Clinical trial NCT04660214: Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.
Official title: Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Zenker Diverticulum
Minimally Invasive Surgical Procedures
Endoscopy
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure
timeFrame: At the moment of the procedure
measure: Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure
timeFrame: One month after the procedure
Secondary outcomes:
measure: Analyze the mean procedure time with each of the two endoscopic techniques
timeFrame: At the end of the recruitment
measure: Analyze immediate and delayed complications with SB-Knife and LigaSure
timeFrame: one month after the procedure
measure: Determine the recurrence rates and the mean time to recurrence for each of the techniques
timeFrame: at least three months after the procedure
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Mª Henar Núñez Rodriguez,
Study officials:
affiliation: Gastroenterology Department, Hospital Rio Hortega
name: Mª Henar Núñez-Rodriguez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: