Phase 2
N=78
Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Esophageal Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01970306 ↗Enrolled (actual)
78
Serious AEs
23.1%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With Anastomotic Leak. — 10; 68 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MatriStem PSM (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anastomotic Leak. |
10; 68 | — |
| SECONDARY Stricture Formation Clinically and by Determination of Dysphagia Score |
14; 54; 10 | — |
| SECONDARY Number of Participants Who Developed Anastomotic Stenosis |
14; 8; 56 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01970306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.