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

Primary Purpose

Esophageal Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MatriStem PSM
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Adenocarcinoma focused on measuring Esophageal Reinforcement, ACell MatriStem, 13-178

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering West Harrison
  • Memorial Sloan Kettering Cancer Center
  • Md Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical intervention

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
cost metrics
Data for cost metrics will be collected postoperatively through POD90 (+/- 14 days). These include metrics such as Length of Stay, Readmission, Complications, Reoperation and Total Hospital Bill.

Full Information

First Posted
October 22, 2013
Last Updated
February 27, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01970306
Brief Title
Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Official Title
A Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2013 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
February 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Integra LifeSciences Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Adenocarcinoma
Keywords
Esophageal Reinforcement, ACell MatriStem, 13-178

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
MatriStem PSM
Intervention Description
All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.
Primary Outcome Measure Information:
Title
rates of anastomotic leak.
Description
Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
stricture formation clinically and by determination of dysphagia score
Description
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.
Time Frame
90 days postoperatively
Title
cost metrics
Description
Data for cost metrics will be collected postoperatively through POD90 (+/- 14 days). These include metrics such as Length of Stay, Readmission, Complications, Reoperation and Total Hospital Bill.
Time Frame
postoperatively (+/- 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Strong, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35426405
Citation
Vos EL, Nakauchi M, Capanu M, Park BJ, Coit DG, Molena D, Yoon SS, Jones DR, Strong VE. Phase II Trial Evaluating Esophageal Anastomotic Reinforcement with a Biologic, Degradable, Extracellular Matrix after Total Gastrectomy and Esophagectomy. J Am Coll Surg. 2022 May 1;234(5):910-917. doi: 10.1097/XCS.0000000000000113.
Results Reference
derived
PubMed Identifier
35426404
Citation
Shannon AB, Straker RJ 3rd, Fraker DL, Miura JT, Karakousis GC. Validated Risk-Score Model Predicting Lymph Node Metastases in Patients with Non-Functional Gastroenteropancreatic Neuroendocrine Tumors. J Am Coll Surg. 2022 May 1;234(5):900-909. doi: 10.1097/XCS.0000000000000144.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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