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

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopy; Zenker Diverticulum; Minimally Invasive Surgical Procedures
• Intervention / Treatment: Device: septotomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mª Henar Nuñez-Rodriguez, MD PhD; Phone Number: 84 433 0034 983420 400; Email: henarnrod@yahoo.es

Study Locations

• Spain
  • Valladolid, Spain, 47001
    • Recruiting
    • Mª Henar Núñez Rodriguez,
    • Contact: Mª Henar Núñez Rodriguez,, MD PhD; Phone Number: 84 433 983 420 400; Email: henarnrod@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 108 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vessel sealing device; Endoscopic diverticulectomy is performed with the LigaSure (TM) device	Device: septotomy; endoscopic diverticulotomy
Active Comparator: Dissecting Knife device; Endoscopic diverticulectomy is performed with the SB-Knife(TM) device	Device: septotomy; endoscopic diverticulotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hospital del Río Hortega
• Investigators: Principal Investigator: Mª Henar Núñez-Rodriguez, MD PhD, Gastroenterology Department, Hospital Rio Hortega

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Zenker Diverticulum
• Other Study ID Numbers: PI208-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes