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

NCT04660214 | Recruiting DMC FDA Device

• 1 other identifier: PI208-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Zenker Diverticulum; Minimally Invasive Surgical Procedures; Endoscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Analyze the mean procedure time with each of the two endoscopic techniques

  At the end of the recruitment

• Analyze immediate and delayed complications with SB-Knife and LigaSure

  one month after the procedure

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

  at least three months after the procedure

Study Arms (2)

Vessel sealing device

ACTIVE COMPARATOR

Endoscopic diverticulectomy is performed with the LigaSure (TM) device

Device: septotomy

Dissecting Knife device

ACTIVE COMPARATOR

Endoscopic diverticulectomy is performed with the SB-Knife(TM) device

Device: septotomy

Interventions

septotomy DEVICE

endoscopic diverticulotomy

Dissecting Knife device; Vessel sealing device

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (1)

Mª Henar Núñez Rodriguez,

Valladolid, 47001, Spain

RECRUITING

MeSH Terms

Conditions

Zenker Diverticulum

Condition Hierarchy (Ancestors)

Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mª Henar Núñez-Rodriguez, MD PhD

  Gastroenterology Department, Hospital Rio Hortega

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mª Henar Nuñez-Rodriguez, MD PhD

CONTACT

0034 983420 400; henarnrod@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 9, 2020
• Study Start: June 28, 2021
• Primary Completion: June 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)