Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.

Hospital del Río Hortega

Status: Enrolling

Conditions: Minimally Invasive Surgical Procedures; Endoscopy; Zenker Diverticulum

Treatments: Device: septotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04660214

PI208-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Vessel sealing device

Active Comparator group

Description:

Endoscopic diverticulectomy is performed with the LigaSure (TM) device

Treatment:

Device: septotomy

Dissecting Knife device

Active Comparator group

Description:

Endoscopic diverticulectomy is performed with the SB-Knife(TM) device

Treatment:

Device: septotomy