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

Esophageal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970306
• Other study ID #: 13-178
• Status: Completed
• Phase: Phase 2
• Start date: October 18, 2013
• Est. completion date: February 24, 2023

Study information

• Verified date: February 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering West Harrison	Harrison	New York
United States	Md Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Memorial Sloan Kettering Cancer Center