Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

Study Overview
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Brief Summary
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The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.

Official Title
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A Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

Conditions
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Esophageal Adenocarcinoma

Intervention / Treatment
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* Device: MatriStem PSM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years of age or older Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal, adenocarcinoma at either MSKCC or a participating site (biopsy may be performed at other institutions but slides must be confirmed at MSKCC or a participating site, as is routine care at our institution) Patient undergoing any resection requiring an anastomosis to the esophagus for curative intent. Including but not limited to esophagectomy or total gastrectomy. Subject is willing to provide written informed consent Subject is willing and able to comply with the follow-up regimen Exclusion Criteria: Pregnant or lactating women Intraoperative evidence of metastatic or locally-unresectable disease Patients with known sensitivity or allergy to porcine materials. Patients undergoing any resection requiring an anastomosis to the esophagus for palliative intent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical intervention<br>Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. Patients undergoing esophagectomy, PG or TG will be evaluated with one routine postoperative contrast swallow study at post-operative day #4-10. | Device: MatriStem PSM<br>* All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Anastomotic Leak. | Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow) | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stricture Formation Clinically and by Determination of Dysphagia Score | Patients will be evaluated in the outpatient clinic and will be assigned a dysphagia score from 0-4 by the RSA. Patients reporting symptoms consistent with stricture will be evaluated with radiographic contrast swallow study or endoscopy. | 90 days postoperatively | 
| Number of Participants Who Developed Anastomotic Stenosis | If during the follow up period, patients report any symptoms suggestive of anastomotic stricture, a contrast study (esophagram) or endoscopy will be obtained at that time to evaluate for stricture. These tests will be performed as per standard postoperative assessment by the surgeon. | 90 days post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Reinforcement, ACell MatriStem, 13-178