Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure
研究概览
简要总结
The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.
详细描述
Patients who meet the inclusion criteria will be randomized on the day of the procedure using a computer system that generates a table of random numbers, to perform endoscopic diverticulotomy using a LigaSure device (LS 1500, Covidien; Medtronic, Minneapolis, MN, USA) or with Stag Beetle (SB) knife standard (Sumitomo Bakelite Co. Tokyo, Japan).
Prophylactic intravenous antibiotic therapy is administered prior to the procedure and will be performed under deep sedation with control by an endoscopist or anesthesiologist in the cases indicated.
Gastroscopy will be performed to identify Zenker's diverticulum, and isolate the septum under endoscopic control using a diverticuloscope or flexible overtube (ZD overtube, ZDO 22/30 Cook Medical), after placing a guide (0.035 ", 450 cm Jagwire, Boston Scientific, Natick MA, USA) in the esophageal lumen. The overtube has two leaflets at one of its ends, a longer one that is placed in the esophageal lumen and the short leaflet is placed in the diverticulum. In those cases in which it is not possible to place the diverticuloscope, the septum will be isolated with the help of a cap on the end of the endoscope. In these cases, the device used will always be the SB-Knife since it is not possible to use the LigaSure and they will be excluded from the study analysis.
The time of the procedure will be counted from when the overtube is placed until it is removed after diverticulotomy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with endoscopically confirmed Zenker's diverticulum and presenting symptoms related to it.
- •Those who complete the symptom and quality of life questionnaires.
- •They must sign informed consent.
排除标准
- •Previous treatment of Zenker's Diverticulum
- •Those for whom Zenker's diverticulum is ruled out at endoscopy.
- •Chewing disorders and/or dysphagia secondary to neurological pathology and Oesophageal motility disorders
- •Those who do not want to participate in the study and/or who do not sign the informed consent.
研究组 & 干预措施
Vessel sealing device
Endoscopic diverticulectomy is performed with the LigaSure (TM) device
干预措施: septotomy (Device)
Dissecting Knife device
Endoscopic diverticulectomy is performed with the SB-Knife(TM) device
干预措施: septotomy (Device)
结局指标
主要结局
Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure
时间窗: At the moment of the procedure
Technical success: achieving septotomy of the mucosa and transverse muscle fibers of the diverticulum septum.
Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure
时间窗: One month after the procedure
Clinical success: disappearance of symptoms or their improvement one month after treatment, evaluated using the Eating-Assessment Tool-10 (\>=3 pathological) and Dakkak and Bennett scales (0: asymthomatic; 4 aphagia)
次要结局
- Analyze immediate and delayed complications with SB-Knife and LigaSure(one month after the procedure)
- Determine the recurrence rates and the mean time to recurrence for each of the techniques(at least three months after the procedure)
- Analyze the mean procedure time with each of the two endoscopic techniques(At the end of the recruitment)
研究者
Mª Henar Núñez Rodriguez, MD PhD
Principal Investigator
Hospital del Rio Hortega