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

Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04660214
• Other study ID #: PI208-20
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Hospital del Río Hortega
• Contact: Mª Henar Nuñez-Rodriguez, MD PhD
• Phone: 0034 983420 400
• Email: henarnrod[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diverticulum
• Endoscopy
• Minimally Invasive Surgical Procedures
• Zenker Diverticulum

Intervention

Device:
• septotomy
endoscopic diverticulotomy

Locations

Country	Name	City	State
Spain	Mª Henar Núñez Rodriguez,	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Río Hortega

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure	Technical success: achieving septotomy of the mucosa and transverse muscle fibers of the diverticulum septum.	At the moment of the procedure
Primary	Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure	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)	One month after the procedure
Secondary	Analyze the mean procedure time with each of the two endoscopic techniques	The procedure time will be counted from the overtube is placed until it is removed after diverticulectomy	At the end of the recruitment
Secondary	Analyze immediate and delayed complications with SB-Knife and LigaSure	Complications during the procedure and post-procedure the first 14 days after the procedure): bleeding (decrease in Hb with hypotension and / or tachycardia and need for a gastroscope and hospital admission) (endoscopically controlled or if surgical treatment is required); perforation: endoscopic control or surgical treatment; odynophagia or neck pain (VAS Scale); Any complication that requires prolonging the hospital stay.; Late complications (from the 15th day and during the first month): Haemorrhage that requires endoscopic / surgical treatment or hospital admission for its control; Oesophageal perforation (conservative or surgical treatment): cervical emphysema, air in the mediastinum.; Pain that requires hospital admission	one month after the procedure
Secondary	Determine the recurrence rates and the mean time to recurrence for each of the techniques	Recurrence: reappearance of symptoms (dysphagia, cough ...) after their disappearance or worsening, reflected in an increase in the scores of the Dakkak and Bennett scales (score =1 or increase of 1 point) and EAT -10 (EAT-10 score =3 or 3-point increase from previous score).	at least three months after the procedure