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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01739426
First received: November 28, 2012
Last updated: October 9, 2014
Last verified: October 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: 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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739426

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
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: October 9, 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
Diverticulum, Esophageal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014