Clinical significance of standardized pathological examination of specimens for en bloc transurethral resection technique with Hybrid Knife to treat NMIBC / 中华泌尿外科杂志

ABSTRACT

Objective To evaluate the pathological stage,the presence of detrusor muscle and the clinical significance for standardized examination of specimens for en bloc transurethral resection technique with Hybrid Knife to treat NMIBC (ERBT) compared with conventional TURBT.Methods This was prospective randomized controlled study.This study was approved by the Ethics Committee of Tongji Hospital,Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20180604),and patients all signed informed consent.The clinical study registration number of this studyNCT03221062.The margin of the tumor was recognized and marked by with Hybrid Knife (0.5 cm away from the normal mucosa).Then water was injected into the submucosa and form a water pad,with a circular cutting layer by layer (0.5 cm away from the marked position),reaching the detrusor muscle in depth.After complete resection,the tumor was removed by specimen bag.Specimens for ERBT cohort were given standard handling.Resected specimen of ERBT stretched with pins on foam and its margin was stained.The basement of specimen was also stained.Total specimen sectioned into appropriate pieces for histological assessment in the department of pathology.TURBT cohort performed traditional surgical methods and pathological examination.All patients received postoperative intravesical instillation according to their pathology.Imaging and cystoscopy were performed every 3 months.The primary study end-point was the quality of resection,including the pathological stage and the presence of DM.Secondary outcomes wereshort-term tumour recurrence rate (18 month),feasibility,and safety.Results From January 2017 to October 2017,109 patients were enrolled.51 patients underwent ERBT,and 58 patients underwent TURBT.The clinical characteristics of the patients in each cohort,such as average age,gender,average BMI,smoking history,the mean number of lesions and tumour size had no significant differences (P ＞ 0.05).The operation of 109 cases was completed successfully.There was no statistical difference between the operative time and the postoperative bladder irrigation time.Major intraoperative or postoperative complications (Clavien ≥ Ⅱ) did not occur in all of the patients.The percentage of T1 staging was higher in the ERBT cohort vs.TURBT cohort [21/51 (41.2％) vs.13/58 (22.4％),P =0.035],of which ERBT cohort accurately detected 9 cases (42.8％) of T1b patients,significantly higher than TURBT cohort (2 cases,15.4％) (P =0.096).All the ERBT samples showed the presence of DM (100.0％),while there was only 77.4％ in TURBT cohort (P ＜ 0.05).Mean follow-up (20.3 ± 3.1) months (ranged from 18 to 24 months).Recurrence rate were 8.9％ (4/45) in ERBT cohort vs.22.2％ (12/54) in TURBT cohort (P=0.059).Conclusions ERBT with Hybrid Knife for treatment NMIBC is a safe,effective,and provides high-quality specimens compared to TURBT.More high-risk NMIBC patients,especially T1 b patients,can be detected obviously by pathologist with the standardized treatment of specimens.