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

Memorial Sloan Kettering Cancer Center3 sites in 1 country78 target enrollmentOctober 18, 2013

ConditionsEsophageal Adenocarcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Esophageal Adenocarcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 78
Locations: 3
Primary Endpoint: Number of Participants With Anastomotic Leak.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 18, 2013

End Date

February 24, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Participants With Anastomotic Leak.

Time Frame: up to 10 days

Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)

Secondary Outcomes

Stricture Formation Clinically and by Determination of Dysphagia Score(90 days postoperatively)
Number of Participants Who Developed Anastomotic Stenosis(90 days post op)