The First Prospective Randomized Study of the Removal of Large Benign Epithelial Neoplasms of the Colon by the EMR and ESD Method in Moscow, Russia.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
Benign epithelial neoplasms of the colon are a significant problem of colorectal surgery and health care not only because of their malignant potential, but also because of their prevalence among the working-age population. Adenomas are more often detected in men than in women (OR = 1.77; 95% CI = 1.66-1.89), increasing in men from 25% at 50-54 years to 39% in people over 70 years old and in women from 15% at 50-54 years to 26% at 70 years of age (p < 0.001) [1]. Colonoscopy is the gold standard among all methods for diagnosing adenomas and adenocarcinomas of the colon. Endoscopic removal of colorectal polyps reduces the incidence and mortality from colorectal cancer (CRC) and is considered a necessary skill for all endoscopists performing colonoscopy [2, 6]. Endoscopic mucosal resection (EMR) was developed in 1984 by M. Tada et al. as a new technique for removing epithelial lesions of the gastrointestinal tract [181]. There are a number of aspects that cause additional complications during mucosectomy, such as convergence of folds, localization of large polyps between two folds, tumor spread beyond two folds, which are factors in tumor fragmentation and require additional study of their impact on long-term treatment outcomes. It is important to note that removal of colon tumors by fragmentation technique is associated with increased recurrence rate, however, in most cases these recurrent lesions are small in size and can be easily removed during dynamic colonoscopy. Predictably high recurrence rate during tumor fragmentation during removal indicates non-radical nature of the intervention performed and safety of this manipulation should be proven. Endoscopic submucosal dissection (ESD) is a relatively new method for removing superficial gastrointestinal neoplasms and was described at the end of the 20th century [85]. The development of the submucosal dissection technique was motivated by the difficulty of removing formations larger than 20 mm in a single block by endoscopic resection of the mucosa. Also, the association of tumor fragmentation during resection with a high risk of local recurrence and the difficulty of morphological evaluation of the removed specimen [133, 136, 190]. However, endoscopic submucosal dissection is a lengthy and energy-consuming procedure. According to Japanese authors, the average time for endoscopic submucosal dissection is 48.5-60 min. [77, 89], and, according to European scientists, the time for performing such interventions ranges from 142 to 176 minutes [7, 78, 144, 187]. According to Japanese clinical guidelines, the preferred method for removing large epithelial neoplasms of the colon with suspected intramucosal invasion is ESD, and European and American guidelines talk about the possible use of EMR, including in parts. In addition, unlike Japanese guidelines, where it is considered unsafe to remove a neoplasm in parts in assessing its radicality, Western guidelines allow the use of EMR in parts. Thus, endoscopic resection of the mucous membrane and endoscopic dissection in the submucosal layer are currently successfully used in the treatment of epithelial formations, but the advantages and disadvantages of each technique for a particular type of neoplasm, its histological nature and localization require systematization and clarification. The place of endoscopic mucosal resection and submucosal dissection in the removal of epithelial lesions of the colon has not been definitively established. Technical aspects, risk factors for complications, and long-term results of these types of endoscopic interventions require additional analysis.
Endoscopic interventions on the colon are accompanied by a certain percentage of complications. The most common complications of endoscopic removal of colon neoplasms are bleeding and perforation, the frequency of which varies from 0.08% to 10% depending on the analyzed method and patient sample [93, 120]. Given the wide variability of the available data, the influence of various factors on the frequency of complications requires additional study due to the need to identify correctable variables.
In June 2022, a group of authors proposed to the world community of specialists a new classification of complications in endoluminal endoscopy of the gastrointestinal tract for standardized assessment and analysis of the safety of endoscopic interventions [1] - "AGREE" (acronym for Adverse events GastRointEstinal Endoscopy) The authors of the classification also recommend recording any complications that arise, both at the stage of preparation for the planned endoscopic intervention (regardless of whether it was ultimately performed or not), and in those30 days after the intervention.[1]. It is these provisions of the AGREE classification that remain controversial and require more careful discussion [3]. In any case, in our opinion, at least a cause-and-effect relationship should be established between the action and the complication.
