缺乏支持重复经尿道切除术 (reTUR) 在非肌层浸润性膀胱癌 (NMIBC) 中的作用的高级证据。评估立即 reTUR 是否对患者预后有影响的随机对照试验 (RCT) 至关重要。然而，由于这样的随机对照试验需要招募大量患者，因此进行初步可行性研究是适当的。 为了评估随机对照试验的可行性，该随机对照试验调查了初始 reTUR 佐剂卡介苗 (BCG) 与初始诱导 BCG 后的影响NMIBC 中的 TUR。符合条件的患者被随机分配接受 reTUR 辅助 BCG 或 TUR 后预先诱导 BCG。宏观上完全切除的高级别 T1 NMIBC、伴有或不伴有原位癌以及初始 TUR 标本中存在逼尿肌 (DM) 的患者被认为有资格纳入。排除标准包括淋巴血管侵犯（LVI）、组织学亚型、肾积水、并发上尿路尿路上皮癌（UTUC）或前列腺尿道内尿路上皮癌。本可行性研究的目的是招募 30 名患者。患者招募率是主要结果。肿瘤学结局（无复发和无进展生存期）是次要终点。总体而言，30 名患者（每组 15 名）在 14 个月的时间内（2020 年 8 月至 2021 年 10 月）被随机分组​​。两名符合条件的患者拒绝随机分组，导致患者对研究方案的依从率为 93.3%。我们在随机化前排除了 49 名不符合条件的患者，原因包括组织学亚型 (n = 16, 33%)、LVI (n = 9, 18%)、TUR 标本中不存在 DM (n = 12, 24%)、转移性疾病 (n = 5, 10%)，伴随 UTUC (n = 3, 6%)，或肾积水 (n = 4, 8%)。在 reTUR 中，四名患者 (29%) 发现持续性疾病，一名 (7%) 患者升级为肌肉侵袭性疾病。在中位随访 17 个月的时间里，reTUR 组的 3 名患者 (23%) 和前期 BCG 组的 6 名患者 (40%) 检测到疾病复发。在一名接受前期 BCG 治疗的患者中观察到进展为肌肉侵袭性疾病。在高级别 T1 NMIBC 中进行比较前期 BCG 与 reTUR BCG 的随机对照试验的可行性已得到证实。我们的结果强调需要对大量患者进行筛查，因为大部分病例的特征符合排除标准。我们发现，对重复外科手术通过尿道切除膀胱肿瘤的作用进行临床试验是可行的患有高级别非肌层浸润性膀胱癌的患者。这些初步结果可能有助于完善重复手术对于此类患者的作用。版权所有 © 2023 作者。由 Elsevier B.V. 出版。保留所有权利。

High-level evidence supporting the role of repeat transurethral resection (reTUR) in non-muscle-invasive bladder cancer (NMIBC) is lacking. A randomized controlled trial (RCT) assessing whether immediate reTUR has an impact on patient prognosis is essential. However, since such a RCT will require enrollment of a high number of patients, a preliminary feasibility study is appropriate.To assess the feasibility of an RCT investigating the impact of immediate reTUR + adjuvant bacillus Calmette-Guérin (BCG) versus upfront induction BCG after initial TUR in NMIBC.Eligible patients were randomly assigned to receive either reTUR + adjuvant BCG or upfront induction BCG after TUR. Patients with macroscopically completely resected high-grade T1 NMIBC, with or without concomitant carcinoma in situ, and with detrusor muscle (DM) present in the initial TUR specimen were considered eligible for inclusion. Exclusion criteria included lymphovascular invasion (LVI), histological subtypes, hydronephrosis, concomitant upper tract urothelial carcinoma (UTUC), or urothelial carcinoma within the prostatic urethra. The aim was to enroll 30 patients in this feasibility study.The patient recruitment rate was the primary outcome. Oncological outcomes (recurrence-free and progression-free survival) were secondary endpoints.Overall, 30 patients (15 per arm) were randomized over a period of 14 mo (August 2020-October 2021). Two eligible patients refused the randomization, resulting in a patient compliance rate of 93.3% for the study protocol. We excluded 49 ineligible patients before randomization because of histological subtypes (n = 16, 33%), LVI (n = 9, 18%), DM absence in the TUR specimen (n = 12, 24%), metastatic disease (n = 5, 10%), concomitant UTUC (n = 3, 6%), or hydronephrosis (n = 4, 8%). At reTUR, persistent disease was found in four patients (29%) and upstaging to muscle-invasive disease in one (7%). Over median follow-up of 17 mo, disease recurrence was detected in three patients (23%) in the reTUR arm and six patients (40%) in the upfront BCG arm. Progression to muscle-invasive disease was observed in one patient treated with upfront BCG.The feasibility of conducting an RCT comparing upfront BCG versus reTUR + BCG in high-grade T1 NMIBC has been demonstrated. Our results underline the need to screen a large number of patients owing to characteristics meeting the exclusion criteria in a high percentage of cases.We found that a clinical trial of the role of a repeat surgical procedure to remove bladder tumors through the urethra would be feasible among patients with high-grade non-muscle-invasive bladder cancer. These preliminary results may help in refining the role of this repeat procedure for patients in this category.Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.