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

Phase 2

Completed

• Conditions: Esophageal Adenocarcinoma
• Interventions: Device: MatriStem PSM

• Registration Number: NCT01970306
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-18
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-28
• Status Verified: 2023-02
• Primary Completion: 2023-02-24
• Study Completion: 2023-02-24
• Results First Submitted: 2023-10-11
• Results First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Results First Posted: 2023-11-03
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical intervention	MatriStem PSM	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Anastomotic Leak.	up to 10 days	Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)

Secondary Outcome Measures

Name	Time	Method
Stricture Formation Clinically and by Determination of Dysphagia Score	90 days postoperatively	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.
Number of Participants Who Developed Anastomotic Stenosis	90 days post op	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.

Trial Locations

Locations (3)

Md Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States