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

Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System

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.

Study Overview

• Status: Completed
• Conditions: Zenker Diverticulum
• Intervention / Treatment: Device: Repair w/LigaSure

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Operational success according to the van Overbeek classification (yes/no)	12 months
Change in Deglutition Handicap Index score	baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Deglutition Handicap Index score		baseline to Day 3
Change in Deglutition Handicap Index score		baseline to 6-8 weeks
Change in visual analog scale for pain	Visual analog scale varying from 0 to 10	baseline to day 1
Change in visual analog scale for pain	Visual analog scale varying from 0 to 10	baseline to day 2
Change in visual analog scale for pain	Visual analog scale varying from 0 to 10	baseline to day 3
Change in Temperature (°C)		baseling to Day 1
Change in Temperature (°C)		baseling to Day 2
Change in Temperature (°C)		baseling to Day 3
Time until the patient restarts eating (hours)		Day 1
Time until the patient restarts eating (hours)		Day 2
Time until the patient restarts eating (hours)		Day 3
Change in weight	Change in weight measured in kilograms	baseline to 6-8 weeks
Change in weight	Change in weight measured in kilograms	baseline to 12 months
Presence/absence of post-operative complications		Day 0 (day of surgery)
Presence/absence of post-operative complications		Day 1
Presence/absence of post-operative complications		6-8 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Sophie Kacha, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: LigaSure V (TM)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Zenker Diverticulum
• Other Study ID Numbers: LOCAL/2012/SK-02; 2012-A01096-37 (Other Identifier: RCB number)