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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-18

Study Completion Date

2023-02-24

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.

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Detailed Description

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Conditions

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Esophageal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical intervention

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.

Group Type EXPERIMENTAL

MatriStem PSM

Intervention Type DEVICE

All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.

Interventions

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MatriStem PSM

All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No