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

Primary Purpose

Zenker Diverticulum, Minimally Invasive Surgical Procedures, Endoscopy

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
septotomy
Sponsored by
Hospital del Río Hortega
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zenker Diverticulum

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mª Henar Núñez Rodriguez,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vessel sealing device

Dissecting Knife device

Arm Description

Endoscopic diverticulectomy is performed with the LigaSure (TM) device

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

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

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
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
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).

Full Information

First Posted
November 24, 2020
Last Updated
March 15, 2022
Sponsor
Hospital del Río Hortega
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1. Study Identification

Unique Protocol Identification Number
NCT04660214
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Río Hortega

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zenker Diverticulum, Minimally Invasive Surgical Procedures, Endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vessel sealing device
Arm Type
Active Comparator
Arm Description
Endoscopic diverticulectomy is performed with the LigaSure (TM) device
Arm Title
Dissecting Knife device
Arm Type
Active Comparator
Arm Description
Endoscopic diverticulectomy is performed with the SB-Knife(TM) device
Intervention Type
Device
Intervention Name(s)
septotomy
Intervention Description
endoscopic diverticulotomy
Primary Outcome Measure Information:
Title
Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure
Description
Technical success: achieving septotomy of the mucosa and transverse muscle fibers of the diverticulum septum.
Time Frame
At the moment of the procedure
Title
Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure
Description
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)
Time Frame
One month after the procedure
Secondary Outcome Measure Information:
Title
Analyze the mean procedure time with each of the two endoscopic techniques
Description
The procedure time will be counted from the overtube is placed until it is removed after diverticulectomy
Time Frame
At the end of the recruitment
Title
Analyze immediate and delayed complications with SB-Knife and LigaSure
Description
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
Time Frame
one month after the procedure
Title
Determine the recurrence rates and the mean time to recurrence for each of the techniques
Description
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).
Time Frame
at least three months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mª Henar Nuñez-Rodriguez, MD PhD
Phone
0034 983420 400
Ext
84 433
Email
henarnrod@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Henar Núñez-Rodriguez, MD PhD
Organizational Affiliation
Gastroenterology Department, Hospital Rio Hortega
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mª Henar Núñez Rodriguez,
City
Valladolid
ZIP/Postal Code
47001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mª Henar Núñez Rodriguez,, MD PhD
Phone
983 420 400
Ext
84 433
Email
henarnrod@yahoo.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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