Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX

NCT02609425 | Completed Results DMC FDA Device

• 1 other identifier: Esophagogastric Anastomosis
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anastomotic Stricture Rate After Esophagectomy

  5-7 days to assess anastomotic integrity

Study Arms (1)

STRATAFIX

Anastomosis of esophagus to stomach

Device: Stratafix PGA Suture

Interventions

Stratafix PGA Suture DEVICE

Subject leak Stricture rates post procedure

STRATAFIX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with esophageal cancer undergoing a planned minimally invasive robot assisted Ivor Lewis esophagogastrostomy.

You may qualify if:

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

You may not qualify if:

• 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).
• Any patient less than 18 years of age

Sponsors & Collaborators

• Henry Ford Health System: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related 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.

  PMID: 22910197 BACKGROUND

• 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.

  PMID: 23371971 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Sarah Meehan
• Organization: Henry Ford Health System

smeehan1@hfhs.org

313-916-9387

Study Officials

• Zane Hammoud, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Clinical Research, Surgery

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: November 24, 2023
• Results First Posted: November 24, 2023

Record last verified: 2023-02

Locations

US (1)