Clinical trial NCT02609425: Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX
Official title: Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2015-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with esophageal cancer undergoing a planned minimally invasive robot assisted Ivor Lewis esophagogastrostomy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic Leak Rate After Esophagectomy
timeFrame: 5-7 Days to assess anastomotic integrity
Secondary outcomes:
measure: Anastomotic Stricture Rate After Esophagectomy
timeFrame: 5-7 days to assess anastomotic integrity
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Zane Hammoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2012 Aug 19.
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.