Esophageal Cancer
Conditions
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.
Interventions
DEVICEStratafix PGA Suture
Subject leak Stricture rates post procedure
Sponsors
Ethicon, Inc.
Henry Ford Health System
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic Leak Rate After Esophagectomy | 5-7 Days to assess anastomotic integrity | Analysis specific to anastomosis leak will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic Stricture Rate After Esophagectomy | 5-7 days to assess anastomotic integrity | Analysis specific to anastomosis stricture will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All patients enrolled on the study | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Race/Ethnicity, Customized African American | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 25 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Region of Enrollment: United States | 30 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: 5-7 Days to assess anastomotic integrity
Population: Data were not collected
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.
Time frame: 5-7 days to assess anastomotic integrity
Population: Data were not collected