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Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX

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ClinicalTrials.gov Identifier: NCT02609425
Recruitment Status : Unknown
Verified December 2016 by Zane Hammoud, MD, Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : November 20, 2015
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Zane Hammoud, MD, Henry Ford Health System

Brief Summary:
Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims: 1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in esophagogastric anastomosis by measure anastomotic stricture rate.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Device: Stratafix PGA Suture Phase 4

Detailed Description:
The purpose of the proposed study is to demonstrate that a hand sewn anastomosis using STRATAFIX is safe and effective after minimally invasive esophagectomy and capture anastomotic leak and stricture rate after esophagectomy. If proven, one may reasonably conclude that STRATAFIX may be safely used in other less complex anastomoses and closures throughout the gastrointestinal tract. Furthermore, the work may promote the utilization of STRATAFIX for other applications, e.g. closure of the vaginal cuff after hysterectomy. The study is proposed to demonstrate the safety and efficacy of utilizing an absorbable running suture for completion of a hand swen intra thoracic esophago-gastric anastomosis during minimally invasive esophagectomy. There are many advantages to hand sewn anastomosis compared with stapled, e.g. EEA anastomosis. Two potential advantages are a lower leak rate and a lower stricture rate. Currently hand swen anastomosis is performed with interrupted suture of absorbable material. While effective, this technique requires multiple sutures, thus increasing operative time and material cost. Utilizing a running suture technique has the potential to reduce operative time and overall operative cost. Furthermore, it may lead to a reduction in postoperative morbidity by reducing anastomotic leak rate and structure formation. The hypothesis of the protocol is to evaluate the use of STRATAFIX in performing a hand swen intrathoracic anastomosis after minimally invasive esophagectomy is non inferior (and may be superior) to historical cases in which the anastomosis was completed using other types of suture material. Inclusion criteria: (1) All patients with esophageal cancer who are deemed candidates for minimally invasive robot assisted Ivor Lewis esophagogastrectomy. (2) Patients who provide written informed consent for the study. Exclusion criteria: Standard minimally invasive esophagectomy technique will be employed. (1) Creation of gastric conduit laparoscopically. (2) Robotic assisted esophageal mobilization through the right chest. (3) Robotic assisted intrathoracic anastomosis at or above the level of the azygous vein. (4) Barium swallow performed on post operative day 5-7 to assess anastomotic integrity. (5) Periodic clinical follow up on an outpatient basis to assess need for any interventions for anastomotic stricture.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX
Study Start Date : December 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
STRATAFIX
Anastomosis of esophagus to stomach
Device: Stratafix PGA Suture
Subject leak Stricture rates post procedure




Primary Outcome Measures :
  1. Incidence of leak or stricture following esophageal anastomosis with STRATAFIX [ Time Frame: 5-7 Days to assess anastomotic integrity ]
    Analysis of leak and stricture rates


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 5 - 7 Days to assess anastomotic integrity ]
    Adverse events related to the suture and procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All patients with esophageal cancer who are deemed candidates for minimally invasive robot assisted Ivor Lewis esophagogastrectomy.
  2. Patients who provide written informed consent for the study.

Exclusion Criteria:

  1. Any patient with esophageal cancer who is not deemed a surgical candidate or who is not deemed a candidate for the Ivor Lewis technique of esophagectomy (with intrathoracic anastomosis).
  2. Any patient less than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609425


Contacts
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Contact: Carly E Cavazos, BS 313-916-1074 ccavazo1@hfhs.org
Contact: Crystal Bradley 313-916-1011 cbradle4@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Carly E Cavazos, BS    313-916-1074    ccavazo1@hfhs.org   
Contact: Crystal Bradley    313-916-1011    cbradle4@hfhs.org   
Principal Investigator: Zane Hammoud, MD         
Sponsors and Collaborators
Henry Ford Health System
Ethicon, Inc.
Investigators
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Principal Investigator: Zane Hammoud, MD Henry Ford Health System