NCT04660214

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospital del Rio Hortega · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Zenker Diverticulum
• Minimally Invasive Surgical Procedures
• Endoscopy

Interventions

Type	Name	Description
DEVICE	septotomy	endoscopic diverticulotomy

Timeline

• Start date: 2021-06-28
• Primary completion: 2024-06-30
• Completion: 2026-12-31
• First posted: 2020-12-09
• Last updated: 2024-02-23

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study