Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX

Esophageal Cancer Clinical Trial

Official title:

Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609425
• Other study ID #: Esophagogastric Anastomosis
• Status: Completed
• Start date: December 2015
• Est. completion date: August 25, 2020

Study information

• Verified date: February 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients with esophageal cancer who are deemed candidates for minimally invasive robot assisted Ivor Lewis esophagogastrostomy.

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

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Device:
• Stratafix PGA Suture
Subject leak Stricture rates post procedure

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2012 Aug 19. — View 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. Epub 2013 Jan 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic Leak Rate After Esophagectomy	Analysis specific to anastomosis leak will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application.	5-7 Days to assess anastomotic integrity
Secondary	Anastomotic Stricture Rate After Esophagectomy	Analysis specific to anastomosis stricture will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application.	5-7 days to assess anastomotic integrity