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 study:NCT03221062.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 were:short-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.
ABSTRACT
Objective To compare the clinical efficacy and safety of Hybrid knife versus triangular tip during peroral endoscopic myotomy(POEM) for patients with achalasia of cardia. Methods Data of patients with achalasia of cardia who received POEM in Nanfang Hospital, Southern Medical University from June 2012 to July 2014 were collected and divided into the Hybrid knife group ( using Hybrid knife) and triangular tip group ( using injection needle and triangular tip). Procedure-related parameters, symptom relief, and adverse events were compared between the two groups. Results A total of 57 patients were selected, including 25 patients in the Hybrid knife group and 32 in the triangular tip group. There were no significant differences on baseline characteristics between the two groups ( P＞0. 05). The mean procedure time was shorter in the Hybrid knife group than that in the triangular tip group (55. 3±17. 7 min VS 69. 5± 9. 4 min, P＝0. 038). The mean frequency of devices exchange was less in the Hybrid knife group than that in the triangular tip group (4. 5±1. 5 VS 10. 7±1. 7, P＝0. 000). No serious complications occurred during operation and periodical follow-up in both groups. At one-year follow-up, the treatment success rate was 92. 0%(23/25) in the Hybrid knife group and 96. 9%(31/32) in the triangular tip group (P＝0. 576). Conclusion Using Hybrid knife in POEM can shorten procedural time and achieve similar treatment success rate compared to triangular tip.
ABSTRACT
Introducción: La disección submucosal endoscópica con Hybrid Knife (DSEH) es una técnica prometedora para la resección de tumores en etapa temprana. Hay poca data en Latinoamérica. Pacientes y métodos: Estudio prospectivo-descriptivo (marzo 2011 - marzo 2012). Se incluyeron 25 pacientes (16 hombres, 9 mujeres), edades comprendidas entre 52-72 años (X=62,52 años). Se realizaron 25 procedimientos DSEH. Las indicaciones fueron: tumores subepiteliales (7), neoplasia de colon y recto (16), neoplasia precoz gástrica (2). Resultados: DSEH fue técnicamente posible en todas (25) las lesiones (100%). La resección en bloque y márgenes libres de lesión se obtuvieron en todos los casos. El tamaño de la mucosa disecada fue entre 2-7 cms (X=3,8 cms). El tiempo endoscópico fue entre 45-120 minutos(X=84,4 minutos). Perforación ocurrió en 2 casos, siendo resuelta con tratamiento endoscópico (clips). Mortalidad no fue reportada. Conclusiones: Los resultados preliminares sugieren que la DSE con Hibrid Knife (DSEH), parece ser una buena opción para el tratamiento endoscópico de tumores en etapa temprana gástricos, recto colónico y tumores carcinoides. Estudios controlados, aleatorizados de la DSE con Hibrid Knife, en comparación con otros dispositivos son necesarios.
Introduction: Endoscopic submucosal dissection Hybrid Knife (ESD-HK) is a promising technique for resection of early stage tumors. Few data in Latin America. Patients and methods: Prospective, descriptive study (March 2011-2012). 25 patients (16 men, 9 women), mean age 62.52 years (52-72 years).25 procedures were performed. Indications: sub-epithelial tumors (7), colorectal neoplasia (16) early gastric neoplasia (2) Results: ESD-HK was technically possible in all (25) lesions (100%). En bloc resection and free margins were obtained in all cases. The diameter of dissected mucosa was between 2-7 cms(X=3.8 cms) The time was between 45-120 minutes(X= 84.4 minutes). Perforation occurred in 2 cases being resolved with endoscopic treatment (clips). Mortality was not reported. Conclusions: Our preliminary results suggest that the DSE with Hibrid Knife (DSEH) seems to be a good option for endoscopic treatment of early stage gastric tumors, colon and rectal carcinoid tumors. Studies controlled, randomized DSE with Hibrid Knife, compared with other devices are needed.