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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Esophageal Adenocarcinoma

Treatments: Device: MatriStem PSM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01970306

13-178

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Surgical intervention

Experimental group

Description:

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.

Treatment:

Device: MatriStem PSM