undergone modified short-course radiotherapy (25 Gy) with subsequent chemotherapy (mTNT). Total pathologic complete response (pCR) was 20% in the iTNT group, 21% in the mTNT group, 22% in the cTNT group, and 12% in the CRT group. Statistically significant difference in pCR rates was detected when comparing iTNT with CRT (odds ratios [OR], 1.76; 95% credible interval [CrI], 1.06-2.8), mTNT with CRT (OR, 1.90; 95% CrI, 1.25-2.74), and cTNT with CRT groups (OR, 2.54; 95% CrI, 1.26-5.08). No differences were found in R0 resection rates. No significant difference was found in long-term outcomes. Conclusion: The early administration of systemic chemotherapy in the TNT regimen has improved short-term outcomes, though long-term results are underreported. Randomized trials with survival as the endpoint are necessary to evaluate the possible advantages of TNT modes.
INTRODUCTION: the NOSES technique allows one to remove specimen without incisions on the anterior abdominal wall and is accompanied by fewer complications by reducing the frequency of wound infections. The results of these surgical operations on colorectal tumors are presented in a limited number of heterogeneous studies, which necessitates obtaining objective data using metaanalysis.STUDY OBJECTIVE: compare the short and long-term outcomes of two methods for surgical treatment of colorectal cancer.MATERIALS AND METHODS: a systematic review is carried out in accordance with PRISMA practice and recommendations.RESULTS: nine comparative studies were selected for the period from 2014 to 2019. 1693 patients were included in the meta-analysis: in 765 (45%), the tumor preparation was removed transanally (NOSES group) and in 928 (55%) it was removed via minilaparotomic access (LA group). The tumor size in the NOSES group was 0.5 cm smaller (OR=0.5, CI95% 0.2-0.8, p=0.0004) than in the LA group. In regards to other parameters the groups had no publication bias. The duration of the operation when comparing NOSES with LA was comparable (p =0.11). VAS pain was on average 2 points (OR=1.8, CI95% 1.2-2.4, p<0.00001) more pronounced in the LA group. The postoperative bed day was less in the group with transanal removal of the preparation (OR=0.8, CI95% 0.4-1.3, p=0.0003). The chance of developing postoperative complications in the NOSES group was (OR=0.5, CI95% 0.4-0.8, p=0.0004) with a frequency of 62/765 (8%) cases, compared with the control group - 130/931 (14%). The chance of developing wound infection was higher in the LA group (OR=0.2, CI95% 0.1-0.3, p <0.00001). There were no differences in the incidence of colorectal anastomotic leakage (p=0.97). There were also no differences in the five-year overall (p=0.74) and cancer-specific survival (p=0.76).CONCLUSION: using NOSES technologies creates better conditions for the rehabilitation of patients due to the low frequency of postoperative complications due to the absence of wound infection and is a safe manipulation. However, the presence of publication biases requires a careful interpretation of the data obtained.
Modern standards of registering the medical information involve a creation of registers of patients with various nosologicalentities, which allows to standardize the services provided by the health care system, as well as to increase the efficiency and safety of treatment in actual clinical practice. The Pancreatic Disease Register of the German Society of General and Visceral Surgery, which is a database of patients with pancreatic diseases and their surgeries, has become very popular in the medical field. The register is a multidisciplinary database with its own infrastructure, coordination center and it contains information on surgical diseases and surgical interventions performed on the pancreas. The register is used to collect and analyze information online and integrates clinics of German-speaking countries (Germany, Switzerland, Austria), as well as doctors from other countries after receiving the relevant permission. The review analyzes the features of information collection and the creation of own register infrastructure, aspects of the implementation of methodological and organizational support, as well as the nuances of its logistics. The ways of statistical processing and validation of the collected information are listed, the possibility of autonomous functioning of the system and the presence of strict measures to protect the confidentiality of data are emphasized. The register is an optimal set of possibilities for correct, full-fledged introduction and analysis of extensive medical data, which is a prerequisite for conducting the prospective randomized studies in the field of pancreatic surgery.
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