Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure (ZENKER LS)

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01739426
First received: November 28, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.


Condition Intervention
Zenker Diverticulum
Device: Repair w/LigaSure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Operational success according to the van Overbeek classification (yes/no) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Change in Deglutition Handicap Index score [ Time Frame: baseline to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Deglutition Handicap Index score [ Time Frame: baseline to Day 3 ] [ Designated as safety issue: Yes ]
  • Change in Deglutition Handicap Index score [ Time Frame: baseline to 6-8 weeks ] [ Designated as safety issue: Yes ]
  • Change in visual analog scale for pain [ Time Frame: baseline to day 1 ] [ Designated as safety issue: Yes ]
    Visual analog scale varying from 0 to 10

  • Change in visual analog scale for pain [ Time Frame: baseline to day 2 ] [ Designated as safety issue: Yes ]
    Visual analog scale varying from 0 to 10

  • Change in visual analog scale for pain [ Time Frame: baseline to day 3 ] [ Designated as safety issue: Yes ]
    Visual analog scale varying from 0 to 10

  • Change in Temperature (°C) [ Time Frame: baseling to Day 1 ] [ Designated as safety issue: Yes ]
  • Change in Temperature (°C) [ Time Frame: baseling to Day 2 ] [ Designated as safety issue: Yes ]
  • Change in Temperature (°C) [ Time Frame: baseling to Day 3 ] [ Designated as safety issue: Yes ]
  • Time until the patient restarts eating (hours) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Time until the patient restarts eating (hours) [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
  • Time until the patient restarts eating (hours) [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
  • Change in weight [ Time Frame: baseline to 6-8 weeks ] [ Designated as safety issue: Yes ]
    Change in weight measured in kilograms

  • Change in weight [ Time Frame: baseline to 12 months ] [ Designated as safety issue: Yes ]
    Change in weight measured in kilograms

  • Presence/absence of post-operative complications [ Time Frame: Day 0 (day of surgery) ] [ Designated as safety issue: Yes ]
  • Presence/absence of post-operative complications [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Presence/absence of post-operative complications [ Time Frame: 6-8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study population

The population is composed of patients with a confirmed Zenker's diverticulum.

Intervention: Repair w/LigaSure

Device: Repair w/LigaSure
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)

Detailed Description:

Our secondary objectives are:

A. To evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters.

B. To evaluate the prevalence of post-operative complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 12 months of follow-up
  • The patient has a Zenkers diverticulum as confirmed by a pharyngo-oesophagean transit test, regardless of van Overbeek classification

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient (or his/her person-of-trust) refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient does not read french
  • The patient is pregnant
  • The patient is breastfeeding
  • The patients has a contraindication for a treatment necessary for this study, or for general anesthesia
  • The patent has a history of complications related to hemostasis
  • The preoperative checkup indicates potential for hemostasis related problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739426

Contacts
Contact: Sophie Kacha, MD +33.(0)4.66.68.32.73 sophie.kacha@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Sophie Kacha, MD         
Sub-Investigator: Jean-Gabriel Lallemant, MD, PhD         
Sub-Investigator: Benjamin Lallemant, MD         
Sub-Investigator: Guillaume Chambon, MD         
Sub-Investigator: Christophe Reynaud, MD         
Sub-Investigator: Caroline Alovisetti, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Sophie Kacha, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01739426     History of Changes
Other Study ID Numbers: LOCAL/2012/SK-02, 2012-A01096-37
Study First Received: November 28, 2012
Last Updated: March 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
LigaSure V (TM)

Additional relevant MeSH terms:
Diverticulum
Zenker Diverticulum
Pathological Conditions, Anatomical
Diverticulum, Esophageal

ClinicalTrials.gov processed this record on April 16, 2014