Detroit, Michigan 48202


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

Esophagogastric Anastomos


NCT ID:

NCT02609425


Secondary ID:


Study Acronym:


Brief Title:

Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX


Official Title:

Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Henry Ford Health System


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Zane Hammoud, MD
Principal Investigator
Henry Ford Health System
Primary Contact:Carly E Cavazos, BS
313-916-1074
ccavazo1@hfhs.org
Backup Contact:Crystal Bradley
313-916-1011
cbradle4@hfhs.org

Study Dates

Start Date:December 2015
Completion Date:August 2017
Completion Type:Anticipated
Primary Completion Date:April 2017
Primary Completion Type:Anticipated
Verification Date:December 2016
Last Changed Date:December 5, 2016
First Received Date:November 17, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Adverse Events
Time Frame:5 - 7 Days to assess anastomotic integrity
Safety Issues:True
Description:Adverse events related to the suture and procedure
Outcome Type:Primary Outcome
Measure:Incidence of leak or stricture following esophageal anastomosis with STRATAFIX
Time Frame:5-7 Days to assess anastomotic integrity
Safety Issues:True
Description:Analysis of leak and stricture rates

Study Interventions

Intervention Type:Device
Name:Stratafix PGA Suture
Description:Subject leak Stricture rates post procedure
Arm Name:STRATAFIX

Study Arms

Study Arm Type:Other
Arm Name:STRATAFIX
Description:Anastomosis of esophagus to stomach

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Henry Ford Health System
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Ethicon, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Sarkaria IS, Rizk NP, Finley DJ, Bains MS, Adusumilli PS, Huang J, Rusch VW. Combined thoracoscopic and laparoscopic robotic-assisted minimally invasive esophagectomy using a four-arm platform: experience, technique and cautions during early procedure development. Eur J Cardiothorac Surg. 2013 May;43(5):e107-15. doi: 10.1093/ejcts/ezt013.
PMID:23371971
Reference Type:Results Reference
Citation:Cerfolio RJ, Bryant AS, Hawn MT. Technical aspects and early results of robotic esophagectomy with chest anastomosis. J Thorac Cardiovasc Surg. 2013 Jan;145(1):90-6. doi: 10.1016/j.jtcvs.2012.04.022.
PMID:22910197

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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