详细描述
Objective of the study: to prospectively compare the immediate, immediate and remote results of endoscopic mucosal resection through an endoscope and endoscopic submucosal dissection performed for non-invasive large-sized (20 mm or more) broad-based epithelial lesions of the colon.
Study objectives:
- To evaluate the accuracy of ultra-high-resolution colonoscopy in white, ultra-clear and narrow-spectrum light with magnification in predicting the histological structure and risks of invasion of large-sized broad-based epithelial lesions of the colon.
- To conduct a comparative assessment of the accuracy of angio-CT/MRI, probe EUS and second-generation narrow-band endoscopy with magnification in determining the depth of invasion and the probability of lymphoregional metastasis of superficial epithelial neoplasms of the colon with malignancy.
- To evaluate the effectiveness of endoscopic ultrasound in predicting submucosal fibrosis and its impact on surgical treatment tactics, and to compare the obtained data with the intraoperative picture using the fibrosis classification scale.
- To conduct a comparative assessment of the completeness (in one block/in parts; R0/R1) and depth of resection of large-sized epithelial lesions of the colon on a broad base according to endoscopic and morphological criteria in EMR and ESD.
- To study the immediate results of EMR and ESD, including conversion and intervention refusal factors.
- To determine the risk factors for recurrence after endoscopic removal of large epithelial neoplasms of the colon and to develop an algorithm for their diagnosis and prevention
- To assess possible intra- and postoperative complications during endoscopic removal of large epithelial neoplasms (bleeding, perforation, postcoagulation syndrome) of the colon using the AGREE endoscopic complication scale and to develop methods for their prevention and treatment.
- To assess the effectiveness of the RDI regimen both for the prevention of an intraoperative source of bleeding and for detecting a source of bleeding during EMR/ESD
- To study comparative indicators of the number of tumor recurrences in the immediate and late periods after endoscopic intervention (from 6 months to 5 years), and the effect of the EMR method and additional ablation of the edges of the wound bottom on the incidence of recurrent formations
General characteristics of the clinical study. Design: prospective, randomized, controlled study. It is planned to include at least 110 patients in the study until statistically reliable indicators are obtained for all analyzed parameters, who will undergo EMR or ESD for large-sized (20-60mm) non-invasive epithelial formations of the colon on a broad base. The method of choosing the operation will be determined using a random number generator (randomizer).
Patient inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with benign non-invasive epithelial formations of the colon on a broad base (Is and II types), 20-60 mm in size
- •Age ≥ 18 years.
- •Signed informed voluntary consent for colonoscopy and removal of formations using the studied methods of EMR and ESD
排除标准
- •. More than one large epithelial lesion on a broad base
- •Colon lesion less than 20 mm and more than 60 mm
- •Recurrent lesion.
- •Reasonable suspicion of an invasive lesion (cancer), including one with submucosal invasion based on the results of preoperative assessment (NICE - 3; JNET - 3; Kudo - Vn).
- •Presence of widespread malignant tumour in any part of the colon.
- •Use of other methods of endoscopic lesion removal.
- •Infectious disease requiring systemic therapy
- •Patient on haemodialysis
- •Uncorrectable coagulopathy (INR> 1.5), inability to discontinue antithrombotic drugs.
- •Refusal to participate in the study.
- •General contraindications to endoscopic examination.
结局指标
主要结局
Postoperative complications
时间窗: 1 months after removal
Postoperative complications that arise from 1 day to 30 days after removal are assessed: postcoagulation syndrome, bleeding, perforation.
Relapse of education
时间窗: 6 and 12 months after removal
The postoperative scar is assessed for the presence of recurrent formation
Radicality of removal
时间窗: 1 months after removal
Based on the pathomorphological report, the radicality of the removal of the epithelial formation by the EMR and ESD methods will be assessed. (R0, R1, Rx)
Duration of the operation
时间窗: at the time of the operation
from the moment of submucosal injection until the complete removal of the formation, the duration of the operation will be recorded
Intraoperative complications
时间窗: at the time of the operation
During the operation, intraoperative complications that arise are recorded: perforation, bleeding.
次要结局
- Endoscopic evaluation of submucous fibrosis(at the time of the operation)
