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Completed

NCT Number: NCT04660214

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.

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Key information

Conditions

Zenker Diverticulum Digestive System Diseases Diverticular Diseases Diverticulum Diverticulum, Esophageal Endoscopy Gastroenteritis Gastrointestinal Diseases Minimally Invasive Surgical Procedures Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mª Henar Núñez Rodriguez,

Valladolid, 47001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

septotomy

Device

endoscopic diverticulotomy

Primary outcomes

  1. Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure

    Time frame: At the moment of the procedure

    Technical success: achieving septotomy of the mucosa and transverse muscle fibers of the diverticulum septum.

  2. Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure

    Time frame: One month after the procedure

    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)

Secondary outcomes

  1. Analyze the mean procedure time with each of the two endoscopic techniques

    Time frame: At the end of the recruitment

    The procedure time will be counted from the overtube is placed until it is removed after diverticulectomy

  2. Analyze immediate and delayed complications with SB-Knife and LigaSure

    Time frame: one month after the procedure

    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

  3. Determine the recurrence rates and the mean time to recurrence for each of the techniques

    Time frame: at least three months after the procedure

    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).

Sponsors and collaborators

Lead sponsor

Hospital del Rio Hortega

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2020
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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