背景:鉴于中国食管癌发病率高,越来越多的患者接受内镜黏膜剥离术(ESD).尽管ESD后的5年生存率可以超过95%,食管狭窄,最常见和严重的术后并发症,影响患者的远期预后和生活质量。已证明自体粘膜移植物可成功预防早期食管癌ESD术后狭窄。
目的:检测脱细胞真皮基质(ADM)替代自体粘膜的可行性,以预防ESD后狭窄。
方法:这是一个前瞻性的,单中心,对照研究。在2017年1月1日至12月31日期间连续招募接受ESD手术并愿意接受自体粘膜移植的患者。在2019年1月1日至12月31日期间连续招募接受ESD手术并愿意接受ADM移植的患者。对接受移植的患者进行了最后三年的随访。
结果:根据目前食管狭窄的发生率,经计算,自体粘膜移植组和ADM组所需的样本量均为160例.由于各种因素,我们共招募了20例自体粘膜移植患者和25例ADM移植患者.根据纳入排除和退出标准,9例患者最终接受自体粘膜移植并完成随访,11例患者接受ADM移植并完成随访。最后,自体黏膜移植组狭窄2例,狭窄率为22.22%,ADM移植组狭窄2例,狭窄率为18.18%,组间无显著差异(P=0.94)。
结论:在此前瞻性中,单中心,对照试验,我们比较了自体黏膜移植和ADM预防食管狭窄的有效性。由于某些条件限制,我们无法招募足够的科目来满足我们的目标要求。然而,我们实施了严格的包容,排除,和退出标准,并成功完成了三年的随访,产生有价值的临床见解。根据我们的发现,我们假设ADM在预防食管狭窄方面可能与自体粘膜移植同样有效,提供一种可比的替代方法。本研究为食管狭窄的预防提供了新的治疗思路和方向。
BACKGROUND: Given the high incidence of esophageal cancer in China, an increasing number of patients there are undergoing endoscopic mucosal dissection (ESD). Although the 5-year survival rate after ESD can exceed 95%, esophageal stricture, the most common and serious postoperative complication, affects the long-term prognosis of patients and the quality of life. Autologous mucosal grafts have proven to be successful in preventing stricture after ESD for early esophageal cancer.
OBJECTIVE: To examine the viability of acellular dermal matrix (ADM) as an alternative to autologous mucosa for the prevention of stricture after ESD.
METHODS: This is a prospective, single-center, controlled study. Consecutive patients who underwent ESD surgery and were willing to undergo autologous mucosal transplantation were recruited between January 1 and December 31, 2017. Consecutive patients who underwent ESD surgery and were willing to undergo ADM transplantation were recruited between January 1 to December 31, 2019. A final three-year follow-up of patients who received transplants was conducted.
RESULTS: Based on the current incidence of esophageal stricture, the sample size required for both the autologous mucosal graft group and the ADM group was calculated to be 160 cases. Due to various factors, a total of 20 patients with autologous mucosal grafts and 25 with ADM grafts were recruited. Based on the inclusion exclusion and withdrawal criteria, 9 patients ultimately received autologous mucosal grafts and completed the follow-up, while 11 patients received ADM grafts and completed the follow-up. Finally, there were 2 cases of stenosis in the autologous mucosal transplantation group with a stenosis rate of 22.22% and 2 cases of stenosis in the ADM transplantation group with a stenosis rate of 18.18%, with no significant difference noted between the groups (P = 0.94).
CONCLUSIONS: In this prospective, single-center, controlled trial, we compared the effectiveness of autologous mucosa transplantation and ADM for the prevention of esophageal stricture. Due to certain condition limitations, we were unable to recruit sufficient subjects meeting our target requirements. However, we implemented strict inclusion, exclusion, and withdrawal criteria and successfully completed three years of follow-up, resulting in valuable clinical insights. Based on our findings, we hypothesize that ADM may be similarly effective to autologous mucosal transplantation in the prevention of esophageal stricture, offering a comparable and alternative approach. This study provides a new therapeutic idea and direction for the prevention of esophageal stricture.